1 Recommendations

1.1 Encorafenib plus cetuximab is recommended, within its marketing authorisation, as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment. It is recommended only if the company provides it according to the commercial arrangements.

Why the committee made these recommendations

Treatment for BRAF V600E mutation-positive metastatic colorectal cancer after previous systemic treatment includes combination chemotherapy, usually FOLFIRI (5‑fluorouracil, folinic acid and irinotecan) followed by trifluridine–tipiracil then best supportive care. Encorafenib plus cetuximab is the first colorectal cancer treatment that targets the BRAF V600E mutation, and could be used second or third line.

Clinical trial evidence shows that encorafenib plus cetuximab increases how long people live compared with FOLFIRI plus cetuximab or irinotecan plus cetuximab. However, these drug combinations are not used in NHS clinical practice, because NICE does not recommend cetuximab beyond first-line treatment for metastatic colorectal cancer. Assumptions are needed to indirectly compare encorafenib plus cetuximab with FOLFIRI or trifluridine–tipiracil using evidence from other clinical trials. This makes the results uncertain.

Encorafenib plus cetuximab meets NICE's criteria for being a life-extending treatment at the end of life. Also, despite the uncertain comparative effectiveness results, the cost-effectiveness estimates are within what is normally considered a cost-effective use of NHS resources. So, it is recommended for routine use in the NHS.

  • National Institute for Health and Care Excellence (NICE)