38410 - Ian Austin - 24-May-2016 (Answered)

Ian Austin
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.

George Freeman

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.