UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

In draft recommendations published today, UK health care watchdog the National Institute for Health and Care Excellence (NICE) is asking US biotech firm Gilead Sciences (Nasdaq: GILD) for more information on its recently approved new drug Sovaldi (sofosbuvir), for the treatment of chronic hepatitis C.

Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “Poor diagnosis rates, combined with a high number of new infections annually means that chronic hepatitis C presents a major public health challenge. The problem is made worse because the potential side-effects of current treatments, such as interferon, which often needs to be given for a long period of time, mean that many people with the disease either don’t complete the full course, or are reluctant to seek treatment in the first place.”

Further information needed to establish cost-effectiveness

She continued: “The availability of new treatments, like sofosbuvir, that can shorten the duration of interferon-based therapy or which in some cases don’t need to be taken with interferon at all, would potentially encourage more people to seek treatment. The available evidence shows that sofosbuvir is an effective treatment for chronic hepatitis C in certain patients. However, evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer. The Committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources.”

Priced at £11,660 per 28-tablet pack