In new draft guidance, the National Institute for Health and Care Excellence says that Gilead Sciences’ blockbuster Sovaldi should be made available on the NHS for treating some patients with chronic hepatitis C.

Following receipt of additional information about the drug’s cost-effectiveness from Gilead, NICE says it is now planning to recommend the drug’s use, in combination with peginterferon alfa and ribavirin for treating: genotype 1 chronic hepatitis C in adults; genotype 3 chronic hepatitis C in adults with cirrhosis; and  genotype 3 chronic hepatitis C in adults without cirrhosis only if they have had treatment for hepatitis C before. 

It does not recommend Sovaldi (sofosbuvir) in combination with peginterferon alfa and ribavirin for treating genotype 4, 5 and 6 chronic hepatitis C in adults.

In combination with ribavirin alone, NICE plans to recommend’s Sovaldi’s use as an option for treating: genotype 2 chronic hepatitis C in adults, only if they have not had treatment for chronic hepatitis C before and are intolerant to or ineligible for interferon therapy, or if they have had treatment for chronic hepatitis C before, regardless of interferon eligibility; and for treating genotype 3 chronic hepatitis C only in adults with cirrhosis.

It does not plan to recommend Sovaldi, in combination with ribavirin alone, for treating adults with genotype 1, 4, 5 and 6 chronic hepatitis C.

'Very complex assessment'

Responding to the draft guidance, Gilead Sciences’ UK general manager, Stelios Karagiannoglou, said the company is “pleased that, following a very complex assessment, NICE has recognised the clinical and economic benefit of treatment with sofosbuvir and have determined it is a valuable use of NHS resources for the majority of hepatitis C patients.”

However, the firm also notes the unmet need that still exists for patients with specific sub-types of hepatitis C for which the NICE draft guidance does not recommend the drug’s use, and points out that a recommendation by the Scottish Medicines Consortium in June enables a broad range of hepatitis C patients in Scotland to receive treatment with Sovaldi.

The Hepatitis C Trust said the new provisional guidance “takes us one step closer to making the elimination of hepatitis C a realistic possibility by improving both cure rates and tolerability.” However, while the Trust is delighted that more patients will have access to this new treatment, “we are equally disappointed that a small group of patients will not benefit,” said chief executive Charles Gore.

“With many other new drugs in the pipeline, we ask NICE to find room in its crowded work programme to assess them as early as possible to ensure all patients have the opportunity to get cured of this cancer-causing virus,” Mr Gore added.

In April, NHS England approved funding for Sovaldi for patients significantly at risk of dying or needing a liver transplant. At  $84,000 for three months’ treatment, or just under £35,000 in the UK, the drug’s high price has led to widespread concern, with the US Senate Finance Committee asking Gilead to provide it with detailed information “because we need a better understanding of how your company arrived at the price for this drug.”

Sales of Sovaldi globally are expected to be close to $10 billion in its first year.

- NICE is asking for comments on this new draft guidance, to be received by September 5.