LORBRENA (lorlatinib) 

SELF ADMINISTRATION - ORAL

Diagnosis considered for coverage:
  • Non-small cell lung cancer (NSCLC): Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Coverage Criteria:
  • Dose does not exceed 100 mg per day, AND

  • Prescribed by or in consultation with an oncologist, AND

  • The patient has a diagnosis of metastatic non-small cell lung cancer (NSCLC), AND

  • The patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND

  • One of the following:

    • Patient has had disease progression on, contraindication or intolerance to, or is not a candidate for one of the following:

      • Alecensa (alectinib) 

      • Alunbrig (brugatinib), OR

    • For continuation of prior therapy

Reauthorization Criteria:

For all indications:

  • Patient does not show evidence of progressive disease while on therapy 

Coverage Duration: 
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Dosing

    • The recommended dosage of LORBRENA is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity

  • Drug Interactions

    • Strong CYP3A Inhibitors: Avoid concomitant use.

    • Strong CYP3A Inducers: Avoid concomitant use.

    • Avoid concomitant use of LORBRENA with fluconazole

Policy Updates:
  • 05/16/2023 – Updated criteria.

References:
  • Lorbrena Prescribing Information. Pfizer Labs. New York, NY. March 2021.

Last review date: June 1, 2019