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<p>The Department has made no such assessment. Elexacaftor, tezacaftor and ivacaftor
combination therapy (or triple therapy, marketed in the United States as Trikafta)
does not yet have a marketing authorisation for use in the United Kingdom and the
dates for licensing have not yet been confirmed.</p><p>The National Institute for
Health and Care Excellence (NICE) is the independent body that makes recommendations
for the National Health Service on whether new medicines represent a clinical and
cost effective use of NHS resources. It is a condition of the agreement reached between
NHS England, NHS Improvement and Vertex that the company will submit its full portfolio
of cystic fibrosis medicines, including its new triple therapy to NICE for appraisal.</p><p>NICE
has begun work for the appraisal and further information is available at the following
link:</p><p><a href="https://www.nice.org.uk/guidance/proposed/gid-ta10566" target="_blank">https://www.nice.org.uk/guidance/proposed/gid-ta10566</a></p><p>NICE
will invite the company to provide an evidence submission immediately after the triple
therapy has been formally referred to its work programme, expected in February.</p><p>Subject
to licensing, in order to recommend the triple therapy for routine NHS funding, NICE
will need to be assured that Vertex have priced it at a level that is fair to both
the NHS and UK taxpayer. In the period leading up that, NICE will work extensively
with the company and other stakeholders on putting the best possible evidence submission
to its independent advisory committee.</p>
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