NICE provisionally recommends Gilead Sciences' hepatitis C drug Sovaldi

The National Institute for Health and Care Excellence stated Friday that it issued further draft guidance recommending Gilead Sciences' Sovaldi (sofosbuvir) as a treatment option for certain patients chronically infected with hepatitis C virus (HCV). The agency, which in June requested additional efficacy data from Gilead, supported the cost-effectiveness of the therapy after the company agreed to offer the drug at a price of about 35 000 pounds ($58 000) for a 12-week course of treatment, representing a discount of about 30 percent to its US price. The regulator is expected to issue final guidance in September.

In its guidance, NICE recommended Sovaldi in combination with peginterferon alfa plus ribavirin for adults with HCV genotype 1, as well as those with HCV genotype 3 if they also have cirrhosis, or if they do not have cirrhosis, but previously received HCV treatment. Meanwhile, the agency also backed Sovaldi in combination with ribavirin alone for adults with HCV genotype 2 if they were previously treated for chronichepatitis C, or for those who had not received prior treatment and were unsuitable for interferon therapy. Sovaldi is also recommended for adults infected with genotype 3 HCV only if they also have cirrhosis.

Carole Longson, director of NICE's Centre for Health Technology Evaluation, said "new treatments, like [Sovaldi], can shorten the duration of interferon-based therapy and in some cases do not need to be taken with interferon at all. This could potentially encourage more people to seek treatment." The regulator estimated that 160 000 people in England are chronically infected with HCV, with more than half of patients unaware of their infection.

Commenting on the news, Gilead stated that although the decision will provide access to Sovaldi to most patients with hepatitis C, an "unmet need still exists" for patients infected with HCV genotypes that were not supported for reimbursement, including subtypes 4, 5 and 6, as well as subtype 1 in the case of Sovaldi plus ribavirin alone.

Gilead has received criticism for the price of Sovaldi, which was approved in the US in December last year and in Europe in January. Members of the US Senate Finance Committee recently asked the company to provide details on how the drug's price was determined, as have members of US House Energy & Commerce Committee. In addition, pharmacy benefit manager Express Scripts suggested it would recommend that its clients use other therapies once they become available because of Sovaldi's "unsustainable" price. Gilead reported that the drug amassed $3.5 billion in second-quarter revenue.

For related analysis, see Physician Views Poll Results - France and Germany lead Sovaldi charge in Europe; little resistance for combination use with Olysio in France and Physician Views Poll Results: Gilead's all-oral hepatitis C combo launch poised to better Sovaldi US debut despite payer scrutiny. See also ViewPoints: Pricing debate unlikely to derail biotech's key growth catalyst Sovaldi.

Separately, Gilead Sciences disclosed Friday that a US arbitration panel determined that Roche failed to establish its claims of rights to the product.

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