Even with New AbbVie Drug, Many Hepatitis C Patients Are Being Turned Away from Treatment

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.

Written by David Heitz | Published on December 22, 2014

Hundreds of thousands of Americans this holiday season wish for nothing more than to “slay the dragon.”

That’s what they call getting rid of the hepatitis C infection raging inside them. “The dragon” saps their energy as it slowly causes cirrhosis, or scarring of the liver. For many, it has done so for so long that they’ve forgotten what it feels like to be healthy.

Now there are ways to kill hepatitis C, or HCV infection, for good without putting people who have the disease through too much agony in the process. But these cures, which are about 90 percent effective, are expensive.

Doctors, insurance companies, and even governments have cried foul over high prices the new medications Sovaldi, Harvoni, and now Viekira Pak. Sick people aren’t getting the treatments they need due to insurance denials and other roadblocks. That angers Dr. Douglas Dieterich, Director of Outpatient Hepatology at The Mount Sinai Hospital in New York City.

“Waiting for cirrhosis to happen to treat HCV is like waiting for cancer to metastasize, or for diabetes to cause complications before treating it,” Dieterich told Healthline. “In reality, all cause mortality, and per patient per year healthcare costs are tripled for patients with hepatitis C, whether they have cirrhosis or not. Clearly, insurers don't understand this. They only tend to worry about the death from liver disease or the liver transplant, which can cost as much as half a million dollars.”

Learn More: New Hep C Drug Sovaldi Ignites Fierce Pricing Debate »

Hepatitis C is transmitted mostly through blood-to-blood contact. It usually progresses very slowly, and it can take decades before symptoms appear. Of the more than 3 million Americans infected with hepatitis C, many if not most don’t know they have it.

Treatment options other than Sovaldi, Harvoni, and AbbVie’s new Viekira Pak can be extremely uncomfortable. While insurers are quicker to approve more inexpensive treatments such as interferon and ribavirin, the medications can have brutal side effects. Interferon causes nausea and depression; ribavirin ramps up agitation.

Dieterich said he saw patients last week who’ve finished a 24-week course of Sovaldi. “They’re just glowing with health. They had [hepatitis C] for 30 years and they didn’t realize how bad they felt. When it goes away, it’s, ‘Oh my God, I forgot what feeling good felt like.’”

Evidence Shows More People Need Treatment

Lucinda Porter, a nurse, patient advocate, and hepatitis C survivor, points to research presented at The Liver Meeting in San Francisco last month as proof that people aren’t getting the help they need.

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Express Scripts drops Gilead hep C drugs for cheaper AbbVie rival

Express Scripts drops Gilead hep C drugs for cheaper AbbVie rival
BY CAROLINE HUMER

Mon Dec 22, 2014 5:37pm EST

(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.

Express Scripts' move reignited investor concerns that pharmaceutical companies will have to bow to pricing pressure from U.S. insurers and lawmakers over novel medications whose cost can reach hundreds of thousands of dollars for some diseases.

Gilead shares dropped 13 percent, or about $14.54, in Monday trading to $93.88, though it was still far above the $65 level reached in April, when insurers launched a major outcry over its multibillion-dollar hepatitis C business. Shares in majorbiotechnology companies such as Amgen, Biogen and Celgene fell more than 2 percent.

Express Scripts opposed the $84,000 price tag of Gilead Sciences' Sovaldi treatment since its approval a year ago. It said the $1,000-a-day pill, shown to cure hepatitis C in most patients, was unaffordable.

Private insurers generally receive discounts of as much as 20 percent, but Gilead has resisted, bringing in $3 billion in quarterly revenue for Sovaldi this year. The company maintains that Sovaldi, and a next-generation version called Harvoni that was approved in October, will save the U.S. healthcare system the costs of caring for advanced liver disease in many patients.

Gilead spokeswoman Cara Miller said on Monday in an e-mailed statement that the company is continuing to negotiate with Express Scripts.

AbbVie's Viekira Pak drug was approved on Friday by U.S. regulators and the company set a list price of $83,319.

But it has agreed to a significantly lower price than Gilead for Express Scripts' National Preferred Formulary, a list of approved and covered drugs for 25 million Americans, Express Scripts Chief Medical Officer Steve Miller said in an interview.

"This is unprecedented," Miller said, explaining that the pricing on specialty drugs of this type tend to be much closer even when a competitor enters the market. He did not provide a specific dollar figure, but said AbbVie had narrowed the price gap to resemble what Western European countries pay for Sovaldi, which runs from $51,373 in France to $66,000 in Germany.

WIDENING TREATMENT

An estimated 3.2 million people in the United States have hepatitis C. Most insurance plans have paid for Gilead's drugs only for patients with advanced liver disease to limit their exposure to its cost. Express Scripts said the AbbVie agreement will allow it to extend treatment to all hepatitis C patients.

Dr. Camilla Graham, co-director of the viral hepatitis center at Beth Israel Deaconess medical center in Boston, said she is hopeful other insurers will follow suit.

"My first thought when I saw this was 'Finally, we have a solution to this public health crisis,'" Graham said.

A significant portion of patients with hepatitis C receive medical care through government-paid programs, including Medicare for the elderly and disabled, Medicaid for the poor and the U.S. Department of Defense.

State Medicaid agencies have also limited access to Gilead's Sovaldi, saying it is too expensive even after they receive a legally mandated 23 percent discount.

Matt Salo, executive director of the National Association of Medicaid Directors, said he is "hopeful but cautious" about the state agencies' ability to extract further rebates on top of the discount from Gilead and AbbVie.

America's Health Insurance Plans, the insurance industry's largest lobbying group, also hopes to see Gilead's prices drop now that there is competition in the market, said spokesman Brendan Buck.

EXCEPTIONS MADE FOR SOVALDI

The AbbVie regimen consists of a cocktail of anti-viral drugs to be taken as three pills in the morning and one in the evening. The regimen requires some patients also to take ribavirin. The U.S. Food and Drug Administration approved the regimen for patients with genotype 1 form of the virus, the most common type of hepatitis C and the most difficult to treat.

Express Scripts said starting Jan. 1, 2015, it would pay for the AbbVie drug only for patients who have genotype 1. Express Scripts will no longer cover Gilead's Harvoni, a one-pill treatment for patients with genotype 1 that costs $94,500 for a 12-week course. It will cover Sovaldi in cases where patients have other types of the disease.

The AbbVie regimen is also not recommended for patients whose livers are not functioning and in people who have not benefited from using older treatments. An Express Scripts spokesman said the company will make exceptions for those patients to allow them to take Gilead's medications.

Mario Molina, chief executive officer of Molina Healthcare Inc., a small Medicaid insurer in California that has criticized Gilead's high prices, said on Monday that he sees more competition on drug prices ahead.

"I think that this is the beginning," Molina said, describing the move as "a harbinger of things to come."

(Reporting by Caroline Humer; Editing by Michele Gershberg, Meredith Mazzilli and Dan Grebler)

FDA Approves AbbVie Combo Hepatitis C Treatment

FDA News Release
FDA approves Viekira Pak to treat hepatitis C
For Immediate Release

December 19, 2014
Español

The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”

Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.

Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.

The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.

Viekira Pak is the eleventh new drug product with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Viekira Pak was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

In Hepatitis C, Treatment Rationing Has Already Begun

To curb an estimated 6% to 11% increase in Medicare Part D spending, 3 states have already placed limitations on which patients with chronic hepatitis C are candidates for treatment with novel antiviral agents. 

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The debate about which patients with hepatitis C are appropriate treatment candidates is a contentious issue, according to Marc G. Ghany, MD, MHSc, in an editorial published in JAMA Internal Medicine.  

 With nearly 30% of cirrhosis cases and 1 in 4 cases of hepatocellular carcinoma caused by hepatitis C, a clear opportunity for prevention of expensive public health issues exists. However, the cost of treatments is also expensive.   

According to a recent study by the Division of Viral Hepatitis at the Centers for Disease Control and Prevention analyzing more than 18,000 patients, a minority of patients with chronic hepatitis C virus infection are receiving treatment—just 7% to 11% of eligible patients.   This low treatment rate may initially have been be due to delays in treatment, or “siloing” patients with the hope that effective treatments would become available, and possibly at a lower cost. With the approval of ledipasvir/sofosbuvir, and the COSMOS trial indicating efficacy of a simeprevir/sofosbuvir combination, the time for treatment may be at hand.   

These new regimens have response rates in excess of 90%, defined by sustained viral response 12 weeks after the end of treatment. With these highly efficacious, all-oral treatments, Ghany argues for universal treatment of all patients with chronic hepatitis C infection, but notes that the high cost of treatment is an impediment to universal use. For instance, a 12-week course of sofosbuvir, as has often been quoted, costs approximately $84,000 to insurers. Similarly, a 12-week course of simeprevir costs $66,000.   

The high cost of these 2 medications alone are expected to increase Part D spending by 6% to 11% over 2015. To curb this trend, 3 states, Colorado, Illinois, and Pennsylvania, have already limited treatment to patients with chronic hepatitis C who are experiencing advanced-stage liver disease.   With limitations on treatment likely to be put in place in other states, it is important for patients with hepatitis C to receive treatment as soon as possible. Limitations on treatment for patients who are not candidates mean that close monitoring is crucial to ensure that limitations on access to treatment do not ultimately result in the spread of hepatitis C, and progression of infection to preventable cases of hepatocellular cancer or cirrhosis due to a lack of monitoring.   

Reference: Ghany MG. The Ongoing Debate of Who to Treat for Chronic Hepatitis C Virus. JAMA Intern Med. 2014. - 

See more at: http://www.specialtypharmacytimes.com/news/In-Hepatitis-C-Treatment-Rationing-Has-Already-Begun#.dpuf

Hello folks, hope everyone is healthy and happy. I shall be away for a short time, the family is flying away to the Magic Kingdom! Nana, along with the short people will be sharing time with Mickey and his friends.

See you all when I get back, be well.

Tina

Summary from AASLD 2014 for Hepatitis C - Main points of discussion with current HCV therapy

Summary from AASLD 2014 for Hepatitis C
Boston 7-11 November 2014

Feedback from the real-world: do HCV cure rates in real-life patient cohorts hold what clinical trials promised?

Jurgen K. Rockstroh M.D., Professor of Medicine
University of Bonn, Germany

Correspondence:
Prof. Dr. J.K. Rockstroh
Department of Medicine I
University of Bonn
Sigmund-Freud-Str. 25
53105 Bonn
Germany
Tel.: +49-228-287 16558
FAX: +49-228-287 15034
e-mail: juergen.rockstroh@ukb.uni-bonn.de

Introduction

After this year EASL it appeared as if numerous interferon- and ribavirin-free DAA combinations were emerging which all promised HCV cure rates above 95% and that other than cost and treatment access issues the revolution of HCV therapy was taking place at an incredible pace leaving little room for further optimization. One of the frequently raised caveats however, was the lack of data in the so-called more difficult to treat "real-life patients" with higher rates of previous non-response to IFN-based therapies and cirrhosis. Also data on more challenging patient groups with additional comorbidities such as renal impairment or from the transplant setting were still scarce. Which role would ribavirin play in the future? How short could HCV treatment duration possibly become?

Clearly there were still many questions floating around from clinical practice. Therefore, this year AASLD was met with high expectations and interest as first data from the increasing use of DAA based HCV therapy from clinical practice outside of clinical trials was to be presented. A great summary on all HCV data was presented at AASLD (reviewing a proud number of 423 HCV presentations including 44 orals and 379 posters on HCV related topics) from Professor Fried and can be assessed through the AASLD website (1). The following conference report aims at covering the main HCV trials and clinical relevant HCV management issues presented at AASLD in Boston from 6-11 November 2014. It does not aim at completeness as the number of presentations on HCV therapy was higher than ever and covering all would produce an unreadable report but rather aims at capturing the main points of discussion with current HCV therapy.

Continue reading @ NATAP

Daclatasvir for hepatitis C: Added benefit not proven

Daclatasvir for hepatitis C: Added benefit not proven

The drug daclatasvir (trade name Daklinza) has been available since August 2014 for the treatment of adults with chronic hepatitis C (CHC) infection. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapy.

The drug manufacturer presented data for patients without cirrhosis of the liver who are infected with hepatitis C virus (HCV) genotype 1, and for patients with HCV genotype 4. However, these data are unsuitable in various aspects to prove an added benefit.

The manufacturer dossier contained no data at all for three further patient groups with HCV genotype 1 infection (pretreated patients, untreated patients with cirrhosis of the liver, and patients with HIV coinfection) as well as for patients with HCV genotype 3 (with compensated cirrhosis and/or treatment-experienced).

Different virus types cause inflammation
Hepatitis C viruses can trigger inflammation in the liver. If this becomes chronic, cirrhosis can develop and organ function progressively deteriorates. Moreover, the risk of liver cancer (hepatocellular carcinoma, HCC) increases. Daclatasvir aims to inhibit the reproduction of HCV by interfering with viral DNA replication. Experts assume that if no viruses are detectable in the blood over a sustained period after treatment (sustained virologic response, SVR), the risk of secondary disease is reduced.

There are six different main types (genotypes) of the hepatitis C virus, which are subdivided into more than 60 subtypes. The effectiveness of different drugs is not the same against all viruses.

Comparison with dual therapy or triple therapy
Depending on the type of virus, the clinical picture and the course of the disease, daclatasvir is used in dual therapy together with the virostatic drug sofosbuvir, in triple therapy with the virostatic drugs sofosbuvir and ribavirin, or in triple therapy with peginterferon alfa to enhance the immune system and ribavirin. According to the approval, treatment duration differs for certain patient groups (12 to 48 weeks).

Depending on patient characteristics, the options for the comparator therapy are dual therapy with peginterferon alfa and ribavirin, or triple therapy consisting of peginterferon alfa and ribavirin plus a protease Inhibitor (boceprevir or telaprevir). The Federal Joint Committee (G-BA) specified a different appropriate comparator therapy for each of six different subindications:

For treatment-naive adults with chronic HCV genotype 1 infection without cirrhosis, and for treatment-experienced patients with HCV genotype 1, the G-BA specified both dual therapy and triple therapy as appropriate comparator therapy.

In four further subindications, daclatasvir was to be compared only with dual therapy: 1) in treatment-naive HCV patients with genotype 1 and cirrhosis, 2) in patients with HCV genotype 1 and additional HIV infection, 3) in patients with HCV genotype 3 infection with compensated cirrhosis and/or treatment-experienced, and 4) in patients with HCV genotype 4 infection.

However, the manufacturer only presented data for treatment-naive adults with chronic HCV genotype 1 infection without cirrhosis and for patients with HCV genotype 4 infection.

Incomplete study pool for HCV genotype 1
Since studies for the direct comparison were lacking, the manufacturer presented an indirect comparison for HCV genotype 1 patients without cirrhosis in its dossier. Using a "historical" comparison of individual arms of different studies, it aimed to derive conclusions on the superiority of daclatasvir versus the triple therapy. The manufacturer did not meet the requirements for the dossier, however: A search in trial registries was not conducted. In addition, the inclusion and exclusion criteria for the choice of studies were unsuitable. At least one relevant study was lacking in the study pool because of this.

The Bayesian Benchmarking Analysis (BBA) additionally cited was used to determine the minimum threshold a study would have to reach in order to show a statistically significant superiority of daclatasvir. The manufacturer did not meet the requirements for the dossier in this analysis either: The search was limited to a period of time up to 2012 and there was no search in trial registries. In addition, the analysis was restricted to the outcome "SVR" without addressing side effects of Treatment.

Genotype 4: unsuitable data due to lacking values
The manufacturer only evaluated one study of the two studies it presented for the direct comparison of daclatasvir in combination with dual therapy versus dual therapy alone in treatment-naive HCV genotype 4 patients. Due to treatment futility, there were treatment discontinuations in both study arms, and hence missing values in the outcome "SVR", the proportions of which differed greatly between the study arms. The imputation strategy for the values was unsuitable because its results were not robust and biased to the disadvantage of the appropriate comparator therapy.

The criteria for discontinuation in the appropriate comparator therapy did not comply with the Summary of Product Characteristics and were also not reasonable because they considerably shorten the treatment duration in a large proportion of patients thus causing a disadvantage for the comparator therapy with regard to the outcome "SVR". In summary, no suitable data were available for treatment-naive HCV genotype 4 patients either.

G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.

Source: Institute for Quality and Efficiency in Health Care

Class Action Lawsuit Challenges the Exorbitant Pricing of Gilead's Hepatitis-C Drug Sovaldi

Class Action Lawsuit Challenges the Exorbitant Pricing of Gilead's Hepatitis-C Drug Sovaldi

HAVERFORD, Pa., Dec. 9, 2014 /PRNewswire/ -- Chimicles & Tikellis LLP of Haverford, PA today announced that it has filed a lawsuit on behalf of the Southeastern Pennsylvania Transportation Authority ("SEPTA") in federal court in Philadelphia, PA against Gilead Sciences, Inc. ("Gilead") related to the sale and pricing of its Hepatitis-C drug, Sovaldi®. Sovaldi is the first drug approved by the Food and Drug Administration for certain types of Hepatitis-C infections that does not need to be injected. It can reportedly cure about 90 percent of patients with the most common form of Hepatitis-C in three to six months, and can do so with relatively minor side effects compared to earlier available treatments.

Gilead has been selling a twelve week regimen of Sovaldi in the United States for approximately $84,000, or $1,000 per pill. This is significantly more than the original price projection for Sovaldi, and in sharp contrast to the prices at which the drug is being made available in other countries. Gilead recently announced its intention to make Sovaldi available in 91 developing countries at deeply discounted prices, and the drug is reportedly available in Egypt for 99% below the U.S. price. This obvious pricing paradox is under investigation by the Senate Finance Committee, which has questioned if the market for Sovaldi "is working efficiently and rationally," and whether "payors of health care….can carry such a load."

While there are some orphan drugs that are similarly expensive, they are typically limited to rare conditions that affect only a very small patient population. In those instances, charging high prices may be necessary to recoup amounts invested in research and development. In the case of Sovaldi, however, there are between 2.7 and 5.2 million people in the United States infected with Hepatitis-C, and 185 million people worldwide. The complaint alleges that, if left unchecked, Gilead's exorbitant pricing scheme has the potential to bankrupt segments of the U.S. healthcare system. According to the complaint, Gilead's pricing practices have also had the effect of pricing certain consumers and government programs out of the Sovaldi market, thus preventing sick patients from obtaining this critical drug. The complaint also cites reports that Gilead's pricing scheme has had a disproportionately high impact on minorities and those in lower income brackets (demographics that have had historically higher incidents of Hepatitis-C infections). Meanwhile, Gilead has recorded an astounding $8.5 billion in Sovaldi sales through the first three quarters of 2014 alone.

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.

CONTACT INFORMATION:
CHIMICLES & TIKELLIS LLP
Nicholas E. Chimicles (Nick@Chimicles.com)
Benjamin F. Johns (BFJ@Chimicles.com)
Joseph B. Kenney (JBK@Chimicles.com)
One Haverford Centre
361 West Lancaster Avenue
Haverford, PA 19041
Telephone: (610) 642-8500/(888) 805-7848
Fax: (610) 649-3633
www.chimicles.com (http://www.chimicles.com/)

For over 30 years Chimicles & Tikellis has pursued hundreds of securities, consumer and shareholder rights cases and recovered billions of dollars for their clients. The firm is nationally recognized, and their litigators hold many professional honors and distinctions.

SOURCE Chimicles & Tikellis LLP

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