NICE requests more efficacy data on Gilead's hepatitis C drug Sovaldi

NICE requests more efficacy data on Gilead's hepatitis C drug Sovaldi
(Ref: Bloomberg, The Wall Street Journal, Financial Times, Yahoo!News, NICE)
June 16th, 2014

By: Lianne Dane

In draft guidance published Monday, the National Institute for Health and Care Excellence said it was "minded not to recommend" Gilead Sciences' Sovaldi (sofosbuvir) for use on the NHS unless the company supplied more data about the hepatitis C drug's effectiveness for the agency to review. "The available evidence shows that [Sovaldi] is an effective treatment for chronic hepatitis C in certain patients," noted Carole Longson, director of NICE's Centre for Health Technology Evaluation, but that efficacy data "is lacking for some subgroups of patients...and there are also substantial uncertainties in the evidence base presented by the manufacturer."

Among the additional data requested by NICE are revised analyses about the oral antiviral's cost-effectiveness in patients with and without cirrhosis or HIV co-infection, as well as by treatment history. The drugmaker has until July 4 to respond to the draft guidance. Gilead indicated that it would "provide the evidence requested to support a positive final recommendation to make [Sovaldi] available…across England and Wales."

In April, the NHS agreed to cover prescription costs for Sovaldi for about 500 patients in England and Wales who are at significant risk of dying or needing a liver transplant unless they receive the drug. Meanwhile, the NHS in Scotland approved Sovaldi last week for restricted use in patients with hepatitis C infection.

The price for Sovaldi in the US, where it was approved last December to treat hepatitis C in patients with genotypes 1, 2, 3 or 4, is $84 000 for a 12-week course of treatment, or $1000 per once-daily dose. The drug has already generated sales of $2.3 billion in the first three months since its launch in the US, but lawmakers there have urged Gilead to explain the cost of the medication, which they described as being "extraordinarily high." NICE, which quoted 2012 figures suggesting there are about 160 000 patients with chronic hepatitis C in England, said the cost of a 12-week course of Sovaldi in the UK is just under 35 000 pounds ($59 400).

Analysts predict the treatment, which was also cleared in the EU in January, will bring in over $9 billion in annual sales this year and more than $14 billion by 2017.

To read more Top Story articles, click here.