Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will bring forward the scheduled review of the Cystic Fibrosis drug Orkambi.

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.

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.