Gilead's Harvoni Less Expensive, but Still a Burden on State Medicaid Programs

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:

• Patients in Alaska must abstain from the use of illicit drugs and alcohol for at least 3 months and will undergo a urine test for verification.
• In some states, such as Arizona, Medicaid patients are only allowed 1 chance at treatment with Sovaldi.
• Illinois only dispenses Sovaldi for 2 weeks at a time with refills available every 2 weeks for the 12-week treatment period.

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.

Around the Web

Gilead's HCV Combo Pill, Harvoni, Convinces the FDA