A panel of California medical experts says two new, once-daily drugs for hepatitis C represent low-value treatment alternatives for the condition because of their high price tags.
The drugs, Gilead Sciences’ sofosbuvir (Sovaldi) and Johnson & Johnson’s simeprevir (Olysio), cost more than $1,000 per pill, pushing the price for the recommended 12-week course of treatment of sofosbuvir to close to $90,000 and treatment with simeprevir to around $66,000, according to the California Technology Assessment Forum (CTAF), an independent group originally convened by the insurance industry to evaluate costs and benefits of treatments.
Courtesy NIH
Sovaldi and Olysio represent low-value treatment alternatives for hepatitis C because of their high price tags, the CTAF concluded.
The Food and Drug Administration approved sofosbuvir and simeprevir late last year. CTAF, which met March 10 to consider the financial and clinical effects of the two new drugs, will issue its final report on the treatments in April.
The group acknowledged in its draft report that therapeutic regimens containing sofosbuvir, approved to treat hepatitis C genotypes 1 through 4, have the potential to "substantially increase" the number of patients achieving sustained virologic response. The drug also offers "the first effective interferon-free option" to patients who can’t take interferon.
"These advantages are considerable," the report said. However, it added, "the clinical advantages of newer treatment regimens would ... come with a substantial potential impact on health care budgets should a large number of patients be treated."
Replacing current care with sofosbuvir-based regimens would increase drug expenditures by $18-$29 billion per year in California alone, the report estimated. Gilead Sciences has maintained that the drug’s up-front costs are justified given that it could decrease the number of patients who ultimately suffer liver failure and need transplants. However, CTAF said it would take 20 years for payers to recoup two-thirds of the drug’s cost.
CTAF was less enthusiastic about simeprevir, which is approved only for treatment of hepatitis C genotype 1. The group said in its report that "use of simeprevir with pegylated interferon and ribavirin appear to provide limited benefit over the previous standard of care," mainly because that regimen decreased anemia and required patients to take fewer pills.
Originally funded and managed by the Blue Shield of California Foundation, in 2013 CTAF became a core program of the nonprofit Institute for Clinical and Economic Review, which includes representatives of payers, clinicians, and drug makers on its board.
Other groups also have complained about the high price of sofosbuvir and simeprevir. For example, in January, the AIDS Healthcare Foundation asked state Medicaid directors to keep sofosbuvir off its formulary because of its cost.
