Pharmacy Prior Authorization Criteria

Rozlytrek (entrectinib)

For diagnosis of Non-small cell lung cancer (NSCLC)
Indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
For diagnosis of Solid Tumors
Indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer (NSCLC)

AND

Presence of ROS1 rearrangement 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)

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Solid Tumors

AND

Presence of neurotrophic tyrosine receptor kinase (NTRK) gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, TPR-NTRK1, etc.) as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [A]

AND

No known acquired resistance mutation (e.g., TRKA G595R, TRKA G667C or TRKC G623R substitutions) [2]

AND

Metastatic
Unresectable (including cases where surgical resection is likely to result in severe morbidity)

AND

Disease has progressed following previous treatment (e.g., surgery, radiation therapy, or systemic therapy) [3]
Disease has no satisfactory alternative treatments

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer (NSCLC), Solid Tumors

2024-09-04, 2023-12-06, 2023-08-28, 2023-07-05, 2022-09-01, 2021-09-08, 2021-05-21, 2019-10-03

Rozlytrek Prescribing Information. Genentech USA, Inc. South San Francisco, CA. January 2024
Drilon A, Nagasubramanian R, Blake JF, et al. A next-generation TRK kinase inhibitor overcomes acquired resistance to prior TRK kinase inhibition in patients with TRK fusion-positive solid tumors. Cancer Discov. 2017 Sep;7(9):963-972.

2024-09-04: 2024 Annual Review. Updated NSCLC criterion to specify requirement for FDA/CLIA-approved genetic testing. Other minor changes to clarify criteria without change to clinical intent. Background updates.
2023-12-06: Updated indication, criteria and reference section. Added new target drug.
2023-08-28: 2023 Annual Review
2023-07-05: Removed specialist requirement
2022-09-01: 2022 Annual Review - Updated background information
2021-09-08: Annual Review
2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
2019-10-03: New guideline created.