NICE has signalled a provisional OK for Gilead’s Harvoni to be used as a treatment for hepatitis C by the NHS.
In draft guidance the healthcare watchdog approved Harvoni (ledipasvir-sofosbuvir) as a treatment for some people with genotype 1 or 4 chronic hepatitis C.
Already approved in the US and Europe to treat this patient type, Harvoni is taken orally as a fixed-dose combination tablet for 8, 12 or 24 weeks, with or without ribavirin.
NICE estimates a basic cost – without negotiated procurement discounts – for a 12-week course of Harvoni to be just under £40,000, and a 24-week course at just less than £80,000. In clinical trials the treatment achieved impressive cure weeks in people given an eight-week course.
On the other hand, NICE calculates Harvoni will achieve cost benefits of up to £77,500 for 24 weeks of treatment, compared with simeprevir plus peginterferon alfa and ribavirin per quality-adjusted life year (QALY) gained.
Gilead argues that the costs are ultimately offset if people with hepatitis C are prevented from developing complications due to viral progression like liver cirrhosis and liver cancer, and prevented from passing on the virus.
The NICE technology appraisal committee also considered Harvoni in combination with ribavirin for people with genotype 3 chronic hepatitis C – an indication that is included in the drug’s European marketing authorisation – but the committee concluded that “based on the evidence presented… that this could not be considered a cost-effective use of NHS resources”.
Commenting on the draft guidance Professor Carole Longson, director of the NICE centre for health technology evaluation, says the current mainstay of treatment for hepatitis C – interferon-based therapy – has side effects that may increase the likelihood that people aren’t treated.
“Ledipasvir- sofosbuvir offers the possibility of a shortened course of treatment without the need for combination therapy with interferon. This could make it more likely that people will seek treatment for their condition.
She adds: “In turn this could have important benefits, not just for people with chronic hepatitis, but also in reducing transmission of the virus to people without the infection. The Committee therefore acknowledged that ledipasvir-sofosbuvir is a valuable new therapy for treating chronic hepatitis C.”
Stelios Karagiannoglou who is the general manager for UK and Ireland at Gilead, says: “We are pleased that NICE has found this treatment to be a cost-effective use of NHS resources for some hepatitis C patients.
“Ledipasvir/sofosbuvir represents an opportunity to reduce overall NHS spending on hepatitis C because of improved treatment efficacy and tolerability, which allow more patients the potential to complete treatment and achieve cure.”