CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alecensa (alectinib) — Coverage and Prior Authorization Criteria

Defines prior authorization, coverage indications, and duration for Alecensa (alectinib) for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlecensa (alectinib) coverage and prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of ALK mutation status to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

ALK+ NSCLCprimary FDA indication

Multiplecompendial indications

ALK statusrequired documentation

Coverage Criteria for Alecensa (alectinib)

Initial coverage criteria

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FDA-approved NSCLC indication: Patient has ALK-positive metastatic non-small cell lung cancer as detected by an FDA-approved test

Supported by FDA-approved indication

Compendial indications: For specified compendial uses (recurrent/advanced NSCLC ALK+, brain metastases from ALK+ NSCLC, ALK+ anaplastic large cell lymphoma, ALK+ large B-cell lymphoma, uterine IMT with ALK translocation, Erdheim-Chester Disease with ALK fusion) the disease is ALK-positive and the requested medication will be used as a single agent

Compendial uses listed in policy

Initial Therapy Criteria

Initial therapy criteria

Initial authorization conditions

Disease status: Disease is advanced, recurrent, metastatic, or inoperable where specified

Section III: disease status requirement

ALK positivity documented: Disease is ALK-positive (documentation required)

ALK positivity required per FDA/compendial criteria

Single-agent use: Requested medication will be used as a single agent

Single-agent requirement for listed indications

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Reauthorization rules

Continued NSCLC therapy: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity while on the current regimen

Applies to NSCLC reauthorization

Continued other indications: Authorization of 12 months may be granted for continued treatment for all other listed indications when there is no evidence of unacceptable toxicity or disease progression while on the current regimen

Applies to compendial indications

Duration and reauthorization

Reauthorization and duration

Authorization duration: Authorization may be granted for 12 months for treatment of covered indications12 months

Prior authorization duration stated for initial and continued therapy

Reauthorization criteria: Reauthorization requires no evidence of unacceptable toxicity or disease progression while on current regimen

Required for continued approval across indications

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization duration and reauthorization

Prior authorization may be granted for up to 12 months for covered, compendial indications. Reauthorization may be approved for 12 months when the member is on the current regimen and there is no evidence of unacceptable toxicity (for NSCLC and other listed indications) and no evidence of disease progression for indications that require absence of progression for continuation.

Initial authorization: up to 12 months for covered indications listed in the policy (e.g., ALK-positive NSCLC, ALCL, LBCL, IMT, Erdheim-Chester Disease).
Reauthorization: up to 12 months when there is no evidence of unacceptable toxicity while on the current regimen.
For indications where continuation requires absence of progression, reauthorization also requires no evidence of disease progression.

Denial Risk

Experimental / Investigational — Not Medically Necessary

Use of the medication for indications not listed in the policy (including uses beyond the compendial and listed ALK-positive diseases) is considered experimental or investigational and is not medically necessary.

All indications not specifically listed in the Compendial Uses section are not covered and considered experimental/investigational.

Documentation Required

Required documentation

Submit documentation of ALK mutation/rearrangement status to initiate prior authorization review.

Provide test results or pathology report confirming ALK-positive status.

Prior Authorization

Single-agent requirement

Therapy will be authorized when requested as a single agent for the listed ALK-positive diseases.

Requests should indicate single-agent use for covered indications (e.g., NSCLC, ALCL, LBCL, ECD).

Key Definitions

ALK-positive definition

DefinitionDisease demonstrating anaplastic lymphoma kinase (ALK) rearrangement or fusion as detected by an FDA-approved test or documented compendial evidence

Confirmatory testingALK positivity must be demonstrated by an FDA-approved test for the FDA-approved NSCLC indication

Compendial evidenceFor listed compendial uses (e.g., recurrent/advanced ALK+ NSCLC, brain metastases from ALK+ NSCLC, ALK+ anaplastic large cell lymphoma, ALK+ large B-cell lymphoma, uterine IMT with ALK translocation, Erdheim‑Chester Disease with ALK fusion), ALK rearrangement/fusion must be documented

Documentation requirementSubmission of ALK mutation/rearrangement status is required to initiate prior authorization review

Exclusion noteAll other indications not listed (outside FDA-approved and compendial uses) are considered experimental/investigational and not medically necessary

Background

Alectinib (Alecensa) is an ALK inhibitor used primarily for ALK-positive metastatic non‑small cell lung cancer (NSCLC) and for several ALK‑rearranged diseases listed as compendial uses, including recurrent or advanced ALK+ NSCLC, brain metastases from ALK+ NSCLC, ALK+ anaplastic large cell lymphoma, ALK+ large B‑cell lymphoma, uterine inflammatory myofibroblastic tumor with ALK translocation, and Erdheim‑Chester Disease with ALK fusion.