Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions his Department has had with (a) the MHRA and (B) NICE regarding the BREAKWATER treatment protocol for patients with BRAF‑mutated bowel cancer.

The National Health Service in England is legally required to fund medicines in line with National Institute for Health and Care Excellence’s (NICE) recommendations. Current treatment options for BRAF-mutated colorectal cancer depend on the stage of the disease and previous treatments. Several medicines for the treatment of colorectal cancer have been recommended by NICE. NICE has also recommended encorafenib in combination with cetuximab as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer after previous systemic treatment.

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. The joint licensing and health technology appraisal pathway was launched on 1 April. It is not possible at this stage to confirm whether the appraisal will follow the joint pathway. 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

Department officials regularly discuss a range of topics with colleagues in the Medicines and Healthcare products Regulatory Agency and NICE.