Mektovi®

Drug - Mektovi® (binimetinib) [Array BioPharma Inc]

June 2019

Therapeutic area - Oncology, Oral – Skin Cancer

Initial approval criteria

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’s baseline left ventricular ejection fraction (LVEF) within normal limits AND
Patient does not have leptomeningeal metastases or other untreated CNS lesions 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
Binimetinib will be used in combination with encorafenib for patients with unresectable locally advanced or metastatic melanoma AND
Initial approval is for 6 months

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 the following: interstitial lung disease/pneumonitis; cardiomyopathy; severe hemorrhagic events; venous thromboembolism; ocular toxicities including retinal vein occlusion (RVO); rhabdomyolysis; etc. AND
Left ventricular ejection fraction (LVEF) has not had an absolute decrease from baseline ≥ 10% and is not below the lower limit of normal (LLN)
Renewal approval is for 6 months

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