CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alectinib (Alecensa) coverage

Coverage policy for alectinib (Alecensa) for ALK-positive malignancies and compendial uses, governing prior authorization, duration, and documentation requirements for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlectinib (Alecensa) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and include ALK mutation/fusion status with the submission.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial authorization duration for most indications

up to 2 yearsmax continued treatment (adjuvant NSCLC)

FDA & compendialcovered indications if criteria met

ALK statusrequired documentation

Coverage Criteria

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General requirement: Member has ALK-positive disease documented (ALK mutation/fusion) as detected by an FDA-approved test for FDA indications or documented for compendial uses

See documentation requirement for ALK status

Covered indications (select applicable): Includes: (1) Metastatic ALK-positive NSCLC (FDA), (2) Adjuvant ALK-positive NSCLC post-resection (tumors ≥2 cm or node positive) (FDA), (3) Brain metastases from ALK+ NSCLC (compendial), (4) Recurrent or advanced ALK+ NSCLC (compendial), (5) ALK+ anaplastic large cell lymphoma (compendial), (6) Inflammatory myofibroblastic tumor with ALK translocation (compendial), (7) ALK+ large B-cell lymphoma (compendial), (8) Erdheim-Chester disease with ALK fusion (compendial)

Each listed indication is eligible for single-agent alectinib when other criteria met

Authorization duration criteria: Initial authorization of 12 months may be granted for listed indications; adjuvant NSCLC initial authorization 12 months with reauthorization allowed up to a maximum of 2 years

Reauthorization contingent on no unacceptable toxicity or disease recurrence/progression per indication-specific notes

Indication	Regimen	Authorization duration / notes
Metastatic or recurrent/advanced ALK‑positive non‑small cell lung cancer (including brain metastases)	Alectinib (Alecensa) — single‑agent therapy	Authorization of 12 months may be granted for treatment as a single agent
Adjuvant treatment of ALK‑positive NSCLC following complete resection (tumors ≥2 cm or node positive)	Alectinib (Alecensa) — single‑agent therapy	Authorization of 12 months may be granted for adjuvant single‑agent therapy
ALK‑positive anaplastic large cell lymphoma (ALCL) — initial palliative or relapsed/refractory disease	Alectinib (Alecensa) — single‑agent therapy	Authorization of 12 months may be granted for initial palliative or relapsed/refractory treatment
ALK‑positive large B‑cell lymphoma — relapsed/refractory	Alectinib (Alecensa) — single‑agent therapy	Authorization of 12 months may be granted for treatment of relapsed/refractory disease
Inflammatory myofibroblastic tumor (IMT) with ALK translocation (including specified criteria for uterine sarcoma vs other soft tissue sarcoma)	Alectinib (Alecensa) — single‑agent therapy	Authorization of 12 months may be granted for treatment as a single agent when criteria are met
Erdheim‑Chester disease (ECD) with ALK fusion — symptomatic or relapsed/refractory	Alectinib (Alecensa) — single‑agent therapy	Authorization of 12 months may be granted for treatment as a single agent

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of therapy. Authorizations of 12 months may be granted for initial therapy and for reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen. For adjuvant NSCLC following complete tumor resection, reauthorization may be granted for up to a maximum of 2 years.

Authorizations typically issued for 12 months
Reauthorization requires no unacceptable toxicity or disease progression
Adjuvant NSCLC reauthorization: up to 2 years total

Denial Risk

Experimental/Investigational Exclusions

All indications not listed as covered (including non–FDA-approved or non‑compendial uses) are considered experimental/investigational and are not medically necessary.

All other indications are considered experimental/investigational and not medically necessary

Documentation Required

Prior authorization submission must include documentation of ALK mutation (ALK rearrangement/ALK-positive) status to support medical necessity.

Include ALK mutation status with PA submission

Note

Authorization Duration — Provider Reminder

Providers should note that authorizations of 12 months may be granted for initial palliative or relapsed/refractory therapy across listed malignancies (e.g., ALCL, large B‑cell lymphoma, IMT, Erdheim‑Chester disease) when criteria are met.

ALCL: initial palliative or relapsed/refractory ALK‑positive ALCL — 12 months
Large B‑cell lymphoma: relapsed/refractory ALK‑positive — 12 months
IMT: ALK‑positive IMT — 12 months when criteria met
Erdheim‑Chester disease: symptomatic or relapsed/refractory ALK‑positive — 12 months
NSCLC: initial or recurrent/advanced/metastatic ALK‑positive NSCLC — 12 months

Line of Therapy

Line of Therapy — first-line | subsequent

Line of therapy: Indicated for initial palliative therapy or treatment of relapsed/refractory disease in the listed malignancies; for NSCLC includes adjuvant and metastatic settings

Policy grants 12 months authorization for initial or relapsed/refractory single-agent therapy; adjuvant NSCLC reauthorization up to maximum of 2 years

Biomarker and Diagnostic Requirements

ALK (anaplastic lymphoma kinase)

Biomarker requiredALK (anaplastic lymphoma kinase) positivity is required for all listed indications

Test type for FDA indicationsAs detected by an FDA-approved test for FDA-approved indications (e.g., metastatic and adjuvant ALK+ NSCLC)

Documentation for compendial usesDocumented ALK translocation or fusion is required for compendial (non‑FDA) indications

Prior authorization documentationPrior authorization submissions must include ALK mutation status

ApplicabilityRequirement applies to all covered indications (FDA-approved and compendial) listed in the policy

ALK-positive

DefinitionTumors with anaplastic lymphoma kinase (ALK) rearrangement or fusion

Detection for FDA indicationsIdentified by an FDA-approved test (per FDA-approved indications such as metastatic and adjuvant NSCLC)

Documentation for compendial usesALK rearrangement/fusion documented in the medical record is acceptable for compendial indications (e.g., brain metastases, ALCL, IMT, LBCL, ECD)

ScopeTerm applies to malignancies and conditions listed in policy as ALK-positive (NSCLC, ALCL, IMT, large B-cell lymphoma, Erdheim‑Chester disease)

Background

Alectinib (Alecensa) is an anaplastic lymphoma kinase (ALK) inhibitor used for ALK-rearrangement–positive disease. Compendial uses listed in this policy include treatment of: (1) brain metastases from ALK rearrangement–positive NSCLC; (2) recurrent or advanced ALK-positive NSCLC; (3) ALK-positive anaplastic large cell lymphoma; (4) inflammatory myofibroblastic tumor with ALK translocation; (5) ALK-positive large B‑cell lymphoma; and (6) Erdheim‑Chester disease with ALK fusion.