CurrentUnitedHealthcarePolicy 2025 P 1267-7

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare prior authorization/notification program defining coverage criteria for Lorbrena (lorlatinib) across multiple oncology indications (NSCLC, ROS1-positive NSCLC, Erdheim-Chester Disease, inflammatory myofibroblastic tumor, uterine sarcoma, ALCL, large B-cell lymphoma, and NCCN-recommended regimens). Includes initial and reauthorization rules, age-exemption for under-19, and program operational notes.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs

Policy CodePolicy 2025 P 1267-7

Change TypeAdded Augtyro as first-line for ROS1 NSCLC (2/2025)

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization/notification applies — document ALK or ROS1 status, diagnosis, and progression per criteria; members under 19 auto-process without review.

POLICY UPDATE CHANGES

Effective 5/1/2025 program updated with Augtyro (repotrectinib) as a first-line therapy option for ROS1 positive NSCLC per NCCN.

2/2024 annual review added criteria for uterine sarcoma, peripheral T-Cell lymphoma and large B-cell lymphoma per NCCN.

Prior revisions updated background and coverage criteria to reflect NCCN guidance (2019-2024 updates).

8Covered Indications (listed)

12Typical Authorization Duration

<19Pediatric automatic processing

Policy number 2025 P 1267-7 (status: CURRENT) defines UnitedHealthcare prior authorization/notification criteria for Lorbrena (lorlatinib). Effective date is 2025-05-01; last review date is 2025-02-01. Scope: coverage for multiple oncology indications including NSCLC, ROS1-positive NSCLC, Erdheim-Chester Disease, inflammatory myofibroblastic tumor, uterine sarcoma, anaplastic large cell lymphoma (ALCL), large B-cell lymphoma, and other NCCN-recommended regimens. Coverage stance is covered_with_criteria. The program typically issues authorizations for 12 months, and members under 19 years auto-process without a coverage review. UnitedHealthcare aligns coverage with the NCCN Drugs & Biologics Compendium and applicable state mandates, which may supersede program language.

Initial Therapy Criteria

Initial Authorization — NSCLC and ROS1-positive NSCLC

Lorbrena will be approved based on all of the following criteria:

ALL of the following

Diagnosis of NSCLC
ONE of
- Option A
  - Disease is recurrent, advanced, or metastatic
  - Anaplastic lymphoma kinase (ALK)-positive
- Option B
  - Disease is advanced, metastatic, or recurrent
  - ROS proto-oncogene 1 (ROS1)-positive
  - Disease has progressed on at least one of the following therapies: Augtyro (repotrectinib), Rozlytrek (entrectinib), Xalkori (crizotinib), Zykadia (ceritinib)

Patients less than 19 years of age

Lorbrena will be approved based on the following criterion:

Patient is less than 19 years of age

Authorization will be issued for 12 months.

NCCN Recommended Regimens

The drug is recognized for treatment when the NCCN Drugs and Biologics Compendium lists the indication with Category of Evidence and Consensus of 1, 2A, or 2B

NCCN Drugs and Biologics Compendium lists the cancer indication for Lorbrena with Category of Evidence and Consensus of 1, 2A, or 2B