CurrentPremera BluecrossPolicy N/A

5.01.538 ALK Tyrosine Kinase Inhibitors

Pharmacy benefit policy describing medical necessity coverage criteria, dose/quantity limits, indications (ALK+ NSCLC and select inflammatory myofibroblastic tumors or ALCL/ROS1 where specified), authorization lengths, reauthorization requirements, and documentation requirements for listed ALK tyrosine kinase inhibitor drugs.

Policy Summary

PayerPremera Bluecross

Policy5.01.538 ALK Tyrosine Kinase Inhibitors

Policy CodePolicy N/A

Change TypeCoverage criteria updates & quantity limits

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit office visit notes documenting diagnosis, relevant history, physical evaluation, and medication history demonstrating that medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Alecensa and Lorbrena for treatment of metastatic or recurrent inflammatory myofibroblastic tumor (iMT) when failure on prior crizotinib therapy.

Updated coverage criteria for Lorbrena adding a prescribed quantity limit per 30 days.

Updated coverage criteria for Alunbrig and Zykadia for iMT to specify metastatic or recurrent disease and prior Xalkori failure requirement.

Updated initial authorization duration for all other reviews from 3 months to 6 months.

7Drugs listed

ALK+ NSCLCPrimary covered indication

Selected iMT coverage

Coverage Summary

Scope: Pharmacy benefit policy describing medical necessity coverage criteria, dose/quantity limits, indications (ALK-positive NSCLC and selected inflammatory myofibroblastic tumors or ALCL/ROS1 where specified), authorization and reauthorization lengths, and documentation requirements for listed ALK tyrosine kinase inhibitor drugs.

Coverage stance: mixed — some indications and uses are considered medically necessary per drug-specific criteria while other uses are investigational.

Subject: ALK Tyrosine Kinase Inhibitors (alectinib, brigatinib, ensartinib, lorlatinib, crizotinib, ceritinib).

Primary covered indications (brief): This policy covers ALK-positive non-small cell lung cancer (NSCLC) as the primary indication (multiple ALK inhibitors with drug-specific age, disease stage, and dose limits). Selected additional covered malignancies include ALK-positive inflammatory myofibroblastic tumor (iMT) for specified agents when prior crizotinib failure is met, anaplastic large cell lymphoma (ALCL) for crizotinib in pediatric/young individuals, and ROS1-positive NSCLC for crizotinib where specified. Benefit application: This policy is managed through the pharmacy benefit.

Policy metadata and thresholds

Effective dateMay 1, 2026

Last reviewApr. 13, 2026

StatusCURRENT

Drugs listed7

Primary covered indicationALK+ NSCLC

Selected iMT coverageiMT (selected) — metastatic/recurrent iMT coverage requires prior crizotinib (Xalkori) failure for Alecensa, Alunbrig, Lorbrena, and Zykadia

Alecensa dose limit1,200 mg daily

Alunbrig dose limit180 mg daily

Ensacove dosing constraintPer prescribing information; coverage requires documented contraindication to Alecensa when applicable

Lorbrena dose limit100 mg daily

Lorbrena quantity limits25 mg tablets: 90 per 30 days; 100 mg tablets: 30 per 30 days

Xalkori dose limit500 mg daily

Zykadia dose limit450 mg per day

Initial authorization length (other reviews)6 months (interim review 05/01/26 approved Apr 13, 2026)

Initial Therapy Criteria (Drug-specific)

Alecensa (alectinib) - Medical Necessity (NSCLC)

Alecensa may be considered medically necessary when ALL of the following are met:

ALL of the following

The individual is aged 18 years or older
Diagnosed with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
ONE of
- Diagnosed with advanced or metastatic disease
- Requires adjuvant treatment following tumor resection with tumors at least 4 cm or node positive

Selected Non-NSCLC Indications (iMT, ALCL, ROS1)

Continuation Therapy & Investigational Uses

Provider Actions / Continuation Guidance

Provider Actions: Submit office visit notes documenting diagnosis, relevant history, physical evaluation, and medication history demonstrating that medical necessity criteria are met.

Documentation requirement

Authorization length and reauthorization: Non-formulary exception reviews for all drugs may be approved up to 12 months; initial and reauthorization approvals for other reviews may be approved up to 12 months when drug-specific criteria are met and chart notes show continued positive clinical response. Initial authorization length for all other reviews updated to 6 months.Initial authorization: 6 months

Reauthorization up to 12 months when criteria met and positive response documented.

Benefit application: This policy is managed through the pharmacy benefit; follow pharmacy benefit billing and dispensing rules.

Provider Actions & Requirements

Documentation Required

Medical record documentation required

Submit office visit notes that include the diagnosis, relevant history, physical examination, and medication history to demonstrate that the medical necessity criteria are met.

Include diagnosis
Include relevant history
Include physical evaluation
Include medication history

Prior Authorization

Authorization length and reauthorization

Non-formulary exception reviews for all drugs listed in the policy may be approved up to 12 months. Initial and reauthorization approvals for other reviews may be approved up to 12 months when the drug-specific coverage criteria are met and chart notes demonstrate continued positive clinical response. Note: initial authorization length for all other reviews was updated from 3 months to 6 months per the 05/01/26 interim review.

Applicable Codes

Codingmixed

No codes listed

Clinical Evidence Summary

Median PFS 25.8 vs 12.7 mo; HR 0.56eXalt3 (ensartinib vs crizotinib) - improved PFS

Improved PFS vs crizotinibCROWN (lorlatinib) - first-line PFS benefit

ORR 50%-61%; response duration ~42-48 wksCrizotinib (Studies A/B) - objective response rate and median duration

Background: Activation of ALK has been described as a primary oncogenic driver in approximately 2–7% of NSCLC individuals, and ALK-positive NSCLC has distinct clinical features. This policy summarizes the mechanism of ALK as an oncogenic driver and clinical trial evidence for included ALK inhibitors and provides coverage criteria for those agents.

This document is a coverage policy that describes medical necessity criteria and operational requirements for pharmacy benefit management; it is not a clinical practice guideline.

Definitions

Definitions:

iMT — Inflammatory myofibroblastic tumor (term used in policy to denote ALK-translocated inflammatory myofibroblastic tumor).

ALK-positive — Tumors with anaplastic lymphoma kinase gene rearrangement/translocation (tumors that harbor ALK fusions or rearrangements and are the targets of ALK tyrosine kinase inhibitors).

Revision History

03/01/26policy_revision

Updated coverage criteria for Lorbrena to add prescribed quantity limits per 30 days; updated Alunbrig and Zykadia iMT coverage to specify metastatic or recurrent disease and requirement of prior Xalkori (crizotinib) failure; added iMT coverage criteria for Alecensa and Lorbrena contingent on prior Xalkori failure.

05/01/26 (approved April 13, 2026)interim_reviewLatest

Interim review approved April 13, 2026 updated initial authorization duration for all other reviews from 3 months to 6 months.

Policy Summary

PayerPremera Bluecross

Policy5.01.538 ALK Tyrosine Kinase Inhibitors

Policy CodePolicy N/A

Change TypeCoverage criteria updates & quantity limits

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit office visit notes documenting diagnosis, relevant history, physical evaluation, and medication history demonstrating that medical necessity criteria are met.

SourceLink

On This Page

Dose is limited to 1,200 mg daily1,200 mg daily

title": "Alecensa (alectinib) - Medical Necessity (NSCLC)"}

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Investigational uses: Claims for uses not listed as medically necessary in the policy are considered investigational and are not covered.

Investigational / Not Covered

All other uses of the medications listed in this policy are considered investigational.

Any use not specified in the drug-specific medically necessary criteria above is investigational.

Non-formulary exception approvals: up to 12 months
Initial/reauthorization approvals: may be up to 12 months if criteria met and clinical response documented
Initial authorization for all other reviews changed from 3 months to 6 months (05/01/26 interim review)

Billing Rule

Benefit application

This policy is managed through the pharmacy benefit. Follow pharmacy benefit billing and dispensing rules for claims and reimbursement.

Managed through the pharmacy benefit
Follow pharmacy billing and dispensing rules

Documentation Required

Contraindication documentation for Ensacove

When requesting coverage for Ensacove (ensartinib) document a contraindication to Alecensa (alectinib) in the medical record to support medical necessity for Ensacove.

Document contraindication to Alecensa when seeking Ensacove coverage

Denial Risk

Investigational uses denied

Claims for any use not specified as medically necessary in the drug-specific criteria are considered investigational and are not covered.

Uses not listed as medically necessary are investigational
Investigational uses are not covered

Operational note: dose and quantity limits are applied per drug-specific criteria. Examples of thresholds include Alecensa: 1,200 mg daily, Alunbrig: 180 mg daily, Lorbrena: 100 mg daily with quantity limits of 25 mg tablets — 90 per 30 days and 100 mg tablets — 30 per 30 days, Xalkori: 500 mg daily, and Zykadia: 450 mg per day. For full, authoritative dosing and quantity limit details see the policy thresholds and the individual drug coverage criteria in this policy.