NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England, in draft guidance released today, has recommended US biotech major Gilead Sciences’ (Nasdaq: GILD) Harvoni (ledipasvir and sofosbuvir) as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C.

Figures from 2012 suggest that around 160,000 people are chronically infected with the hepatitis C virus in England. More than half of people with chronic hepatitis C do not know they are infected because they only have mild symptoms or no symptoms at all for a long period of time, according to the NICE. About 1 in 3 people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue. A small percentage of people with chronic hepatitis C and cirrhosis also develop liver cancer.

The marketing authorization for ledipasvir-sofosbuvir recommends treatment for genotypes 1, 3 (in combination with ribavirin) and 4 hepatitis C. Genotypes 1 and 3 hepatitis C account for the majority of chronic hepatitis C cases in England (46% and 43%, respectively). Genotype 4 hepatitis C accounts for around 4% of cases.

Ledipasvir-sofosbuvir is administered orally as a single tablet (with or without ribavirin) and works by inhibiting the replication of the hepatitis C virus.

Harvoni offers possibility of shortened course of treatment

“Ledipasvir- sofosbuvir offers the possibility of a shortened course of treatment – in some cases as little as eight weeks – without the need for combination therapy with interferon,” noted Carole Longson, director of the NICE Centre for Health Technology Evaluation. “This could make it more likely that people will seek treatment for their condition. 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,” Prof Longson explained

The Committee also considered ledipasvir-sofosbuvir in combination with ribavirin for people with genotype 3 chronic hepatitis C. Based on the evidence presented the Committee concluded that this could not be considered a cost-effective use of NHS resources.

Drug pricing and cost

Harvoni costs £12,993.33 ($20,074) per 28 tablet pack (excluding VAT; company’s evidence submission). The cost of a 12 week course of treatment is £38,979.99 and a 24 week course is £77,959.98 (both excluding VAT), not including the cost for ribavirin.