Showing posts with label Sofosbuvir/Cost. Show all posts
Showing posts with label Sofosbuvir/Cost. Show all posts

Thursday, June 7, 2018

Half of hepatitis C patients with private insurance denied life-saving drugs


Open Forum Infectious Diseases
Infectious Diseases Society of America
Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study
Charitha Gowda Stephen Lott Matthew Grigorian Dena M Carbonari M Elle Saine Stacey Trooskin Jason A Roy Jay R Kostman Paul Urick Vincent Lo Re, III
Open Forum Infectious Diseases, Volume 5, Issue 6, 1 June 2018, ofy076, https://doi.org/10.1093/ofid/ofy076
Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.
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Half of hepatitis C patients with private insurance denied life-saving drugs

PHILADELPHIA - The number of insurance denials for life-saving hepatitis C drugs among patients with both private and public insurers remains high across the United States, researchers from the Perelman School of Medicine at the University of Pennsylvania reported in a new study published in the journal Open Forum Infectious Diseases. Private insurers had the highest denial rates, with 52.4 percent of patients denied coverage, while Medicaid denied 34.5 percent of patients and Medicare denied 14.7 percent.

The data was revealed through a prospective analysis of over 9,000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Direct-acting antiviral drugs (DAAs) - once-a-day pills that first became available in the United States in 2014 - are highly effective, with a 95 percent cure rate and few side effects for patients with chronic hepatitis C, but expensive. Because they can cost between $40,000 and $100,000, both private and public insurers have restricted access to the medications, approving the drugs only for patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit drug use, for example.

More recently, some of those restrictions had been relaxed because of vocal stakeholders and leaders, class action lawsuits, and greater drug price competition that experts believed would help increase the overall approvals by insurers. However, analysis of the data suggests otherwise.

"Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector," said study senior author Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology. "It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states."

The reason for the higher than expected denial rate is unclear, the authors said, but may be due to the varying restrictions on reimbursements that exist among the states. It's likely there were more attempts to treat patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist, they wrote.

The team analyzed prescriptions from 9,025 patients between January 2016 and April 2017 submitted to Diplomat Pharmacy Inc. throughout 45 states. Among those patients, 4,702 were covered by Medicaid; 1,821 by Medicare; and 2,502 by commercial insurance. In all, 3,200 (35.5 percent) were denied treatment.

The denial rates appear to be increasing, as well. The overall incidence of denials across all insurance types increased during the study period from 27.7 percent in the first quarter to 43.8 percent in the final quarter. In addition, a Penn study from 2015 found that just five percent who had Medicare received a denial, while 10 percent who had private insurance did.

That same study also found that 46 percent of Medicaid patients were denied coverage, compared to the current study's 35.7 percent. A statement from the Centers for Disease Control and Prevention in 2015 indicating that restrictions violated federal law prompted class action suits and legal action against Medicaid, which likely contributed to the public insurer easing its criteria across some states and improved approval rates, the authors said. Still, Medicaid denials increased over the study period.

"From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer," Lo Re said. "In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the liver, such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others."

A recent report from the National Academies of Science, Engineering, and Medicine determined that at least 260,000 chronic hepatitis-infected patients must be treated yearly to achieve elimination of the virus in the United States by 2030. To reach that goal, they recommended that public and private insurers remove restrictions to the hepatitis C drugs that are not medically indicated and offer treatment to all chronic hepatitis C-infected patients. Those recommendations are also consistent with guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America.

"Eliminating hepatitis C in the U.S. is a feasible goal," Lo Re said, "but that's going to be hard to achieve if payers are not reimbursing for the treatment."

Today's News
Judge gives early OK to deal to expand Medicaid hep C relief
DETROIT (AP) - A judge has given preliminary approval to a deal that would expand access to hepatitis C treatments for Michigan residents on Medicaid.

On This Blog
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Tuesday, June 5, 2018

Cost‐effectiveness of generic sofosbuvir/velpatasvir versus genotype‐dependent direct‐acting antivirals for hepatitis C treatment

In Case You Missed It
*Article downloaded and shared by @HenryEChang via Twitter. 

Cost‐effectiveness of generic pan‐genotypic sofosbuvir/velpatasvir versus genotype‐dependent direct‐acting antivirals for hepatitis C treatment
Amit Goel Qiushi Chen Jagpreet Chhatwal Rakesh Aggarwal
First published: 04 June 2018 https://doi.org/10.1111/jgh.14301

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Abstract
Background
Treatment of HCV infection with low‐cost generic direct‐acting antivirals (DAAs) available in India and other developing countries needs determination of HCV genotype (‘genotype‐dependent' regimens). Generic velpatasvir, a DAA that obviates the need for genotype determination (‘pan‐genotypic' regimen) recently became available but is costlier.

Aim
To evaluate the cost‐effectiveness of genotype‐dependent versus pan‐genotypic DAA treatments in India.

Methods
A previously‐validated microsimulation model, adapted to Indian population, was used to compare the costs and long‐term outcomes of three scenarios: no treatment, and treatment with genotype‐dependent and pan‐genotypic regimens. Input parameters were derived from literature. Using a payer's perspective and life‐time time horizon, quality‐adjusted life years (QALYs), total costs, and incremental cost‐effectiveness ratio (ICER) were calculated. Both deterministic and probabilistic sensitivity analyses were also conducted.

Results
At the current price (US$ 223 for 4 weeks), pan‐genotypic regimen was cost‐saving compared to no treatment. Compared with genotype‐dependent regimens, it increased QALYs by 0.92 and increased costs by US$ 107, but was deemed cost‐effective with an ICER of US$ 242 per QALY gained. Probabilistic sensitivity analysis also supported the cost‐effectiveness of pan‐genotypic regimen. At the reduced price of US$ 188 for 4 weeks, the pan‐genotypic regimen will become cost‐neutral to genotype‐dependent regimens (current price: US$100 for 4 weeks).

Conclusions
At current prices, velpatasvir‐based pan‐genotypic regimen is cost‐effective for HCV treatment in India where generic drugs are available. A reduction in the prices of pan‐genotypic regimen has the potential to make its use cost‐saving, while simplifying treatment in community‐level programs aimed at HCV elimination.
Continue reading:
https://jumpshare.com/v/AGnldst6EL08X8iGM13N

Available On This Blog
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Monday, June 4, 2018

DDW 2018 - Is an HCV cure rate of 100 percent realistic?

DDW News | Jun 4, 2018 | 2018, AASLD, DDW Daily News, Monday Issue 2018, Watch Videos

David E. Bernstein, MD, FAASLD, discusses the possibility of an HCV cure rate of 100%

Is an HCV cure rate of 100 percent realistic?
David E. Bernstein, MD, FAASLD, wants to break down the barriers preventing access to curative therapies for hepatitis C virus (HCV). Although antiviral therapy has led to a cure rate of more than 90 percent of HCV cases, Dr. Bernstein thinks more can be done to increase the cure rate.

In this DDW Daily News video exclusive, he discusses several obstacles preventing patients’ access to curative therapies, including cost concerns, public policy issues and insurance variations that have led to different state rules and regulations. Dr. Bernstein also addresses the benefits of HCV therapy and whether it’s possible to eradicate HCV and achieve 100 percent cure rate.

“It’s the only viral disease that we can actually cure, but from a public policy standpoint a significant portion of our population does not have access to these life-changing and curative therapies for unclear reasons,” says Dr. Bernstein, director of the Sandra Atlas Bass Center for Liver Diseases at the Zucker School of Medicine at Hofstra/Northwell, East Garden City, NY.
Video:
http://blog.ddw.org/is-an-hcv-cure-rate-of-100-percent-realistic/

Links
Digestive Disease Week® (DDW) 2018 June 2-5, 2018
Website - Digestive Disease Week® (DDW)
DDW Blog
DDW Daily News
On Twitter - #DDW18

DDW 2018 - Insurance coverage and mortality in patients with hepatitis C

HCV outcomes worse for patients with public insurance, Medicaid
WASHINGTON — In this exclusive video perspective from Digestive Disease Week 2018, Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, discusses insurance coverage and mortality in patients with hepatitis C in the U.S.
Video:https://www.healio.com/hepatology/hepatitis-c/news/online/%7B3714098b-f39c-4e99-86d1-e3a7e9bebb5d%7D/hcv-outcomes-worse-for-patients-with-public-insurance-Medicaid

MedPage Today
WASHINGTON -- Adults with hepatitis C virus (HCV) were more likely to die if they were on Medicaid than other insurance plans, while uninsured HCV-infected …

Digestive Disease Week® (DDW) 2018
Coverage @ Healio
Healio staff will report live on breaking news presented at the meeting and capture video interviews with experts to gain their perspectives on important presentations.

Links
Digestive Disease Week® (DDW) 2018
June 2-5, 2018
Website - Digestive Disease Week® (DDW)
DDW Blog
DDW Daily News
On Twitter - #DDW18

Tuesday, May 29, 2018

Novel Medicaid Strategy Proposed to Increase Access to HCV Treatment

Infectious Disease Advisor
Novel Medicaid Strategy Proposed to Increase Access to HCV Treatment
Zahra Masoud
Implementing a novel drug purchasing strategy may dramatically increase access to drugs for hepatitis C virus (HCV) infection for patients enrolled in Medicaid without increasing state and federal costs, according to a study recently published in the Annals of Internal Medicine.

Although the annual HCV-related death toll in the United States exceeds that of a combination of HIV and 59 other infectious diseases, curative treatments introduced in 2013 resulted in sustained virologic response that has been associated with lower mortality in individuals with chronic HCV infection.

Read More: https://www.infectiousdiseaseadvisor.com/hepatitis/hepatitis-c-virus-treatment-access-may-improve-with-proposed-medicaid-strategy/article/768917/

New At Infectious Disease Advisor
Does Substance Use Disorder Affect Sustained Virologic Response to DAAs?
Infectious Disease Advisor
Although hepatitis C virus (HCV) treatment adherence is worse in patients with comorbid substance use disorders, sustained virologic response (SVR) to …

Thursday, May 24, 2018

With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs

PBS News Hour
May 23, 2018

Watch the program

With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs
New drugs can cure up to 95 percent of patients with hepatitis C, a virus that can be debilitating or deadly. And there’s been a 20 percent rise in new infections from 2015 to 2016 due to the opioid epidemic. In Oregon, a state hard-hit by the disease, new medicines combined with the big surge in those looking for treatment has led to a unique care model. Special correspondent Cat Wise reports.

Full Transcript 
https://www.pbs.org/newshour/show/with-highest-hepatitis-c-mortality-rate-in-u-s-oregon-expands-access-to-life-saving-drugs

Judy Woodruff: Now the latest on a medical breakthrough that’s starting to have an impact on a hidden, deadly epidemic in this country. New drugs can cure up to 95 percent of patients with hepatitis C, a virus that often leads to debilitating or deadly results. The drugs can save lives, prevent expensive hospitalizations and liver transplants. But some states are feeling the squeeze of the cost of this medicine. Special correspondent Cat Wise has our report for our weekly series on the Leading Edge of science.

Cat Wise: Three-point-five million Americans are living with a potentially deadly virus, and half don’t even know it. It’s hepatitis C, a blood-borne pathogen which attacks the liver and can eventually cause serious liver problems, including cirrhosis and liver cancer. Three-quarters of those with the virus are baby boomers, exposed from unscreened blood transfusions, I.V. drug use, and other blood-to-blood contact prior to the early ’90s. But now the opioid epidemic has led to a 20 percent rise in new infections from 2015 to 2016. One state where the young and the old have been hit hard by the disease is Oregon. Oregon has the highest hepatitis C mortality rate, per capita, in the country. It’s estimated about 100,000 Oregonians have been infected with the virus and more than 500 die every year. It’s been a very difficult disease to treat, but over the last four years, there’s been a revolution in hep C drugs. Many are being cured around the country now, and here in Oregon, many are coming here to the Oregon Clinic for those treatments.

Dr. Kent Benner: We never talked about cure of hep C until the last few years, and now we’re all talking about cure of hep C.

Cat Wise: Dr. Kent Benner is a gastroenterologist and hepatologist at the clinic in Portland. He says people are still dying from the disease, often because they haven’t been tested and aren’t aware they have virus until they are quite sick. But Benner says much has changed since he first started treating patients several decades ago.

Dr. Kent Benner: Treatment at that time was interferon. This required injections, shots several times a week. Quite a few side effects. We felt we were doing well if we could cure 15 or 20 percent of patients. Since late 2013, there’s been a remarkable development from a number of different companies. They have developed drug combinations that provide 95 percent cure rates in patients we treat.

Cat Wise: Costly liver transplants are often the only option when the liver becomes too badly damaged. But at earlier disease stages, the liver often starts to heal once the medicines have cleared virus from the body.

Dr. Kent Benner: Not only are we seeing liver function improve, but patients with more advanced liver disease occasionally can come off the transplant list.

Cat Wise: Sixty-four-year-old Rob Shinney, who recently had knee surgery, is one of those cured by the new hep C drugs known as direct-acting antivirals, or DAAs. Like many others of his generation, he doesn’t really know how he contracted the virus. Under the care of Dr. Benner, Shinney began a three-month treatment in late 2016 after his liver showed signs of moderate scarring known as fibrosis. Tests later confirmed he was virus-free.

Rob Shinney: I had a serious chronic illness hanging over my head that I knew could kill me. And that’s gone now.

Cat Wise: We spoke at a local pub he visits now and again with his choir friends, something he never did when he had the virus.

Rob Shinney: I swear I felt like I was 20 years younger. I had energy. I could do things. It’s great just to be able to sit around and have a beer with everybody and, you know, just enjoy life. Cat Wise: The cost of the drugs used to cure Shinney, who has private insurance, aren’t cheap. Since Gilead Sciences’ Sovaldi first hit the market in late 2013 at a whopping $84,000 for a course of therapy, competitors have steadily lowered the costs. Last year, a new medication called Mavyret was released for around $26,000. Many payers often, though, negotiate even lower prices with the drug company. Still, the drugs are expensive, and they aren’t a vaccine. If someone is cured, they can become reinfected. Access to the drugs varies widely around the country. A report last year by two national advocacy organizations found that many public and private payers choose to limit access to DAAs due to their cost, as well as other concerns. Oregon is among a number of states which have had restrictive Medicaid requirements, including denying coverage to patients in the early stages of disease and those who are abusing drugs and alcohol. But some of those restrictions are beginning to ease.

Dr. Dana Hargunani: In January, we just started covering individuals with lower stages or lower levels of fibrosis.

Cat Wise: Dr. Dana Hargunani is the chief medical officer for the Oregon Health Authority, which oversees the state’s Medicaid program. She says, while the state is starting to expand access, costs are still a significant issue. Oregon has spent more than $94 million on the drugs since 2014, covering about 1,500 people.

Dr. Dana Hargunani: The newer treatments for hepatitis C have a significant budget impact for our state. We had to get additional funding through the legislative process. We’re trying to manage our limited resources to ensure coverage for those who need it immediately for the hepatitis C treatment, as well as all the other individuals in our Medicaid program.

Cat Wise: Hargunani says another reason the state delays coverage until patients have mild liver scarring, not everyone needs the medicines.

Dr. Dana Hargunani: One in five individuals who get infected with hepatitis C will spontaneously clear their infection. Right now, the data doesn’t help us understand how to know which individuals will need to have a high-cost drug to treat and cure their infection.

Dr. Brianna Sustersic: Luckily, he doesn’t have any evidence of cirrhosis.

Cat Wise: Dr. Brianna Sustersic is a medical director at Central City Concern, a federally funded health center in downtown Portland which serves a large number of homeless individuals, many of whom have substance abuse disorders; 25 percent to 50 percent of the patients have hep C.

Dr. Brianna Sustersic: The Medicaid requirements have limited access to treatment for many of our patients. From a public health standpoint, if we are able to treat the population who is contracting this, and spreading it, then we can move toward eradicating the disease.

Cat Wise: To prove that point, and to meet a big need, the clinic and a local syringe exchange program began a small drug company-sponsored study last year to treat patients who otherwise wouldn’t have qualified for the medications; 56-year-old Kim Trano is now virus-free thanks to that trial. She says she’s felt a lot of stigma being a recovering drug user and it was hard to learn she had initially been denied drug coverage. To those who would question giving expensive medicines to someone who might become reinfected, she says:

Kim Trano: Everyone is worthy of a chance. If I were to relapse, I would all precautions not to be reinfected. And that’s pretty easy to do. Most people know how to do that.

Cat Wise: The new medicines combined with the big surge in those looking for treatment has led to a unique care model. Chris Hulstein is not a doctor. He’s a clinical pharmacist and part of a new program at Portland’s Providence Hospital. Over the past year, about 50 patients have been successfully treated by Hulstein and his colleagues. Another 30 are currently in treatment.

Chris Hulstein: A lot of the specialists are very busy managing very complex patients, and that is their role. Having a pharmacist being able to manage the patient gets patients treated faster and more successfully than we ever have been able to do before.

Cat Wise: Hepatitis C advocates are now working with the state and private insurers to open up more access to the drugs. For the “PBS NewsHour,” I’m Cat Wise in Portland, Oregon.

https://www.pbs.org/newshour/show/with-highest-hepatitis-c-mortality-rate-in-u-s-oregon-expands-access-to-life-saving-drugs

Wednesday, May 23, 2018

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions
May 23, 2018
Sydney Lupkin, Kaiser Health News

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/

This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Tuesday, May 15, 2018

How states could be saving more hepatitis C patients

How states could be saving more hepatitis C patients
BY Stephanie Hedt May 14, 2018

USC’s Neeraj Sood and colleagues propose an approach that leverages competition among drug manufacturers, saving states money and ensuring that more people get treatment

There is a cure or the nation's deadliest infectious disease, hepatitis C, but at tens of thousands of dollars per patient in upfront costs, most insurance companies can't afford to provide the treatment to all of the estimated 2.7 million to 3.9 million of Americans who are infected. This is especially true for patients on Medicaid or in the prison system, where funding has historically been restricted.

Leading experts on hepatitis C treatment policy are recommending a new novel pricing strategy, implemented at the state level, that could help many more patients access the treatment. The recommendations were published on May 14 in the Annals of Internal Medicine, and as an extended USC-Brookings Schaeffer Initiative for Health Policy report.

"These innovative therapies can cure hepatitis C, but the high costs put them out of reach for the most vulnerable populations," said Neeraj Sood, lead author on the report and an economist at the USC Schaeffer Center for Health Policy and Economics. "We wanted to come up with a better solution where we dramatically improve access to cures, control drug spending but still maintain incentives for the development of new cures."

Recognizing the important role state programs could play in this, Sood and his colleagues have developed a novel pricing strategy targeted at state policymakers. They outline an approach that leverages competition among drug manufacturers. The end result would save the state money and would ensure treatment for a larger share of the population -- all while providing incentives for future innovation in treatments.

Leveraging State Programs to Increase Access
Given current financing systems, most states can only afford to provide treatment to a small percentage of patients with hepatitis C each year. Furthermore, drug manufacturers know the only way they can increase profits is by increasing the price per pill.

"Increasing prices raises incentives for pharmaceutical innovation but limits patient access. This is the crux of the problem," said Sood, who is also a Professor and Vice Dean for Research at the USC Price School of Public Policy.

"Negotiating on revenues rather than price is the answer. Revenue-based contracting allows us to increase profits and incentives for innovation without limiting access."

Under the proposed model, states would leverage their resources to make a deal with one pharmaceutical company, offering a lump sum payment over a contracted period. The negotiated amount would be higher than the expected revenue for any one company over that timeframe, but still less than the total amount that the Medicaid program would pay to all the drug companies producing the treatment.

In return, the company would agree to provide a 100 percent rebate on drug purchases for the population designated to receive the cure, such as Medicaid patients or prisoners with hepatitis C. The move would make the drug essentially free of additional cost. It also would give the states the opportunity to significantly expand access to the treatment while maintaining their budget.

Vulnerable Populations Still Face Significant Hurdles in Accessing Treatment
According to a 2017 report, less than 3 percent of the 700,000 people with hepatitis C in state Medicaid programs and prisons receive treatment each year. This is due in large part to restrictions that many state programs implemented that limit access to the cure by requiring patients to have reached a certain decline in liver function or have remained sober for a set timeframe.

Though not supported by clinical guidelines, these restrictions are designed to narrow access, thereby limiting the immediate impact on state budgets that might arise from guaranteeing the treatment to everyone.

The consequences of these decisions are especially concerning given the recent rise in heroin use resulting from the opioid epidemic, which has led to a significant increase in new hepatitis C infections.

"Our concern is that the public health burden of hepatitis C infections will continue to grow even though we have a cure if we don't implement innovative financing programs," said Sood.

https://news.usc.edu/143172/how-states-could-be-saving-more-hepatitis-c-patients/

Thursday, May 10, 2018

Civil Society Groups Bar The Way To Hepatitis C Patents

Collective Efforts By Civil Society Groups Bar The Way To Hepatitis C Patents
10/05/2018 by Catherine Saez, Intellectual Property Watch

Many hold the view that Gilead’s revolutionary treatment against hepatitis C (sofosbuvir) marked the beginning of a shift in position toward the high prices of medicines, as high-income countries were also faced with an untenable burden to their health systems. In a number of lower and middle-income countries civil society organised itself to increase access to sofosbuvir for millions in need.

Continue reading: http://www.ip-watch.org/2018/05/10/collective-efforts-civil-society-groups-bar-way-hepatitis-c-patents/

Friday, April 27, 2018

There’s A Cure For Hepatitis C, But Oregon Limits Access

There’s A Cure For Hepatitis C, But Oregon Limits Access
By Amelia Templeton / OPB
Oregon’s decision to continue to limit treatment based on a patient’s fibrosis score conflicts with guidelines set by health professional groups.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend that all patients with chronic hepatitis C should be treated.

The groups note that treating patients early, before significant fibrosis has developed in the liver, appears to be a particularly effective way of reducing deaths associated with hepatitis C.

Wednesday, April 25, 2018

Liver disease burden and required treatment expenditures for hepatitis C virus (HCV) infection in Thailand

Liver disease burden and required treatment expenditures for hepatitis C virus (HCV) infection in Thailand: Implications for HCV elimination in the new therapeutic era, a population-based study
Rujipat Wasitthankasem, Preeyaporn Vichaiwattana, Nipaporn Siripon, Nawarat Posuwan, Chompoonut Auphimai, Sirapa Klinfueng, Napha Thanetkongtong, Viboonsak Vuthitanachot, Supapith Saiyatha, Chaiwat Thongmai, Saowakon Sochoo, Natnada Pongsuwan, Kittiyod Poovorawan, Pisit Tangkijvanich, Yong Poovorawan

Published: April 24, 2018
https://doi.org/10.1371/journal.pone.0196301

Full-Text
Available Online

Abstract
The prevalence of hepatitis C virus (HCV) infection has been decreasing globally, but the growing effects of HCV-related morbidity and mortality remain of concern. Advances in curative medicine, involving direct-acting antivirals (DAAs), have led many countries to aim to eradicate HCV. Information on epidemiology and disease burden is essential for national policy development. Thus, this study aimed to determine the HCV-related hepatic disease burden in areas of Thailand with high and average HCV prevalence in order to extrapolate the viral burden across Thailand. Patients previously diagnosed as positive for anti-HCV antibodies were recruited to assess chronic HCV infection (CHC) status, liver function, HCV-RNA level and hepatic fibrosis. The number of patients eligible for Universal Health Coverage (UC) scheme and the approximately required expenditure on interferon (IFN)-based treatment were estimated. In areas of both high (12%) and average (2%) HCV viremic prevalence, over half of the patients (52.2% to 62.5%) had advanced liver fibrosis (F3 and F4). A striking percentage of patients with F4 (38.9%) were found in the high-prevalence area, while comparable proportions of advanced liver fibrosis presented in the two areas and disease burden peaked at 50–59 years. Under the current UC program treatment scenario, 78–83% of CHC patients with stage F2–F4 fibrosis were eligible for treatment. The estimated expenditure required for overall CHC treatment across the whole country was 1,240 million USD at this current status, but the declining cost of generic DAA-based therapy may reduce the requirement to <90 million USD. This study provides information on the estimated number of CHC patients, liver disease burden and expenditure requirements for Thailand. To eliminate HCV by 2030, proactive government strategies raising public health to minimize transmission and emphasizing targeted screen-and-treatment programs, novel therapeutic guideline development for decentralizing treatment, and effective budget allocation are urgently needed.
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0196301

Thursday, April 12, 2018

Liver Congress™ 2018 Affordable hepatitis C combination treatment - Target price of US$300 for a 12-week treatment

Related
Video Healio:
April 13, 2018
PARIS — Using a new medication and generic sofosbuvir, researchers reached 97% sustained virologic response in patients with hepatitis C both with and without…

New affordable hepatitis C combination treatment shows 97% cure rate
Results support a public health approach to hepatitis C

An affordable hepatitis C combination treatment including the new drug candidate ravidasvir has been shown to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases, according to interim results from the Phase II/III STORM-C-1 trial presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference in Paris.

The results indicate that the sofosbuvir/ravidasvir combination is comparable to the very best hepatitis C therapies available today, but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programmes,” said Dr Bernard Pécoul, Executive Director, DNDi.

The trial using medicines produced by Egyptian drug manufacturer Pharco Pharmaceuticals was run by DNDi and co-sponsored by the Malaysian Ministry of Health, in ten sites in Malaysia and Thailand. Agreements signed in 2016 and 2017 enabling the trials and patient scale-up in Malaysia set out a target price of US$300 for a 12-week treatment, an almost 100% drop from existing treatment prices in Malaysia.

“As hepatitis C has become a major public health concern in Malaysia, it is crucial to increase access to treatment for the benefit of the nation,” said Datuk Dr Noor Hisham Abdullah, Director General of Health, Ministry of Health, Malaysia. In September 2017, the government of Malaysia issued a “government-use” license on sofosbuvir patents to allow 400,000 people living with hepatitis C in Malaysia to access generic HCV regimens in public hospitals.

DNDi conducted the STORM-C-1 open label trial to assess the efficacy, safety, tolerance, and pharmacokinetics of the drug candidate ravidasvir combined with sofosbuvir. 301 chronically infected adults were treated with the ravidasvir/sofosbuvir combination for 12 weeks for patients without cirrhosis of the liver, and for 24 weeks for those with compensated cirrhosis. In accordance with international standards defining cure for HCV treatments, 12 weeks after treatment completion, 97% of those enrolled were cured (95% CI: 94.4-98.6). Cure rates were very high even for the hardest-to-treat patients: people with liver cirrhosis (96% cured), people living with HIV using their usual treatment (97%), people infected with genotype 3 (97%) including those with cirrhosis (96%), and people who had been exposed to previous HCV treatments (96%). Importantly, patients combining several of these risk factors were cured, and no unexpected safety signals were detected.

Click on image to enlarge


“From a treatment provider perspective, this is very exciting as we have been waiting for a simple, affordable, robust treatment tolerated by all patients groups, including those whose treatment outcomes are currently poorer, like patients under antiretroviral therapy,” said Pierre Mendiharat, Deputy Operations Director for Médecins Sans Frontières / Doctors Without Borders (MSF). “This will be crucial to expand treatment to the most vulnerable categories of patients in developing countries.” MSF and DNDi are working together to increase access to care and treatment for HCV patients in key low- and middle-income countries, through the STORM-C project financed by MSF’s Transformational Investment Capacity (TIC) initiative.

Over 71 million people live with hepatitis C worldwide, a disease which causes 400,000 deaths a year. Although highly effective treatments have existed for a number of years, less than three million people are on treatment, with more people infected every year than are put on treatment. The World Health Organization aims for 80% of people diagnosed with HCV to be put on treatment by 2030.

Ravidasvir is an oral NS5A inhibitor licensed to DNDi by Presidio Pharmaceuticals. Most people enrolled in the DNDi trial in Malaysia and Thailand had genotype 1 (42% of participants) or genotype 3 (53%), thereby confirming the combination’s effectiveness for those two additional genotypes. Further trials are planned to document the efficacy and safety of the combination in patients infected with the other HCV genotypes and in particularly vulnerable groups, to enable a public health approach to the treatment of hepatitis C.

“Pharco is proud to enable a public health approach to hepatitis C treatment by providing affordable treatments. We look forward to future collaboration in additional clinical trials to confirm the safety and efficacy of ravidasvir,” said Dr Sherine Helmy, CEO, Pharco.

Poster reference
Isabelle Andrieux-Meyer, Tan Soek Siam,Nicolas Salvadori, François Simon, Tim R. Cressey, Hajiah Rosaida Hi Mohd Said, Muhammad Radzi Abu Hassan, Haniza Omar, Hoi-Poh Tee, Chan Wah Kheong, Goh Khean Lee, Sharifah Faridah Syed Omar, Adeeba Kamarulzaman, Suresh Kumar, Satawat Thongsawat, Kanawee Thetket, Anchalee Avihingsanon, Suparat Khemnark, Sombat Thanprasertsuk, Jean-Michel Piedagnel, Sasikala Siva, Nur Asimah, Nelson Da Silva, Jennifer Brenner, Bernard Pecoul, Marc Lallemant, Shahnaz Murad. Safety and efficacy of ravidasvir plus sofosbuvir 12 weeks in non-cirrhotic and 24 weeks in cirrhotic patients with hepatitis C virus genotypes 1, 2, 3 and 6: the STORM-C-1 phase II/III trial. International Liver Congress, Paris, April 11-15 2018, France. Poster LBP-032.

About DNDi
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit R&D organization working to deliver new treatments for neglected patients, in particular sleeping sickness, Chagas disease, leishmaniasis, filaria, paediatric HIV/AIDS, and hepatitis C. www.dndi.org

In the media
Health drug prices
Fortune
Hepatitis C Drugs Can Cost $84,000. This New One May Be Just As Good—But Cost $300
By Sy Mukherjee
Striking advances in hepatitis C drug development over the past five years have made the infectious, liver-wasting viral disease a curable one—if you can afford the drugs. Made by companies like Gilead, AbbVie, Merck, and others, drugs that treat the disease are listed at tens of thousands of dollars in the U.S. But a nonprofit is making its own hepatitis C combination medication that it says is just as effective as those created by for-profit drug giants. And it could cost just $300 for 12 weeks of treatment in poor nations like Malaysia.

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Sunday, April 8, 2018

Putting lives above profits for Hepatitis C treatment


Saturday, 7 Apr 2018
Putting lives above profits for Hepatitis C treatment
by loh foon fong
A HIGHLY effective drug which can cure Hepatitis C hit the market in 2013 but five years later, over 70 million people around the world are still not getting the needed treatment.

In Malaysia, that was initially the fate of an estimated 400,000 pa­­tients for this disease, amid intense debates whe­ther the cheaper generic version of drugs should be made available to more people.

Monday, April 2, 2018

The direct-acting virals revolutionized the treatment of hepatitis C


Take a Bow, Pharma, for the Hepatitis C Drugs
March 28, 2018

The direct-acting virals revolutionized the treatment of hepatitis C. They also ushered turbocharged pricing. At least patients—and society—got a major health benefit in return.

The change in hepatitis C treatment is undeniably phenomenal. “Taking out interferon was a huge deal from a side effect perspective,” says Andrew Muir, MD, the gastroenterology chief at Duke, and chair of AASLD’s hepatitis C interest group.

Other benefits include having several treatment choices to pick from, he says, in contrast to when the interferon and ribavirin combination was the only option. Patients with hepatitis C tend to have a wide range of liver, renal, and cardiac comorbidities. Many were ineligible for interferon therapy, so they were, in effect, forced to live with hepatitis C. “Now, it is gratifying to be able take it off their plate,” Muir says.

Thursday, March 8, 2018

Podcast - Huge pharmaceutical corporations rake in government money

Podcast; Huge pharmaceutical corporations rake in government money

Listen Here
https://www.spreaker.com/user/radiosputnik/huge-pharmaceutical-corporations-rake-in

From
Loud & Clear Interviews
It’s the dirty little secret of Big Pharma. The American taxpayer is funding Big Pharma’s research and development, primarily through the National Institutes of Health. So where do all those pharmaceutical profits go? Straight into the pockets of corporate leaders and investors. There’s a new study out by the Center for Integration of Science and Industry (CISI) that we’ll dive into today. Bryn Gay, the Hepatitis C Virus Project Co-Director at Treatment Action Group who has previous policy and advocacy experience with the United Nations, Doctors of the World and The North-South Institute, joins the show. 

Wednesday, March 7, 2018

Generic Hepatitis C Drugs Begin to Emerge

Recommended Reading
J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print]
Full Text - Download Article
Shared by @HenryEChang via Twitter.

Secialty Pharmacy Times
Generic Hepatitis C Drugs Begin to Emerge
Laurie Toich
Associate Editor Publish Date: Wednesday, March 07, 2018
The cost of hepatitis C virus (HCV) antivirals has been at the forefront of health care spending conversations for years. Although it has slowed, spending on the blockbuster drugs remains high. Despite the curative ability of the treatments, it is likely that a significant need for antiviral drugs will remain into the foreseeable future due the prevalence of undiagnosed HCV cases.
Continue Reading

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Thursday, March 1, 2018

States consider bringing prescription drugs from Canada to US as costs soar


States consider bringing prescription drugs from Canada to US as costs soar

In the face of surging prescription drug prices, some US states are proposing to import medicines in bulk from Canada, where many drugs are cheaper thanks to government price controls.

One of those hepatitis C drugs, called Sovaldi, is a good example of how prices can vary between countries. In the US, a course of Sovaldi lasts 12 weeks and costs $90,000 US retail.

American insurers typically negotiate a discount of 41%, according to a Bloomberg News analysis. That puts the cost of the drug at $17,700 per month in the US.

But in the United Kingdom, that drug costs $16,770 per month, and in Canada $14,493.


Wednesday, February 21, 2018

Revisiting policy on HCV treatment under the Thai Universal Health Coverage: An economic evaluation and budget impact analysis

Revisiting policy on chronic HCV treatment under the Thai Universal Health Coverage: An economic evaluation and budget impact analysis
Waranya Rattanavipapong ,Thunyarat Anothaisintawee ,Yot Teerawattananon

Published: February 21, 2018
https://doi.org/10.1371/journal.pone.0193112

Full Text Article:

Abstract
Thailand is encountering challenges to introduce the high-cost sofosbuvir for chronic hepatitis C treatment as part of the Universal Health Care’s benefit package. This study was conducted in respond to policy demand from the Thai government to assess the value for money and budget impact of introducing sofosbuvir-based regimens in the tax-based health insurance scheme. The Markov model was constructed to assess costs and benefits of the four treatment options that include: (i) current practice–peginterferon alfa (PEG) and ribavirin (RBV) for 24 weeks in genotype 3 and 48 weeks for other genotypes; (ii) Sofosbuvir plus peginterferon alfa and ribavirin (SOF+PEG-RBV) for 12 weeks; (iii) Sofosbuvir and daclatasvir (SOF+DCV) for 12 weeks; (iv) Sofosbuvir and ledipasvir (SOF+LDV) for 12 weeks for non-3 genotypes and SOF+PEG-RBV for 12 weeks for genotype 3 infection. Given that policy options (ii) and (iii) are for pan-genotypic infection, the cost of genotype testing was applied only for policy options (i) and (iv). Results reveal that all sofosbuvir-based regimens had greater quality adjusted life years (QALY) gains compared with the current treatment, therefore associated with lower lifetime costs and more favourable health outcomes. Additionally, among the three regimens of sofosbuvir, SOF+PEG-RBV for genotype 3 and SOF+LDV for non-3 genotype are the most cost-effective treatment option with the threshold of 160,000 THB per QALY gained. The results of this study had been used in policy discussion which resulted in the recent inclusion of SOF+PEG-RBV for genotype 3 and SOF+LDV for non-3 genotype in the Thailand’s benefit package.

Opinion - It's criminal what Illinois is doing to Medicaid patients with hepatitis C

It's criminal what Illinois is doing to Medicaid patients with hepatitis C
By: OLUWATOYIN ADEYEMI, ANDREW ARONSOHN, BASMATTEE BOODRAM, DANIEL JOHNSON and MAI TUYET PHO 

Every day, Illinois Medicaid patients with hepatitis C are denied access to a simple cure to a disease that jeopardizes their life because of outdated and unconscionable restrictions on who can get this proven treatment.

Hepatitis C is a viral infection that causes inflammation and scarring of the liver. People who are infected with hepatitis C usually have no or few symptoms for decades until it reaches the end stages of disease, where patients are at risk of liver failure, liver cancer and death. Hepatitis C is a leading cause of liver-related death and need for liver transplantation in the United States. An estimated 150,000 people are affected by hepatitis C in this state alone, according to the Illinois Department of Public Health.

Monday, February 12, 2018

Medicaid Skimps on Hepatitis C Treatment in Many States

Medicaid Skimps on Hepatitis C Treatment in Many States
by Liz Highleyman
Contributing Writer, MedPage Today
"Hepatitis C: The State of Medicaid Access," issued by the National Viral Hepatitis Roundtable (NVHR) and the Center for Health Law and Policy Innovation (CHLPI) at Harvard Law School, evaluated hepatitis C treatment policies in all 50 states, the District of Columbia, and Puerto Rico.

The report shows that 12 states cover treatment only for people with advanced liver fibrosis, 20 states require at least 6 months of abstinence from drug or alcohol use, and nine require treatment to be prescribed by a liver disease specialist, NVHR executive director Ryan Clary reported at the American Association for the Study of Liver Diseases (AASLD) annual Liver Meeting in October.

Hepatitis C kills more Americans each year than all other infectious diseases combined, yet more than half of U.S. Medicaid programs continue to impose discriminatory and medically unfounded restrictions on hepatitis C cures," Clary told MedPage Today. "