CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alecensa (alectinib) — Drug Policy / Coverage Criteria

Defines accepted indications, coverage criteria, exclusions, and authorization requirements for alectinib (Alecensa) for members of Neighborhood Health Plan of Rhode Island; affects providers requesting coverage for the drug.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlecensa (alectinib) — Drug Policy / Coverage Criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

Key ActionObtain prior authorization with documentation of ALK rearrangement and supporting evidence (FDA labeling, ASCO guidelines, or peer-reviewed literature) before coverage will be approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

600 mgsingle dose maximum listed

240maximum monthly capsule limit

FDA+ASCOevidence required

ALK+ NSCLCprimary covered indication

Coverage Criteria for Alecensa (alectinib)

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NSCLC - Initial/Subsequent Therapy

Covered when ALL of the following are met

Alecensa coverage for NSCLC: Member has recurrent or metastatic NSCLC and Alecensa (alectinib) is being used as a single agent; the tumor is ALK positive; and Alecensa is used as first-line therapy OR is being used as subsequent therapy (including as adjuvant treatment following tumor resection in adults with ALK-positive metastatic NSCLC).

From policy section B

Coverage will be denied when any of the exclusion conditions apply. Key triggers include: concurrent use with chemotherapy, and lack of documentation of ALK rearrangement in tumor tissue (the tumor must be documented ALK positive). Dosing that exceeds the policy thresholds is also excluded — specifically, a single dose greater than 600 mg or total treatment that exceeds 240 (150 mg) capsules per month. Requests that meet these exclusion criteria should not be authorized.

Use of Alecensa (alectinib) for investigational or off‑label indications is considered not medically necessary unless supported by sufficient clinical evidence. The policy defines insufficient evidence to include: inadequate representation of the patient or cancer characteristics in the published data; the regimen or combination evaluated does not match the requested therapy; outcomes are not clinically meaningful (ASCO thresholds such as a hazard ratio < 0.80 or a survival benefit of at least 3 months for OS/PFS are expected); poor or inappropriate study design; reliance on uncontrolled case reports or meeting abstracts without a full peer‑reviewed article. Uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature should be denied.

Key Coding & Limits

inv-04: Maximum single dose — 600 mg

Maximum single dose600 mg

Applies toAlecensa (alectinib) dosing per single administration

Exclusion effectRequests exceeding this single-dose limit are listed as exclusion criteria

inv-05: Maximum monthly capsules — 240 (150 mg) capsules/month

Maximum monthly capsules240 (150 mg) capsules/month

Unit strength150 mg capsules

Exclusion effectTreatment exceeding this monthly limit is listed as an exclusion

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is supported when Alecensa (alectinib) is used as a single agent for ALK-positive recurrent or metastatic non-small cell lung cancer (NSCLC) consistent with FDA labeling, ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards.

Affected drug: Alecensa (alectinib)
Indication: ALK-positive recurrent or metastatic NSCLC as single-agent therapy
Policy owner: Evolent processes medication requests on behalf of the payer

Note

Continuation Exemption

Continuation requests for a previously used medication that would otherwise be non‑approvable may be exempt from prior authorization if all of the following are met: the requested medication was used within the last year; the member has not experienced disease progression or intolerance to the medication; and no additional medications are being added to the continuation request.

Time window: use within last 12 months
Clinical stability: no progression or intolerance documented
No changes: no additional medications added to the same request

Documentation Required

Required Supporting Documentation

Requests must be supported by appropriate documentation: FDA approved product labeling, ASCO clinical practice guidelines, or relevant peer‑reviewed literature that meets CMS standards. Documentation should include tumor ALK status and records supporting prior use or rationale for use in the requested indication.

Required supporting evidence: FDA labeling, ASCO guidelines, or peer‑reviewed literature meeting CMS criteria
Clinical documentation: pathology/report confirming ALK rearrangement in tumor tissue
For continuation: documentation of prior use, absence of progression/intolerance

Denial Risk

Triggers for Denial

Denial triggers include concurrent chemotherapy use with Alecensa, lack of documentation of ALK rearrangement in tumor tissue, dosing that exceeds the single‑dose limit (600 mg), monthly quantity limits (exceeds 240 capsules of 150 mg/month), or investigational/off‑label use lacking sufficient evidence per CMS‑recognized compendia or acceptable peer‑reviewed literature.

Concurrent use with chemotherapy — denial risk
Absence of documented ALK rearrangement — denial risk
Single‑dose exceedance: >600 mg — denial risk
Monthly quantity exceedance: >240 (150 mg) capsules/month — denial risk
Investigational/off‑label use lacking sufficient evidence (case reports/abstracts alone are insufficient) — denial risk

Background

Alectinib (Alecensa) is an oral ALK inhibitor indicated for treatment of ALK‑positive non‑small cell lung cancer (NSCLC). The policy focuses on single‑agent use in adults with recurrent or metastatic ALK‑positive NSCLC, including first‑line and subsequent therapy and adjuvant use after tumor resection where applicable. Therapy must align with documented ALK positivity and the evidence requirements outlined in the policy.

Definitions

inv-11: ALK rearrangement in tumor tissue — ALK positive

DefinitionALK rearrangement in tumor tissue = ALK positive

Requirement for coverageTumor must be ALK positive for Alecensa coverage in NSCLC

DocumentationLack of documentation of ALK rearrangement is an exclusion

Initial Therapy

Initial therapy coverage: Alectinib used as single-agent first-line therapy for ALK-positive recurrent or metastatic NSCLC is covered when tumor is ALK positive.

Section B

Continuation Therapy Criteria

Continuation requests

Criteria for continuation requests

Continuation exemption: Requested medication was used within the last year; the member has not experienced disease progression and/or no intolerance to the requested medication; additional medication(s) are not being added to the continuation request.

Exemption from Evolent policy for not-approvable medications

Quantity Limits

inv-14: Alecensa (alectinib) — 240 (150 mg) capsules

ProductAlecensa (alectinib)

Packaged strength150 mg capsules

Quantity limit240 (150 mg) capsules per month

Indication contextUsed as single-agent therapy for ALK-positive recurrent or metastatic NSCLC (first-line or subsequent therapy, including adjuvant use)