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<p>The Government has made no such assessment itself. The National Institute for Health
and Care Excellence (NICE) is the independent body responsible for developing authoritative,
evidence-based guidance for the National Health Service on whether drugs and other
treatments represent a clinically and cost effective use of NHS resources. NICE published
guidance on the use of Orkambi for the treatment of cystic fibrosis in July 2016 and
was not able to recommend it for routine use on the NHS.</p><p> </p><p>NICE has advised
that it has not been notified of any new data published in February 2018 related to
the use of Orkambi. NICE periodically reviews its technology appraisal guidance to
determine whether any new evidence, including new trial data, has emerged that may
affect its original recommendations. NICE is next scheduled to review its guidance
on the use of Orkambi in July 2019, at which point it will conduct a search for new
evidence. NICE’s guidance may be reviewed before the expected review date if significant
new evidence emerges that is likely to change the recommendations. The company or
any other stakeholder can alert NICE to new evidence in line with its established
processes to request an early review.</p>
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