CurrentUnitedHealthcarePolicy 2025 P 1267-7

Lorbrena (lorlatinib) prior authorization criteria

UnitedHealthcare prior authorization/notification policy for Lorbrena (lorlatinib) specifying initial and reauthorization coverage criteria for multiple indications (ALK-positive NSCLC, ROS1-positive NSCLC, Erdheim-Chester disease, inflammatory myofibroblastic tumor, uterine sarcoma, select lymphomas), special rules for patients <19, and program/billing notes.

Policy Summary

PayerUnitedHealthcare

PolicyLorbrena (lorlatinib) prior authorization criteria

Policy CodePolicy 2025 P 1267-7

Change TypeAnnual review (added repotrectinib)

Effective DateMay 1, 2025

Next Review Date

Key ActionMembers must meet the listed initial authorization criteria (diagnosis and biomarker status, prior therapy where specified) for coverage; authorization issued for 12 months when approved.

POLICY UPDATE CHANGES

Added Augtyro (repotrectinib) as a first-line therapy in prior therapy list (2/2025 annual review).

Annual review updated background and criteria to reflect NCCN guidance (2/2025).

9Explicit covered indications listed

12 monthsAuthorization duration when approved

Age <19Automatic processing population

Coverage Summary

UnitedHealthcare prior authorization/notification policy for Lorbrena (lorlatinib) specifies initial authorization and reauthorization coverage criteria for multiple indications including ALK-positive metastatic NSCLC, ROS1-positive NSCLC, Erdheim-Chester Disease (ECD), inflammatory myofibroblastic tumor (IMT), uterine sarcoma, and select lymphomas. The policy includes special rules that prescriptions for members <19 years of age will automatically process without a coverage review and, when authorization is issued, the authorization duration is 12 months. Reauthorization requires documentation that the patient does not show evidence of progressive disease while on Lorbrena therapy. The program also notes that state mandates, plan-specific benefits, supply limits, and automated approval based on claims/medication history or diagnosis codes may apply.

Key summary

Explicit covered indications listed9

Authorization duration when approved12 months

Automatic processing populationAge <19

Policy status and effective dateCURRENT; Effective 2025-05-01; Last review 2025-02

Initial Therapy Criteria

Initial Authorization - ALK-positive or ROS1-positive NSCLC

Lorbrena will be approved based on all of the following:

ALL of the following

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

ref”:”b1_0

title”:”Initial Authorization - ALK-positive or ROS1-positive NSCLC

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Initial Authorization - Erdheim-Chester Disease (ECD)

Lorbrena will be approved based on all of the following:

ALL of the following

Diagnosis of Erdheim-Chester Disease (ECD)
Disease is ALK-positive

Initial Authorization - Inflammatory Myofibroblastic Tumor (IMT)

Lorbrena will be approved based on all of the following:

ALL of the following

Diagnosis of inflammatory myofibroblastic tumor (IMT)
Disease is ALK-positive

Initial Authorization - Uterine Sarcoma

Lorbrena will be approved based on all of the following:

ALL of the following

Diagnosis of uterine sarcoma
Disease status
- Advanced
- Recurrent/metastatic
- Inoperable
Disease is ALK-positive

Initial Authorization - Select Lymphomas (ALCL or Large B-Cell lymphoma)

Lorbrena will be approved based on all of the following:

ALL of the following

Diagnosis
- Anaplastic large cell lymphoma (ALCL)
- Large B-Cell lymphoma
Disease is relapsed or refractory
Disease is ALK-positive

Patients < 19 years of age

Automatic approval rule

ALL of the following

Patient is less than 19 years of age

NCCN Recommended Regimens

Coverage when recommended by NCCN

Recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

ref”:”b1_6

title”:”NCCN Recommended Regimens

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Continuation / Reauthorization Criteria

Reauthorization - NSCLC

Reauthorization criteria

ALL of the following

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

Reauthorization - Erdheim-Chester Disease (ECD)

Reauthorization criteria

ALL of the following

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

Reauthorization - IMT

Reauthorization criteria

ALL of the following

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

Reauthorization - Uterine Sarcoma

Reauthorization criteria

ALL of the following

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

Reauthorization - Select Lymphomas

Reauthorization criteria

ALL of the following

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

Provider Actions & Billing Notes

Prior Authorization

Prior authorization required

Members must meet the listed initial authorization criteria (diagnosis and biomarker status, prior therapy where specified) for coverage. Authorization is issued for 12 months when approved.

Authorization issued for 12 months

Prior Authorization

Automatic processing for pediatric patients

For members under age 19, the prescription will automatically process without a coverage review. When an authorization is issued for these pediatric patients, it will be for 12 months.

Authorization issued for 12 months

Documentation Required

Progression documentation for reauthorization

Reauthorization requires documentation that the patient does not show evidence of progressive disease while on Lorbrena therapy.

Billing Rule

Supply limits and automated approval

Supply limits may be in place. UnitedHealthcare may approve initial authorization and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic (use of automated approval and re-approval processes varies by program).

Revision History

2025-02material_changeLatest

Material change: Added Augtyro (repotrectinib) to the list of prior therapies that disease must have progressed on for some NSCLC approvals; documented in the 2/2025 annual review as inclusion of repotrectinib as a first-line therapy in the prior therapy list.

2025-02annual_review_updateLatest

Annual review update: Background and coverage criteria updated to reflect NCCN guidance, continuing NCCN-recommended uses (including uterine sarcoma and select lymphomas) and updating references (noted as part of the 2/2025 annual review).

OpenPayer

Lorbrena (lorlatinib) prior authorization criteria

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Provider Actions & Billing Notes

Applicable Codes & Referenced Therapies

Clinical Evidence & Background

Definitions

Revision History

Augtyro	repotrectinib (listed as prior therapy option)
Rozlytrek	entrectinib (listed as prior therapy option)
Xalkori	crizotinib (listed as prior therapy option)
Zykadia	ceritinib (listed as prior therapy option)