Monday, March 3, 2014

Reducing the cost of new hepatitis C drugs

2016 Updates

Starting in March 2016 please view all updates, here......

For Patients Drugs Under Development

Patient Advocate Foundation Offers New CareLine for Hepatitis C Patients

Are you struggling to afford the costs of Hepatitis C treatments? A new program through the HealthWell Foundation may be able to help.

In The News
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Starting in March 2016 please view all updates, here....

Updated February 18, 2016
Feb 18
The cost of the curing Hepatitis C - BBC Newsnight

Feb 17
Massachusetts attorney general challenges Gilead's pricing of HCV drugs
Massachusetts Attorney General Maura Healey recently wrote a letter to John C. Martin, PhD, chairman and chief executive officer of Gilead Sciences, regarding the cost of Sovaldi and Harvoni. Specifically, Healey urged Martin to reduce the price of the two drugs.

Feb 16
Gilead Responds to WZZM 13 News: Disagreed with the conclusions of the senate report
Gilead appreciates the importance of making healthcare accessible for all. We believe we were cooperative and transparent in our response to U.S. Senators Wyden’s and Grassley’s inquiry, and we provided the Senators

Feb 10
Are States Obligated To Provide Expensive Hepatitis C Drugs?
“A medically necessary treatment is a medically necessary treatment, no matter what the cost,” said Gavin Rose, an attorney for the American Civil Liberties Union, which brought the class action in Indiana in December on behalf of Medicaid beneficiaries in that state who have hepatitis C.

Feb 9

Feb 6
A Must Read: Lucinda K. Porter's article in this months issue of HCV Advocate offer us some insight into generic HCV drugs sold from outside the United States; HealthWise—Generic Hepatitis C Drugs.

NYS Gov Cuomo Plan to Cap Drug Prices 
Gov. Andrew Cuomo is seeking effectively to cap the price of certain pharmaceuticals and require unprecedented transparency from manufacturers.

Feb 5
Insurers sued for denying access to hepatitis C drugs
By ED SILVERMAN @Pharmalot
The lawsuits, which were filed late last month in state court and seek class action status, charge that Group Health Cooperative and BridgeSpanrestricted access to the medicines except to the “most severely ill” people, but not for a “clinical purpose.” Instead, the consumers charge the insurers do so due to “financial concerns.” And they want the insurers to provide coverage.

Hepatitis C Curing Drug Inaccessible to Veterans
By Tia Rinehart - Veterans are missing out on a cure for hepatitis C because of the cost of the drug – a drug that a Department of Veterans’ Affairs research employee created.

Jan 30
Merck ushers in price war for hepatitis C medicines with new drug 
JANUARY 29, 2016
By comparison, the list price for the Harvoni drug sold by Gilead Sciences is $94,500, while AbbVie charges $83,300 for its Viekira Pak for 12-week regimens. List prices, however, do not reflect any rebates, which can vary. Despite receiving such partial refunds, though, many insurers and government health programs have restricted coverage of these treatments in order to contain costs.
Continue reading.. 

Looking For A Hep C Price War? Merck Just Started It
Jan. 29, 2016 12:29 PM ET
About: Merck & Co Inc. (MRK)GILD

If the sector wants signs that the drug pricing debate is having an effect on new launches, look no further than Merck & Co’s (NYSE:MRK) new hepatitis C pill Zepatier. The New Jersey group says it will charge $54,600 for the three-month course of medication, a significant discount on the list price and probably even the off-invoice charge for its main rival, Gilead Sciences’ (NASDAQ:GILD) Harvoni.

Assuming further rebates, Merck’s combination of grazoprevir and elbasvir could come within a price that cost-effectiveness assessors estimate is sufficient to justify paying for treatment of all patients, not just the sickest. The emerging price war confirms the sellside’s belief that 2015 was hep C’s peak year.

Jan 27
AG calls on Gilead to lower price of hepatitis C medicines
State Attorney General Maura Healey is warning Gilead Sciences Inc. it faces possible legal action unless it lowers the price of two popular hepatitis C medicines.

Watch - Sovaldi - Pamela Anderson Opens Up About Hepatitis C Cure

Increasing Prevalence of Cirrhosis among US Adults Aware or Unaware of their Chronic Hepatitis C Virus Infection

Hepatitis C Can Be Cured in Canada, But This Life-Saving Drug Is Outrageously Expensive

Jan 19
Contra Costa Times editorial: End prescription drug price gouging

Kiwi hepatitis C patients getting treatment from Australian drug buyers club

Jan 15
Earlier HCV Treatment Improves Cost Effectiveness of Care
Treating hepatitis C virus (HCV) infection at early stages of fibrosis not only improves health outcomes but is cost-effective, according to a new study

Aetna HCV Drug Criteria

Jan 10
Op-ed: Exorbitant drug prices are nothing short of evil
Salt Lake Tribune
It cost her about $13,000 for 11 months of difficult treatments to be cured, thereby avoiding liver cirrhosis later in life, not to mention infecting others over time.

Jan 5
The Wyden-Grassley US Senate Investigation Into The Pricing Of Sovaldi: A Report Part I
By Transplanted—January 5, 2016
I began with an open mind. Like everyone else, when I first became aware of the high price of Gilead Sciences’ front line cures for hepatitis C, I was shocked. At $1,000 per pill, my first thought was, never take this drug while standing over the kitchen sink. However, my reaction was soon tempered by news of Gilead’s patient assistant program. I was so relieved, I wrote about it. Gilead encouraged patients to try for approval with their insurances. After two denials, patients needed only to present proof of infection, a script, and a recommendation from their doctors, and Gilead would then supply Harvoni at little or no cost.
Continue Reading...

For 2016, the top-selling drug projected to hit shelves actually isn't a new drug at all — it's a variation on a medication used for years to treat HIV. Most of the other drugs coming down the pipeline also treat life-threatening conditions, including cancer, multiple sclerosis, hepatitis C and hypertension, but one is aimed at severe cases of dermatitis, a skin inflammation condition.

Jan 1

HCV Advocate 2016 Newsletter

Dec 29 2015
The sofosbuvir rivals are aggressive about expanding the customer base by making the pills affordable and diagnosis easier. Dr. Reddy’s, for example, set up a venture with lender Arogya Finance to offer no-interest loans for patients, and Abbott Laboratories worked with French medical equipment company Echosens SAS to supply Indian hospitals with 13 ultrasound machines that determine the level of fibrosis, or hardening, without a liver biopsy.

NPR - States Deny Pricey Hepatitis C Drugs To Most Medicaid Patients

Gilead licensed 11 Indian firms to make generic versions of Sofosbuvir, and they sealed marketing deals with others, making the competition extremely fierce

Because of this high cost, insurer authorisation often requires that people have advanced fibrosis (F3 or above) or cirrhosis. Investigators from Yale Liver Center wanted to see how many people with HCV were obtaining authorisation for therapy with SOF ...

Dec 26
Hep C patient goes offshore for cure

India - Govt. adds Cancer, HIV, Hepatitis C to list of essential medicines

Dec 11
Time to do away with the FDA
For individuals suffering from hepatitis C, a blood-borne virus causing liver inflammation, life can be difficult. For 70-85 percent of those with the virus, the condition is chronic, with
effects ranging from liver infection to cirrhosis to death.

Dec 10
Activists dressed as Gilead butchers greeted participants at the European Conference on HIV and Hepatitis Coinfection
On the morning of Thursday 10th December 2015, a public action targeted specifically at big pharma profiteering from the lives of people with hepatitis C happened in central London. Activists dressed as Gilead butchers greeted participants as they arrived at the European Conference on HIV and Hepatitis Coinfection

A new drug can cure Hepatitis C, but Indiana won't always pay for it under ...
Sarah Jackson knows she has hepatitis C, a disease that if left untreated could leave her with lasting damage to her liver.

Indiana ACLU Sues To Demand Medicaid Reimburse For Hepatitis C Drugs
Sarah Jackson had quit abusing drugs and was sober for six months before finding out she has hepatitis C. The Fort Wayne mom says she was newly focused on starting her career and on raising her six kids.

Dec 6
Gilead gained federal approval for its drug Sovaldi in late 2013 and ultimately settled on the price of $84,000 for a 12-week course of treatment. To the company, that price seemed to deliver the right balance: value to shareholders while also not so high that insurers would “hinder patient access to uncomfortable levels,” according to internal documents. But they also got more than they bargained for: an outpouring of outrage from the public, a backlash from government and private payers, and political scrutiny.

At the same time, Senators Wyden and Grassley issued a report attacking Gilead, the company that developed the first hepatitis C cure, for its pricing of Sovaldi saying that “Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C ...

Dare we Dream of a Hep C-free Australia?
The Liver Clinic at St Vincent's Hospital in Sydney will now monitor patients who are having their Hepatitis C treated with Indian generics.

Dec 2

Dec 1
Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug
A report released Tuesday by US Senators Ron Wyden and Charles Grassley claims that Gilead Sciences priced the hepatitis C treatments Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) with the sole goal of maximising revenue. The report was based on an investigation of 20 000 pages of internal company documents, dozens of interviews with health care experts and data from Medicaid programmes in all 50 states and the District of Columbia.
“Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences. There was no concrete evidence in emails, meeting minutes or presentations that basic financial matters such as R&D costs or the multi-billion dollar acquisition of Pharmasset, the drug’s first developer, factored into how Gilead set the price....

VA can't afford drug for veterans suffering from hepatitis C
On Tuesday, a Senate report found Gilead Sciences, which makes a cure for a fatal form of hepatitis, is more interested in profits than patients. The cure was invented under the leadership of a celebrated doctor in the Department of Veterans Affairs, but at $1,000 a pill, even the VA can't afford to save the lives of veterans who need it.

Dr. Raymond Schinazi founded the company, Pharmasset, and led the scientific team that discovered sofosbuvir. He also works for the Department of Veterans Affairs and has since 1983.
He said he is only a 7/8th's government employee. So what he does with his remaining time is up to him.

He said he is spending less than 1/8th of his time on private companies.

"Well, even less than that. I'm very efficient," he said

Nov 30
Bristol-Myers Squibb Co. has signed a broad agreement with Medicines Patent Pool, allowing the United Nations-backed organization to distribute licenses for generic-drug companies to copy its hepatitis C treatment in more than 100 developing and ...

Expensive drugs that cure hepatitis C are worth the cost, even at early stages of liver fibrosis

Nov 20
Hepatitis C progresses uniquely in each person and none of the voices calling for improved treatment access say every patient requires immediate treatment.

Instead, we continually advocate for hepatitis C prevention, testing, education and monitoring of patient health. We believe that decisions around treatment should be made between the patient and their provider, not the insurer, Health Authority or CCO. It is rewarding to know that CMS shares this belief.

AASLD - Clinicians Have Multiple First-line Options for Treating HCV; Challenge is Implementation: all patients have right to be treated
A succession of discoveries has led to infection cure rates of better than 90% in the quarter century since the discovery of the hepatitis C virus (HCV).

Nov 18

NEJM EDITORIAL: Simple, Effective, but Out of Reach? Public Health Implications of HCV Drugs
The results of four clinical trials showing the excellent safety and efficacy of a 12-week course of sofosbuvir (an NS5B inhibitor licensed in the United States in 2013) and velpatasvir (a new NS5A inhibitor) in treating patients with hepatitis C infection (HCV) are reported now in the Journal.1-3 In two of these studies, ASTRAL-1 and ASTRAL-2, 97 to 100% of patients with HCV genotype 1a, 1b, 2, 4, 5, or 6 had a sustained virologic response at 12 weeks after the end of therapy, a marker that is indicative of virologic cure. Similar efficacy was observed among patients in whom previous treatment had failed and those with compensated cirrhosis, factors that have been associated with a reduced response to the treatment of HCV infection

Nov 15
Patient advocacy groups protest limits of Gilead's support program
SAN FRANCISCO — At the Liver Meeting 2015, patient advocacy groups stood in protest of restrictions implemented this summer to the patient support program, demanding reinstatement of free treatment access to all patients with hepatitis C virus.

Nov 12
Firms that have risked millions (or perhaps even billions) to develop and test a drug in large-scale trials want to recoup that investment, and then some. For instance, Gilead Sciences, which manufactures Sovaldi, spent $11 billion in 2011 to acquire Pharmasset Inc., the pharmaceutical company that invented the drug in the first place.

The second factor in the drug’s cost is the calculated “value” of the regimen to a patient. Dr. Nancy Reau, a liver disease expert and a paid consultant for pharmaceutical companies that make hepatitis C medications, argues that the price of a hepatitis cure is "priceless" and still cheaper than the alternative: a lifetime of liver complications.

Nov 11
CMS Enters Pricey Hepatitis C Drug Debate
The Centers for Medicare & Medicaid Services recently sent letters to Medicaid directors of all 50 states, as well as to AbbVie, Gilead Sciences Inc., Johnson & Johnson and Merck & Co.

Addenbroooke's consultant hails drugs announcement for hepatitis patients a ...
An Addenbrooke's consultant has welcomed the news that new drugs are to be funded by the NHS to treat the majority of adult patients with chronic hepatitis C. Hepatitis C patients in England and Wales will soon be able to be treated with a new once day ...

Knowns and unknowns of US drug pricing

Faster, Cheaper Hep C Cures on the Horizon?

Template and white paper for State Insurance Commissioners re: HCV Tx Access
Attached is a template for advocates to use to reach out directly to your State Insurance Commissioner re: Removing Illegal Restrictions to Access to Hepatitis C Treatment. This document was shared with us by Hepatitis Education Project.

Nov 8
France secured Europe's lowest price for treatment with the drug that precipitated much of the current debate on pricing, the so-called “miracle drug” for hepatitis C, Sovaldi: it pays €41,000 for a 12-week course, compared to €77,000 in the United States.

Nov 6

Nov 5
Federal Officials Warn States on Hepatitis C Drug Restrictions (WSJ-$) (CMS Blog)

Nov 4

Primrose Healthcare has just launched an innovative calculator tool to help health insurers and other payers uncover and better understand the total costs associated with the hepatitis C virus (HCV) within their populations.

Health care officials in Washington state thought thousands of Medicaid patients would line up to receive a breakthrough hepatitis C treatment that went on the market late last year.

HCV Guideline Update: Treat All Patients With New Drugs
An update has suggested that all patients, with the exception of patients with short life expectancies not related to HCV, should be treated with newer HCV medications.

Oct 28
Huffington Post‎
Imagine that you have a disease and you have two choices of treatment. Both treatments are highly effective ...

Oct 18
Treating ALL with HCV is Best Value for Society - New Modeling Study Reports - Broad Hepatitis C Treatment Scenarios Return Substantial Health Gains, But Capacity Is A Concern
......"Limiting access to new therapies to a subset of diagnosed patients prolongs disease transmission and generates less value.....treating all diagnosed patients immediately reduces the disease burden from hepatitis C infection most rapidly and generates the greatest social benefits, compared to other scenarios.....we have shown that a strategy that treats patients earlier in the disease progression can cost less, increase total QALYs more, and reduce future medical expenditures further than a strategy that treats them later. In fact, the cumulative expenditures over fifty years under a strategy of earlier treatment are $105 billion lower than those under a strategy of treating only the sickest patients (Exhibit 3, net expenditures of the "treat 5 percent" scenario compared to those of the "treat advanced" scenario). Identifying the optimal treatment strategy-given limited public and private payer budgets now and health benefits that accrue much later-may be one of the most vexing health policy challenges facing the United States."

Oct 16
Medicare Spending for Hepatitis C Cures Surges
The cost of drugs for the liver disease in the first half of 2015 almost matches the total for all of 2014.
by Charles Ornstein ProPublica
Medicare’s prescription drug program spent nearly $4.6 billion in the first half of this year on expensive new cures for the liver disease hepatitis C — almost as much as it spent for all of 2014.

The U.K.'s National Institute for Health and Care Excellence (NICE) signed off on the once-daily pill in combination with other treatments for patients with genotypes 1, 3 and 4 of the disease, backpedaling on an earlier decision in July to exclude genotype 3, a difficult-to-treat form of hep C. About 214,000 people in the U.K. have chronic hep C, and almost half of those patients--or around 100,000--have genotype 3, BMS said in a statement.

How insurance providers deny hepatitis C patients lifesaving drugs
Al Jazeera America
Amber Rojas was almost eight months pregnant when she learned she had hepatitis C. After her daughter was born on Dec. 23, 2014, Rojas had hoped to start treatment with a newly approved, highly effective drug called Harvoni.

Oct 6
Employers seek ROI on costly drugs

Treating 5 percent of hepatitis C patients with new drugs would reduce cost ...Treating 5 percent of all hepatitis C patients with the latest drugs would be more effective at reducing infections and health care costs than the current approach, a new study shows.

Cost Effectiveness and Resource Allocation 2015, 13:17  doi:10.1186/s12962-015-0043-y
New all oral therapy for chronic hepatitis C virus (HCV): a novel long-term cost comparison

Oct 4

Report: wide variance in Medicaid use of costly hepatitis C drug
A groundbreaking - but very expensive - new drug that cures many people with hepatitis C caused rapid and widespread increases in Medicaid ...

Searching for Sovaldi: Buying Generic Sofosbuvir in India: A Travel Journal

Sep 29
Federal Health Minister urged to get new Hep C drugs listed on PBS
ABC Online-Sep 29, 2015
Federal Health Minister urged to get new Hep C drugs listed on PBS ... At the moment, the drugs cost more than $100,000 and are out of reach

Sep 25
The True Cost of an Expensive Medication
There's a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for ...

Sept 24
Let Medicare Tackle High Drug Costs - Bloomberg View
What has rightly made drug costs a political issue, however, are the astronomical prices of a few specialty medicines. Sovaldi, a cure for hepatitis C, costs $1,000 ...

Rational Drug PricingJeffrey Sachs
Drug pricing has taken center stage in U.S. politics, and it's high time that it should. The soaring prices for drugs like Sovaldi ($1,000 a pill) and the recent hike of Deraprim from $13.50 to $750 a pill after the supplier was bought by a shady hedge-fund manager, have caused white-hot fury in the public.

FDA's Unapproved-Drugs Initiative Culprit Behind Huge Price Spikes for Old Drugs
The little-known FDA program that's driving drug prices higher ....
In many of these cases, the new manufacturers had done little to alter, much less improve, the traditional drugs before claiming FDA-mandated exclusivity periods ranging from three to seven years .... LA Times

When So Many Lives are at Stake
The recent decision of a U.S. pharmaceutical company, Turing Pharmaceuticals, to acquire the generic drug Daraprim (used to treat the potentially fatal parasitic infection toxoplasmosis) and hike its price from $13.50 to $750 per pill, set off worldwide controversy. The New York Times reported that this was “not an isolated example,” but part of a new “business strategy of buying old neglected drugs and turning them into high-priced ‘specialty drugs.'” The outrage at the 50-fold price hike eventually forced Turing to reverse the move. However, the controversy over drug pricing should not go away as this controversy recedes from memory. Here, Triple Crisis contributor weighs in on the prices of the drugs used to treat Hepatitis C, and why they are so much higher in Malaysia than in India.

Sept 20
What We Talk About When We Talk About Hepatitis C
Since 2007, more people have died every year from hepatitis C than from HIV. Fortunately, the latest hepatitis C medications can cure nearly everyone in a relatively quick, easy fashion.

Sept 2
New drugs to treat hepatitis C are tremendously effective - and tremendously costly - raising fears that the high prices might outstrip the ability of public and private insurers to pay.

Aug 29
Posted on August 27, 2015
In a newly published, thought-provoking article in the journal Clinical Infectious Diseases, Stacey B. Trooskin and colleagues discuss how the high cost of newer hepatitis C therapies has become a major treatment access barrier in the US

One in Four Hepatitis C Patients Denied Initial Approval for Drug Treatment
New Haven, Conn. -- Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats the most common strain of the infection, according to a Yale School of Medicine study.

Aug 25
New hepatitis C drugs offer patients hope — at high cost
South Carolina Medicaid and the private managed care plans that provide benefits under the low-income health insurance program spent more than $8 million this past fiscal year covering two new hepatitis C drugs for a mere 119 patients.
WASHINGTON — Federal and state Medicaid officials should widen access to prescription drugs that could cure tens of thousands of people with hepatitis C, including medications that can cost up to $1,000 a pill, health care experts have told the White House.

Surprising Updates to the HCV Guidelines
off-label recommendations for daclatasvir.

Aug 24
Hepatitis C finally given approval in United Kingdom after 'inexcusable wait'
It comes as wonderful news for untold thousands of Hepatitis C sufferers, albeit one that came after an "Inexcusable wait.

CRS: Something's got to give on pricing of specialty drugs
24 August 2015
Mari Serebrov / BioWorld
With specialty drugs taking an ever bigger bite of the U.S. prescription drug spend, pressure is mounting for more controls on pricing.

Aug 23
AASLD/IDSA Update - HCV guidance for Cost, Reimbursement and Cost-Effectiveness ConsiderationsAn update to the HCV guidance for Cost, Reimbursement and Cost-Effectiveness Considerations was recently published online, here.

Sofosbuvir: The Miracle HCV Drug By Gilead

Aug 22
Counterpoint: The truth behind the high cost of hepatitis C
Minneapolis Star Tribune-Aug 20, 2015
Last week's commentary “Who gets hepatitis C drugs? Who pays?” (Aug. 10) by North Memorial Health Care CEO Kevin Croston and Medica ...

Drug which cures hepatitis C given the go-ahead by NHS
A cure for the deadly hepatitis C virus has finally been granted NHS funding after ‘an inexcusable wait’ that has seen patients with the disease fall ill unnecessarily, say campaigners.

Investment commentary
The scary news for hepatitis C patients is that the cost of their treatments could rise even further if a new study released from the Henry Ford Health System and CDC is correct.

Is a regimen combining interferon (IFN) with a highly effective direct-acting antiviral agents (DAA) still an acceptable choice in 2015? 

Aug 20
It is straight from the script of Hollywood movie Dallas Buyers Club — an Australian hepatitis C sufferer has taken on a global pharmaceutical company, accusing them of failing to provide a life-saving medication at an affordable cost.

In July the California Department of Health Care Services ordered a new protocol that will mean many thousands of Medi-Cal patients will have to wait for treatment. But far from jeopardizing lives, the department is helping to lead the way out of the hepatitis C conundrum with a sensible policy: Treat everyone who needs it, but not until treatment is necessary.

Aug 18
If Washington wants to do something about the public health issues left behind by the opioid abuse epidemic, it might have to start doing something about prescription-drug costs.

Aug 16
Health experts concerned about decision not to extend Daklinza treatment to patients with genotype 3 strain of virus

Many hepatitis C patients with serious liver disease to be denied a chance of a cure* as NICE announces decision to restrict use of the daily oral pill, Daklinza (daclatasvir)1,2 -

Aug 11
New HCV Drugs Cost-effective but Costly: Now What?
The new generation of hepatitis C virus (HCV) drugs save lives. They are also enormously expensive, which leaves the healthcare system struggling with questions about who should get the drugs and who should pick up the hefty tab.

Once Disparaged, 'Me-Too' Drugs Crucial For Lower Costs Of Cholesterol, Hepatitis C And Cancer Drugs
While the high cost of new drugs is worrisome, those responsible for drug benefit plans in the U.S. are especially concerned. When a cure for a hepatitis C drug, Sovaldi, was launched by Gilead at a cost of $84,000 for a 12-week cost of therapy, payers were outraged.

Aug 6
AbbVie drugs are also licensed in the U.S., where they are known as Viekira Pak.

Aug 4

Aug 3
The bottom line must be access. Gilead's patent rights must not be construed as the right to leave millions to suffer or die from a disease for which a low-cost cure exists. By abusing patents in that way, Gilead and the US political system in recent years have turned the proper use of patents -- as an important tool to incentivize R&D -- into a veritable 

July 31

July 27

Cost keeps cure out of reach for those with Hepatitis C

July 8
Study Predicts Huge Toll of Hep C Drugs on Calif. Budget
Cost estimates range from $512 million to $5.1 billion

July 6
Addressing the Restricted Use of DAA therapies
Posted on July 6, 2015
Results of a new US cost effectiveness study indicate that effective direct acting antiviral (DAA) therapies should be not be restricted to only those HCV-infected patients with advanced fibrosis. Authors note that as a society, we have an opportunity to eliminate hepatitis C by taking appropriate and timely steps, and we should be willing to pay for the current HCV therapies by providing additional resources and giving hepatitis C the attention it deserves.

June 29
Full Text

Veterans Administration Ending Hepatitis C Treatments

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi 

June 29
State restrictions for hepatitis C drug may go too far(Reuters Health) - State-run insurance programs for the poor may be putting up illegal barriers that prevent people with hepatitis C from getting a new treatment, a new study suggests.

The Food and Drug Administration was sued by two advocacy groups seeking to force the faster disclosure of clinical trial data that helped Gilead Sciences Inc win approval for two blockbuster hepatitis C drugs.
In their June 25 lawsuit, Yale University's Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, said doctors and patients deserve more information about the "enormously costly" drugs Harvoni and Sovaldi to make informed decisions about whether to use them...

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data
A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.01%’ hepatitis C treatments on a timely basis.

******June 25
Public Health Groups Sue FDA For Disclosure of Clinical Trial Data for Costly Hep C Drugs

June 27

June 19

June 15

June 12
Latest in testing and treatment of Hepatitis C
Dr. Ron Valdiserri, Director of the Office of HIV/AIDS and Infectious Disease Policy, sits down at the 2015 National Summit on HCV and HIV with Dr. John Ward, Director of CDC's Division of Viral Hepatitis to discuss the latest in testing and treatment of Hepatitis C.
The 2015 Summit will was held on June 4-6, 2015 in Arlington, VA.

Effects of delaying Hepatitis C treatment
June 12
David Rowlands' latest poll examines the issues around treating earlier or waiting.
Deferring antiviral therapy for HCV until a person progresses to advanced liver disease has clear drawbacks, including lower treatment effectiveness and an increased risk of clinical events and death, according to a study of US veterans presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress in Vienna recently.

June 11
The cost of curing hepatitis C
Up to 150 million people are estimated to be infected with hepatitis C and it kills around 500,000 people every year. Now there’s hope in the form of a new drug, but it’s expensive. How much should a cure cost?
Continue reading....

June 10
NHS England agrees funding for new drug treatments for Hep C totalling almost a quarter of a billion pounds.

Sovaldi fight shows we will pay for treatment but not a cure

Merck May Dent Gilead's Hepatitis C Sales 
Merck recently filed a combination therapy for Hepatitis C (grazoprevir and elbasvir) for FDA review, which shows high cure rates for genotypes 1, 4 and 6. This puts it directly on Harvoni’s turf, which is an all oral interferon and ribavarin free therapy offered by Gilead Sciences. 

To Nalebuff, the thing to do is "protect insurers against a radical rise" in the quantity of patients taking the drugs. His idea? Rather than paying as each patient is diagnosed and treated--and stalling till patients get really sick, to control costs--insurers could pay a flat fee per member.


Experts: Fight Hepatitis C epidemic with more testing, caps for co-pays
WASHINGTON, D.C. ( June 4, 2015 ) — With mounting evidence that many public and private health plans are deliberately rationing care for Americans with the hepatitis C virus ( HCV ), those on the front lines in fighting viral hepatitis and HIV/AIDS today urged lawmakers to overturn state Medicaid and managed care policies that discourage testing, add prior authorization requirements on clinicians, and create significant hurdles for patients to receive new curative treatments — all contributing to only 5% to 6% of individuals with HCV being successfully treated

Protests targeted high profile hedge fund investors who have reaped substantial profits from the California-based pharmaceutical giant Gilead Sciences. 
Hedge Fund Billionaires Are New Target for Hepatitis C Cure Protests
The New York City home and offices of former hedge fund manager Julian H. Robertson were targeted by protest groups in a series of simultaneous direct actions in early May. Robertson is ranked No. 512 on Forbes' list of "the world's billionaires" with a reported net worth of $3.4 billion. "Robertson is making a killing off of people with Hep C," read one sign.

Controversy swirls around cost of hepatitis C drug
A California woman last month sued her insurance provider over a drug to treat hepatitis C, the latest episode involving the skyrocketing costs of specialty medications.

June 4
Over the past 18 months, the emergence of Harvoni and its predecessor, Sovaldi, has given tens of millions of hepatitis C patients around the world hope that they can be permanently rid of a debilitating illness. Not since the introduction of HIV/AIDS drug cocktails almost two decades ago has the appearance of a therapy spurred such demand. 

The promise of a cure, however, doesn’t come cheap. After Sovaldi received approval from the U.S. Food and Drug Administration in December 2013, Gilead announced the drug would cost $84,000 for a 12-week course, or exactly $1,000 a pill. That’s more than double what Pharmasset, the biotech company that developed an early experimental version of the drug, initially said it planned to charge—until Gilead bought Pharmasset in 2011. For 2014, Sovaldi generated $10.3 billion in sales, making it one of the most lucrative pharmaceutical launches ever. In just the final three months of 2014, Harvoni added $2.1 billion. Gilead’s market capitalization has soared from $29 billion to $167 billion in five years. The net worth of its chief executive officer, John Martin, exceeds $1 billion.

June 2
His plan: Dock a cruise ship flying an Indian flag off the coast of Miami. Stock the ship with versions of Sovaldi sold in India for $83,000 less than the U.S. retail price for 12 weeks of treatment. Ferry U.S. patients to the boat and send them home with the potentially life-saving medicines at a huge discount.

Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas
Now, say hello to hep C tourism. As Jonathan Edelheit, CEO of the Florida-based Medical Tourism Association, toldBloomberg, "I know people who have hepatitis C and the only thing they can think about is getting this drug. There is definitely a high interest in going abroad."

So, companies that set up medical-related trips abroad--which often means plastic surgery or joint replacements these days--are starting to put together channels for hepatitis C treatment. Doctors who'll prescribe to foreign patients, for instance. One Indian company that specializes in sourcing hard-to-find drugs has been getting dozens of calls every day since the first generics rolled out there

May 27
Experts say the lawsuits are not surprising, and that more can be expected. “It’s every man for themselves and insurance carriers will do whatever they can do to minimize their cost of doing business, including coverage provision interpretation,” says Randy Vogenberg a partner at Access Market Intelligence, a consulting firm that specializes in managed care

May 22
NHS England accused of interference over hepatitis C drug
Officials at NHS England have been accused of interfering in a process to decide whether a drug which can cure Hepatitis C should be made available to patients on the health service.

Hepatitis C: Weighing the Price of a Cure
A new class of drugs has proven to be an exceptional clinical success, but it's their equally striking costs that are garnering more attention.

May 21
Hep C Drugs: Insurers’ Reasons for Coverage Denials
May 19, 2015 | DDW 2015 | Gale Scott
Treating hepatitis C with new antivirals saves lives and—in the long run—money spent on patient care. But some patients and their physicians are learning there are barriers to getting prescriptions approved by patients’ carriers.

Gilead Patents on Costly Hepatitis C Drug Challenged in 5 Countries
A U.S. group is trying to block patents in five countries for Gilead Sciences Inc's costly hepatitis C drug Sovaldi (sofosbuvir), in a bid to give almost 60 million afflicted people access to cheaper generic versions.

HealthWell Foundation's New Fund Brings Financial Relief to Underinsured People Living with Hepatitis C

Of Interest
 HEALTHCARE ECONOMICS / SVR Improves Health, Mortality / Early HCV Therapy Prefer
SVR Improves Health / Cost Outcomes 

May 19
Achieving SVR can lessen economic impact of HCV, save $3 billion
WASHINGTON — By treating hepatitis C virus with the latest medications and achieving sustained virologic response, physicians can predict a…

Hep C Drugs: Not Always Covered
There has been much concern that the high cost of the new generation of antivirals that treat hepatitis C would mean many patients will not get them. A Detroit, MI study presented May 19 at the Digestive Disease Week conference in Washington, DC, by researchers from Henry Ford Hospital found that is not the case. But the team also found disparities in coverage based both on provider and the drugs prescribed. Khalid George, MD and colleagues at the hospital’s department of gastroenterology and hepatology looked at 398 patients prescribed a regimen of sofosbuvir (Sovaldi/Gilead). Of these patients, 258 were prescribed sofosbuvir and ribavirin with or without interferon. A second group of 140 patients were prescribed sofosbuvir with simeprevir (Olysio/Janssen Therapeutics). The major of patients (92%) had private insurance and 5.8% had Medicare coverage and 2.5% had Medicaid coverage. Patients in the group getting sofosbuvir plus ribavirin (Rebetol/Merck) had a prescription approval rate of 83% if they had private coverage, but Medicare approved the prescriptions only 67% of the time and Medicaid paid 80% of the bills for its patients who got those prescriptions. In the group prescribed sofosbuvir with simeprevir, private insurers approved 79% of the prescriptions, Medicare 63%, and Medicaid 78%. The private insurers were less likely than Medicare and Medicaid to require prior authorization for patients to get their medications. “Our results demonstrate that specific insurance types can lead to disparities in access to therapy for hepatitis C,” the team concluded.

Payer restrictions of HCV treatment contradict medical society guidance, are discriminatory
WASHINGTON ─ Hepatitis C virus is moving from chronic disease to curable; however, there are obstacles to eradication and “the hope of ending…

May 18
Hep C patient sues Blue Cross for blocking access to Harvoni
It had to happen: A patient denied the latest hepatitis C drugs has sued her insurance company. In this case, it's Anthem Blue Cross, and the California plaintiff says her plan blocked her from treatment because she's not sick enough to qualify under its rules.

Business is Booming: Weighing the Wisdom of Expanded HCV Screening
Many organizations, including the CDC, have endorsed expanding widespread screening for hepatitis C virus, but experts writing in The BMJ warn that physicians should resist screening until more evidence on the risk-benefit ratio and long-term clinical improvements with antiviral therapy becomes available.

May 17

May 16
Hepatitis C - Lawsuit Claims Plaintiffs allege Blue Cross withholds Harvoni treatment for financial reasons

Connecticut- Costly Hepatitis C Drugs Sovaldi, Harvoni and Viekira Pak More Accessible To Medicaid Patients

May 12
Sanders Asks VA to Break Patents on Gilead and AbbVie Hep C Drugs
U.S. Sen. Bernie Sanders (I-VT.) has asked the U.S. Department of Veterans Affairs to use emergency powers to break – or override – the patents on high-priced hepatitis C medicines sold by several drug makers, including Gilead Sciences

“I cannot think of another situation where the government-use provision [of the law that allows the VA to break the patents] should be applied,” Sanders wrote in a letter to Robert McDonald, the U.S. Department of Veterans Affairs Secretary. “Our nation’s veterans cannot, and should not, be denied treatment while drug companies rake in billions of dollars in profits.”

Making Hepatitis C Treatment Affordable
Now that the World Health Organization has formally classified these medications as essential for patients, the result may be reforms in pricing

A number of sources have today confirmed the Therapeutic Good Administration (TGA) has now approved the use of Harvoni as a prescription medicine in Australia. This is a necessary step before it can be listed on the Pharmaceutical Benefits Scheme (PBS), which the Australian Government is currently considering.

May 8
WHO adds hepatitis C drugs to essential list, urges lower prices
The World Health Organization has added new curative treatments for hepatitis C to its essential medicines list, but the U.N. agency said prices needed to fall to make them accessible to patients in poorer countries.

May 5
Are We Seeing Innovation In The "Me Too" Hep C Space?
The whirlwind hepatitis C therapeutic market seems to have accelerated in the past few weeks. When I think about industry competition, even the high-profile non-small cell lung cancer (NSCLC) immunotherapy race and the sprint to approve the promising PCSK9 inhibitors for cholesterol pale in comparison to hepatitis C. Perhaps this interest was born out of the drama of the AbbVie/Gilead/Express Scripts pricing hoopla, but it certainly seems this market has grabbed the industry’s attention and won’t let it go

May 4
Gilead’s Gaffe Leads Drugmakers to Pledge More Openness on Price
Insurers and hospitals felt blindsided by the introduction of Sovaldi, which was a “case study of how not to collaborate,” said Betsy Nabel, president of Brigham and Women’s Hospital. The medical center hadn’t planned for the steep price, which also put pressure on the Massachusetts state Medicaid budget for medicine, she said at a conference last week in Boston.

Egypt opens first factory for locally produced Sovaldi

Mylan launches hepatitis-C Sovaldi tablets in India

May 1
Will competition push down the high prices that make Hepatitis C drugs too expensive for some patients?

New Hepatitis C Guidelines Tackle Drug Costs, Access
VIENNA — New hepatitis C treatment guidelines address cutting-edge direct-acting antiviral agents that offer a cure for most patients. Guideline authors from the European Association for the Study of the Liver (EASL) also take on the treatment of patients with complex disease, the high cost of the drugs, and access to care.

April 24
Mylan Pharmaceuticals launches generic hepatitis C drug MyHep in India
In September 2014, Mylan had entered into a licensing and technology transfer agreement with Gilead granting Mylan the non-exclusive rights to manufacture and distribute generic Sofosbuvir in 91 developing markets, including India.

April 22
Gilead uses Georgia as free-drug testbed for hepatitis C elimination

That Gent, Ed -- Over At Pharmalot -- On Gilead's Latest Hep C "Social Experiment Cure" In Former Soviet Nation

State panel OKs more hepatitis-C drug buys

April 19
'Revolutionary' specialty drugs carry huge promise and a hefty price tag
Article by: CHRISTOPHER SNOWBECK , Star Tribune
Updated: April 19, 2015 - 7:06 AM
The problem has big implications for both private and government insurers as more promising drugs come down the pipeline...

April 14
U.S. prescription drug spending rose 13 percent in 2014: IMS report

April 13
Gilead Sciences, Inc. (GILD) To Rule The Hepatitis C Market In 2015, Outperforming AbbVie Inc (ABBV)
According to latest analysis by Bloomberg Intelligence, Gilead is expected to cover 79% of the hepatitis C market this year

Specialty, generic drug costs drive Medicaid costs up
JEFFERSON CITY, MO. (AP) -- Increasing costs for drugs in Missouri's Medicaid program are likely to continue to increase, driven by pricey specialty drugs and the rising cost of generic medications.

From fiscal year 2010 to 2014, drug costs for Missouri's Medicaid program rose 33 percent to $1.16 billion while the number of claims fell slightly by less than one-tenth of one percent, according to data provided to The Associated Press.

The Missouri House gave initial approval Thursday to a supplemental budget for this year with costs partly driven by the high cost of providing a new Hepatitis C medication.

But the state's top Medicaid official Joe Parks says the unpredictability of future specialty drugs and other costs will continue to make budgeting for pharmacy costs difficult.
(Copyright ©2015 by The Associated Press. All Rights Reserved.)

April 8
Gilead’s $1,000 Pill Is Hard for States to Swallow
The data show patient access to Sovaldi varied widely state by state, reflecting different coverage of the drug and also long-standing disparities in how states deliver health benefits to the poor. Many states limited Sovaldi’s availability to the very sickest patients, primarily those with severe liver scarring.

April 7
Pricing of Drugs and Formulary Placement: Making Sense of Hepatitis C Treatment
The webinar took place on Tuesday, March 31, 2015.
View the complete program, here.
Assessment of Needs
The IAS–USA offers this state-of-the-art activity as part of a nationwide CME effort for physicians on the evolving challenges of managing hepatitis C virus. This webinar will explore how insurance companies determine access to hepatitis C regimens, and what clinicians can do to help ensure that the best decisions are being made for people living with hepatitis C.

A Conversation With Steve Miller, MD: Come in and Talk With Us, Pharma
Let’s turn to the hepatitis C drugs. There are other costly specialty drugs out there. Was there something special about the hepatitis C drugs?
There are many expensive drugs that we pay for, and we do that without complaining at all because we think it’s appropriate. The difference with hep C was that this was the first time we had an extraordinarily high-priced drug for an extraordinarily large population. When you price a drug at almost $100,000 for a treatment regimen, and you have 3.2 million people that could benefit from it—there’s never been a drug that potentially could generate over $300 billion in sales. I know they weren’t all going to be treated in one year, but even if you treated them over a decade, that’s an enormous increase in drug spend for the country.

April 5
High price of specialty drugs prompts backlash
Medicines to treat rare conditions, called “orphan drugs,” for years have been priced high to recoup the expense of developing a drug for a relatively small number of patients. But until Sovaldi, it was unheard of for a drug aimed at a commonplace disease to cost so much, critics said.

April 2
WHO Issues Guideline For Manufacturers Of Generic Hepatitis C Medicine

Mar 30
Richard Lehman’s journal review—30 March 2015
This week’s JAMA is much like last week’s NEJM: it’s about curative regimens for hepatitis C, but with concurrent HIV thrown in. I could go all shouty again about pricing, but I’ve already done that for this week. If drug manufacturers want to pull in profits equal to 20 times the development and manufacturing costs of a product, there is very little anyone can do to stop them.

ProPublica/The Washington Post: New Hepatitis C Drugs Are Costing Medicare Billions 
Medicare spent $4.5 billion last year on new, pricey medications that cure the liver disease hepatitis C — more than 15 times what it spent the year before on older treatments for the disease, previously undisclosed federal data shows. The extraordinary outlays for these breakthrough drugs, which can cost $1,000 a day or more, will be borne largely by federal taxpayers, who pay for most of Medicare’s prescription drug program. But the expenditures will also mean higher deductibles and maximum out-of-pocket costs for many of the program’s 39 million seniors and disabled enrollees, who pay a smaller share of its cost, experts and federal officials said. (Ornstein, 3/29)

New hep C treatments cost-effective for some patients, yet may exceed insurers' willingness to pay
New therapies for hepatitis C virus (HCV) are cost-effective for some patients, but current costs may be higher than U.S. insurers are willing to pay, according to a study published in Annals of Internal Medicine. Recently approved sofosbuvir administered in combination with ribavirin can be used to treat patients with chronic HCV genotype 2 or 3 without interferon, yielding cure rates greater than with the previous standard of care without the fear of toxicity. However, sofosbuvir costs approximately $28,000 for 4 weeks of treatment, which may be too expensive for patients on publicly funded health insurance programs which do not guarantee access to such costly drugs. Using a simulation study, researchers sought to estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States. They found that at current cost, sofosbuvir-based HCV therapy improves outcomes and provides good economic value in patients with cirrhosis and genotype 2 or 3 infection and in those who were previously treated with interferon. However, in treatment-naive noncirrhotic patients, the incremental cost-effectiveness ratio would be well over $100,000 per quality-adjusted life-year, a cost that may exceed U.S. insurer's commonly cited willingness-to-pay threshold. The authors of an accompanying editorial from the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health suggest that cost may be the only thing standing in the way of eradicating HCV.

In Case You Missed It
Minimum target prices for production of direct-acting antivirals and associated diagnostics to combat hepatitis C virus
'Mass treatment programs to cure the hepatitis C virus in developing countries are only feasible if the costs of treatment and laboratory diagnostics are low.' This article offers the minimum costs of direct-acting antiviral treatment and associated diagnostic monitoring.
Source - Hepatology
Volume 61, Issue 4, pages 1174–1182, April 2015
Minimum Target Prices for Production of Direct-Acting Antivirals and Associated Diagnostics to Combat Hepatitis C Virus
Combinations of direct-acting antivirals (DAAs) can cure hepatitis C virus (HCV) in the majority of treatment-na€ıve patients. Mass treatment programs to cure HCV in developing countries are only feasible if the costs of treatment and laboratory diagnostics are very low. This analysis aimed to estimate minimum costs of DAA treatment and associated diagnostic monitoring. Clinical trials of HCV DAAs were reviewed to identify combinations with consistently high rates of sustained virological response across hepatitis C genotypes. For each DAA, molecular structures, doses, treatment duration, and components of retrosynthesis were used to estimate costs of large-scale, generic production. Manufacturing costs per gram of DAA were based upon treating at least 5 million patients per year and a 40% margin for formulation. Costs of diagnostic support were estimated based on published minimum prices of genotyping, HCV antigen tests plus full blood count/clinical chemistry tests. Predicted minimum costs for 12-week courses of combination DAAs with the most consistent efficacy results were: US$122 per person for sofosbuvir1daclatasvir; US$152 for sofosbuvir1ribavirin; US$192 for sofosbuvir1ledipasvir; and US$115 for MK-87421MK-5172. Diagnostic testing costs were estimated at US$90 for genotyping US$34 for two HCV antigen tests and US$22 for two full blood count/clinical chemistry tests. Conclusions: Minimum costs of treatment and diagnostics to cure hepatitis C virus infection were estimated at US$171-360 per person without genotyping or US$261-450 per person with genotyping. These cost estimates assume that existing large-scale treatment programs can be established.
(HEPATOLOGY 2015;61:1174-1182)
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Mar 24
Lack of insurance bars some from hepatitis C treatment

Our Readers Say: Cost of prescription drugs determined by price or policy?

Multiple Canadian Provinces to Provide Public Funding for Gilead's Harvoni™

Mar 23
FDA Update - Important safety information: Harvoni , and Sovaldi‏
Read FDA update and Gilead Sciences issued letter to Healthcare Providers
The biotech company, on Friday, announced a drug warning in an email to the healthcare providers, (see below) disclosing that six patients experienced symptoms of bradycardia within 24 hours of the treatment. The remaining three patients experienced the symptoms within two to twelve days of the treatment. The email stated that all the said patients were on amiodarone, three were also taking Harvoni, five were using Sovaldi with daclatasvir, another hepatitis C treatment from Bristol-Myers Squibb Co. (NYSE:BMY), and one patient had been receiving Sovaldi along with Olysio, a hepatitis C drug by Johnson & Johnson (NYSE:JNJ). Gilead said that the mentioned combination of drugs is not recommended and that it will soon be updating its product labeling to add the warnings.

Dr Reddy's partners Hetero to sell Hepatitis C drug in India

Full Text @ Medscape
Cost-effectiveness of Ledipasvir/sofosbuvir Regimens for HCV
Alimentary Pharmacology & Therapeutics, March 23, 2015

The 2014 Drug Trend Report 
The Express Scripts Drug Trend Report provides the most detailed analysis of prescription drug costs and utilization, as well as a better understanding of the dynamic changes in the marketplace which affect current and future drug trends.

Which new hepatitis C treatments is most cost effective? 
March 2015
 Exciting developments, dizzying in number have occurred in the last decade leading to new improvements for the treatment of Hep C and cures. A number of options are now available, so researchers in a March 2015 study in Ann. of Intern. Med. asked which was most cost effective. According to a Consultant 360 Medical Resource summary: "The researchers discovered that sofobuvir-ledipasvir was the optimal strategy for genotype 1 and would be cost-effective if the drug cost less than $5500. For genotype 2, sofosbuvir-ribavirin-PEG would be cost-efficient if sofobuvir cost less than $2250 every week, and sofosbuvir-ledipasvir-ribavirin would be the most cost-saving for genotype 3 if sofosbuvir cost less than $1500 per week.

Mar 20
HCV therapy found cost-effective in patient with severe liver disease

Gilead Sciences gathering details of buyers of hepatitis-C drug to prevent its diversion

Mar 19
Australians with Hepatitis C hope new drugs will be approved by Pharmaceutical Benefits Scheme

Mar 18
Fact sheet: Gilead's chronic hepatitis C treatment restrictions
Yesterday, Médecins Sans Frontières/Doctors Without Borders (MSF) released a fact sheet and press release elaborating on the agreement between Gilead and Indian companies to produce generic versions of sofosbuvir, calling out Gilead for a program "which places multiple restrictions and demands on people receiving treatment"

Mar 17
HCV Drugs Cost-effective, but Who Should Get Them?

Hep C meds cost-effective, but affordable? With new 46% discounts, maybe

Pricey new hepatitis C drugs may require prioritization

Zydus Cadila launches Gilead’s Hepatitis C drug in India 

The Life-Saving Drug that Almost No State Can Afford
So far, Gilead’s Sovaldi has dominated the market – earning the title of fastest selling drug in history. It reportedly raked in $8.6 billion in the first nine months of 2014. Still, Abbvie is quickly gaining momentum since federal regulators approved it in December. Abbvie’s chief executive officer Rick Gonzalez told Forbes in January that he expects to get access to 40 percent of insured people with Hepatitis C this year.

Mar 16
Harvoni is cost-effective for most patients with hepatitis C virus infection, but additional resources and value-based patient prioritization are needed, according to newly published data in Annals of Internal Medicine.

Prescription drug spending has gone through the roof — and now we know why

Analysts fret over cuts to hep C budget

Mar 15
New market for liver disease spawns race for better testing

New Hepatitis C Drugs: State is advised to cover sickest

Mar 14
Specialty drugs save lives, come with daunting price tags

Mar 13

Mar 12
Natco Pharma gets nod to sell Hepatitis C medicine in India

Doctors urge Hepatitis C patients to seek help now due to rising costs

$10 copy of Gilead’s blockbuster Sovaldi appears in Bangladesh

Mar 7
Experts Discuss: Cost-Based Treatment Decisions, Comparing Adverse Events of HCV Drugs And More...

Mar 5
State OKs new Hep C drug for Medicaid patients
he director of the Oregon Health Authority, which oversees the state’s Medicaid program, the Oregon Health Plan, approved new criteria this month that permits some OHP beneficiaries with Hepatitis C to access a new drug: Harvoni. Hepatitis C is a disease that causes inflammation of the liver and can lead to liver failure or liver cancer.

Ending an Epidemic: Overcoming the Barriers to an HCV Free Future

Mar 4
Sovaldi - Attacking the Patent System for Pricing Issues Is a Non-Starter

Mar 3
Gilead's Harvoni gains NICE yes - but won't face funding delay - genotype 1, 4 , but not genotype 3
unlike the company's Sovaldi, which won’t be paid for until the summer
Gilead's next generation hepatitis C pill Harvoni is set to be backed by NICE - and this time NHS England won't be delaying its funding as it has done with the firm's other hep C drug Sovaldi.

Pharmalot, Pharmalittle: We’re Reading About Gilead, Hepatitis C Drug Prices and More!!
A 30-member panel of doctors and health experts will, for the first time, address the cost effectiveness of hepatitis C drugs in updated guidelines that may change prescribing and coverage for the medicines, Bloomberg News reports....

Mar 2
MUMBAI-Natco Pharma ties up with Gilead on hepatitis C drugs
(Reuters) - Natco Pharma Ltd said on Monday it has agreed a deal with Gilead Sciences Inc to supply generic copies of the U.S. drugmaker's chronic hepatitis C medicines, including $1,000-a-pill drug Sovaldi, in 91 developing nations.

Factory making fake Hepatitis C drug raided
Islamabad - One of the drugs being produced at this factory was Sofosbuvir sold under the brand name Sovaldi, used to treat hepatitis C, which costs a patient Rs55000 for one month of treatment and six months of treatment is required. Another drug Everlong, the registration for which was cancelled by the DRAP, was also being manufactured unlawfully at the factory.

Feb 25
NICE guidance recommends sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen) for treating hepatitis C
The NICE guidance on sofosbuvir recommends its use in combination with ribavirin, with or without peginterferon alfa, as an option for some people with genotypes 1-6 chronic hepatitis C.

Feb 24
California Lawmaker Wants Pharma to Reveal Costs for Pricey Drugs

Canada - With hep C, no province is an island
So far, PEI has committed to spend $1.6-million a year for three years to purchase a drug combo called Holkira Pak, a product of AbbVie Canada with a list price of $55,860.

Mylan Signs Exclusive Agreement with Gilead Sciences to Distribute Sovaldi® and Harvoni® in India

Feb 12
Are Sky-High Prices For New Drugs Justified?

$5M Hepatitis C strategy announced by P.E.I. government
A new $5-million hepatitis C management strategy unique to P.E.I. was announced by the province's Health and Wellness Minister Thursday morning.

Gilead agrees 41,000 eur hep-C drug price for 12 week treatment

Feb 11-10
Gilead faces challenge to European patent on pricey hep C drug

Lowering the cost of hepatitis C drugs is possible and it is key to achieving global access to treatment, according to new research.

Feb 5
Rolling out hepatitis C treatments will be costly | Editorial

Catamaran Selects Gilead Sciences as its Exclusive Hepatitis C Treatment Provider
This new program will provide clients of Catamaran and BriovaRx an innovative new approach to hepatitis C treatment. Centered on producing positive health outcomes, the program will allow for overall treatment costs to take into account clinical results. Patients will be monitored during their entire treatment regimen through their participation in BriovaRx's Hepatitis C Patient Management Program in order to support full adherence.

Since December 2013, regulatory approval of new treatments for hepatitis C have brought long simmering debates on drug pricing and value to full boil. The drugs—Gilead’s Sovaldi and successor combination treatment Harvoni, AbbVie’s Viekira Pak—represent significant steps forward for treatment in hepatitis C, demonstrating cure rates well above 90 percent in the clinical trial setting as well as greater tolerability for patients.

Kaiser - Gilead Stock Dips On Details About Discounting Of Hepatitis Drugs
Despite record sales of its new hepatitis C drugs, Gilead Sciences saw its stock price drop as much as 10 percent after the company acknowledged that it planned to double the discounts given on those drugs in 2015. The average discount was more than investors had anticipated.

What the ‘Shocking’ Gilead Discounts on its Hepatitis C Drugs Will Mean
The Wall Street Journal: Gilead Sciences Down On Discounting News 
Marketplace: Insurers Often Take Sting Out Of High Price Of Drugs 
Los Angeles Times: California Lawmakers Target $1,000 Hepatitis Pill, Other Costly Drugs 

Feb 2
More patent-opposition on Gilead’s hepatitis C drug, sofosbuvir
PT Jyothi Datta
Mumbai, Feb 2
A fresh bout of opposition has been filed against Gilead’s patent application on hepatitis c drug sofosbuvir. This comes close on the heels of a spate of developments involving the drug, last month.

State Medicaid Programs Seek Discounts on Pricey Hepatitis C Drugs
Several state Medicaid programs are offering to make certain hepatitis C treatments the preferred therapies for their beneficiaries in return for large rebates from the drugs' makers, the Wall Street Journal reports. The high cost of the newer HCV treatments, including Harvoni and Viekira Pak, have come under much scrutiny in recent months.

Feb 1
For Patients -
Video Weekend-Dr. Galati On New HCV Treatments: Sovaldi, Harvoni, Olysio, and Viekira Pak

Jan 30
In the first of several such deals to come,Gilead Sciences Inc. has agreed to lower the price of their expensive Hepatitis C drugs for Harvard Pilgrim Health Care customers.

Of Interest:HCV/Aging Hospitalizations/Costs Tripled in 6 Years

Jan 29
Hepatitis C Scorecard: Express Scripts Drafts Inferior Drug —Express Scripts' peers choose Harvoni/Solvadi over Viekira Pak.
As we've stated over the past several weeks, AdverseEvents is not a fan of drug manufacturer and payer exclusivity deals. We believe strongly that they are not in the best interest of drug safety and set a dangerous precedent.

Jan 28
UnitedHealth backs Gilead's Harvoni as preferred hepatitis C treatment
Wed Jan 28, 2015 5:36pm EST
(Reuters) - UnitedHealth Group Inc, the largest U.S. health insurer, on Wednesday backed Gilead Sciences Inc's Harvoni as the preferred hepatitis C treatment on its 2015 commercial drug coverage list, another victory for Gilead over competitor AbbVie Inc.

New Hepatitis C drug will save Missouri 4.2 Million Dollars
State officials say Missouri's Medicaid program will save an estimated $4.2 million in fiscal year 2016 by using a newer, cheaper drug to treat hepatitis C.

The state joined a group of 25 other states to receive rebates on Viekira from drug maker AbbVie. The state in most cases will provide that drug instead of Gilead Science's Sovaldi in an agreement announced Monday.

The expensive treatment with Sovaldi, about $84,000 for a normal course, was cited as one driver of increased Medicaid costs for the state in 2015 by the state budget director.

Republican lawmakers have said the state should work to better control drug costs within the program.

Jan 27
PBM EnvisionRx chooses Gilead hepatitis C drugs for its formulary
EnvisionRx said Gilead's Sovaldi and its newer two-drug combination pill Harvoni would be available on its formulary, with other hepatitis C drugs, such as AbbVie's Viekira Pak, allowed only as an exception in some cases.

Jan 26
Press release
Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

Gilead to Allow Generic-Drug Makers to Produce New Hepatitis C Treatment
Gilead Sciences Believes New Version Will Be More Effective at Treating Hepatitis C

Gilead Expands Generic Sovaldi Pact to Add Investigational Pill Gilead Sciences Inc. 
(GILD) said it aims to launch Sovaldi, its blockbuster hepatitis C drug, in India by June while expanding the reach of a generic licensing agreement with Indian drugmakers to include an investigational combination pill. The pill, which combines sofosbuvir, the chemical name for Sovaldi, with GS-5816, a compound in advanced clinical trials in the U.S., could treat six genotypes of hepatitis C if approved by regulators...

Jan 24
German insurers win discounts on Gilead's Sovaldi
FRANKFURT (Reuters) - U.S. biotechnology company Gilead (GILD.O) has conceded its first discounts in Germany on its key hepatitis C drugs Sovaldi and Harvoni, German business weekly WirtschaftsWoche reported.

Jan 22
Express Scripts' Miller says hepatitis C price war to save billions
(Reuters) - Gilead Sciences Inc and AbbVie Inc are in a price war over their hepatitis C treatments that is driving costs lower and has changed the way drugmakers price new medicines, a top executive for pharmacy benefit manager Express Scripts said on Thursday

Benefits firms shouldn't play drug favorites: CEO
Matthew J. Belvedere | @Matt_Belvedere
Watch Video
Regeneron Pharmaceuticals' CEO told CNBC on Tuesday that benefits companies should not try to practice medicine.
Dr. Leonard Schleifer was reacting to the recent news that Express Scripts, the country's largest pharmacy benefits manager, dropped reimbursement for Gilead Science's hepatitis C treatment because it got deep discounts from an AbbVie alternative.

Jan 16
Hepatitis C drug Victrelis (boceprevir) gets pulled from manufacturer
The pharmaceutical company, Merck, has announced that they will stop the manufacture and distribution of their hepatitis C (HCV) protease inhibitor Victrelis by December 2015. As the landscape of HCV treatment has rapidly evolved, providers are no longer prescribing the medication and patients are no longer taking it in favor of newer regimens that are easier to take, and have shorter treatment durations and higher cure rates. In a similar move, Vertex discontinued their HCV drug Incivek (telaprevir) in October 2014.

Fri Jan 16, 2015 2:34pm EST Jan 16
(Reuters) - Aetna Inc, the third-largest U.S. health insurer, said it has negotiated a discount with Gilead Sciences Inc for its hepatitis C treatment and will offer it as the preferred choice to its nearly 20 million commercial customers.

Viekirax (ombitasvir/paritaprevir/ritonavir tablets)+EXVIERA® (dasabuvir) gets European approval for Hepatitis C
AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX®(ombitasvir/paritaprevir/ritonavir tablets)+ EXVIERA® (dasabuvir tablets).1,2 The treatment has been approved with or without ribavirin (RBV) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.1,2 Additionally, VIEKIRAX has been approved for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.

NICE backs new hepatitis C treatments
But Sovaldi faces funding delay and Olysio not backed in all indications

Many say the tide shifted with a campaign by insurers and pharmacy benefits companies against Gilead Sciences Inc's (GILD.O) $84,000 hepatitis C treatment Sovaldi. The drug represented the first effective cure for hepatitis C and quickly raked in billions of dollars in sales within its first few months on the market in 2014. Sovaldi's cost is based on a 12-week treatment regime and amounts to $1,000 a pill. By contrast, the treatment costs about $57,000 in the U.K.

Gilead Denied Patent for Hepatitis C Drug Sofosbuvir in India
The Indian Patent Controller today rejected one of Gilead’s key patent applications, which covered the drug sofosbuvir, used to treat hepatitis C (HCV). 

Humana acknowledged late Tuesday it has an exclusive deal to offer Gilead Sciences' hepatitis C drugs to its members.

The development of pharmaceuticals is among the riskiest of businesses. It now takes 10-15 years for a pharmaceutical company to get a new drug approved, and on average the cost exceeds $2.5 billion. To establish its safety and effectiveness, a candidate drug or vaccine undergoes a lengthy process of laboratory, animal and clinical studies, and then regulatory review by the highly risk-averse FDA.

Jan 13
Aetna CEO says no decision yet on how to cover hepatitis C drugs
(Reuters) – The chief executive of health insurer Aetna Inc on Tuesday said that the company had not yet decided which hepatitis C drugs to cover now that there are two breakthrough treatments on the market, but said that the company was actively working on a decision.

Jan 12
UPDATE: Gilead (GILD), AbbVie (ABBV) Hep. C Drugs Both Given Prefered Status at Prime
Gilead (Nasdaq: GILD) and AbbVie (NYSE: ABBV) Hep. C drugs were both given prefered status at Prime. 
People with Hepatitis C who are served by pharmacy benefit manager Prime Therapeutics LLC (Prime) will now have greater support for the treatment recommended by their physician. This is a result of new agreements between Prime and pharmaceutical companies Gilead Sciences and AbbVie. Beginning immediately, the agreements place both Gilead's Harvoni® and AbbVie's Viekira Pak® on Prime's preferred drug list (formulary), meaning members can more easily get the medicine they need to feel better and live well.

Brown's Budget Proposal Allocates Millions For Hepatitis C Drugs
The new proposed California budget -- released on Friday by Governor Jerry Brown -- sets aside roughly $300 million for high-cost drugs, particularly for the treatment of Hepatitis C.

Hepatitis Drug Prices Fall So Low, No Exclusives Needed
By Robert Langreth
Gilead Sciences Inc. (GILD:US) and AbbVie Inc. (ABBV:US), engaged in a price war over hepatitis C drugs, are offering such substantial discounts that one benefit manager has decided to cover both medicines rather than get a lower price for one through an exclusive deal.

Spain vows hepatitis C action after calls for new drugs
A new committee will draw up a proposal within three weeks of examining the extent of the illness and clinical criteria, aiming to "include newly authorised drugs" in treatment plans, the health ministry said in a statement.

Jan 9
Express Scripts and CVS Exclusivity Deals: Immediate Cost Savings Overshadow Long-Term Medical Concerns
Getting patients access to life saving medications is not just a good thing, it’s a great thing. However, we also believe that these exclusive deals are setting a dangerous precedent because they:

Take treatment decisions out of the hands of provider and patient

Create an environment where product cost is the main determinant of a treatment, rather than clinical guidelines (new guidelines favor Gilead’s Harvoni over Abbvie’s Viekira Pak, which is more cumbersome and may require additional medications such as ribavirin that have additional side effects)

Emphasize immediate cost savings rather than total costs of care
Health insurer Anthem Inc on Thursday said it reached a deal under which Gilead Sciences Inc's hepatitis C drug Harvoni will be the primary treatment for patients infected with the most common strain of the liver-destroying virus.

At $594 Per Dose Gilead Sciences, Inc. (GILD) Hepatitis Drug Is Too Costly For Veterans Affairs Department
To consider the impact of Sovaldi’s $84,000 12-week treatment cost, the Veterans Affairs Department provides this therapy only to the sickest patients who need it. The Department is the largest single provider of hepatitis C care in the U.S., which enabled it to negotiate more than 40% discount to the $594 per-dose price with Gilead.

Hep C Drug Deal Raises Patient-Choice Concerns
Jan. 8, 2015 3:51 p.m. ET
At a time when the rising cost of medicines is causing consternation, an exclusive deal between Express Scripts Holding Co. , the nation’s largest pharmacy-benefits manager, and AbbVie Inc., a big drug maker, over a new hepatitis C treatment is generating concern about the implications for patient choice.
Continue reading....

5 Health Care Megatrends That May Prove Costly In 2015
Robert Pearl, M.D. Contributor
The Food and Drug Administration (FDA) approved several new drugs in 2014 for the treatment of hepatitis C, a chronic liver infection. The biopharmaceutical company Gilead introduced two oral medications that eliminate the hepatitis C infection in around 90 percent of patients. With few major side effects, these drugs signaled a major medical advancement in 2014.
Continue reading @ Forbes

Hepatitis C Drug Discount Deals Still Miss Many Patients
Bruce Japsen
Despite recent deals designed to extract discounts from the makers of expensive Hepatitis C pills, there are still large numbers of Americans, particularly the poor covered by Medicaid insurance, that are missing out on lower costs and in some cases can’t access the treatment.
Continue reading @ Forbes

Express Scripts' Miller lays out manifesto to fight sky-high drug prices
FiercePharma | January 7, 2015
It's no secret that Express Scripts Chief Medical Officer Steve Miller is hankering for some changes in the pharma business. But what many may not know, he told PharmExec, is that he's got a four-point solution to fix what he sees as the industry's biggest problems.
Continue reading...

Interview: Express Scripts Talks About AbbVie Hepatitis C Drug Deal

Gilead exclusive provider of hepatitis C medicine for CVS
Gilead Sciences Inc. was chosen over AbbVie Inc. as the main provider of hepatitis C medicine for patients covered through CVS Health Corp., intensifying a rivalry to treat patients with pills that cost $1,000 or more a day.

Drug pricing concerns? Not at Gilead
After drug pricing concerns weighed on Gilead Sciences' stock toward the end of December, the drugmaker has kicked off 2015 the same way it did the previous two years: by increasing prices on several products.

Is there a balm for Gilead?
Express Scripts negotiated the discount for Viekira Pak but couldn’t get the price of Harvoni down below about $84,000. Gilead thought the superiority of its product deserved no less, apparently. So Express Scripts decided it would only allow patients who get their hepatitis C drugs through an Express Scripts program to receive Viekira Pak. Because Express Scripts has more than 60 percent of the “pharmacy benefit manager” market, this is a big deal and portends many similar deals on the horizon.
Express Scripts helpfully gave patients until Jan. 1, 2015, to adjust to this new regime.

New drugs offer hope, barriers for hepatitis C patients
Doctors say they have to go to great lengths to get Medicaid patients approved, generating up to four denials before a final rejection. They say that employees must spend eight to 12 hours to get a patient drug approval.

Washington Health Care Authority updates hepatitis C policy
The Health Care Authority (HCA) has issued an interim updated hepatitis C policy that reflects the rapidly changing field of treatment for the chronic disease. The policy will be presented to the Washington State Drug Utilization Board for final approval in February.

A new report found that prescriptions for ledipasvir and sofosbuvir, the newest hepatitis C treatment, are growing rapidly but the minimal reduction in sofosbuvir prescriptions indicates an overall expansion of the eligible treatment population rather than the former drug replacing the latter, according to a press release.

AHF favors cheaper Hepatitis C treatment
by Amanda Rupp
“The decision by Express Scripts to choose the Viekira Pak over Sovaldi demonstrates the limits of big pharma’s greed and arrogance,” Michael Weinstein, president of AHF, said. “Gilead wrongly believed they could get away with charging through the roof for Sovaldi and now their strategy has clearly backfired. With private insurers and taxpayers footing the bill for most of these life-saving treatments, it is now incumbent that the government and other companies follow suit in standing up to these attempts at public extortion.”
Consumers in most Western European countries pay between $51,000 and $66,000 for similar treatments.

Express Scripts turns to AbbVie in huge hepatitis C deal - News Facts

AbbVie Win The Exclusivity Rights For Their Newly Approved Cheaper Hepatitis C Drug
AbbVie has won the exclusive rights for their newly approved Viekira Pak drug for Hepatitis C treatment. In order to win an exclusive deal with Express Script, the largest manager of prescription drug manager in USA, AbbVie cut the price of their drug. In an announcement on Monday, Express Script decided to go with the AbbVie`s Viekira Park treatment for hepatitis C genotype-1. According to the deal Express will exclude Gilead’s ledipasvir/sofosbuvir combo (Harvoni) and Janssen Therapeutics’ simeprevir (Olysio). This is a welcome news for both doctor and patient as Express Script decided to provide the medicine to a patient regardless of the stage of Hepatitis C the patient is carrying.

So we spoke to doctors, patient advocates and other drug-benefit providers to get their takes. And here’s what we found…

New HCV Option Effective, Safe, Well-Tolerated — And Use Will Likely Be Driven by Payors
Paul E. Sax, MD
As expected, the FDA approved the next treatment option for HCV on Friday — “Viekira Pak”, a (sometimes complete) regimen consisting of ritonavir-booted parataprevir and ombitasvir given as a two pills once a day, plus one pill of of dasabuvir given twice daily. It is indicated for treatment of HCV genotype 1. For those of you mechanistically inclined, parataprevir is a protease inhibitor, ombitasvir an NS5A inhibitor, and dasabuvir the first approved non-nucleoside polymerase inhibitor. Ritonavir is there for PK boosting. Cure rates have been outstanding — 90% and higher – and severe adverse events rare. All good news so far. So what’s the issue?

Obviously, many patients will require concomitant administration of ribavirin, which makes this a considerably more complex regimen than the sofosbuvir/ledipasvir combination pill that has been available since October. Two other disadvantages include more drug-drug interactions (ID/HIV doctors are certainly familiar with ritonavir), and the potential for broader antiviral resistance if the treatment fails.Whether these make a difference or not in clinical practice is a key unknown. But you can bet good Hanukkah get that payors are highly motivated to find out. Here’s some proof.

Another drug called Viekira Pak, developed by the pharmaceutical company AbbVie, got the green light from the U.S. Food and Drug Administration on Friday, Dec. 19. But many were disappointed upon discovering that the drug would cost $83,319 for a 12-week course, only slightly less than Sovaldi. The medical community had hoped that market competition would drive prices much, much lower.

Even with New AbbVie Drug, Many Hepatitis C Patients Are Being Turned Away from Treatment
Expensive medications to cure hepatitis C have far fewer side effects than the drugs that came before, but getting insurers to pay for them is an uphill battle.

(Reuters) - The largest U.S. pharmacy benefit manager said on Monday it has lined up a cheaper price for AbbVie Inc's newly approved hepatitis C treatment and, in most cases, will no longer cover Gilead Sciences Inc's treatments after trying for nearly a year to win a deeper discount.

FDA Approves AbbVie Combo Hepatitis C Treatment

Class Action Lawsuit Challenges the Exorbitant Pricing of Gilead's Hepatitis-C Drug Sovaldi
The complaint alleges that, under these extraordinary circumstances, Gilead's pricing cannot be justified by any patent rights it purports to have related to Sovaldi. The lawsuit seeks class action status on behalf of all persons and entities that have paid some or all of the purchase price of Sovaldi, and those who have been prevented from obtaining a needed Sovaldi regimen due to its excessive price. The complaint asserts causes of action for unjust enrichment, for violations of provisions in the Sherman Antitrust Act and Affordable Care Act, and based on a breach of contract theory

Hepatitis C patients dying while they wait for Health Ministry decision on funding two new drugsTwo new drugs have revolutionized care for those with hepatitis C. Sovaldi was so ground-breaking its first-year sales outpaced every other previous drug, including Viagra. Harvoni became only the seventh drug ever to be designated by American regulators as a breakthrough therapy.

But though sales of Sovaldi and Harvoni shot through the roof elsewhere, Ontarians with the disease and without private insurance are playing a waiting game some won’t survive.

High costs threaten veterans' access to hepatitis C drug Sovaldi
The treatment cost is especially significant to the VA because the disease affects veterans – particularly Vietnam-era veterans – at a rate higher than the general population. Approximately 174,000 veterans currently enrolled in VA have been diagnosed with hepatitis C.

Hepatitis C drug only available to wealthy in Ontario
But though sales of Sovaldi and Harvoni shot through the roof elsewhere, Ontarians with the disease and without private insurance are playing a waiting game some won't survive.

Insurers ask policy makers to stem tide of prescription cost increases
The survey shows that the expensive Hepatitis C drug Sovaldi, which cost Association members with managed Medicaid populations more than $60 million in claims for the 2014 rate year, was only one of several specialty drugs that contributed to prescription cost increases in the last several years.

Health Economics/Cost Effectiveness: AASLD:
Cost-Effectiveness of Novel Hepatitis C Drug Regimens Among Treatment-Experienced U.S. Veterans 

Health Economics/Cost Effectiveness: AASLD: Direct Costs of Care for Hepatocellular Carcinoma in patients with Hepatitis C cirrhosis 

France pegs Gilead hepatitis C drug at "lowest price in Europe"
Twelve weeks of treatment will now cost 41,000 euros ($51,373) before tax, against 56,000 euros previously. In the United States, where Sovaldi's high price has sparked controversy and pushed up insurance companies' costs, a 12-week course costs $84,000, or $1,000 per pill.

Costly Hepatitis C Treatments Help Drive 12 Percent Drug Spending Jump
WebMD News from Kaiser Health News
By Roni Caryn Rabin
Thu, Nov 20 2014
The report anticipates the pace of spending increases will slow to 7 to 9 percent in 2015, as the impact of the new hepatitis C drugs declines, less expensive biosimilar products become available and several brand-name drugs — such as cancer drug Gleevac and the antipsychotic Abilify — are replaced by generics.

NHS asks Nice to delay ground-breaking hepatitis C drug
It is a drug that cures hepatitis C in 90 per cent of cases and was considered ground-breaking when it came on to the market.

Manufactured by Gilead, Sofosbuvir was licenced for use late last year. And in April this year, NHS England took the unusual step of setting up a special access scheme so patients with less than a year to live were able to be treated without waiting for the National Insitute for Health and Care Excellence (Nice) to evaluate whether it should become routinely available on the NHS.

Developing a Drug Costs $2.6 Billion, but not Everyone Believes This
By Ed Silverman
The cost to develop a new drug and win FDA marketing approval is now pegged at nearly $2.6 billion, according to a new report from the Tufts Center for the Study of Drug Development. The figure includes two basic components – the average amount of money that is actually spent is $1.395 billion. Then there are opportunity costs of $1.16 billion.

Are consumers getting gouged on health-care?
It’s often seen in the balance sheets of biopharmaceutical giants, where net margins are double or even triple that of a normal, healthy corporation. Finance gets injected into the medical system when doctors are able to charge triple what Medicare’s fees are by staying out of public health programs and keeping their true expenses under wraps....

65th Annual Meeting of the American Association for the Study of Liver Diseases. 
Health Economics/Cost Effectiveness: AASLD: FIB4 Score and Gender Predict the Incidence of Hepatocellular Carcinoma (HCC) among Patients with Chronic Hepatitis C Virus (HCV) Infection: Chronic Hepatitis Cohort Study (CHeCS) - (11/17/14)

"There's a difference between prescribing (hepatitis C) drugs and actually being able to get these drugs for our patients," said Dr. Andrew Aronsohn, a liver specialist at the University of Chicago Medical Center. "It's becoming a very complicated issue."

Highly effective, expensive new medicine for Hepatitis C
KANSAS CITY, Mo. — More than three million Americans, most of them Baby Boomers, have Hepatitis C. The disease has killed around 15,000 Americans a year. But new treatments can cure Hepatitis C in the vast majority of patients. A treatment recently approved by the FDA is the first to involve taking only a pill. It doesn’t involve injections of interferon and the flu-like symptoms and depression that came with it.

The Cost Debate on HCV Treatment in Europe
While the cost of hepatitis C treatment continues to be a major topic of debate—with the approval of simeprevir (Olysio), sofosbuvir (Sovaldi), and now the combination, sofosbuvir and ledipasvir (Harvoni)—those in favor of the treatment provide a strong research-based argument. In a recent issue of Evidence-Based Immunology and Infectious Disease, we heard both sides of the discussion.1,2 Disease complications—cirrhosis, end-stage liver disease, hepatocellular carcinoma, and liver transplantation—cost the US healthcare system approximately $6.5 billion annually, expected to touch $9.1 billion by 2024.3 At $1000 per dose, sofosbuvir alone will cost $84,000 for the typical 12 weeks of therapy in the United States, while its combination with ledipasvir is estimated at $94,500.

Treating All Patients with Hepatitis C Who Would Be Diagnosed by Age-based Screening Is Cost Effective
The authors concluded that birth cohort screening followed by treating all HCV (+) patients was the most cost-effective strategy with ICERs well below the accepted threshold of $50,000 per quality adjusted years of life gained. The lead investigator, Zobair Younossi MD, MPH, FAASLD concluded that "screening and treating baby boomers with highly effective and well tolerated all oral anti-HCV regimens are highly cost-effective with great health and economic benefits at the population level." Dr. Younossi is Chairman of Medicine, Inova Fairfax Medical Campus and Vice President for Research, Inova Health system, Falls Church, Virginia.

New Federal HCV Policy Direction Needed...'find new champions in White House, Congress, funding for screening, open access to treatment'
We have reached an unacceptable new pinnacle this week with major commercial payers denying treatment access, United HealthCare not only required F3 but denied access to drug & alcohol users and used the AASLD/IDSA/ISA-USA Guidelines to support their position & they are a among numerous commercial payers doing this & the numbers will grow of payers doing this. This will NOT STOP, its getting worse...

Bristol-Myers Plan to Widen Access to its Hep C Drug, But Meets Criticism
A Bristol-Myers spokeswoman would not comment on the criticism or the study, but did send a note saying “our prices in developing countries will take into consideration several factors that include economic development and the burden of disease within a country, as well as the commitment of the government to holistically address hepatitis C, including treatment and care. We are currently engaged in discussions with several high disease burden developing-countries on their plans to address cepatitis C, and the role that Bristol-Myers Squibb can potentially play.”
Continue reading @ WSJ

BMS Statement: HCV Developing World Strategy

Médecins Sans Frontières (MSF) responds to the news of BMS’s plans on access and licencing for daclatasvir:
“Unfortunately, history seems to be repeating itself with BMS, who haven’t learnt from the company’s poor track record responding to the HIV epidemic; it is disappointing that BMS is choosing to lock out millions of people from gaining affordable access to daclatasvir, and will not commit to registering the drug in all countries that have a hepatitis C burden, even those that do not represent a commercial opportunity for BMS.

Insurers May Cover Costly Hepatitis C Drugs Only For The Very Ill

UPDATE 3-Aetna sees higher medical cost spending than expected

Investment Commentary 
Centene's (CNC) CEO Michael Neidorff on Q3 2014 Results - Earnings Call Transcript
Now hepatitis C therapies. We continue to manage the utilization of hepatitis C drugs in a responsible way on behalf of our state customers. Our medical management capabilities and Centene's clinical policies in addition to sound state guidelines have enabled us to successfully manage hepatitis C costs. Our experience to date has been consistent with our estimates. The net cost impact to Centene in the third quarter of 2014 declined sequentially. However, additional costs have lightly increased as new therapies continue to be approved. In early October, an all oral hepatitis C drug was approved with genotype 1 patients. We are engaged in ongoing discussions with our states to ensure that all new treatments are properly managed and fully reflected in our reimbursement

High Drug Prices Could Increase Industry Innovation
Dr. Peter B. Bach is a physician at Memorial Sloan Kettering Cancer Center and the Director of its Center for Health Policy and Outcomes. He is a passionate advocate for patients and often eloquently expresses concerns on the high prices of drugs, particularly new cancer therapies. When he speaks, many people including myself pay close attention. However, his guest post on entitled “Could High Drug Prices Be Bad For Innovation” unfortunately is off-base.

AHF to Gilead: Do Your Patriotic Duty and Lower Hep. C Drug Prices for Veterans
AIDS organization calls out Gilead Sciences for offering its Hepatitis C drugs Sovaldi and Harvoni to India and other countries for $900, yet charging the U.S. Department of Veteran Affairs nearly $50,000 per veteran. With rates of Hepatitis C nearly five-times higher among veterans than in the general population, Sovaldi and Harvoni are expected to cost the VA over $1.3 billion over the next two years.

Australia's rejection of costly new treatment sofosbuvir a 'death sentence for Hepatitis C sufferers'
Dr Miriam Levy, the director of gastroenterology at Sydney's Liverpool Hospital, told the conference the recent decision by the Pharmaceutical Benefits Advisory Committee (PBAC) to refuse subsidies for a breakthrough treatment for Hepatitis C had effectively delivered a death sentence to up to 50,000 Australians who would die from the disease in the next few years.

First Edition: October 21, 2014
Kaiser Health News
Today's headlines include reports about health law positions taken by Republican governors -- including Ohio Gov. John Kasich.

Kaiser Health News: More Plans Setting Spending Limits For Some Medical Services
Kaiser Health News consumer columnist Michelle Andrews writes: “Aiming to contain health care costs, a growing number of employers and insurers are adopting a strategy that limits how much they’ll pay for certain medical services such as knee replacements, lab tests and complex imaging. A recent study found that savings from such moves may be modest, however, and some experts question whether “reference pricing,” as it’s called, is good for consumers” (Andrews, 10/21). Read the story.

The Associated Press: In Louisiana, Both Sides Claim Defense Of Medicare
An old political standby — the future of Medicare — is emerging as the go-to issue in Louisiana’s bitter Senate race as the candidates woo seniors who typically wield strong influence in midterm elections. The challenge for voters is to figure out which side, if either, is telling the whole truth about who would cut and who would protect the popular insurance program. Medicare serves more than 50 million people and accounts for about 15 percent of federal spending, with about 10,000 new beneficiaries added daily as baby boomers reach age 65. The issue is so powerful that it’s cropping up in North Carolina and Iowa, too, amid a national battle for control of the Senate (10/21).

The Associated Press: GOP Governors Don’t See ‘Obamacare’ Going Away
While Republicans in Congress shout, “Repeal Obamacare,” GOP governors in many states have quietly accepted the law’s major Medicaid expansion. Even if their party wins control of the Senate in the upcoming elections, they just don’t see the law going away. Nine Republican governors have expanded Medicaid for low-income people in their states, despite their own misgivings and adamant opposition from conservative legislators. Three more governors are negotiating with the Democratic administration in Washington (10/20).

Politico: Gov. John Kasich: Repeal Obamacare, But Not All Of It
A political firestorm broke out Monday when The Associated Press quoted Kasich as saying that Obamacare repeal was “not gonna happen.” That view is almost unheard of — at least in public — among most Republicans, let alone those who might run for the White House in 2016. Kasich said AP got it wrong, and he called POLITICO Monday night to correct the record. He said he was talking specifically about repeal of the expansion of Medicaid — which Ohio has implemented — and not of the Affordable Care Act more broadly (Wheaton, 10/21).

The New York Times: Ohio Governor Backpedals On Repeal Of Health Law
Wait, that’s not what I really meant. Gov. John Kasich of Ohio said his comments about a Republican-led Congress being unlikely to repeal the Affordable Care Act — which commentators on the right and left pounced upon Monday — were taken out of context. Mr. Kasich, a Republican mentioned as a 2016 presidential hopeful, in an interview distanced himself from the notion that he had accepted the health care law as a fait accompli. The idea is anathema to almost all Republican officials, and especially the party’s base (Gabriel, 10/20).

The Washington Post: Kasich: I ‘Don’t Back Obamacare’ And I ‘Want It To Be Repealed’
Ohio Gov. John Kasich (R) is pushing back on reports that he'd said Obamacare was here to stay, saying Monday night that he opposes the federal health care law and believes it could be repealed and replaced under a Republican president and GOP-controlled Congress. "I don't back Obamacare. I never have. I want it to be repealed," he told The Washington Post in a telephone interview (Sullivan, 10/20).

The Washington Post’s Wonkblog: How The Supreme Court Could Still Wreak Havoc On Obamacare
Obamacare may not be the political issue it was this time last year, when a faltering Web site threatened to derail the program, but that doesn't mean it's in the clear. Ongoing legal challenges to one aspect of the law could still put its coverage expansion in serious jeopardy. The dispute has to do with whether the subsidies can be provided through public health insurance marketplaces in states that refused to set up their own, instead leaving the job to the feds. The administration and Obamacare supporters say the law was designed to provide premium subsidies to all states, regardless of who runs the marketplace (Millman, 10/21).

USA Today: New Doctors Site Rates For Experience, Quality
The first comprehensive physician rating and comparison database launches Monday in time for open enrollment on federal and state health exchanges, as well as for many employer-provided plans. The new version of the website uses about 500 million claims from federal and private sources and patient reviews to rate and rank doctors based on their experience, complication rates at the hospitals where they practice and patient satisfaction (O’Donnell, 10/20).

Politico: Few Motives To Fix Busted Health Data
Someday, doctors will have our data at their fingertips and will use it to prevent drug reactions, nip diabetes and cancers in the bud and lengthen our lives while preventing unpleasant and costly hospital stays. But for most doctors, that free-flowing information highway is a beautiful dream that doesn’t pay the bills (Allen, 10/20).

The Wall Street Journal’s Pharmalot: Senate Lawmaker Eyes Hearing On The Cost Of Hepatitis C Treatments
Responding to the ongoing controversy over the prices for new hepatitis C treatments, U.S. Sen. Bernard Sanders (I-Vt.) will probably hold a hearing – possibly before the year ends – to examine how the cost is affecting the U.S. Department of Veterans Affairs, according to his spokesman. Sanders is chairman of the Senate Committee on Veterans’ Affairs (Silverman, 10/20).

The New York Times: On Ebola Response, Congressional Republicans Put New Focus On Visa Suspensions
But a supercharged political atmosphere is making legislative nuance difficult two weeks before midterm elections and days before a hearing on Friday on the Ebola response called by the House Oversight and Government Reform Committee, a panel riven by partisan division. Republicans on the campaign trail continue to goad Democrats to embrace a broad travel ban, although no direct flights to the United States from Liberia, Sierra Leone or Guinea exist (Weisman, 10/20).

The Washington Post: CDC Issues Formal Guidelines Giving Workers More Protection Against Ebola
Federal health officials Monday tightened infection-control guidelines for health-care workers caring for Ebola patients, explicitly recommending that no skin be exposed. The beefed-up guidelines also call for health-care workers to undergo rigorous training, and to be supervised by trained monitors when putting on and taking off personal protective equipment. The government will issue step-by-step instructions for workers to follow in doing that (Sun and Berman, 10/20).

Los Angeles Times: New Ebola Protection Guidelines Leave No Bare Skin
After pointed criticism from healthcare workers and relatives of an Ebola-infected nurse, the U.S. Centers for Disease Control and Prevention announced new guidelines Monday for hospital protective gear. The guidelines, which were scheduled to be posted on the CDC's website late Monday night, were described by CDC Director Thomas Frieden during a telephone news conference (Morin, 10/20).

Politico: Dude, Where's My Czar?
The White House announced Friday that Ron Klain would be the country’s public point-person on Ebola, but so far what the “Ebola czar” isn’t doing has been clearer than what he is. Klain won’t be testifying this Friday on the Hill. He didn’t participate in a Saturday meeting of top officials on Ebola. And administration officials haven’t yet confirmed that he’s talked with the president since their conversation the day his selection was made public. Klain will be starting work on Wednesday, White House principal deputy press secretary Eric Schultz said Monday, but he won’t be testifying before the House Oversight and Government Reform Committee at the end of the week as Chairman Darrell Issa (R-California) had requested (Epstein, 10/20).

Los Angeles Times: Health Insurers Boost No On 45 Funding
California insurers have pumped more than $12 million over the last five days into a campaign to defeat Proposition 45, an initiative on the Nov. 4 ballot that would regulate health insurance rates. Blue Shield gave $2.66 million, WellPoint $6 million, Kaiser Permanente $3.73 million and Health Net $350,000, according to late filings at the secretary of state's office (Lifsher, 10/20).

The Washington Post: Booz Allen Buys Baltimore-Based Health Division Of Genova Technologies
Booz Allen Hamilton has acquired the health care division of Genova Technologies, an Iowa-based government contractor, for an undisclosed sum. The health care group, made up of about 40 employees, is based in Baltimore. The office has already been integrated into Booz Allen, said Susan Penfield, executive vice president of Booz’s health business (Jayakumar, 10/20).

The Associated Press: La. Health Dept. Seeks End To Billing Rape Victims
Sexual assault victims in Louisiana should not have to pay for their treatment in emergency rooms, the health department said Monday, announcing a proposal that would have a state victims’ assistance board finance the exams (10/20).

The Wall Street Journal: Judge Blocks Cancellation Of Philadelphia Teachers Contract
A judge on Monday temporarily blocked the Philadelphia public-school system from canceling the teachers union contract and requiring educators to pay a share of their health insurance premiums starting in December. The union, the Philadelphia Federation of Teachers, sought the injunction, claiming the five-member School Reform Commission that governs the district lacked legal authority to impose the changes. The school district said it would appeal Monday’s ruling (Calvert, 10/20).

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United Healthcare Criteria for Harvoni  Effective Date 10/15/2014
Harvoni™ (ledipasvir/sofosbuvir) is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.

Reform Update: Medicaid programs crafting limits on Harvoni usage
Which Medicaid beneficiaries will have access to Gilead Sciences' newest high-cost hepatitis C treatment, Harvoni, and when they'll get that access, now depends on prior-authorization criteria being hammered out by various state agencies.

Senate Lawmaker Eyes Hearing on the Cost of Hepatitis C Treatments
Responding to the ongoing controversy over the prices for new hepatitis C treatments, U.S. Sen. Bernard Sanders (I-Vt.) will probably hold a hearing – possibly before the year ends – to examine how the cost is affecting the U.S. Department of Veterans Affairs, according to his spokesman. Sanders is chairman of the Senate Committee on Veterans’ Affairs.

Harvoni: The Hepatitis C Cure that Most Can’t Get
These guidelines led to stringent prior authorization criteria, and ultimately denial of treatment to many who have been waiting for treatment for decades.

Harvoni: What You Need to Know about the Newest Hepatitis C Treatment

Despite steep price tag, use of hepatitis C drug among prisoners could save money overall
There’s nothing free about the revolution that’s shaking up hepatitis C treatment. A slew of newer drugs, including sofosbuvir, are nearly eliminating the virus with fewer side effects than the old standbys, pegylated interferon and ribavirin, which had limited effectiveness and caused fatigue, nausea and headaches. But at a cost of $7,000 a week, it seems obvious they are more expensive.

HCV - Medicaid Pharmacy Program Criteria & Prior Authorization (PA) Update
Evidence of Stage 3 or 4 hepatic fibrosis including one of the following
Evidence of extra-hepatic manifestation of HCV, such as type 2 or 3 essential mixed cryoglobulinemia with end- organ manifestations (e.g. vasculitis), or kidney disease (e.g. proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis). Documentation of the presence of extra-hepatic manifestations based on lab results or imaging results (e.g. CBC, erythrocyte sedimentation rate (ESR)/ C-reactive protein (CRP), urinalysis, BUN/ creatinine and angiography) must be submitted.
HIV-1 co-infection
Debilitating fatigue impacting quality of life
(e.g., secondary to extra-hepatic manifestations and/or liver disease) 

Effective October 16, 2014, the fee-for-service (FFS) pharmacy program will implement the following parameters associated with the treatment of Hepatitis C Virus (HCV). The clinical criteria and/or point of service editing below is the result of recommendations made by the Drug Utilization Review Board (DURB) at the September 18, 2014 meeting. Other recommendations made by the DURB at the September meeting will be implemented at a future date.

Drug Utilization Review (DUR) Board will meet on November 20, 2014 from 9:00 a.m. to 3:30 p.m., Meeting Room 3, Concourse, Empire State Plaza, Albany

Can AbbVie ABBV +0.51% make a dent in the burgeoning hepatitis C market? Now that the FDA has approved the Harvoni treatment from Gilead Sciences GILD -3.53% and a $94,500 price for a 12-week regimen has been established, attention is turning toward AbbVie and the steps the big drug maker must take to win market share. Already, though, some Wall Street prognosticators believe AbbVie may find it daunting.

Payers hit back at Gilead for $94,500 price tag on brand-new hep C combo pill
The price for the cocktail--which combines NS5A inhibitor ledipasvir and Sovaldi, a drug that recently became the fastest-ever to reach blockbuster status--is already sparking pushback from doctors, payers and consumers alike.

Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment

State Medicaid programs restrict use of new hep C drugs

Harvoni (ledipasvir/sofosbuvir) FDA Approved On Oct 10, 2014
HCV Newsetters: Everything you need to know about Gilead's Harvoni

As Hepatitis Pill Harvoni Joins Sovaldi, States Erect Medicaid Hurdles
A so-called insurer “prior approval” in Sovaldi’s case requires candidates for these new Hepatitis treatments to have a liver biopsy “to determine the severity of the disease,” according to Viohl, which interviewed state Medicaid administrators and analyzed pharmacy policies and preferred drug lists.

Sovaldi - How Some State Medicaid Programs Limit Drugs to Only the Sickest Patients
Because of its high cost, some state Medicaid programs and prison systems are refusing to provide Sovaldi to any but the sickest patients. Most recently, Oregon last month threatened to limit access to the drug unless it can get Sovaldi at a deeply discounted price.

Viohl & Associates
The Sovaldi®Squeeze:High Costs Force Tough State Decisions.

Watch - Sovaldi - What Can We Learn from Recent Hepatitis C Treatments?
On October 1, the Engelberg Center for Health Care Reform and the USC Schaeffer Center for Health Policy and Economics hosted a half-day forum to discuss the serious coverage challenges that accompany breakthrough treatments, such as the much-discussed new treatment for Hepatitis C, Sovaldi.

Why extremely expensive drugs are often worth the cost

Weekend Reading; Friday, anticipated date for FDA decision on Gilead's ledipasvir/price?
Investment Commentary
What will be the price of the Ledipasvir/Sofosbuvir combo?

So she received insurance approval for the expensive dual-drug combination of sofosbuvir and simeprevir, which she took May through July, with a $10,000 copay and a total medication cost of $144,000, she said. And it worked. Since her blood test in July, she has had no signs of infection...

WASHINGTON (MarketWatch) — With the California-based drug manufacturer Gilead Sciences planning to roll out another hepatitis C medication, academics said Wednesday that policy changes are needed in the costly drug market so the interests of patients, health insurers and pharmaceutical companies align.

France uses tax to put pressure on hepatitis C drug prices
The Socialist government said it had designed a "progressive contribution scheme" ensuring all patients can access new and more effective treatments against the liver-destroying virus, while limiting the burden of these drugs on state finances.

Cost-effectiveness Analysis of Sofosbuvir Plus Peginterferon/ribavirin in the Treatment of Chronic Hepatitis C Virus Genotype 1 Infection
This study comprises a health economic analysis of sofosbuvir + pegIFN/RBV for the treatment of patients with HCV genotype 1. Outcomes from the cost-effectiveness model show that sofosbuvir + pegIFN/RBV yields the most favourable future health economic outcomes compared with other currently available regimens across a broad spectrum of patients, including those with different treatment experiences and severity of fibrosis as well as individuals with and without HIV co-infection.

HCV Fall Issue: Gilead's Islands - The Road to Treatment Access
According to Andrew Hill, PhD, of the University of Liverpool and colleagues, three months of sofosbuvir could be mass-produced at a profit, and sold for as little as US$105. In September 2014, Gilead announced licensing agreements for generic sofosbuvir in 91 LMICs. The countries that are not included in these licenses must buy higher-priced sofosbuvir from Gilead. Limiting the countries where generic sofosbuvir can be sold will make it difficult for producers to reduce the price, because they cannot achieve economies of scale....

The academics argue that the reported value of drugs donated for research could be staggering for some studies. As an example, they point to Sovaldi, the hepatitis C treatment, which costs about $1,000 per pill for a 12-week regimen. An investigator enrolling 10 patients would be reported having receiving $840,000 from Gilead Sciences GILD -1.03%, the manufacturer.

Brunell: New drugs' cost has big impact on health care

As a result, more Americans are angry at the way their healthcare is delivered. For example, more than 90 percent said a $37.50 bill for a single Tylenol is outrageous. Eighty-nine percent believed that a doctor who orders an MRI because he owns the machine is also outrageous. And 80 percent found that a $1,000 per pill hepatitis C treatment was also outrageous.

Australia: Government refuses subsidy for hepatitis C medication, Sovaldi 
However, the Government’s Pharmaceutical Benefits Advisory Committee has rejected the medicine for subsidy because it says it too expensive and “would have a high financial impact on the health budget”.

New Hepatitis C Drugs and Faulty Journalism
Journalism is supposed to report the facts, but in reality, sometimes the goal is to agitate readers and raise doubt. These "news items" are saying, "Hey we have this expensive hepatitis C drug and although it cures nearly everyone, quite a few people discontinue taking it. What a waste of money. We should pity these poor insurance companies and understand why they don't want to pay for these expensive treatments."

ledipasvir/sofosbuvir - Gilead Signs generic licensing agreement for hepatitis C drug
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies - Cadila Healthcare Ltd.Cipla Ltd.,Hetero Labs Ltd.Mylan Laboratories Ltd.Ranbaxy Laboratories Ltd.Sequent Scientific Ltd. andStrides Arcolab Ltd. - to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries

Gilead Close to Sending $84,000 Drug to Poor Countries
Gilead Sciences Inc. (GILD:US) is close to a pact with generic drugmakers to bring low-cost versions of its $84,000 hepatitis C drug Sovaldi to about 80 developing countries including India, Indonesia, and Pakistan.

The broad licensing deal could be completed as soon as mid-September and would allow the generic manufacturers to produce Sovaldi and an experimental pill that combines Sovaldi with another Gilead hepatitis drug, said Gregg Alton, an executive vice president for Gilead, in a telephone interview...

Great Article:
We Now Have the Cure for Hepatitis C, but Can We Afford It?
A long, difficult and costly research effort gives doctors a new cure for hepatitis C

Why Is Everybody Picking on Sovaldi?
At Sovaldi’s present price, there is considerable resistance to diagnosing and treating everyone. State Medicaid programs, and likely many private insurers as well, are restricting Sovaldi to patients who have progressed beyond chronic HCV infection into cirrhosis. The State of Illinois has 25 criteria for prior approval and will not pay for patients with a history of drug and alcohol abuse. Since former and current drug users comprise the biggest infected group, not many in Illinois will be eligible for treatment. For now, Texas does not cover Sovaldi or Olysio. A majority of the medical experts in the California Technology Assessment Forum decided both Sovaldi and Olysio should be used only on patients with severe liver complications....
Continue reading...

New hepatitis C drugs could stop an epidemic that now claims more lives in the U.S. than AIDS. An estimated 250,000 New Yorkers are living with hepatitis C, a viral infection that can lead to cirrhosis, liver failure and liver cancer. But hepatitis C can be cured with only a few months of treatment by a combination of drugs that includes Gilead’s Sovaldi as the backbone.

NATAP Jules Levin
Australia's PBAC, Pharmacy Benefits Program, akin to Medicaid in USA, Rejects Sofosbuvir, here is their language 
They however recommended simeprevir+peg/Rbv. In the US several medicaids have set up harsh & punitive restrictions essentially denying access to drug users who show evidence of drug use in the past 12 months & only allowing access to those with advanced liver disease, when it is very late to treat putting patients at increased risk for liver cancer. Lawsuits are being threatened in the US & there is reason to think these actions by these medicaid programs are illegal, you can read more detailed discussions about this and a link to the Social Security Act Medicaid Rebate Law where it appears that in return for receiving a 23% discount & 44% for VA the medicaid's are required to provide access, again hopefully lawsuits will be launched to challenge this, interestingly the lawsuits apparently will come from individual patients, why don't HCV advocacy organizations launch a lawsuit or at least challenge the legality of the restrictions with federal & congressional officials & political representatives. Jules Levin

California Department of Health Care Services Utilization and Treatment Policy for Simeprevir and Sofosbuvir in the Management of Hepatitis C
New California HCV Treatment Policy Requires Urine Analysis for Substance Use; Denies Access to Drug Users(IDUs) & Patients with Early HCV Disease: patients must have documented advanced HCV disease
Read more @ NATAP

Curing hep-C will take a diverse strategy, including price breaks from drug-makers
(Guest column)
We should consider win-win strategies to make curative HCV medications available to HCV patients in need. I would propose several strategies with a goal to cure all HCV patients:

Prioritize the patients with more advanced liver disease who would benefit most from early treatment and plan to treat patients over five years.

Request of the pharmaceutical industry, which is making its greatest profit in the U.S., price reductions for the medically underserved U.S. population to match reductions offered to underserved international populations. For example, up to 90 percent price reductions are offered in parts of Egypt and India.

Request of the federal government a specific “carve out” to increase funding of hepatitis-C in the Oregon Medicaid population....

Hepatitis Australia today welcomed the recommendation to add simeprevir (Olysio) to the Pharmaceutical Benefits Scheme (PBS) for the treatment of genotype 1 chronic hepatitis C. 
Responding to the PBAC decision to reject an application to subsidise the antiviral medication sofosbuvir (Sovaldi), Ms Tyrrell said “it’s a sad day when access to game-changing therapy is denied. This is a bad outcome for people living with hepatitis C”.

Sovaldi and the politics of high-priced drugs: are we asking the right questions?
Other countries' assessments-
Many other countries have concerns about paying for high-cost drugs. But unlike the US, several, including Canada, Scotland, England, France, Germany, Australia, Brazil, and South Korea, have formal Health Technology Assessment (HTA) agencies to evaluate the effectiveness and/or cost-effectiveness of such drugs.

As researchers at Zitter, we wanted to find out how these parties would react to the expected steady, almost rhythmic approval of hepatitis C agents expected between 2014 and 2018. In January of this year, we began by surveying 100 payer representatives about their attitudes and management expectations for the category. We also surveyed 150 specialist physicians and 50 primary care doctors to gather their attitudes and reactions to the new entrants and payer decisions. Finally, we conducted interviews with a handful of practice managers at infectious disease and gastroenterology practices to get the story behind how payer policies impact treatment decisions and day-to-day operations...

Patients First: Cost–Benefit Considerations in HCV Therapy
Hello folks, with all this controversy over the high price of Gilead's Sovaldi, it was refreshing, and informative to watch a video presentation where the focus is on the HCV patient, and not only on drug cost.

Instead of complaining about how much Sovaldi costs why not use the drug to stage a war on hepatitis C?
"It strikes me that we are going about this in entirely the wrong way. Instead of complaining about how much Sovaldi costs and trying to tamp down its use, why not use the drug to stage a war on hepatitis C? "

$1,000 Sovaldi now hepatitis treatment of choice
Wednesday, August 20, 2014
WASHINGTON — The price is sky-high, but so is demand. A new $1,000-per-pill drug has become the treatment of choice for Americans with hepatitis C, a liver-wasting disease that affects more than 3 million...
Even with insurers reluctant to pay, Sovaldi prescriptions have eclipsed those for all other hepatitis C pills combined in a matter of months, new data from IMS Health indicate. The promise of a real cure, with fewer nasty side effects, has prompted thousands to get treated...

James Raftery: Sofosbuvir for hepatitis C—moving to country specific prices
Pharmaceutical companies have tended to charge a single global price, but it is based on the US market, which accounts for over half of all branded pharmaceutical sales. This might be termed the Apple strategy, in that an iPhone costs more or less the same in all countries. While this can ensure enormous profits, its application to effective drugs is often seen as unethical.

Investment Commentary
Don't worry about a hep C pricing war, analysts tell Gilead-watchers

The Medical Innovation Threat
The attack on a near-cure for Hepatitis C is a prelude to price controls.
Sovaldi is the kind of medicine that the drug scolds claim to want—a true scientific advance with a near-perfect cure rate for Hepatitis C, the liver-destroying virus that infects one of every 100 Americans and some 150 million world-wide. The old critique was that pharmaceutical discovery had stalled and the industry produced only me-too drugs. Now they attack Sovaldi because its price is $84,000 a patient. The claim by the insurance industry and liberals is that the market is producing irrational and anticompetitive prices. So politicians are moving to do what comes naturally, which is transfer pricing control to government....

American ingenuity can make it happen
Sovaldi represents great pharmaceutical innovation. Results have been exceptional. Unfortunately, the drug's maker — taking advantage of a lack of competition fostered by patent protection — has priced it so high as to be a major threat to health care affordability.

States typically have to cover drugs from makers that participate in Medicaid’s drug rebate program, which includes Gilead Sciences, the company that sells Sovaldi. According to the company, 47 states are covering the drug for their Medicaid populations. But in order to limit its use, about half are enforcing “prior authorization,” essentially creating lists of criteria that patients must meet before a doctor can prescribe the drug. Most commonly those criteria require a patient to be in the worst stage of hepatitis C, which is cirrhosis, and that they be drug-free for a period of time. The goal is to restrict Sovaldi to people who already have severe liver damage, which opponents argue is too late. Among the states limiting Sovaldi are California, Florida, Louisiana and Oregon, which typically have larger Medicaid populations and more patients with hepatitis C....

Medicaids/ Feds Deny HCV Treatment to Poor/Disenfranchised, Those Most Affected by HCV-
HCV Restrictions New Meeting Dec 18, 2014 by California Panel (CTAF) That Previously was the 1st to construct absurd restrictions .....the CTAF meeting in March 2014 was the 1st "kangaroo court" to restrict HCV treatment access, it appeared rigged as all these efforts are, they are not in the best interests of patients/marginalized patients and are opposite of the spirit of Medicaid & federally funded healthcare...they say - HCV treatment is too expensive...we can't treat everyone....we will construct restrictions that in affect deny access to drug users & treat only those with advanced disease

This month a new section was added to AASLD/IDSA recommendations for testing, managing, and treating Hepatitis C titled; When and in Whom to Initiate HCV Therapy. Alan Franciscus, Editor-in-Chief at HCV Advocate offers a review with commentary on the update, view the entire report here, on their website.
The revised guidelines contain good news and bad news portions, but I think I get why these societies took this approach given the limited resources and high prices of the current standard of care drugs for treating hepatitis C. More on this later; but first I would like to recap the recommendations. I have also added my comments after each section of the recommendations.

The Associated Press: Medicaid Insurers Seek More From Massachusetts
Companies that insure Medicaid patients in Massachusetts are pressing for an increase in the payments they receive from the state for serving low-income residents. The health insurers say $140 million in losses since the start of the year are the result of an expensive new hepatitis C drug and a surge of nearly 190,000 new members assigned to the companies by MassHealth, the state Medicaid program. Insurers say the state did not budget enough money to cover added costs.

September issue of "Annals of Hepatogly" addressing the cost of new HCV therapies.
PDF - The good, the bad and the ugly of the new treatments for hepatitis C virus 
The cost of new hepatitis C treatments
Karen V. Silva-Vidal, Nahum Méndez-Sánchez. Liver Research Unit ...

Updated - Debunking the Myths of Treating Hepatitis C
Myth: New treatments for hepatitis C are not worth the cost.
Fact: New and forthcoming hepatitis C treatments can cure over 90 percent of patients, providing tremendous value to patients and society.
  • Until recently, available therapies used to treat HCV infection cured only about half of patients, but with debilitating flu‐like side effects. For those who failed to respond to treatment, there were no alternative medicines to treat the disease.
  • With new and forthcoming treatments, patients will be more likely to adhere to their medication regimens given that there are fewer side effects and non-injectable options are now available.
  • The availability of more effective treatments provide the opportunity to improve outcomes for HCV patients who are frequently unable to work or have significantly more lost work days per employee than other workers, including sick leave, short‐term disability, and long‐term disability.....
UK Says Sovaldi Is Worth It. We Should Listen.
It’s rare that I get to say this – but we can learn something from the United Kingdom. As our “free-market” healthcare system deliberates whether Gilead is charging a “just” price for its Hepatitis C (HCV) drug, Sovaldi, the UK’s National Institute for Health and Care Excellence (NICE) just approved the drug as being cost-effective, and recommended it for subgroups of patients...

UK Recommends Covering Sovaldi Hepatitis C Pill
After reviewing the data, though, NICE agrees that Sovaldi is an effective improvement over existing treatments. The Gilead drug, by the way, can cure nine of 10 patients. The decision was likely helped by the lower price tag in the U.K. Gilead is selling its drug for about $56,000, according to a NICE spokesman. “It’s a lot cheaper here,” he tells us. The agency is recommending Sovaldi, plus interferon and ribavirin, for adults with genotype 1, which is the most common form of hepatitis C, and accounts for 46% of all cases in the U.K., a NICE spokesman says. The recommendation also extends to patients with genotype 3, which accounts for 43% of hepatitis C sufferers (read the complete NICE document here).

Sovaldi Debate Hurts Access for Opioid Treatment Patients
The tussle over the cost of the Sovaldi hepatitis C medication may prevent yet another segment of the population from being treated – people who are enrolled in opioid treatment programs.

New Hepatitis-C drug Sovaldi 99% cheaper in India
"The pricing of Sovaldi in India at $300 per bottle, is our low income pricing, similar to the price negotiated with Egypt for its government-run programme. We hope with local production by our partners in India, higher volumes and continued research & development on the drug will lead to a further reduction in prices at a later stage", Gregg Alton, executive V-P (corporate & medical affairs), Gilead Sciences told TOI in a telecon from the US. 

Listen-Solving Sovaldi: David Harlow Talks Value-Based Payment with Cyndy Nayer
We have been deluged with stories about the $100-a-pill medication for Hepatitis C. Is it really worth $87,000? (Well, it's cheaper than a $600,000 liver transplant.) I had the opportunity to speak with Cyndy Nayer, of the Center of Health Engagement, about the issues surrounding this drug and its use, value-based approaches to payment, and the question of whether we are able to solve this problem in our current environment at all...

Last week, we heard that Medicare would have to pay up to $5.8 billion next year to treat just a fraction of eligible patients with the expensive new drugs--including Gilead Sciences' ($GILD) Sovaldi, which runs $84,000 for a 12-week course, and Johnson & Johnson's ($JNJ) Olysio at $66,300...

Op-Ed: Hepatitis C cures available — For $36,000 and $55,000?
Hepatitis C is a very nasty, very common disease. It destroys the liver, and is highly transmissible, even through sharing a razor blade. A cure using drugs called Simeprevir and Sofosbuvir is available, but it’s incredibly expensive.

Inside Views Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens
Summary: Compulsory licences should be issued to roll out generic versions of innovative HCV drugs. Only generic competition can push down the extortionate prices of these lifesaving medicines, while placing equitable access and public interest before monopolistic pharma companies’ business strategies.

What Will the new Hepatitis C Medicines do to Medicare Part D?
By Ed Silverman
In the latest salvo fired over the cost of hepatitis C treatments, a new report projects that the cost of these drugs – including the Sovaldi medication sold by Gilead Sciences GILD +0.74% – will increase 2015 federal spending by Medicare Part D between $2.9 billion to $5.8 billion.
Continue Reading..

Illinois Med Director on Gilead Hep C Pill: “We Want to be Compassionate” 
The $84,000 per patient cost for the Sovaldi hepatitis C treatment has caused a national uproar amid an intensifying debate among lawmakers, insurers and economists about the value of expensive medicines to society at large. The dilemma caused by Sovaldi, however, is also forcing state Medicaid programs to make hard choices. In Illinois, for instance, officials recently instituted a new set of 25 stringent criteria for using Sovaldi, which include treating only those patients with the most advanced stage of liver disease and limiting treatment for those with a history of drug use and alcohol abuse. We spoke with Arvind Goyal, medical director for the Illinois Department of Health Care and Family Services, about the process. This is an edited version.

Pharmalot: What was your reaction when you heard about the Sovaldi price?
Goyal: If I were a patient who needed Sovaldi, I imagined what I would do about a 20% deductible, which would cost me $200 a day for 12 weeks. The state doesn’t pay me that well… My second reaction, at the time, was I could see a problem coming. We began to notice the number of requests for prescriptions going up. And after nearly three months after Sovaldi hit market in January, we had 186 requests. None were denied and it was costing the program upwards of $1 million a week....
Continue reading...

Gilead struggles to shift debate over $1,000 hepatitis pills from costs to cures
When Gilead Sciences Inc. President John Milligan recently told Wall Street analysts that he expected more stories centering on the growing number of patients benefitting from the company’s pricey hepatitis C drug Sovaldi, he wasn’t kidding.

The head of Blue Shield of California on Monday said Gilead Sciences’ controversial hepatitis C drug is unsustainable at $1,000 a day, joining a growing chorus of payers who are unhappy with the price.

“How much can we afford to pay for one drug? How much profit does one company deserve for producing that drug?” wrote President and CEO Paul Markovich in an editorial that appeared exclusively in The Chronicle. “With last month’s release of record earnings for Gilead Sciences — nearly $6 billion in profits in half a year from the hepatitis C drug, Sovaldi, these questions need to be answered.”

Headquartered in San Francisco, Blue Shield of California serves about 3 million members statewide.

Gilead Faces New Pressure From U.S. Senators & Europe Over Hep C Pricing
By Ed Silverman
The moves come amid tremendous controversy over pricing. The medication can cure about 90 percent of the patients who have the common form of hepatitis C, but costs about $1,000 a day for a 12-week course, or $84,000 for one patient. Given that there are about 3.2 million people in the U.S. who are chronically infected, and as many as 4 million people are infected each year, according to the World Health Organization, the potential sales have been exciting Wall Street....

Gilead has agreed to charge much less in some countries, such as Egypt, where the same treatment will cost $900, but several European nations, led by France, do not expect to receive a similar break. Numerous medical associations in France have reportedly issued a joint warning over the cost of Sovaldi and other forthcoming drugs....

EU nations join forces against 'exorbitant' hepatitis C drug
(MENAFN - AFP) France said Thursday it has joined forces with 13 other European countries to negotiate a lower price for a promising new hepatitis C drug that has drawn controversy for its astronomical cost.

Sovaldi, made by US pharmaceutical firm Gilead Sciences, has shown huge potential at helping cure the liver disease but its price - more than 50,000 euros (68,000) for a 12-week course of treatment - has health authorities concerned.

"If we accept such a high price, firstly we won't be able to treat everyone and we will also be creating a risk for our social security system, which means for other patients," French Health Minister Marisol Touraine said Thursday.

The Coming Debate Over Specialty Drugs
 Drug costs represent just 15% of total health spending, compared to nearly one-third spent on inpatient care. Short-term budget spikes could become long-term savers from both a cost and health standpoint. For the most severe patients, the price of Hep C medication – that is nearly 90% effective – is three to six times less than treating a lifetime of cirrhosis ($270,000) or providing a liver transplant ($580,000.) Patients essentially “cured” of Hepatitis C can go on to have productive, long lives.

Patients First: The Right to Be Treated and Cured, by Alan Franciscus 
The problem of the high cost of current medications is already impeding access to treatment.  Insurance companies, government payers (Medicare, Veterans Healthcare, etc.) are trying to come to terms with the expense of the medications when the great number of people who need to be treated is factored into the equation.

Hepatitis C - We all pay for $1,000 a pill drug 
"At $1,000 per pill, Sovaldi costs $84,000 for a single course of treatment, and well over $100,000 when combined with other medications."
High-priced drugs are not a new phenomenon. Drug makers have long used monopolies to inflate prices. But the trend with so-called specialty drugs is a game changer. Startling as the price of Sovaldi is, it's just the canary in the coal mine...
Read the complete article here.... 
A hepatitis C primer

Why does Sovaldi cost $84,000? Gilead Sciences being pressed hard for an answer
Payers, politicians and some regulators have been balking at the $84,000 price tag on Gilead's ($GILD) hepatitis C treatment Sovaldi ever since it hit the market in January. Now two top members of Congress are demanding that the company appear at a congressional hearing to explain the product's high price.

Of Interest:
Reducing the cost for Gilead's hepatitis C drug Sovaldi
Stephen Vogt, PharmD, Chief Executive Officer and President of BioPlus Specialty Pharmacy, discusses the ongoing debate surrounding the high price of Hepatitis C treatments versus the efficacy of the drug. This video was shot at the Armada Health Care Specialty Pharmacy Summit and Expo in May 2014.

Gilead Hepatitis-C Drug Boost Seen on Medicare Test Plan
Medicare, the U.S. health plan for older Americans, will cover the cost of screening for hepatitis-C, a decision that may further open the government’s wallet for Gilead Sciences Inc. (GILD:US)’s $84,000 cure for the disease.

Adults at high risk for infection, including those who inject illegal drugs or had a blood transfusion before 1992, are eligible, as is anyone in Medicare age 49 to 69, the agency said in a memo today. A hepatitis-C diagnosis could lead to further use of Gilead’s Sovaldi, which costs $84,000 for a 12-week course of treatment and cures the disease.

While 2.7 million Americans may be infected with Hepatitis-C, health officials say many don’t know it since the virus can lay without symptoms for decades before scarring the liver, leading to cancer, organ failure and a transplant. Medicare didn’t previously cover screening, according to the Centers for Medicare and Medicaid Services, or CMS.

The decision to pay for testing “should increase the rate of diagnosis and at a minimum help CMS make informed treatment decisions,” said Ian Somaiya, an industry analyst at Nomura Securities International Inc. in New York, in an e-mail. “The net of all this points to higher Sovaldi sales.”

Quebec Becomes First Province to Reimburse Sovaldi® for the Treatment of Chronic Hepatitis C
MONTREAL, June 2, 2014 /CNW/ - Gilead Sciences Canada, Inc. is pleased to announce that the Health and Social Services Ministry has placed Sovaldi® (sofosbuvir), the newest treatment for chronic hepatitis C virus (HCV) infection approved for sale in Canada, on the Liste de médicaments (effective June 2, 2014). With this listing, Quebec becomes the first Canadian province to provide access to Sovaldi for treatment-naïve patients with genotypes 1 and 4 HCV infection regardless of liver severity.

The coming epidemic
Based upon data available, as many as five to ten per cent of the population of Pakistan is infected with Hep C. And even though this disease can be controlled with medications, a vast majority of those infected either don’t know that they are infected or else do not have the wherewithal to pay for treatment. The important thing to remember about both these diseases is that even after infection it takes many years before the symptoms start to appear and by that time it is often too late to do much at least as far as Hep C is concerned. The interesting question is how so many people in Pakistan got infected with Hep C.

Sovaldi - When ‘miracle’ cures, cost collide
“My virus is now undetectable,” said Barnstable resident Laurel Welch, 65, a retired nurse who contracted hepatitis C through contact with contaminated blood 25 years ago and began taking Sovaldi in January. “I was so sick for so long. Now I’ve got a new life.”
Sovaldi, sold by California-based Gilead Sciences Inc., may also represent the future of cutting-edge drugs in another way: At $1,000 a pill and $84,000 for a full treatment regimen — plus the cost of companion medicines — it’s straining the finances of insurance companies.

Why does Gilead's Sovaldi cost $84K in the U.S. and $57K in Britain?
May 29, 2014 | By
As AARP's Debra Whitman told Kaiser Health News, "This is an issue other countries have solved." In Germany and the U.K., Sovaldi's price is far less, because regulators actually consider cost as they decide whether to pay for particular treatments.
In Germany--which launched a strict pricing program as part of budget cuts--Sovaldi costs $66,000 for a 12-week treatment course, Whitman said. In Britain, where the National Institute for Health and Care Excellence (NICE) measures the cost-effectiveness of new treatments, it's $57,000, she said.

Sovaldi : A medical breakthrough actually worth paying for
So is this yet another case of Big Pharma holding patients hostage with their colossal prices? Not quite. If price is truly a reflection of value (as it should be), then it should come as no surprise that these new oral treatments hit the market at a higher price than their clinically inferior predecessors.

At $1,000 per pill, new Hepatitis C drug has insurers and CCOs scratching their heads
Coordinated Care Organizations, which serve Oregon Health Plan patients, also are grappling with the issue. About 5,600 OHP clients have hep-C, but another 13,000 are likely infected, or altogether 24 percent of total patients in the state.

Curing Hepatitis C - U.S. Health Care System Is 'Penny Wise & Pound Foolish'
Curing Hepatitis C not only dramatically improves patients’ lives, but has the potential to save the U.S. health care system as much as $9 billion per year by preventing expensive hospitalizations and avoiding thousands of liver transplants that routinely cost over $500,000 each.

The Price is Right: New Hepatitis C Drug is Really a Priceless Breakthrough
As an infectious disease physician I greet the release of path-breaking new treatments for any infecting pathogen with excitement. Such innovations represents another instance of man’s mind succeeding in the continual war with microbes.

Hepatitis C is a scourge that is the leading cause for liver transplantation infecting close to 4 million Americans and over 180 million individuals globally. The historical treatments for this virus have been long, cumbersome, and laden with horrible side effects. The newest drug in our armamentarium, Sovaldi (sofosbuvir), offers the promise of substantially shortening treatment regimens while, at the same time, enhancing treatment response. In short, this is a wonder drug that we all should be grateful to scientists for developing and pharmaceutical companies for funding..

‘National Dialogue’ Urged On Cost Of New Hepatitis C Drug
The outcry continues over the $1,000-a-pill hepatitis C drug made by California-based Gilead Sciences.

While the drug is a significant advance over older treatments for the viral liver disease, the price set by the company “represents an abuse of market power,” said John Rother, president and CEO of the National Coalition on Health Care, which includes businesses, unions, insurers, consumers and some drugmakers, including Teva Pharmaceuticals and the Generic Pharmaceutical Association

On Wednesday, the group urged a “national dialogue” on the cost, saying Sovaldi’s price tag threatens the budgets of government run-health programs as well as the premiums for everyone who has private insurance.

Expensive New Hepatitis C Drug Raises Alarms
Many payers and pharmacy benefit managers have begun to push back against Sovaldi's price, with some threatening to stop using the drug once a rival medicine is approved in the United States. State Medicaid directors have also raised concerns, saying that taxpayers will have to shoulder much of Sovaldi's costs since many hepatitis C patients get their health care from the government.
Some insurers, including a number of state Medicaid programs and the Department of Veterans Affairs, have decided to limit use of Sovaldi to patients with more advanced disease, saying others can wait without risk because the disease progresses slowly. This approach has also been advocated by an expert panel.

Insurers scrutinize drug costs after $84,000 Sovaldi surprise
(Reuters) - Shocked by the rapid adoption of a new $84,000 hepatitis C treatment, U.S. health insurers are trying to make sure they aren’t blindsided by other drugs being developed and are looking for ways to limit their use from the day they are launched.

Manufacturer Gilead Sciences Inc says 30,000 people have received hepatitis drug Sovaldi so far, and that sales hit a record-breaking $2.3 billion within a few months. The treatment, typically 84 pills taken over 12 weeks, completely cures the disease in more than 90 percent of patients.

Gilead Sciences' Sovaldi - The $84,000 question: Will focusing on drug prices rein in costs?
Why are U.S. prices so much higher? For one, governments in other countries negotiate drug prices, something Medicare, the U.S. insurance plan for the elderly and disabled, is prohibited by law from doing. For another, it's still politically untenable in the U.S. to push back on drug prices, said Mark Schoenebaum, an analyst with ISI Group.

Weekend Reading - HCV in Egypt and Gilead’s Sovaldi
Egypt will not patent new hepatitis C drug
 A longer version of this article was published in the South-North Development Monitor (SUNS), under the title "No sofosbuvir patent in Egypt, but Gilead deal still expensive", issue #7782, April 10, 2014. This Article was published on Mada Masr on the 23rd of May 2014
Translated by: Amira Elmasry -----
The agreed price, US$300 per month, is equivalent to approximately LE2,000, which is the average monthly income of an Egyptian family. However, the Egyptian Ministry of Health considered this price a success.

Medicaid Directors Question Need for $1,000 HCV Pill
Published: May 22, 2014By Michael Smith, North American Correspondent, MedPage Today
According to the report, studies of sofosbuvir (Sovaldi) are generally of poor quality, mostly directed by the drug's maker, and don't answer key questions, including whether the drug is better and safer than the current standard of care.
The evidence base for one of the star hepatitis C drugs is poor and the guidelines for its use are flawed, according to a report prepared for the National Association of Medicaid Directors.

Illinois prisons approve Sovaldi, but not for all
IDOC spokesman Tom Shaer noted that the state is paying a discounted $65,000 per course of treatment, but conceded that not every inmate with hepatitis C will receive it.

U.S. health insurers say Gilead hepatitis C drug too costly
The latest salvo in the war on escalating U.S. healthcare costs came from AHIP - America's Health Insurance Plans - and targeted Sovaldi, the new $84,000 hepatitis C treatment from Gilead Sciences Inc.

Q&A: How much would Hepatitis C cure cost?
This is not an isolated predicament. Specialty drugs account for less than 1 percent of all prescriptions but more than a quarter of spending. Other high-cost specialty medicines in the pipeline include treatments for high cholesterol and diabetes.

NPR Update
Medicare Backs Down On Denying Treatment For Hepatitis Patient
 Late Tuesday, Bianco's doctor got word that the earlier denials had been reversed.

Monday HCV News Ticker - Medicare Struggling With Hepatitis-C Cure Costs 
However, the private insurer that handles his medication coverage for the federal Medicare program has twice refused to pay for the drugs his doctor has prescribed.

AbbVie's $84,000 question
By Andrew L. Wang
May 12, 2014
AbbVie Inc. has 84,000 reasons to believe that its new treatment for hepatitis C will be a blockbuster.
That's how many dollars pharma rival Gilead Sciences Inc. is charging for a 12-week regimen of Sovaldi, its new treatment for the potentially fatal liver disease. A cure rate of more than 90 percent is driving demand for the drug despite its lofty price tag, earning the Foster City, California-based company $2.3 billion in the first quarter.   Gilead's windfall is no doubt figuring into AbbVie's strategy for how it introduces its own treatment in the fourth quarter. AbbVie CEO Richard Gonzalez has said only that the North Chicago-based company's unnamed therapy intends to compete with Sovaldi on merit rather than price....

Medicare Struggling With Hepatitis-C Cure Costs 
Another part of Medicare's problem is that new hep-C medications are among the priciest of any drugs. One called Sovaldi, federally approved last December, costs $1,000 a pill - or $84,000 for a typical 12-week treatment course. The other recently approved drug, Olysio, costs around $66,000. Others in the pipeline are expected to be similarly expensive.

Updated: VA puts Gilead's $1,000-a-pill hepatitis C drug on its list of meds
The formulary decision by the VA comes as a panel assembled by the system last month recommended that doctors warehouse hepatitis C patients, putting those with advanced liver disease on Sovaldi first. By triaging patients, health care providers can absorb the patient load — and Sovaldi's cost — over 10 to 15 years, said Gilead President John Milligan. What's more, the strategy allows those lower-risk patients to receive next-generation treatments under development by Gilead and others.....

Gilead's Sofosbuvir- NHS forced into emergency action to fund ‘game-changing’ Hep C drug
Three weeks ago, we revealed that NHS England had agreed to early funding of the drug, Sofosbuvir, for 500 patients with a severe form of the disease who were otherwise likely to die or to need a liver transplant within a year. However, no patient has yet received the drug after it emerged that NHS England had not worked out a procedure for moving the funding to the doctors who wanted to prescribe the drug.

Merck CEO: Act now to prevent higher hepatitis C costs later

May the best drug win. That's how Merck Chief Executive Ken Frazier views the competition to treat the as many as 150 million people worldwide with hepatitis C....

Watch: The discovery of HCV and why drugs like Gilead’s Sovaldi are the center of an economic debate
 Thirty years ago patients who received a blood transfusion had a 30% chance of contracting hepatitis infection, in this video Dr. Harvey Alter, whose research led to the discovery of hepatitis C will discuss his work and the history of HCV.
We also examine how Chiron’s secret six-year effort led to the tests that virtually eliminated the virus from the blood supply, why drugs like Gilead’s Sovaldi are the center of an economic debate on the treatment of HCV, and envision a world in which HCV has been eradicated.
And we talk with Dr. Steven Pearson , who led a health technology assessment of Sovaldi.

Watch Donald Jensen MD on Chicago Tonight on the high price of new hepatitis C treatments
An estimated 3.2 million Americans live with hepatitis C. Traditional treatments didn’t always cure the viral infection and often came with severe side effects. Late last year, the Food and Drug Administration approved two new drugs, Sovaldi and Olysio, for the treatment of hepatitis C.
But the drugs come with a hefty price tag, starting at $66,000 for Olysio and $84,000 for Sovaldi. Brandis Friedman has more on the treatments and their costs.

Gilead says its drug gives hepatitis C patients more cost-effective cure
Patients who weren’t getting proper treatment for hepatitis C now are getting it thanks to Sovaldi, the controversial new hit drug from Gilead Sciences Inc., an official from the company said Wednesday.

The cure for hepatitis C is upon us, but at a costly penny
here is a revolution coming to the treatment of hepatitis C. But a big fat asterisk is required with that assertion.
In the coming months, a number of drugs are going to be rolled out that can essentially “cure” hepatitis C. (More on the C-word in a moment.) The most talked-about, by far, is Sovaldi, a product of Gilead Sciences Inc. It is a single pill that contains the drugs sofosbuvir and ledipasvir.
The clinical trials involving this drug have produced some eye-popping results. They show that treating people infected with HCV, the virus that causes hepatitis C, with a single pill a day for as little as eight weeks can reduce the virus levels in their bodies to undetectable levels. This is referred to as a “functional cure” or remission, because relapse is possible. But the relapse rate is only 5 per cent after eight weeks, and it drops to 2 per cent if the regime is followed for 12 weeks, and to 0.2 per cent after 24 weeks of treatment....

Sovaldi PBS Video :Report on Gilead's profits, coverage and costs
A new drug has a 90 to 100 percent chance of curing the Hepatitis-C virus, but costs tens of thousands of dollars for a course of treatment. The announcement by the manufacturer that it earned more than $2 billion in the year’s first quarter raises the question, who should pay when drugs are highly effective, but extremely expensive? Hari Sreenivasan reports on the profits, coverage and costs. 

DAA is $1,000 a pill; SVR is priceless 
The Price of a Cure
The new generation of direct-acting antiviral agents for the treatment of hepatitis C virus promise a potential cure for an estimated 3 million infected Americans, but also promise to come with a high price.

UnitedHealth: New hepatitis C drug costs far more than forecast
Daniel Schumacher, chief financial officer of the group's UnitedHealthcare division, said the spending on Sovaldi could begin to moderate after the first big wave of patients are treated with the drug.

Sovaldi is widely viewed as a breakthrough in treating the liver-wasting virus, since it has been shown to cure most patients after a 12-week course of therapy.

Many doctors had waited for drug, which was approved for use in the United States in December, before prescribing treatment for their patients.....

Nature News: Hepatitis C drugs not reaching poor
Three decades after wrestling to lower the cost of AIDS drugs (prices fell from about US$10,000 per patient per year in the 1990s to less than $100 in the mid-2000s), they are once again asking how expensive life-saving medicines can be made affordable for patients. 

New Hep C Medicines a Bargain Compared to Alternatives
Drugmaker Studies Find a Bargain in $84,000 Medicine .... Older approaches required injections of two medicines, the immune-system booster interferon and the antiviral ribavirin, for as long as a year, causing side effects including flu-like symptoms and anemia. Combined with Vertex Pharmaceuticals Inc.’s Incivek, those treatments cost almost $200,000 per cure ....
Continue reading @ Bloomberg

Gilead Sciences agrees Sovaldi discount with Doctors Without Borders: report
Gilead Sciences reached a deal allowing Doctors Without Borders to procure the company's hepatitis C drug Sovaldi (sofosbuvir) at $900 for a 12-week treatment course, significantly below the price of $84 000 in the US, Bloomberg reported Friday. Isabelle Meyer-Andrieux, an adviser at Doctors Without Borders, said the discounted price applies to countries including Kenya, Mozambique, Myanmar and India.

Texas Medicaid holds off on proposed limits for Gilead hepatitis drug
By Caroline Humer
Fri Apr 11, 2014 2:49pm EDT
(Reuters) - Texas is reconsidering whether to impose strict limits on Gilead Sciences' $84,000 hepatitis C treatment for patients on the state's Medicaid health plan for the poor, at the urging of outside advisers, a state official said on Friday....

Reuters - Doctors welcome hepatitis C drug rivals, Gilead still leads
"Competition will drive the price down, but probably not far enough," said Markus Peck-Radosavljevic, professor of medicine in the Medical University of Vienna and secretary-general of EASL.

The current U.S. price for a 12-week course of treatment with Sovaldi is $84,000, and Gilead has said the price in the United Kingdom is about $57,000.....

U.S. drug industry group defends price of Gilead hepatitis drug
The leading U.S. pharmaceutical industry trade group on Thursday defended the cost of Gilead Sciences Inc's new hepatitis C drug, Sovaldi, saying such treatments offer a priceless breakthrough for patients with the liver-destroying virus.

"Their lives, in short, will be transformed," Pharmaceutical Research and Manufacturers of America (PhRMA) President John Castellani said at the group's annual meeting in Washington. "The value to these patients, and to their loved ones and society - you can't put a price tag on it."

Reuters - Natco moves to oppose Gilead hepatitis C drug patent in India
(Reuters) - India's Natco Pharma Ltd has formally asked the Indian patent office to deny U.S. drugmaker Gilead Sciences Inc's breakthrough hepatitis C drug Sovaldi a patent in India, a source with direct knowledge of the matter said. If successful, the move could clear the way for the Indian company to launch a generic version of the drug. Natco has filed a so-called "pre-grant opposition" with India's Controller General of Patents, Designs & Trademarks, said the source, who declined to be named because the information was not public yet. Reuters could not immediately obtain a copy of the filing. Natco Chief Executive Rajeev Nannapaneni declined to comment. Officials at the Indian patent department in Mumbai were not immediately available for comment. India's patent laws allow a third party to dispute the validity of a pending patent application. Natco has opposed the patent on the grounds that Sovaldi is not "inventive" enough, the source said. Foster City, California,-based Gilead aims to license Sovaldi to three or four Indian generic manufacturers to allow sale of the medicine at lower prices in some 60 developing nations including India.

Emerging Markets Pay 1% of U.S. Price for Gilead Sovaldi
Developing countries such as Egypt, India and Brazil won discounts to pay 1 percent of the $84,000 price Gilead Sciences Inc. (GILD) is charging U.S. patients for its new hepatitis C drug. Wealthier countries such as Ukraine and China may not be so lucky, according to Doctors Without Borders, the nonprofit international aid group.
Countries including Kenya, Mozambique, Iran and Burma also negotiated a $900 price for a 12-week course of Gilead’s Sovaldi, Isabelle Meyer-Andrieux, an adviser at Doctors Without Borders, said today at a liver disease meeting in London. The medicine is typically given for 12 weeks.
Egypt has one of the world’s highest rates of infection of hepatitis C and has treated more than 350,000 patients at the government’s expense over the last six years, said Wahid Doss of the National Hepatology and Tropical Medicine Institute in Egypt. While Gilead asked Egypt for a higher price at first, the country was able to win better terms, Doss said...........

Express Scripts adds fuel to the fire in fight over Gilead Sciences' Sovaldi
There has been pushback by others, including states that believe the cost of treating hep C patients could overwhelm their Medicaid programs. The World Health Organization is trying to figure out how to make the drug available in countries that won't be able to afford it....

Gilead Aims to License Hepatitis C Drug to 3-4 Indian Firms
Under the hepatitis C plan, Indian-made generics would be available in most of sub-Saharan Africa, selected Asian countries including India, Pakistan and Myanmar, and some smaller developing nations.

Gilead is also working to establish "tiered pricing" for Sovaldi in other low- and middle-income countries, Samuel said.

The company struck the first such tiered pricing deal last month in Egypt, where it has agreed to supply the government at just over 1 percent of the U.S. price, or $300 for a 28-day bottle against $28,000.

For India, the company is currently discussing a price of $2,000 based on 24 weeks of treatment, although no final deal has been reached, Samuel added.

Egypt has the world's highest prevalence of the liver-destroying hepatitis C virus, which is spread through blood, making it an obvious first market for more affordable, tiered pricing....

WHO joins clamor to make new hepatitis C pills affordable
By Ben Hirschler
LONDON Wed Apr 9, 2014 7:07am EDT
(Reuters) - The World Health Organization wants a "concerted effort" to drive down the cost of new hepatitis C drugs that offer a cure for the liver-destroying virus but are unaffordable for most infected people worldwide.

The forthright comments from the UN agency on Wednesday add to pressure on drugmakers such as Gilead Sciences - which is already facing protests in the United States over its $1,000-a-day pill - to do more to improve access.
Read more..........

A Call For Pricey Treatment For Millions With Hepatitis-C

Express Scripts Trying To Shame Gilead Into Reducing Sovaldi Price: Who Is Really The Greedy One?

Gilead Sciences: How Serious is the Pricing Problem?
Express Scripts could move to force Gilead to trim Sovaldi cost.

Ohio Medicaid admits ‘strong merit’ to treating hepatitis C with Sovaldi, but $1K pills give pause
For private plans that run Medicaid managed care, the problem was that the drug was approved late last year after they’d set 2014 monthly per-member payments from states. Plans are responsible for excess medical costs above that fixed amount unless a state makes an exception to directly pay for certain treatments and drugs.

“While an official decision is likely to be made some time soon, there does appear to be strong merit to making this drug available through prior authorization and under the close guidance of specialists in hepatitis C treatment,” said a statement from the Ohio Department of Medicaid.
More here...... 

Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 HCV in interferon ineligible/intolerant individuals, or Daclatasvir+Sofosbuvir 
The study results suggest that a 12-week course of sofosbuvir/simeprevir is a more cost-effective treatment for genotype 1 chronic hepatitis C virus than 24 weeks of sofosbuvir/RBV among interferon-ineligible/intolerant individuals, supporting the AASLD/IDSA guidance and offering implications for both clinical and regulatory decision-making as well as pharmaceutical pricing. Download the PDF here  provided by NATAP

Costs to Public of USD 84,000 Hep C Drug 'Outrageous'
Kaiser Permanente said it is using Gilead Sciences' new hepatitis C drug, Sovaldi (sofosbuvir), even though its $84,000 treatment price is 'outrageous.'

Gilead says has discounted hepatitis C drug for some health plans
Alton said the company has deals for "supplemental discounts" for government-funded agencies such the Veterans Administration and the Department of Defense, on top of the 23 percent. He would not provide details.

He said the VA, which accounts for about 10 to 15 percent of the hepatitis C population in the United States, has been "proactive" in recognizing the need to treat the disease, which can lead to liver failure and necessitate liver transplants.

He estimated that patients eligible for Medicaid, the government-funded health plan for the poor, account for another 10 to 15 percent of Americans with hepatitis C...

Breaking The Bank: Sovaldi And The Cost-Innovation Paradox In The US Healthcare System
By any objective metric, Sovaldi is a good value. The drug costs less on an absolute basis than Incivek (~$100,000 per year), which is reimbursed without question, and is an even better deal if one applies a “cost per cure” methodology (A recent Mt. Sinai study shows a $189,000 cost per cure for Incivek-containing regimens.) Moreover, remember that the government pays nowhere near list price; Medicaid receives a mandatory 23.1% discount on branded drug prices (Sovaldi is covered by privately-administered Medicare Part D plans for patients over 65 years old)......

India-Plea against Gilead's patent bid
The civil society groups' intention is to prevent unmerited patent applications from being granted, and to open up the market for generic producers and increase competition, which will result in lower prices and increased access....

Gilead has reportedly said that the drug will be available in India at $2,000 for a 12-week treatment....

A 12-week course of sofosbuvir, produced generically, is estimated to cost between $130-270; daclatasvir, a highly effective drug from a different class, produced by BMS, may cost only $10-30 per treatment course....

One Of Pharma's Biggest Enemies Goes After The Future's Best-Selling Drug
Just making noise about Sovaldi’s price could help foster competition. Other companies are developing their own all oral hep C combos. AbbVie and Enanta are in the lead, followed by Merck, and Bristol-Myers Squibb. AbbVie’s entry looks worse that Gilead’s; it includes many more pills. But might patients be willing to use it instead if their insurance company tells them it is saving them money?

Mar 21
Hepatitis C- Gilead offers Egypt Sofosbuvir at 99 percent discount
Gilead Sciences, facing mounting criticism over the high price of its new hepatitis C pill Sovaldi, has offered to supply the medicine to Egypt at a 99 percent discount to the U.S. price.

While the drug will still cost $900 for a 12-week course of treatment, that is a fraction of the $84,000 charged for a course of treatment in the United States.

The high price tag in America prompted questions from U.S. lawmakers on Friday, after U.S. health insurers said they were seeking help from state health officials to foot the bill...
Source - (Reuters

Gilead-Democratic Leaders Request Briefing on Hepatitis C Drug Pricing
In summary, the letter sent to Gilead from the House of Representatives on Thursday suggests the $84,000 per treatment proposed cost of its Hepatitis C vaccine, Sovaldi, and the more probable $150,000 per treatment cost imposed by combination therapies offered by physicians, would not be affordable by most of the persons diagnosed with Hep-C because those are typically lower income demographics. In addition, and what was not as direct, the letter suggested that the Government, who would ultimately have to pay that bill, was not willing to pay what Gilead was asking. In no uncertain terms, the Government is doing everything in their power to reduce the cost per treatment, and if they are successful as they probably will be, the revenues from this seemingly successful vaccine will come down considerably from that $84,000 estimate.

WellPoint says new hepatitis c drug prices are too high

Mar 20
Of Interest
Read This Twitter Chat About Gilead and the Cost of its Hep C Drug

March 3
Hepatitis C Drug Price Limiting State Medicaid Approvals
People in Medicaid, the government health plan for the poor, are prime candidates for Gilead’s Sovaldi, which works better and carries fewer side effects than existing therapies. The $84,000 cost for the cure over 12 weeks, the most expensive medicine for the disease, has states from Pennsylvania to Colorado limiting its use to only the sickest patients, according to health officials and private insurers that manage care for Medicaid programs.

Steven Flamm, MD, discusses the hepatitis C drug pipeline, cost of new drugs and coverage
As with any new specialty drugs, insurers, pharmacy benefit managers and physicians must weigh the value of the new products, balancing cost, efficacy, effectiveness and ease of use. 
Managed Healthcare Executive recently convened three key thought leaders to discuss the impact of simeprevir and sofosbuvir and whether they will stand the test of time.

Reuters - Insurers, Medicaid fear multibillion-dollar hepatitis C drug tab
By Caroline Humer
(Reuters) - U.S. health insurers are seeking help from state health officials to foot the bill for a new generation of hepatitis C treatments that could cost the nation $200 billion or more in the next five years.

Kaiser Health News:
There’s a Life-Saving Hepatitis C Drug. But You May Not Be Able To Afford It.
There's a new drug regimen being touted as a potential cure for a dangerous liver virus that causes hepatitis C. But it costs $84,000 -- or $1,000 a pill. And that price tag is prompting outrage from some consumers and a scramble by insurers to figure out which patients should get the drug —and who pays for it (Appleby, 3/3).

Bangkok, Thailand, February 28, 2014 —Thirty-eight activists from 22 countries joined forces at the first-ever Hepatitis C Virus (HCV) World Community Advisory Board (CAB) to demand equitable access to treatment for hepatitis C virus (HCV) from six multinational pharmaceutical companies. Yet AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck, and Roche refused to provide a plan for equitable access to treatment for HCV, a curable infection that kills over 350,000 people each year.

USA Today
Could new hepatitis C drugs bust state budgets?
More people now die of hepatitis C than HIV/AIDS, according to the U.S. Centers for Disease Control and Prevention (CDC).The infectious disease can lead to scarring of the liver, cirrhosis, liver cancer, liver failure and death. For some sufferers, the only option for survival is a liver transplant. 
Mar 3

The Washington Post: Costly Hepatitis Drug Sovaldi Rattles Industry
When the Food and Drug Administration approved a medication called Sovaldi in December, it was hailed as a breakthrough in the fight against hepatitis C, a blood-borne disease that affects 3.2 million Americans and kills more people in the U.S. annually than AIDS. Then California-based Gilead Sciences, the manufacturer, announced the price: $84,000 for a 12-week course, more than what many cancer treatments cost in a year. The hefty price tag has rattled patient advocacy groups and insurance companies, who say most costly new treatments coming on the market are targeted for a smaller patient population. Putting such a premium on a drug that could help so many will be crushing, they say (Somashekhar, 3/1).

Stateline: Could New Hepatitis C Drugs Bust State Budgets?
Two new medications to treat the deadly epidemic of hepatitis C promise millions of Americans a better chance of a cure, shorter periods of treatment and fewer side effects than older drugs. They also threaten to bust state budgets and raise private insurance rates. 

The new hepatitis C medications present a dilemma for Medicaid and other insurers, who must balance the cost against the huge number of people who could benefit from the treatment. A course of treatment costs between $84,000 and $168,000 -- or $1,000 to $2,000 per pill (Ollove, 2/28). 

This is part of Kaiser Health News' Daily Report - a summary of health policy coverage from more than 300 news organizations. The full summary of the day's news can be found here and you can sign up for e-mail subscriptions to the Daily Report here. In addition, our staff of reporters and correspondents file original stories each day, which you can find on our home page.

1 comment:

  1. So what will Medicare do and when will they do it to cover retirees who are on fixed incomes but are old enough to be in the advanced stages?