Pharmacy Prior Authorization Criteria

Alecensa (alectinib)

For diagnosis of Treatment of Metastatic ALK-Positive Non-Small Cell Lung Cancer
Indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
For diagnosis of Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer
Indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test

*CLIA-certified laboratories: https://wwwn.cdc.gov/clia/Resources/LabSearch.aspx

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

2024-05-30, 2023-07-05, 2023-06-08, 2022-04-28, 2021-09-29, 2021-09-07, 2021-08-04, 2020-07-13

Alecensa prescribing information. Genentech. South San Francisco, CA. April 2024.

A quantity limit of 8 capsules per day was developed to ensure use does not exceed the FDA recommendation of 600 mg twice daily. Alecensa (alectinib) is available as 150 mg capsules.

2024-05-30: Background update to include new indication as Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer. No criteria changes.
2023-07-05: update guideline
2023-06-08: Program update to remove "Patient has anaplastic lymphoma kinase (ALK)-positive disease as detected with an FDA-approved test or test performed at a Clinical Laboratory Improvement Amendments (CLIA)-approved facility*" criterion and to remove "metastatic" from diagnosis. Also updated reauth language to standard "Patient does not show evidence of progressive disease while on therapy."
2022-04-28: Annual review - no criteria changes, background update
2021-09-29: add EHB formularly
2021-09-07: Update GPI
2021-08-04: Annual Review
2020-07-13: Annual Review - Updated References