NICE no for Pierre Fabre's Braftovi

The National Institute for Health and Care Excellence has published the outcome of an appraisal of Pierre Fabre's Braftovi (encorafinib), turning down NHS funding for the drug as a treatment for some patients with advanced colorectal cancer.

In preliminary guidelines, the Institute said it is not recommending NHS use of Braftovi in combination with cetuximab for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment.

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.

Braftovi plus cetuximab is the first colorectal cancer treatment that targets the BRAF V600E mutation, and could be used as second or third-line treatment.

However, while clinical trial evidence shows that the regimen increases how survival compared with FOLFIRI plus cetuximab or irinotecan plus cetuximab, these drug combinations are not used in NHS clinical practice, NICE said.

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

Also, while Braftovi plus cetuximab meets NICE’s criteria for being a life-extending treatment at the end of life, the cost-effectiveness estimates are higher than what is normally considered value for money for the NHS, and “so it cannot be recommended for routine use”, the Institute concluded.