CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Zykadia (ceritinib)

Defines coverage, authorization criteria, and exclusions for Zykadia (ceritinib) for treatment of ALK-rearranged non-small cell lung cancer for members whose medication requests are processed by Evolent/Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Zykadia (ceritinib)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of ALK rearrangement by an FDA‑approved test and supporting evidence per FDA label or recognized compendia/guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

450 mgsingle dose maximum

84 capsmonthly maximum

1st or subsequenttherapy lines

11/13/24policy approval

Coverage Criteria for Zykadia (ceritinib)

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Continuation therapy

Continuation (renewal) allowed when ALL of the following are met

Continuation criteria: Requested medication was used within the last year; member has not experienced disease progression or intolerance to Zykadia; no additional medications are being added to the continuation request.

Continuation requests for not-approvable medications shall be exempt if these conditions are met

Requests for Zykadia (ceritinib) will be excluded or denied when any of the following apply: disease progression while taking Zykadia; lack of documentation of ALK rearrangement by an FDA‑approved test (a list of approved tests is available at the FDA Companion Diagnostics website); concurrent use with chemotherapy; dosing that exceeds a single dose of 450 mg; or treatment that exceeds the monthly maximum of 84 (150 mg) capsules/tablets.

Additionally, requests will be denied when the proposed use is investigational or off‑label without sufficient supporting evidence. Insufficient evidence includes reliance on abstracts without full peer‑reviewed articles, case reports, or other anecdotal reports. The policy requires that the clinical population, regimen, and outcomes be adequately represented in the published literature (for example, studies meeting recognized standards for clinically meaningful outcomes and appropriate study design).

Use of Zykadia (ceritinib) for off‑label indications that are not supported by CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature is considered investigational and not approvable. Abstracts (including meeting abstracts) without the full published article from an approved peer‑reviewed journal do not provide sufficient evidence to support coverage.

The policy further clarifies that case reports are generally considered uncontrolled and anecdotal and do not constitute adequate evidence. Sufficient evidence should demonstrate that the patient population, treatment regimen, and clinically meaningful outcomes are represented in the literature and meet accepted standards for clinical relevance.

Initial Therapy

Initial therapy

Initial coverage conditions

Initial therapy: Use as monotherapy for first-line or subsequent therapy of ALK-rearranged metastatic NSCLC; indication must be supported by FDA label, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature.

Documentation of indication and supporting evidence required per policy

Continuation (Renewal) Criteria

Continuation therapy

Continuation (renewal) conditions

Continuation: Medication used within last year AND no disease progression or intolerance AND no additional medications added to request

Continuation requests for not-approvable medication may be exempt if criteria met

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zykadia (ceritinib). Use must align with FDA-approved product labeling or CMS-recognized compendia/guidelines (e.g., NCCN, ASCO) or peer-reviewed literature meeting CMS standards. Zykadia may be permitted as monotherapy for ALK rearrangement–positive metastatic NSCLC when criteria are met.

Prior authorization required
Use must align with FDA labeling or CMS-recognized compendia/guidelines
Permitted as monotherapy for ALK+ metastatic NSCLC

Prior Authorization

Continuation / Renewal Conditions

Continuation/renewal (re-authorization) may be authorized when all of the following are met: the member has used the requested medication within the last year; the member has not experienced disease progression while on Zykadia and has not had intolerance to the requested medication; and no additional medications are being added to the continuation request. Documentation of ongoing clinical benefit or stability should be provided.

Request for continuation must show use within the last year
No documented disease progression or intolerance to Zykadia
No additional medications added to the continuation request
Provide documentation of response or clinical stability

Documentation Required

Required Diagnostic and Evidence Documentation

Required diagnostic and supporting evidence must be submitted with the request. Documentation must include detection of ALK rearrangement by an FDA-approved test (see FDA companion diagnostics listings) and supporting evidence consistent with FDA labeling or CMS-recognized compendia/guidelines or acceptable peer-reviewed literature that meets CMS criteria.

Document ALK rearrangement detected by an FDA-approved test (list available from FDA companion diagnostics)
Provide supporting clinical evidence aligning with FDA labeling, NCCN/ASCO guidelines, CMS-recognized compendia, or acceptable peer-reviewed literature meeting CMS standards

Denial Risk

Exclusion-Triggered Denials

Requests will be denied when exclusion criteria are met. Denials include situations of documented disease progression while on Zykadia, lack of documentation of ALK rearrangement by an FDA-approved test, concurrent use with chemotherapy, dosing in excess of the single-dose limit (450 mg), treatment exceeding the monthly maximum of 84 (150 mg) capsules/tablets, or investigational/off-label uses lacking sufficient evidence as defined by CMS compendia or acceptable peer-reviewed literature.

Progression occurred while on Zykadia — request denied
No documentation of ALK rearrangement by an FDA-approved test — request denied
Concurrent use with chemotherapy — request denied
Dosing exceeds single-dose limit of 450 mg — request denied
Monthly quantity exceeds 84 (150 mg) capsules/tablets — request denied
Investigational or off-label indications without sufficient evidence (per CMS compendia or acceptable peer-reviewed literature) — request denied

Coding and Limits

inv-05: Single dose limit — 450 mg

Single dose maximum450 mg

ContextDosing above 450 mg in a single administration is an exclusion criterion and will lead to denial of the request.

Source guidanceRefer to the policy's exclusion list for enforcement of single-dose maximums.

inv-06: Monthly quantity limit — 84 (150 mg) capsules/tablets per month

Monthly quantity limit84 (150 mg) capsules/tablets per month

InterpretationTotal monthly supply must not exceed 84 capsules/tablets of 150 mg strength or equivalent total mg per month.

ConsequenceTreatment requests exceeding this monthly limit are listed as an exclusion and may be denied.

Definitions

inv-12: ALK rearrangement — ALK rearrangement documented by an FDA-approved test

Required diagnostic findingALK rearrangement documented by an FDA-approved test

Verification resourceA list of FDA-approved companion diagnostic tests is available at FDA Companion Diagnostics (www.fda.gov/CompanionDiagnostics).

Policy impactLack of documentation of ALK rearrangement by an FDA-approved test is an exclusion and may result in denial.

Background

Ceritinib (Zykadia) is an ALK inhibitor indicated for patients with ALK‑rearranged metastatic non‑small cell lung cancer. The medication is permitted as monotherapy for first‑line or subsequent therapy when the indication is documented and supported by FDA labeling, recognized compendia, or acceptable peer‑reviewed literature. Provider documentation must include evidence of ALK rearrangement detected by an FDA‑approved test.