- The FDA last week approved Merck's Zepatier for the treatment of adult patients with chronic hepatitis C virus infections (genotypes 1 and 4). Zepatier will be priced at $54,600 for a 12 week regimen, compared to $94,500 for 12 weeks of treatment with Gilead's Harvoni.
- The big payers in the market, including Express Scripts and CVS Health, are currently evaluating Zepatier's medical benefit, as well as its cost, according to a report from Reuters.
- Gilead's Harvoni and Sovaldi, along with AbbVie's Viekira Pak, have dominated the Hep C market and commanded high list prices. The entry of a lower cost treatment, albeit one requiring greater liver monitoring, may boost the leverage of payers seeking to limit costs.
The hepatitis C has so far been divided between Gilead and AbbVie. With a third major player now entering the market, pricing and coverage dynamics may change dramatically. Gilead's hepatitis C drugs are on formulary at CVS Health and Aetna, while AbbVie has an exclusive contract with Express Scripts.
Gilead's nearly complete dominance could decline as Merck's new two-in-one combo drug comes to market. UBS Securities has estimated that Merck will get 8% of the genotype 1 hep C market in the U.S. this year, and 15% in 2017.
Although payers are searching for the lowest-cost hep C option, price is not the only factor. Gilead's Harvoni is the only hepatitis C treatment with eight-week curative regimen, offering greater flexibility.
In addition, both Viekira Pak and Zepatier require liver function testing on a regular basis. In fact, the FDA in October issued a warning about Viekira Pak, making AbbVie update its label to reflect increased risk of liver injury and liver failure in patients with cirrhosis (which is 15% to 30% of all hepatitis C patients).
"Increasingly, safety is being factored into the overall value equation," said Brian Overstreet, President of Advera Health Analytics, in an interview with BioPharma Dive last year. "Payers, as well as hospital systems, are starting to take risk mitigation, downstream medical costs, patient safety and the rate of adverse events into account during the decision-making process."
Zepatier is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg).