New hep C drugs shift treatment plans

On December 6, FDA approved Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon, and is the second drug approved by FDA in the past 2 weeks to treat chronic HCV infection. On November 22, FDA approved Olysio (simeprevir).

“Managed care’s strategy for new entrant, extremely high cost agents to treat hepatitis C such as Sovaldi (sofosbuvir), will include prior authorization, genotype testing, appropriate dose, concomitant therapy and duration of use monitoring,” says Ruth Ann Opdycke, Pharm D, MS, president of TPG Healthcare Consulting. “However, for oral products such as this, the more advanced programs will implement or continue to use case management and adherence monitoring programs to assure that the products are taken as prescribed for the full duration of treatment.  Regardless of how effective the agents are, the implications of non-compliance will continue to be a barrier to effective treatment.”

The new treatment protocol changes the outlook for patients with chronic HCV, reducing treatment time to as little as 12 weeks, and reducing or eliminating the need for interferon injections. However, patient advocates worry that the price could be unaffordable even with insurance coverage: a 24-week supply is reportedly priced at $84,000. A 20% coinsurance payment at that price would be $16,800 in out-of-pocket costs.