FPC Welcomes FDA Approval of AbbVie’s New Pangenotypic HCV Combination Mavyret

Wholesale Acquisition Cost price of $26,400 for eight-week course marks significant departure from prohibitive drug prices set for first-generation cures.

NEW YORK, NY, AUGUST 4, 2017  – The Fair Pricing Coalition (FPC) today applauded U.S. Food and Drug Administration approval of the first eight-week pangenotypic, ribavirin-free, curative regimen for hepatitis C virus (HCV) infection and expressed its appreciation for a wholesale acquisition cost (WAC) that should translate into improved affordability, with fewer access restrictions, to insurers and people living with the virus.

“This is very good news for people living with HCV in the United States,” said Tim Horn, co-chair of the Fair Pricing Coalition. “The majority of people using Mavyret will be able to complete treatment in just eight weeks, compared with standard 12-week courses, depending on their treatment history and cirrhosis status.  The favorable U.S. launch price set by AbbVie should also be good news to public and private payors, resulting in fewer access barriers, a substantial increase in the number of cures, and significant progress toward HCV elimination. FPC remains committed to ensuring access the U.S. and, globally, working with its partners toward affordable pricing in low- and middle-income countries.”

The U.S. WAC price for 12 weeks of Mavyret therapy has been set at $39,600. For patients without cirrhosis who are new to treatment—approximately 78% of people living with the virus in the U.S., according to AbbVie’s estimates—an eight-week course of treatment is recommended, with a WAC price of $26,400. This price is in stark contrast with the WACs set for its pangenotypic predecessors, including Gilead’s Vosevi and Epclusa (both $74,760 for 12 weeks of therapy), and is by far the lowest WAC of any direct acting antiviral (DAA) regimen currently available for HCV infection in the U.S.

“FPC believes that all direct acting antiviral combinations for HCV should be priced not higher than $40,000 in the U.S., with the ability for payors to meaningfully negotiate and get to a place where they would be willing to increase access and cure more people living with HCV,” said Emalie Huriaux, FPC co-chair. “At this WAC price point, public payors, including Medicaid programs and correctional systems with limited budgets, would be in a much better position to get to a price that is both high value and cost-savings at best or cost-neutral at worst.”

According to a 2015 analysis by the University of California, San Francisco, and the Institute for Clinical and Economic Review, a price range for highly curative HCV treatment of $34,000 to $42,000 should serve as a benchmark for keeping U.S. health system cost increases below a threshold of 0.5%–1.0%.[1] According to ICER, this threshold budget impact for a single new treatment is viewed by many payors as manageable, without resorting to severe treatment delays or cuts in others services.

“It’s clear that our discussions with AbbVie in the lead-up to approval were not in vain,” said Huriaux. “The company did the right thing in launching with a WAC price that is, we believe, within the bounds of what the U.S. market can reasonably bear—public and private payor negotiations will ultimately reduce the cost further. It is now incumbent upon payors to eliminate restrictions, such as limiting treatment to only patients with advanced liver disease and degrading evaluations related to drug and alcohol use, neither of which are consistent with evidence-based guidelines. State Medicaid programs and correctional systems have, understandably, cried foul with respect to ensuring coverage for these life-saving therapies. With Mavyret’s significant price differential, the issue of unencumbered access is now in payors’ hands. U.S. activists have worked hard to achieve the former; we must now focus intently on the latter.”

Mavyret, a once-daily regimen containing glecaprevir (an NS3/4A protease inhibitor) and pibrentasvir (an NS5A inhibitor), was approved on August 3rd as curative therapy for adults with HCV genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. A game changer, Mavyret shows high sustained virologic response rates (SVRs) of 95 percent for people with the more difficult-to- treat HCV genotype 3, without cirrhosis, with 8-week treatment. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Clinical trial data submitted by AbbVie in their approval application indicate that Mavyret is equally effective in people coinfected with HIV and HCV. As with all current HCV curative formulations, the label carries a black box warning to screen for and treat Hepatitis B co-infection.

[1] ICER. Newest treatment for hepatitis C: final report. Boston, MA: Institute for Clinical and Economic Review. 2015 January 30. Available from: https://icer-review.org/wp-content/uploads/2016/01/CTAF_HCV2_Final_Report_013015.pdf