The UK has become the latest country to put the price of Sovaldi under the microscope and Gilead’s hepatitis C drug has stumbled at its first hurdle.
In draft guidance the cost-effectiveness watchdog NICE said it was “minded not to recommend” Sovaldi (sofobuvir), adding that it has asked the drug’s manufacturer for much more detailed information about its use and cost.
The first all-oral treatment for chronic hep C to be approved in Europe, Sovaldi is taken for an average of 12 or 24 weeks, depending on patient needs, giving it a UK list price of £35,983 (€45,041) or £69,966 (€87,575) for a course of treatment.
In the US, where its higher price runs to $84,000 for a 12-week course, Gilead has run into trouble with US politicians, some of whom have questioned its high price.
NICE hasn’t exactly said the drug is too expense for the health service, but the Institute does want further information from Gilead before its advisors decide whether sofosbuvir is a cost-effective use of NHS resources.
Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “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.”
Specifically NICE is asking for things like a further series of analyses on Sovaldi in combination with ribavirin for certain genotypes of hep C, revised cost-effectiveness estimates and a new economic model that be used to check the new information provided.
But NICE acknowledged the scale of the public health problem posed by chronic hep C, which can be a life-long condition that causes liver cirrhosis in a third of sufferers and, in a small percentage of patients, liver cancer.
Professor Longson said: “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.
“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The draft guidance on Sovaldi’s use to treat chronic hepatitis C applies to England and Wales and has now been put out for consultation, with final guidance expected from NICE in October.