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DrugMektovi®  (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 


  • 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

  • 204 tablets/34 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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