UK's NICE Recommends Gilead's Sovaldi For Hepatitis C

The National Institute for Health and Care Excellence (NICE) in the U.K. announced in a press release that it has recommended Gilead’s Sovaldi (sofosbuvir) for Hepatitis C treatment. The medication has been under intense scrutiny due to its high cost of $84,000 for a 12-week regimen. The Wall Street Journal reports that NICE often denies financial coverage for medications and “often butted heads with drug makers and patient groups over its decisions.” After asking Gilead for more information, the U.K. agency decided that Sovaldi was an improvement over existing treatments, and the selling cost of $54,000 in the U.K. may have swayed its decision.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, commented on the decision saying that Hepatitis C is a major health concern and is difficult to diagnose, with many new infections every year. She said the problem worsens due to the long dosing period of interferon, patient non-compliance, and side effects. She said, “New treatments, like sofosbuvir, can shorten the duration of interferon-based therapy and, in some cases, don’t need to be taken with interferon at all. This could potentially encourage more people to seek treatment.”

NICE Provisional Recommendation

NICE’s recommendation is a draft or provisional recommendation subject to final guidance by the National Health Service (NHS), which is directed to make local decisions on funding Sovaldi until final approval. Stakeholders may comment until September 5, 2014. The agency is only recommending the medication for some people, however.

Details are available in the NICE Appraisal Consultation Document. The agency says that Sovaldi, plus interferon and ribavirin, is for adults with genotype 1, which accounts for 46 percent of the Hepatitis C patients in the U.K. The treatment also extends to patients with genotype 3, accounting for 43 percent of patients.

However, NICE’s recommendation does not allow coverage for patients with genotype 1. This decision was made upon NICE’s measurement of the quality of patients’ remaining years while taking a medication and the cost to attain that quality. For this subgroup, Sovaldi’s cost-effectiveness was $80,000.

NICE Approval Concerns

The concerns post-NICE approval are centered around how NICE will decide which patients are cost-effective to treat. In a Bloomberg article, the author states that this is the same concern in the U.S., saying that Sovaldi’s “cost has prompted some insurers in the U.S. to deny coverage to patients they deem not sick enough.” Gilead responded in kind saying, “An unmet need still exists.”