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.”
Realizing and reaping the benefit of a cure for veterans with HCV puts the VA in a unique position. Other insurers see beneficiaries come and go from their rolls, so there is no guarantee that the company that pays for the cure will actually be the one that saves money from not having to treat advanced liver disease later.
Even in other federal settings, such as the Bureau of Prisons, where the government is required to provide patients with the current standard of care, the transient nature of the population makes absorbing the cost of newer HCV treatments a difficult pill to swallow. The Bureau of Prisons recommends waiting to treat prisoners who do not have advanced liver disease. For those who do, however, they have adopted the American Association for the Study of Liver Disease (AASLD) and the Infectious Diseases Society of America (IDSA) recommendations for sofosbuvir-based treatment regimens.
The VA’s Treatment Considerations also state that it is “reasonable to defer therapy in hepatitis C patients with less-advanced disease because of the anticipated FDA approval of new treatments later this year that are more effective, less toxic and easier to administer. However, this guidance also makes clear that this decision should be based on patient-physician discussion regarding what is best for the patient.”
Rapidly Changing Guidelines
The VA and BOP recommendations are in keeping with American Association for the Study of Liver Diseases-Infectious Disease Society of America (AASLD-IDSA) guidance from this summer that noted that limited resources may require prioritization of treatment with sofosbuvir for very ill patients with HCV and that patients who could wait might benefit from new treatments expected to be approved in the next few months. In late October, however, the guidance was revised to state that “treatment will benefit almost all patients in all stages of chronic infection and that urgent initiation of therapy is needed in patients with certain conditions.”
The update followed the FDA approval in early October of a much-anticipated, once-a-day, all-oral, ribavirin- and interferon-free therapy for HCV, genotype 1. Genotype 1 accounts for about 70% of HCV cases in the U.S.
The new breakthrough drug combines sofosbuvir and ledipasvir and is the first therapy that does not require the addition of ribavirin or interferon. Three Phase III clinical trials submitted to the FDA showed that less than one percent of study participants discontinued therapy because of adverse side effects and that 12 to 24 weeks of the combination achieved sustained virologic response rates ranging from 94% to 99%.
The new drug is even more expensive than sofosbuvir on a per-pill basis, but no other drugs need to be taken with it. About 50% of patients may only need an eight-week course, though, which could bring the retail price for the full course of treatment down to about $65,000.
“Currently, VA continues to monitor treatment options and financial impact of these new breakthrough therapies for veterans with chronic hepatitis C,” said Ross. Funding for sofosbuvir has already been allocated and distributed to the VISNs for use by VAMCs and clinics.
The VA guidelines are being updated to reflect the rapidly changing treatment environment and recommendations. As for the newest treatment options, Ross said that “where clinically appropriate, the new hepatitis C treatments are underway. VA is taking appropriate actions to ensure funding continues to be available so veterans receive these new therapies.”