Perspective on the Rx Pipeline - Mavyret™
Class: HCV NS5A Inhibitors; HCV NS3/4A Protease Inhibitors
The FDA has approved Mavyret, a pan-genotypic (treats genotypes 1-6) medication for the treatment of Hepatitis C Virus (HCV) in adult patients without cirrhosis and who have not previously been treated.
An expensive, but curable condition: HCV is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the CDC, an estimated 2.7 to 3.9 million people in the United States have chronic HCV. Advances in medicine have provided several treatment options, offering a cure for this once incurable disease, but HCV is one of the most costly therapeutic classes.
New option brings big savings and faster therapy: The Average Wholesale Price (AWP) for HCV medications ranged from $65,500 to $113,400 per treatment prior to the introduction of Mavyret, which is being offered at a staggeringly low AWP of $31,700. This is causing manufacturers of other therapies to offer rebates and incentives to compete. Additionally, Mavyret, a once-daily, interferon-free medication is the first treatment that provides a regimen of only eight weeks—significantly shorter than 12+ weeks of other treatments.
Impact to the Pharmacy Care Experience
Formulary: Due to its clinical effectiveness and lower cost, Mavyret was added to the EnvisionRx Standard and Select formularies as a preferred medication alongside Harvoni® and Epclusa® effective January 1, 2018. All three medications are remaining on our formularies due to their varying clinical values—Harvoni has a pediatric indication, Epclusa can be used in decompensated cirrhotic patients and Mavyret can be used in end-stage renal disease patients.
Additionally, EnvisionRx was able to leverage Mavyret’s low cost to negotiate significantly higher rebates on Gilead’s Harvoni and Epclusa that were implemented in October 2017 and have substantially lowered spend within the HCV therapeutic class for plan sponsors.
Pharmacy Network: As with other curative therapies, Mavyret is available at many retail pharmacies, but due to its complex nature, a specialty pharmacy should be mandated. A specialty pharmacy will be more knowledgeable on the treatment and better able to monitor and manage adherence and side effects.
Plan Design: Because Mavyret is not optimal for all patients, EnvisionRx has instituted a prior authorization to ensure the correct clinical parameters are matched with the correct treatment by reviewing liver status, genotype, prior treatment history, concurrent drugs, renal function and other concerns. These clinical parameters will also determine the appropriate length of therapy so the correct amount is dispensed.
Clinical: In clinical studies of 2,300 adults with genotype 1-6 HCV infection without cirrhosis or mild cirrhosis, Mavyret resulted in no virus detected in the blood work for 92% to 100% of participants after completing eight, 12 or 16 weeks of treatment, suggesting that the infection was cured.
Member Engagement: This update will not result in any member disruption and will generate a positive change by providing access to the only pan-genotypic, eight-week therapy for HCV. Due to the complexity, we recommend that all chronic HCV treatment regimens are managed at a specialty pharmacy that offers a high-touch care model with an assessment prior to therapy, monitoring during treatment and followup post therapy. By utilizing a specialty pharmacy, prior to treatment, pharmacists counsel patients on the medication and manage any side effects, over-the-counter drug-drug interactions, alcohol consumption or high-risk behaviors that can compromise the therapy’s outcomes. During therapy, pharmacists monitor for any barriers to adherence and provide side effect mitigation strategies. After the last dose is taken, pharmacists confirm the therapy is complete and provide next steps, as well as options to avoid re-infection.
Payer Action Plan
Review Formulary Design: Mavyret has been added to a preferred status for EnvisionRx clients using Standard or Select formularies. For clinical reasons, coverage should include Mavyret, Harvoni and Epclusa.
Specialty and Prior Authorization Considerations: EnvisionRx recommends that payers review their plans and include a mandate that HCV drugs be filled at a specialty pharmacy that offers an aggressive, patient-centered, reportable Hepatitis C clinical program in order to achieve optimal outcomes. Additionally, prior authorizations are recommended to ensure the patient is a fit for this therapy. Please note, for those using Envision formularies, Mavyret has been assigned to a preferred tier with prior authorization and no action is required.
 U.S. Food & Drug Administration (2017). FDA approves Mavyret for Hepatitis C. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm570038.htm
Our Clinical Steering Committee
The Envision Clinical Steering Committee brings together leaders across our national pharmacy care company to monitor the drug landscape, provide recommendations on how to address changes, and to ensure our clients and patients are prepared—in advance.
With any new development, we partner with our Pharmacy & Therapeutics (P&T) Committee and consult with our best-in-class specialty pharmacy, to provide a balanced perspective on the clinical effectiveness of all available options, the cost impact to our plan sponsors and patients, and the impact on the overall patient experience.
Kel Riley, MD
Chief Medical Officer