Mekinist

Drug - Mekinist (trametinib) [GSK]

January 2018

Therapeutic area - Oncology

Approval criteria

Melanoma

• Patient must be at least 18 years of age AND
• Patient must have a diagnosis of unresectable or metastatic melanoma with BRAF V600E or V600K as detected by an FDA-approved test AND
• Mekinist must be used as a single agent OR
• Mekinist must be used in combination with Tafinlar

Non-small cell lung cancer (NSCLC)

• Patient must be at least 18 years of age AND
• Patient must have a diagnosis of metastatic NSCLC with BRAF V600E mutation as detected by an FDA-approved test AND
• Mekinist must be used in combination with Tafinlar

Renewal Criteria

• Documentation must be supplied at time of request showing patient has no disease progression AND
• Absence of any one of the following unacceptable toxicities from the drug:
  • All Grade 4 hemorrhagic events or any Grade 3 hemorrhagic events that do not improve
  • Symptomatic cardiomyopathy 
  • Persistent, asymptomatic left ventricular dysfunction of >20% from baseline that is below LLN that does not resolve within 4 weeks
  • Documented RVO (Retinal Vein Occlusion)
  • Treatment-related interstitial lung disease or pneumonitis

Exclusion Criteria

Patients with melanoma who have progressed on prior BRAF-inhibitor therapy

Quantity limit

• 0.5 mg tablets = 90 per 30 days
• 2 mg tablets = 30 per 30 days

Background information

Mekinist is not FDA-approved for treatment of patients with melanoma who have progressed on prior BRAF-inhibitor therapy.

Questions?

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