| answer text |
<p>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.</p><p> </p><p> </p><p>
</p><p>NICE published initial draft guidance in June 2014 which stated it was minded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 NICE published further draft guidance for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:</p><p> </p><p> </p><p> </p><p><a href="http://www.nice.org.uk/guidance/indevelopment/gid-tag445"
target="_blank">www.nice.org.uk/guidance/indevelopment/gid-tag445</a>.</p><p> </p><p>
</p><p> </p><p>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.</p><p> </p><p> </p><p>
</p><p>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its final draft guidance on sofosbuvir, shortly.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.</p><p> </p><p> </p><p> </p><p>NICE currently expects to publish its
final guidance on sofosbuvir in February 2015, although this is subject to any appeals
being received.</p><p> </p>
|
|
