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New HTA Decisions in England
January 2021
Drug name
BRAFTOVI® (encorafenib)
Company
Pierre Fabre Ltd
Decision date
20/11/2020
Therapeutic area
Cancer
Therapeutic sub area
Colorectal cancer
Decision
Recommended
Indication
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.
Decision Detail
It is recommended only if the company provides encorafenib according to the commercial arrangement (there is a commercial access agreement for encorafenib and cetuximab which includes a confidential simple discount).
Summary
Clinical evidence was presented from BEACON CRC, a multinational, open-label, randomised, phase 3 trial comparing encorafenib plus cetuximab with the investigator's choice of chemotherapy (FOLFIRI or irinotecan) plus cetuximab. Results showed that encorafenib plus cetuximab increased overall survival more than the investigator's choice of either FOLFIRI plus cetuximab or irinotecan plus cetuximab. However, these drug combinations are not currently 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, making the results uncertain. The committee concluded that encorafenib plus cetuximab met the criteria to be considered a life-extending end of life treatment. 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.