Lorbrena®
Drug - Lorbrena® (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
OR
- 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
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
