It is looking likely that patients with hepatitis C will get National Health Service access to Gilead’s combination therapy Harvoni (ledipasvir-sofosbuvir) in England and Wales.

The National Institute for Health and Care Excellence says in draft guidelines that the pill should be considered as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C (HCV), but not for those with genotype 3.

Standard treatment for HCV is currently interferon-based therapy, but this is often lengthy and linked with significant side effects that could prevent some patients from completing their treatment or even put them off from starting in the first place. 

Harvoni could help address compliance issues as it offers a once-daily, all-oral, interferon- and ribavirin-free treatment option for treating HCV, and also the possibility of a shortened course of treatment, in some cases as little as eight weeks.

“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,” noted Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation.

Value for money

At £38,979.99 for a 12-week course and £77,959.98 for a 24-week one (both excluding VAT and the cost of ribavirin), the therapy seems expensive, but across a range of different scenarios for patients with genotype 1 or 4 forms of HCV experts have concluded that the cost per QALY falls within the realm of what is considered value for money for the NHS.

Harvoni was approved in Europe in November on the back of Phase III data showing that is achieved cure rates - sustained virologic response - of 94%-99%.