Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to help (a) ensure that the BREAKWATER treatment protocol for patients with BRAF‑mutated bowel cancer is evaluated and funded as a matter of urgency, and (b) secure equal access to this protocol for patients across the UK.

The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service on whether new licensed medicines and licence extensions for existing medicines should be routinely funded by the NHS based on an assessment of clinical and cost effectiveness. NICE aims wherever possible to issue guidance for the NHS on new medicines close to the time of licensing, and cancer drugs are eligible for funding from the point of a positive draft NICE recommendation.

The BREAKWATER study is investigating encorafenib, a BRAF inhibitor, in combination with cetuximab and fluorouracil-based chemotherapy for the potential treatment of colorectal cancer. This regimen does not currently have a United Kingdom marketing authorisation for use in the treatment of previously untreated BRAF V600E mutation positive metastatic colorectal cancer. NICE has prioritised an appraisal of encorafenib for this indication in anticipation of it being granted a UK marketing authorisation and will schedule the appraisal so that guidance can be published as close as possible to the expected licensing date. Further information on the appraisal’s status is publicly available on NICE’s website at the following link:

https://www.nice.org.uk/guidance/awaiting-development/gid-ta11961

The clinical trial was assessed and approved in the UK and is currently active, with further information available at the following link:

https://clinicaltrials.gov/study/NCT04607421?term=BREAKWATER&viewType=Card&rank=1