By: Marcus J. Hopkins, Blogger
Over the past month, the U.S. Food and Drug Administration has approved two new Direct Acting Antivirals (DAAs) for use in treating Chronic Hepatitis C (HCV) – Vosevi (Gilead) and Mavyret (AbbVie). Both of these drugs are pan-genotypic, meaning that they can be used to treat HCV Genotypes 1-6, making them the second and third pan-genotypic regimens to be approved by the FDA. What makes Vosevi unique is that it’s the first drug approved by the FDA for patients who have previously been treated with other DAA drugs (Brooks, 2017). That, alone, gives Gilead some leeway when it comes to setting their Wholesale Acquisition Cost (WAC), which they set at $74,760 for twelve weeks of treatment.
That was in July 2017. Then, came Mavyret, from AbbVie. Rather than even bother to hide their intention, AbbVie seriously threw a spanner in the works by pricing their new drug just under 50% lower than Vosevi for a similar regimen length. For twelve weeks of Mavyret, the WAC is $39,600 – roughly 48% the cost of Vosevi. But, that’s not the kicker: Mavyret’s recommend dosage for treatment-naïve patients is an eight-week regimen, coming in at $26,400. Vosevi also has an eight-week regimen option, but at a significantly higher price point. Shots. Fired.
This isn’t the first time that AbbVie has played this pricing game, before, in an attempt to undercut Gilead. In 2014, they released Viekira Pak – a four-tablet regimen for use in treating HCV Genotype 1a & 1b – at a WAC of $83,319. While this is significantly more expensive, at the time, it was something of a blow to Gilead and Janssen (makers of Olysio). Individually, Gilead’s Sovaldi had a WAC $84,000 for twelve weeks; however, the drug was intended to be used in combination with Olysio (Janssen), which boasted a WAC of $66,360, making the total cost of the regimen $150,360. Gilead’s newer product, Harvoni – a single-pill regimen designed to be used without Olysio – came in at $94,500.
Despite the lower price, Viekira Pak never really caught on as the go-to treatment regimen for HCV, for a number of reasons: (1.) Gilead had already established relatively deep market penetration and brand recognition; (2.) the four-pill regimen was/is thought to be too cumbersome to ensure compliance with the regimen; (3.) the price wasn’t low enough to get payers to bite. Of these three issues, AbbVie managed to solve the multi-pill regimen part in 2016 with their single-pill Viekira XR, which is now the preferred regimen over the original formulation.
But, pricing wars are tricky, particularly in the world of HCV therapies. The first truly significantly lower price point came in 2016 with Zepatier – Merck’s single-pill answer to HCV treatment – with a WAC of $54,600. But, even that price wasn’t enough to overcome the drug’s significant barriers to treatment – it was notoriously difficult to prescribe, as it had several counterindications (negative drug interactions) with drugs used to treat other illnesses. This was particularly true in the case of HIV. In addition to individual pricing concerns, treatment indications often require that the drugs be used in combination with other medications, the most common of which is Ribavirin, which can cost between $550 – $850 for twelve weeks, depending on brand vs. generic pricing.
What Mavyret does that Viekira Pak/XR did/does not is put on the market a single-tablet regimen to treat six genotypes of HCV, making it incredibly versatile. Whether or not they will be able to overcome Gilead’s market dominance, however, is another question.
- Brooks, M. (2017, July 18). FDA Clears Pan-Genotypic Vosevi for Chronic Hepatitis C. New York, NY: Medscape, LLC: Medscape: News & Perspective: Medscape Medical News: FDA Approvals. Retrieved from: http://www.medscape.com/viewarticle/883095
Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.