Encorafenib (Braftovi)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Braftovi, in combination with cetuximab and modified leucovorin (folinic acid), fluorouracil, and oxaliplatin (mFOLFOX6), be reimbursed by public drug plans for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E gene mutation, as detected by a validated test, if certain conditions are met.
• Evidence from 1 clinical trial showed that Braftovi, in combination with cetuximab and mFOLFOX6, results in improved progression-free and overall survival in patients with mCRC with a BRAF V600E gene mutation, compared with the trial investigator’s choice of chemotherapy, with or without bevacizumab. The pan-Canadian Oncology Drug Review Expert Review Committee determined that adding Braftovi to cetuximab plus mFOLFOX6, demonstrates acceptable clinical value compared with chemotherapy with or without bevacizumab in patients with mCRC with a BRAF V600E gene mutation, and addresses the need identified by both patients and clinicians for more effective therapy to delay disease progression and extend survival. This determination was enough for the pan-Canadian Oncology Drug Review Expert Review Committee to recommend that Braftovi be reimbursed for this indication. Given that Braftovi is expected to be an alternative to chemotherapy with or without bevacizumab, acceptable clinical value refers to added value over chemotherapy with or without bevacizumab.
• Braftovi, in combination with cetuximab and mFOLFOX6, should only be covered for adult patients with mCRC with a confirmed BRAF V600E mutation. Patients should have good performance status and should not have active or symptomatic cancer in the brain or spinal cord. Braftovi should not be covered for patients who have received prior drug treatments for mCRC, or oxaliplatin treatment before (neoadjuvant) or after (adjuvant) surgery, if they experienced disease progression during treatment or recurrence within 6 months of completing it.
• Braftovi, in combination with cetuximab and mFOLFOX6, should only be reimbursed if the patient is under the care of a clinician who has expertise in managing mCRC and the cost of Braftovi is reduced. Treatment should be discontinued if the cancer worsens or if the patient experiences unacceptable side effects. Important budget impact considerations must be addressed for health systems to be able to adopt Braftovi.