Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what assessment they have made of the impact of the delay in the publication of the National Institute for Health and Care Excellence guidance on sofosbuvir on the health of patients with liver cirrhosis caused by hepatitis C.

The National Institute for Health and Care Excellence (NICE) was asked to develop technology appraisal guidance on the use of sofosbuvir within its marketing authorisation for the treatment of chronic hepatitis C in October 2013. Sofosbuvir received its marketing authorisation for this indication in January 2014.

NICE published initial draft guidance in June 2014 which stated it was minded not to recommend use of sofosbuvir within its marketing authorisation and requested further information from the manufacturer. NICE published further draft guidance for consultation in August 2014, in which it recommended sofosbuvir for certain patients. Following consideration of the responses to this consultation on its draft recommendations, NICE requested further analyses from the company, which necessitated additional Committee discussion. NICE then carried out a further consultation in December on a proposal to extend the mandatory timescale for National Health Service commissioners to fund its recommendations on sofosbuvir. A similar consultation was also undertaken for simeprevir, another drug currently undergoing a NICE appraisal for chronic hepatitis C. A timeline of the process for the development of NICE’s guidance on sofosbuvir is published at:

www.nice.org.uk/guidance/indevelopment/gid-tag445.

We have not made an assessment of the impact of this delay on patients with hepatitis C. Until NICE’s final guidance comes into effect, NHS England has in place an interim commissioning policy on sofosbuvir with ledipasvir and an interim policy for simeprevir which makes these treatments available to patients meeting specified clinical criteria during 2014-15. So far, this has made an additional £38 million available to cure patients at risk of liver failure. In addition, NHS England has made an assessment of need for patients with cirrhosis from April 2015 and will be finalising its plans shortly for this wider patient group.

NICE’s consultation on extending the funding period closed in December and we understand that it expects to publish the outcome of that consultation, along with its final draft guidance on sofosbuvir, shortly. The Department’s response to the consultation will be published alongside other stakeholders’ comments. We are confident that NICE will carefully consider all the comments it has received before taking a final decision.

NICE currently expects to publish its final guidance on sofosbuvir in February 2015, although this is subject to any appeals being received.