Braftovi™
Drugs - Braftovi™ (encorafinib) [Array BioPharma Inc.]
June 2019
Therapeutic area - Oncology, Oral – Skin Cancer
Initial approval criteria
- Patient has a diagnosis that is listed in the FDA-approved label
OR
- Patient is at least 18 years or older AND
- Patient has diagnosis of unresectable locally advanced or metastatic melanoma AND
- Patient must have BRAF V600E or V600K mutation as detected by FDA approved test; AND
- Patient has not received more than one prior line of immunotherapy (e.g., PD-l, PD-L1, CTLA-4 agents) for unresectable locally advanced or metastatic disease AND
- Patient has not received prior therapy with BRAF and/or MEK inhibitors (e.g., vemurafenib, dabrafenib, cobimetinib, trametinib, etc.) AND
- Patient’s baseline left ventricular ejection fraction (LVEF) within normal limits AND
- Patient does not have leptomeningeal metastases or other untreated CNS lesions AND
- Encorafenib will be used in combination with binimetinib for patients with unresectable locally advanced or metastatic melanoma AND
- Initial approval is for 6 months
Renewal criteria
- Patient continues to meet the above criteria AND
- Documented tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: major hemorrhagic events, QTc prolongations, uveitis, new primary malignancies, etc.
- Renewal approval is for 6 months
Quantity limits
- 50 mg capsule: 4 capsules/day
- 75 mg capsule: 6 capsules/day
- 450 mg/day
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411