Gilead Sciences' Harvoni represents the first once-a-day, complete treatment pill approved by the FDA to treat the hepatitis C virus (HCV). And for some patients, the drug will be less expensive than Gilead's other HCV treatment, Sovaldi.
Gilead Sciences’ Harvoni represents the first once-a-day, complete treatment pill approved by the FDA to treat the hepatitis C virus (HCV). And for some patients, the drug will be less expensive than Gilead’s other HCV treatment, Sovaldi, which has become the poster child for high-cost specialty drugs.
Sovaldi costs $1000 a pill, for a total of $84,000 for a 12-week course of treatment. However, Sovaldi must be used with other drugs. Harvoni is one pill that comprises a combination of sofosbuvir (Sovaldi) and ledipasvir.
Since Harvoni is being viewed as a replacement for Sovaldi, interferon, and ribavirin, each pill will cost $1125, according to reports from The New York Times and Investors.com. The cost of a 12-week course of treatment will be even more expensive than Sovaldi at $94,500. However, many patients will be able to take Harvoni for only 8 weeks, which would cost a total of $63,600.
“By providing very high cure rates in as little as 8 weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States,” Nezam Afdhal, MD, director of Hepatology at Beth Israel Deaconess Medical Center, professor of Medicine at Harvard Medical School, and a principal investigator in the Harvoni clinical trials, said in a statement.
Harvoni’s Phase 3 studies evaluated treatment with Harvoni with or without ribavirin for 8, 12, or 24 weeks. For individuals in the ribavirin-free arms, the cure rates were 94-99%. Just 1% or fewer of patients discontinued treatment due to adverse events.
Despite the potentially shorter treatment period, Harvoni’s cost could still be a sticking point. Following Sovaldi’s rollout, 35 states mandated that Medicaid patients needed prior authorization before receiving the drug, according to Forbes.
A report from Viohl & Associates, released shortly before the FDA approved Harvoni, highlighted some of the ways states are attempting to curb the use of Sovaldi, including:
According to Forbes, it is still unclear how Medicaid programs will handle Harvoni or any other HCV drugs that are expected to receive FDA approval.
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