CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1182-11

Alecensa (alectinib) prior authorization/notification — Coverage Criteria

Defines prior authorization and notification criteria for coverage of alectinib (Alecensa) for UnitedHealthcare Commercial members, including adult and pediatric indications per FDA label and NCCN recommendations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAlecensa (alectinib) prior authorization/notification — Coverage Criteria

Policy CodePolicy 2025 P 1182-11

Change TypeMaterial additions to indication criteria

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Alecensa with documentation of ALK-positive diagnosis; approvals are issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added criteria for adjuvant treatment following tumor resection of ALK-positive NSCLC per FDA label.

Added criteria for pediatric diffuse high-grade gliomas per NCCN guidelines.

Added criteria for B-cell lymphoma, CNS cancer, and inflammatory myofibroblastic tumors per NCCN guidelines.

12 monthsauthorization duration for approved uses

Under 19 auto-approvemembers <19 process without coverage review

Multiplecovered indications

2025-09-01

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Coverage and Clinical Authorization Criteria

inv-01: Initial Authorization - NSCLC

Covered when ALL of the following are met

NSCLC initial auth: (1) Diagnosis of non-small cell lung cancer (NSCLC) AND (2) Disease is anaplastic lymphoma kinase (ALK)-positive AND (3) One of: (a) Disease is recurrent, advanced, or metastatic OR (b) Used as adjuvant treatment following tumor resection.

Authorization will be issued for 12 months

inv-03: Initial Authorization - Erdheim-Chester Disease

Covered when ALL of the following are met

Erdheim-Chester initial: (1) Diagnosis of symptomatic Erdheim-Chester Disease AND (2) Used as targeted therapy for ALK-fusion AND (3) Disease is relapsed or refractory.

Authorization will be issued for 12 months

inv-04: Initial Authorization - ALCL

Covered when ALL of the following are met

ALCL initial: (1) Diagnosis of anaplastic large cell lymphoma (ALCL) AND (2) Used as initial palliative intent therapy or second-line and subsequent therapy AND (3) Disease is relapsed or refractory AND (4) Anaplastic lymphoma kinase (ALK)-positive.

Authorization will be issued for 12 months

inv-05: Initial Authorization - Large B-Cell Lymphoma

Covered when ALL of the following are met

Large B-Cell lymphoma initial: (1) Diagnosis of large B-Cell lymphoma AND (2) Disease is relapsed or refractory AND (3) Anaplastic lymphoma kinase (ALK)-positive.

Authorization will be issued for 12 months

inv-06: Initial Authorization - CNS / Pediatric CNS

Covered when ALL of the following are met

CNS indications: One of: (a) Diagnosis of metastatic brain cancer from NSCLC OR (b) Diagnosis of pediatric diffuse high-grade glioma, AND (2) Tumor is anaplastic lymphoma kinase (ALK)-positive.

Authorization will be issued for 12 months

inv-07: Initial Authorization - IMT

Covered when ALL of the following are met

IMT initial: (1) Diagnosis of inflammatory myofibroblastic tumor (IMT) AND (2) Presence of ALK translocation.

Authorization will be issued for 12 months

inv-08: Pediatric (<19) Coverage

Covered when the following is met

Pediatrics <19: Patient is less than 19 years of age.

Prescription will automatically process without a coverage review; authorization will be issued for 12 months

inv-09: NCCN Recommended Regimens

Covered when recognized by NCCN

NCCN recommendation: Drug recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B evidence and consensus.

May support coverage for listed off‑label indications

This policy notes that state mandates may supersede the policy language for mandated off‑label medication coverage or required compendium references. Where applicable state laws or mandates exist, they take precedence over the criteria and provisions in this document. No additional clinical exclusions are specified in the policy; coverage limitations and denials are applied only where listed criteria are not met or when other administrative rules (for example, prior authorization logic or supply limits) trigger a denial.

Initial Therapy Authorization Rules

inv-17: Initial Therapy

Initial authorization criteria by indication

Initial therapy nodes: See indication-specific initial authorization criteria (NSCLC, Erdheim-Chester, ALCL, large B-cell lymphoma, CNS/pediatric HGG, IMT, pediatric <19).

Authorization will be issued for 12 months when criteria met

Reauthorization and Continuation Rules

inv-02: Reauthorization

Covered when the following is met

Reauthorization: Patient does not show evidence of progressive disease while on Alecensa therapy.

Authorization will be issued for 12 months

inv-18: Continuation Therapy / Reauthorization

Reauthorization criteria

Continuation: Patient does not show evidence of progressive disease while on Alecensa therapy.

Authorization for 12 months if met

What Providers Must Do / Watch For

Prior Authorization

Prior Authorization Required

Prior authorization is required for Alecensa for the listed oncologic indications. Approvals are typically issued for 12 months when criteria are met. Providers must submit documentation confirming ALK-positive status (FDA‑approved test) and relevant diagnosis codes or prior medication/claim history as applicable.

Prior authorization required for Alecensa for covered indications; approvals issued for 12 months when criteria met.
Coverage based on diagnosis confirmed by an FDA‑approved test for ALK positivity; include relevant pathology/genetic test results and ICD‑10 diagnosis codes.
Automated approval logic may use previous claim/medication history and diagnosis codes; requests may be denied if documentation or claims history does not support approval.
Supply limits may apply.

Step Therapy

Step Therapy / Prior Medication History

No formal step therapy sequence is specified in these criteria, but prior medication/claim history may be used by automated processes to approve or deny requests. Providers should document prior therapies where relevant.

Step Therapy and Prior Medication Considerations

Step	Requirement
1	No explicit step therapy requirement; automated approval processes may consider prior medication history, diagnosis codes, and claim logic when issuing initial or reauthorization approvals.

Supply and Quantity Limit Notes

Quantity Limits — Alecensa (alectinib)

Quantity limit statusSupply limits may be in place for Alecensa (alectinib)

Limit timingLimits apply to dispensing/supply (per month or per fill as managed by plan)

Authorization interactionSupply limits may trigger denial or require adjustment during prior authorization or automated approval

Program variabilityUse of automated approval/re-approval processes and any applied limits varies by program/therapeutic class

Site of Care Constraints

Note

No site-of-care restrictions specified

The policy does not specify any site‑of‑care restrictions for administration; no infusion center limitations are listed.

Background and Drug Information

Alectinib (Alecensa) is an ALK kinase inhibitor indicated for treatment of adult patients with ALK‑positive metastatic non‑small cell lung cancer (NSCLC) and for adjuvant treatment following surgical resection of ALK‑positive NSCLC for tumors ≥4 cm or node‑positive disease as detected by an FDA‑approved test. In addition, NCCN‑recognized uses include several other ALK‑fusion positive neoplasms such as Erdheim‑Chester Disease, certain lymphomas, CNS metastases from NSCLC, pediatric diffuse high‑grade glioma, and inflammatory myofibroblastic tumors; these recommendations may support coverage for those indications when cited in the NCCN Drugs and Biologics Compendium.

Key Definitions

ALK-positive — Definition

DefinitionPresence of anaplastic lymphoma kinase (ALK) rearrangement or fusion as detected by an FDA-approved test

Relevant useRequired for coverage of ALK-targeted indications including metastatic NSCLC, CNS tumors, lymphomas, Erdheim-Chester Disease, and IMT

DocumentationCoverage is based on diagnosis confirmed by an FDA‑approved test (per policy background and referenced labeling/compendia)

Pediatric relevanceALK‑rearrangement positivity applies to pediatric indications such as diffuse high-grade glioma when detected by an FDA‑approved test