Mektovi®
Drug - Mektovi® (binimetinib) [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’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
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 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
Quantity limits
Questions?
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