Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what discussions he has had with Vertex on the provision of Orkambi to people with cystic fibrosis; when he plans to respond to the Accelerated Access Review; what his policy is on the provision of Orkambi to people with cystic fibrosis; and if he will make a statement.

Ministers and Government officials have had a number of discussions with Vertex and NHS England in which the availability of Orkambi for the treatment of cystic fibrosis was raised.

The National Institute for Health and Care Excellence (NICE) is the independent body that develops guidance for the National Health Service on whether new drugs and treatments represent a clinically and cost effective use of resources.

NICE published final guidance on the use of Orkambi (lumacaftor-ivacaftor) for treating cystic fibrosis homozygous for the F508del mutation in July 2016 that does not recommend this treatment.

Where NICE has not been able to recommend a treatment, funding decisions should be made by the relevant NHS commissioner, based on an assessment of the available evidence.

We are considering the Accelerated Access Review’s recommendations and will respond in due course.