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.

SourceLink

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

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Coverage Summary

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

Continuation / Reauthorization Criteria

Reauthorization — NSCLC, ROS1-positive NSCLC

Lorbrena will be approved for reauthorization based on:

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

Reauthorization — ECD

Lorbrena will be approved for reauthorization based on:

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

Reauthorization — IMT

Lorbrena will be approved for reauthorization based on:

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

Unproven / Exclusions

There are no explicit non-covered indications listed in the brief. Coverage is tied to NCCN Compendium recognition (Category of Evidence and Consensus 1, 2A, or 2B) and to specified biomarker/diagnosis criteria. Indications that fall outside NCCN categories 1/2A/2B, or cases that are not documented as ALK-positive or (where applicable) ROS1-positive, are not supported by this policy and therefore would not meet the coverage criteria. State mandates or other federal requirements could modify coverage scope.

Applicable Codes

ICD-10 diagnoses referenced in coverage logic (examples mentioned generically)ICD-10

No codes listed

Provider Actions / Requirements

Prior Authorization

Prior authorization/notification required

Prior authorization/notification applies to Lorbrena. Members must meet the listed diagnosis and biomarker (ALK or ROS1) and therapy progression criteria for coverage. Members under 19 years of age will have prescriptions automatically process without a coverage review.

Documentation Required

Biomarker and disease status documentation

Document ALK-positive or ROS1-positive status (as applicable), the specific cancer diagnosis, and when required, evidence of disease progression on the specified ROS1 therapies (Augtyro/repotrectinib, Rozlytrek/entrectinib, Xalkori/crizotinib, Zykadia/ceritinib).

Clinical Evidence & References

Evidence and approval history: Pharmacy & Therapeutics (P&T) approvals occurred in 12/2018, 12/2019, 12/2020, 2/2022, 2/2023, 2/2024 (twice), and 2/2025. Primary references include the Lorbrena package insert, Pfizer, April 2023 and the NCCN Drugs & Biologics Compendium (accessed 12/20/2024). Material change: effective 5/1/2025 the program was updated to reflect NCCN adding Augtyro (repotrectinib) as a first-line option for ROS1-positive NSCLC, which affects prior therapy sequencing in coverage rules.

Background

Background: Lorbrena (lorlatinib) is an ALK-targeted kinase inhibitor indicated for adult patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). The NCCN additionally recommends Lorbrena for ALK- or ROS1-rearranged malignancies including Erdheim-Chester Disease (ECD) with symptomatic or relapsed/refractory disease, inflammatory myofibroblastic tumor (IMT) with ALK translocation, advanced/recurrent/metastatic or inoperable uterine sarcoma, limited and extensive brain metastases in ALK-positive NSCLC, and relapsed/refractory ALK-positive peripheral T-Cell and large B-Cell lymphoma. UnitedHealthcare’s coverage aligns with NCCN Compendium recommendations and relevant state mandates.

Revision History

2025-02materialLatest

Annual review added Augtyro (repotrectinib); program updated effective 5/1/2025 to include Augtyro (repotrectinib) as a first-line therapy option for ROS1-positive NSCLC per NCCN.

2024-02material

Annual review added criteria for uterine sarcoma, peripheral T‑Cell lymphoma and large B‑cell lymphoma per NCCN; background and references updated.

2019-2024non-material