NICE backs Gilead's Harvoni in hepatitis C, but refuses use in common strain

LONDON, Mar 3 (APM) - NICE on Tuesday recommended in first draft guidance National Health Service (NHS) funding for Gilead's Harvoni (ledipasvir+sofosbuvir) in hepatitis C, but rejected its use in one of the disease's most common strains while restricting treatment length in other populations.
In a statement NICE said it rejected Harvoni in combination with ribavirin in genotype 3, which according to the cost-effectiveness body represents about 43% of patients in England.
NICE also restricted use of 12 and 24 week courses of the drug in some genotype 1 patients, the most common form which accounts for 46% of the disease population.
There were also restrictions on use of 12 and 24 week courses in the rare genotype 4 form of the disease in the guidance applying to England and Wales.
NICE did recommend Harvoni in treatment naïve patients with genotype 1 without cirrhosis for eight weeks, and 12 weeks for treatment naïve genotype 1 patients with cirrhosis.
It also recommended Harvoni for 12 weeks for treatment-experienced genotype 1 patients without cirrhosis.
The cost of a 12 week course of treatment is almost 39,000 pounds (53,000 euros) and a 24 week course is nearly 78,000 pounds (107,000 euros) both excluding value-added tax, and not including the cost for ribavirin. Costs may vary in different settings because of negotiated procurement discounts, NICE said.
NICE's appraisal committee noted that all the incremental cost-effective ratios (ICER) in treatment-naive genotype 3 HCV with or without cirrhosis were over 30,000 pounds (41,000 euros) per QALY gained - above its generally-held maximum cost per QALY gained.
It noted that the ICERs for people with treatment-experienced, genotype 3 HCV and cirrhosis for whom interferon was not suitable ranged from 18,000 to 30,500 per QALY gained for 24 weeks of Harvoni plus ribavirin (compared with no treatment), and agreed this may increase when accounting for the additional uncertainty associated with the evidence.
The ICER for 24 weeks of Harvoni in people with treatment-experienced genotype 1 or 4 HCV with cirrhosis was 32,500 pounds (45,000 euros) per QALY gained compared with Sovaldi (sofosbuvir) plus peginterferon alfa and ribavirin.
NICE has already backed Gilead's Sovaldi and J&J's Olysio (simeprevir) in hepatitis C in final guidance published last week (APMHE 41617).
NICE has begun a consultation on its proposals, lasting until March 23, before publication of a second draft. The guidance is available at:



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