UK's NICE gives Gilead's Sovaldi a qualified 'yes'
- NICE had previously requested additional cost-effectiveness evidence from Gilead.
- Based on draft guidance, NICE plans to recommend Sovaldi (sofosbuvir) in combination with peginterferon and ribavirin for the treatment of genotype 1 HCV in adults, as well as genotype 3 HCV in adults with cirrhosis, and genotype HCV in adults without cirrhosis if they have already received previous treatment for HCV.
- NICE is not recommending Sovaldi for treatment of genotypes 4, 5, and 6 HCV.
NICE has made a very complex assessment of Sovaldi use for treating various subtypes of chronic HCV, both with and without ribavirin and/or interferon. “[We are] 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,” said Gilead's UK general manager in a statement.
According to Bloomberg, HCV genotypes 1 and 3 make up 89% of all hep C cases in England. Analysts estimate that Sovaldi could clear $11.5 billion in sales in its first year alone.