What We’re Reading: Merck’s New HCV Drug Increases Competition

The director of the FDA’s Office of Antimicrobial Products – Edward Cox – said the approval of Zepatier “provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon”.

The drug, elbasvir and grazoprevir (Zepatier-Merck & Co.), was approved with or without ribavirin to treat chronic HCV genotypes 1 and 4 infections in adults.

Zepatier, sometimes paired with another antiviral drug, ribavirin, was evaluated in 12-to-16-week clinical studies involving almost 1,400 people.

Merck & Co. said the price will be $54,600 for a 12-week treatment regimen.

The latest entrant in the booming market is now predisposed to compete with other expensive drugs from Gilead Sciences, Inc. Despite this, the drug generated not more than $1.1 billion in the first nine months previous year, with Gilead’s Harvoni still dominating an estimated 95% share of the HCV-1 market. AbbVie announced Q4 sales of Viekira Pak, its own hep C treatment, of $554M, including US sales of $197M and global sales of $357M. Gilead reaped $10.3 billion in sales from Sovaldi alone in 2014, and analysts estimate that Sovaldi and Harvoni together will generate more than $18 billion in 2015 sales. Insurers will demand significant discounts to cover the drug, in any case.

CVS Health Corp, the No. 2 drug benefit manager, which now gives preferred status to Gilead’s hepatitis C drugs, said in an email that it is “employing a strategic assessment of the therapy landscape and engaging with drugmakers to evaluate options”. “The price has been chosen after considering that the majority of patients with chronic hepatitis C haven’t been treated, in some cases due to cost constraints”.

The new drug’s FDA label says liver-related blood tests should be performed prior to starting therapy and at certain times during treatment. Merck added that it anticipates that this price, as well as its “strategy to seek broad coverage across commercial and public segments”, will help broaden and accelerate patient access to treatment.

The spread of the virus is more common through contact, with blood of an infected person and can easily lead to serious liver disease if left unattended.