CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Alecensa (alectinib) — coverage criteria

Defines accepted indications, coverage criteria, exclusions, and utilization management for Alecensa (alectinib) for members, including FDA‑approved and certain off‑label uses supported by recognized compendia or literature. Applies to prior authorization and medication requests processed by the UM department.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Alecensa (alectinib) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionSubmit prior authorization to Evolent/UM with documentation of ALK rearrangement in tumor tissue to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

600 mgsingle dose limit

240 caps/momonthly limit

05/31/2024effective date

05/08/2024approval date

2016-2024committee reviews

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Coverage Criteria for Alecensa (alectinib)

Covered indications

Covered when ALL of the following are met for NSCLC:

NSCLC initial/continuation criteria

Tumor ALK status: Tumor is ALK positive
Document ALK rearrangement in tumor tissue
Line of therapy: Alecensa is used as first-line therapy OR Alecensa is used as subsequent therapy
Policy permits first-line or subsequent single-agent use

Adjuvant use: Alecensa (alectinib) may be used as adjuvant treatment following tumor resection in adult members with ALK-positive metastatic NSCLC

Adjuvant use allowed per policy

Coverage will be denied when any of the exclusion conditions apply. Key exclusion criteria include: concurrent use with chemotherapy, absence of documented ALK rearrangement in tumor tissue, and dosing that exceeds the single dose limit of 600 mg for Alecensa (alectinib). Requests that would result in treatment exceeding the policy’s maximum limit of 240 (150 mg) capsules per month should also be denied. These exclusions are applied during prior authorization review and are reasons for non-approval if documentation or dosing does not meet the limits stated in the policy.

Alecensa use for off‑label indications is considered investigational and not approvable when the supporting evidence is insufficient or not generally accepted by the medical community. The policy defines insufficient evidence to include situations where published evidence does not adequately represent the patient or tumor clinical characteristics, does not reflect the therapy regimen under consideration, fails to demonstrate clinically meaningful outcomes (e.g., ASCO‑recommended thresholds), relies on inappropriate study design, is limited to single case reports, or is presented only as abstracts without full peer‑reviewed articles. Such investigational/off‑label uses should be denied.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. All medication requests for Alecensa (alectinib) must be processed by Evolent/UM and meet the coverage criteria in this policy. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Requests processed by Evolent/UM
Authorization required prior to dispensing

Step Therapy

Step therapy is not specified for Alecensa (alectinib). Alecensa may be used as first-line therapy or as subsequent single‑agent therapy for ALK-positive NSCLC; no mandated prior agents are required before approval under this policy.

No step therapy sequence required
Allowed as first-line or subsequent single-agent therapy

Key Definitions

DEFINITION: ALK-positive

DefinitionAnaplastic lymphoma kinase (ALK) rearrangement detected in tumor tissue (ALK positive) indicating eligibility for ALK-targeted therapy.

Documentation requirementEvidence of ALK rearrangement in tumor tissue must be provided as part of the clinical documentation for coverage determinations.

Clinical contextMember must have recurrent or metastatic NSCLC and Alecensa is to be used as a single agent when tumor is ALK positive.

Initial Therapy Coverage Rules

Initial therapy

Initial therapy coverage rules for NSCLC

Initial therapy: Member has recurrent or metastatic NSCLC; tumor is ALK positive; Alecensa (alectinib) is used as a single agent as first-line therapy

Policy permits first-line single-agent use

Continuation Therapy and Exemptions

Continuation exemption

Continuation requests for a medication that would otherwise be not approvable are exempt if ALL of the following are met:

Continuation exemption conditions: Requested medication was used within the last year AND member has not experienced disease progression and/or intolerance to the requested medication AND additional medications are not being added to the continuation request

Applies to continuation requests for not-approvable medications

Quantity Limits for Alecensa (alectinib)

QUANTITY LIMIT — Alecensa (alectinib) monthly maximum

Maximum monthly quantityMaximum 240 capsules per month when using 150 mg capsules (policy limit: 240 [150 mg] capsules/month).

Applies toAlecensa (alectinib) quantity limit applies to outpatient pharmacy dispensing and prior authorization evaluations.

Exclusion if exceededTreatment requests that would exceed this monthly maximum are listed in the exclusion criteria and may be denied.

SINGLE DOSE LIMIT — Alecensa (alectinib)

Single dose limitSingle dose limit for Alecensa (alectinib) is 600 mg; dosing that exceeds 600 mg per dose is an exclusion criterion.

Policy consequenceRequests with dosing that exceed the single dose limit may be denied per the policy's exclusion criteria.

Background

Alectinib (Alecensa) is an ALK inhibitor indicated for treatment of ALK‑positive non‑small cell lung cancer (NSCLC). The policy recognizes Alecensa for use as first‑line or subsequent single‑agent therapy in recurrent or metastatic ALK‑positive NSCLC and permits adjuvant use following tumor resection in adults with ALK‑positive metastatic NSCLC. Use must align with FDA labeling or authoritative compendia and guidelines and authorization requires documentation of ALK rearrangement in tumor tissue.