Gilead’s Sovaldi Wins Backing of U.K. Health-Cost Regulator

Gilead Sciences Inc.’s hepatitis C drug Sovaldi won the backing of the U.K.’s health-cost regulator, paving the way for the treatment to be reimbursed by British taxpayers at a price of almost $700 a pill.

A standard 12-week course of Sovaldi will cost almost 35,000 pounds ($58,380), not including tax or the price of interferon and ribavirin, the immune-boosting therapies that may be taken alongside the drug, the National Institute for Health and Care Excellence said in a statement today.

The therapy has become a lightning rod for debate about drug pricing globally because its cost has prompted some insurers in the U.S. to deny coverage to patients they deem not sick enough. The drug is transforming the treatment of hepatitis C by boosting cure rates to more than 90 percent and allowing patients to shorten the time they spend taking interferon and ribavirin, which can cause side effects including depression and rash.

“Many people with the disease either don’t complete the full course, or are reluctant to seek treatment in the first place,” Carole Longson, director of the NICE Centre for Health Technology Evaluation, said in the statement. Sovaldi “could potentially encourage more people to seek treatment.”

Approved in the U.S. in December and in the European Union in January, Sovaldi may earn Foster City, California-based Gilead more than $11.5 billion in sales in its first year on the market.

Liver Scarring

The drug is a cost-effective treatment when taken together with interferon and ribavirin for the two strains of the virus that account for almost 90 percent of hepatitis C cases in England, NICE said. Gilead charges $84,000 for the same course of treatment in the U.S., and recently agreed to supply the drug for $900 a course in Egypt, the country with the most hepatitis C patients.

The agency is recommending Sovaldi, plus interferon and ribavirin, for adults with genotype 1 of hepatitis C, which accounts for 46 percent of all cases in England, and genotype 3, which makes up 43 percent. People with type 3 will only qualify if they have liver scarring or have tried other, cheaper therapies first, NICE said. Those patients may also be able to get Sovaldi with ribavirin alone, avoiding interferon.

Patients with type 2, which is generally easier to treat than other types, may be able to get Sovaldi with just ribavirin if they’ve been treated before or can’t tolerate the side effects of interferon. NICE said Sovaldi wasn’t cost-effective for use against genotypes 4, 5 and 6.

While NICE’s recommendation will potentially grant access to Sovaldi for the majority of hepatitis C patients, an “unmet need still exists” for those with sub-types who aren’t recommended for treatment under the guidance, Gilead said in an e-mailed statement.

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