Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if he will make it his policy to continue supplying Orkambi to cystic fibrosis patients currently receiving that drug as part of a clinical trial in the event of that drug not being approved for NHS use by the NICE.

The National Institute for Health and Care Excellence is currently appraising Orkambi (lumacaftor-ivacaftor) for the treatment of cystic fibrosis homozygous for the F508del mutation.

NHS England has advised that it has published policies that cover the different circumstances where a patient is on a clinical trial and where the drug is not subsequently approved for National Health Service use. In the circumstances of a commercially funded trial it is normally the responsibility of the manufacturer or the hospital to consider whether they wish to continue making it available to individual patients.