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www.fdanews.com/articles/169688-nice-expands-sovaldi-recommendations

NICE Expands Sovaldi Recommendations

January 23, 2015

The UK’s health cost-benefit watchdog is recommending Gilead Sciences’ blockbuster hepatitis C cure, Sovaldi, be offered through the National Health Service to patients with three additional types of hepatitis C beginning in July.

National Institute for Health and Care Excellence had originally recommended the drug in combination with peginterferon alfa and ribavirin for adults with genotypes 1, 2 and 3 hepatitis C virus, it is now recommending expanding the indications to cover patients with genotypes 4, 5, and 6 who also have liver cirrhosis.

Cost-effectiveness analyses showed that providing Sovaldi (sofosbuvir) to patients with the expanded indications would fall at the high end of NICE’s acceptable range, but in final draft guidance NICE found that those patients represent a significant amount of unmet medical need. These patients will also be required to take peginterferon alfa and ribavirin.

A 12-week course of Sovaldi costs $53,300 in the UK, far less than its $84,000 price tag in the U.S.

Stakeholders now have the opportunity to make any appeals on the final draft. NICE expects to release a finalized guidance next month.

Read the final draft at www.fdanews.com/01-15-15-Sovaldifinaldraft.pdf. — Lena Freund