How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer

Closed for comments This consultation ended on at   Request commenting lead permission

1 Recommendations

1.1 Encorafenib plus cetuximab is not recommended, within its marketing authorisation, for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment.

1.2 This recommendation is not intended to affect treatment with encorafenib plus cetuximab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

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 as second or third-line treatment.

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. When evidence from other clinical trials is used to indirectly compare encorafenib plus cetuximab with FOLFIRI, and with trifluridine–tipiracil, the assumptions used make the results unreliable.

Encorafenib plus cetuximab meets NICE's criteria for being a life-extending treatment at the end of life. But the cost-effectiveness estimates are higher than what is normally considered a cost-effective use of NHS resources, so it cannot be recommended for routine use in the NHS.

Collecting further data is unlikely to address the clinical uncertainty. Also, with the current economic modelling, encorafenib plus cetuximab does not have potential to be cost effective compared with current treatment. So it cannot be recommended for use through the Cancer Drugs Fund.