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<p>In July 2016 the National Institute for Health and Care Excellence (NICE) published
guidance on Orkambi for treating cystic fibrosis in people 12 years and older who
are homozygous for the F508del mutation. This guidance is scheduled for review this
year (2019). If NICE updates the existing recommendations, and the company participates,
updated guidance for these patients is expected late 2020/early 2021.</p><p>In March
2019, NICE received Ministerial referral to appraise Orkambi in people aged between
2 and 11 years old who are homozygous for the F508del mutation. NICE is in the process
of inviting the company and other stakeholders to participate in this appraisal. If
the company participates, NICE expects to be able to come to a decision on the use
of Orkambi for this group of children in the autumn of 2020.</p><p>The Secretary of
State for Health wrote to Vertex in August offering a further meeting again with Vertex,
as soon as possible, to consider what the barriers are to an agreement and how the
situation can be resolved. We continue to urge Vertex to accept NHS England’s generous
offer. In the absence of an agreement NHS England and Improvement continue to explore
other options.</p><p> </p><p> </p>
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