Cost-Benefit Analysis of Sofosbuvir and Simeprevir for Hepatitis C

A group of health care providers say a new breakthrough hepatitis C drug is too costly to be of great value to all but a select group of people seeking treatment for the blood borne virus.

“You are doing good things for patients clinically but on a financial basis, it’s not a winner,” Steve Pearson, the panel moderator and president of the Institute for Clinical and Economic Review (ICER), said about the pricey new drugs.

Following a day-long review of new hepatitis C drugs, a fifteen-member panel of independent medical experts from across California voted that Gilead Sciences new drug called Sovaldi (sofosbuvir) represents “low value” treatment because of its high cost.

Clinicians, insurance payers, policy experts and a patient advocate joined the discussion that was held in San Francisco this week and sponsored by the California Technology Assessment Forum, an organization that evaluates new treatments in a public forum.

The group plans to issue a report that will include vote results on Sovaldi and Olysio (simeprevir), another new hepatitis C drug from Johnson & Johnson, along with recommendations and a patient information guide, Pearson said.

In December, the FDA approved Sovaldi, considered a breakthrough drug for hepatitis C treatment in part because it is taken only once a day, as a component of a combination antiviral treatment regimen. Debate continues over the cost of the drug, priced at nearly $1000 a day for 12 weeks of treatment.

Pharmaceutical companies often defend the pricing of new drugs by noting the years of research and development invested to bring a product to market. Gilead offers an assistance program to eligible patients to help pay for Sovaldi.

The Centers for Disease Control and Prevention estimate that at least 2.7 million people in the US are chronically infected with hepatitis C but a lack of symptoms may cause the virus to go unchecked. A long-lasting hepatitis C virus infection can damage the liver and lead to liver cancer or the need for a liver transplant.

Until recently, typical treatment involved a combination of interferon injection and oral antiviral agents that could cause severe side effects. New drugs to treat the virus have a high cure rate in test trials, faster treatment times and fewer side effects but cost more than the older drugs.

“At the end of the day we seem to have a broken model for paying for something on this scale, with this number of patients at this price,” Pearson said.

Finance models that looked at what it would cost to treat all eligible patients five to 20 years out indicated no real cost savings or return on the money spent upfront, Pearson said. The exception might be in treatment of patients with advanced fibrosis who have the highest risk of liver failure, he said.

The panel was presented with how much the new drug costs to treat a patient, costs for the whole system if certain patient populations were treated and comparison costs of older drugs. Participants weighed the drug benefit and ranked its value based on three levels - low, reasonable and high, Pearson said.

“I do think that it was pretty clear that overall they viewed the new drugs as low value,” Pearson said, noting that the panel voted more favorably when considering clinical effectiveness of the same new drugs.

The panel vote, though not binding, reflects a larger debate nationwide about spiraling costs of new drugs.

“Not many health care systems have the luxury of saying we can spend a whole lot now and then get it back 20 years from now,” Pearson said.