By Annette M. Boyle
WASHINGTON – While commercial insurers responded to the approval of the breakthrough drug sofosbuvir for hepatitis C (HCV) by implementing prescribing restrictions, limiting use to the sickest patients and charging higher co-pays because of the drug’s expense, the VA has left use of the drug up to the physician and patient to determine.
Sofosbuvir gained Food and Drug Administration approval in December 2013. The VA began prescribing it in January 2014 and added sofosbuvir to the national formulary in March.
VA guidelines issued in May recommend use of the drug for treatment of HCV genotypes 1, 2 or 3 with or without co-infection with human immunodeficiency virus (HIV). As of September, 5,500 veterans have taken sofosbuvir, according to David Ross, MD, director of the VHA’s HIV/HCV and public health pathogens program.
“VA continues to make use of therapeutic advances for combating the hepatitis C virus to benefit veterans. Our mission is to provide the best quality, safe and effective healthcare veterans have earned and deserve,” Ross told U.S. Medicine.
The VA has one significant advantage over commercial insurers in using sofosbuvir: pricing. The drug costs $1,000 per pill retail, but federal supply schedule pricing means that the VA pays 40% less, $600 per dose, according to Ross.
That’s still quite a lot of money, particularly as sofosbuvir must be taken with ribavirin with or without interferon. It also is sometimes prescribed with another pricy new drug, simeprevirin, for patients who cannot tolerate interferon, though that combination has not yet received FDA approval. The total retail cost for the combination therapy runs $95,000 to $150,000 (if simeprevir is used) for a 12-week course of treatment.
For the VA, though, even that cost represents a real savings. “Although no precise savings projection is available, sofosbuvir-based regimens are expected to substantially increase the number of veterans achieving a cure, which may translate into significant downstream cost offsets to drug treatment,” Ross said. “Specifically, successful treatment of hepatitis C infection is anticipated to result in reductions in liver-related complications, which may otherwise lead to hospitalization, hepatocellular carcinoma or the need for transplant.”