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DrugLorbrena® (lorlatinib) [Pfizer, Inc.]

June 2019

Therapeutic area - Oncology Oral, Lung Cancer

Initial approval criteria

  • Patient has a diagnosis that is listed on the FDA-approved label 


  • Patient age ≥ 18 years old AND
  • Patient has metastatic non-small cell lung cancer (NSCLC) AND
  • Confirmation of anaplastic lymphoma kinase (ALK)-positive as detected by FDA approved test AND
  • Patient has tried and failed crizotinib and at least 1 other ALK inhibitor (e.g., alectinib or ceritinib) OR
  • Patient has tried and failed alectinib or ceritinib
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the above criteria AND
  • Demonstrated tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
  • Absence of unacceptable toxicity from the drug (e.g., serious hepatotoxicity with concomitant strong CYP3A4 inducers, interstitial lung disease/pneumonitis, severe CNS effects, AV block recurrence in the absence of a pacemaker)
  • Renewal approval is for 6 months

Quantity limits

  • 34 tablets/34 days


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

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