CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zykadia (ceritinib)

Defines accepted indications, continuation criteria, exclusions, dosing limits, applicable lines of business, coding, and evidentiary sources for Zykadia (ceritinib) for treatment of cancer, principally ALK-rearranged metastatic non-small cell lung cancer (NSCLC).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZykadia (ceritinib)

Policy CodePolicy N/A

Change TypeAdministrative / template revision

Effective Date

Next Review Date

Key ActionProvider must supply documentation of ALK rearrangement detection using an FDA-approved test; lack of such documentation is an exclusion.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1265 Zykadia (ceritinib).

Updated NCH verbiage to Evolent and added new references.

1Primary Covered Indication (ALK+ metastatic NSCLC)

84Monthly capsule limit (150 mg)

450 mgSingle dose limit (mg)

J8999Billing code

Coverage Summary

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Coverage stance: Covered with criteria. Zykadia (ceritinib) is authorized as monotherapy for adult members with ALK‑rearrangement positive metastatic non‑small cell lung cancer (NSCLC) when all specified criteria are met. The policy explicitly allows use as first‑line or subsequent therapy for ALK‑rearranged metastatic NSCLC and requires documentation and prior authorization per the policy requirements.

Initial and Continuation Use — NSCLC

Zykadia (ceritinib) may be used as monotherapy in adult members for first line or subsequent therapy of ALK rearrangement positive metastatic NSCLC when ALL of the following are met:

Patient and Diagnostic Criteria
- Age: Member is an adult
- Diagnosis of metastatic non-small cell lung cancer (NSCLC)
- Biomarker: Tumor is ALK rearrangement positive
- Biomarker Test: Detection of ALK rearrangement must be documented by an FDA-approved test
  List of FDA-approved tests available at www.fda.gov/CompanionDiagnostics

Continuation Therapy Criteria — Exemption

Continuation requests for a not-approvable medication shall be exempt from this Evolent policy provided ALL of the following are met:

No progression: Member has not experienced disease progression on the requested medication
Recent use without lapse: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additions: No additional medication(s) are being added to the continuation request

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Evolent is responsible for processing medication requests. Prior authorization is required; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Affected billing code: J8999. Continuation exemption rules apply as specified in the policy.

J8999

Documentation Required

Document ALK rearrangement by FDA-approved test

Detection of ALK rearrangement must be documented by an FDA‑approved test. A list of FDA‑approved companion diagnostics is available at www.fda.gov/CompanionDiagnostics and lack of such documentation is an exclusion.

Denial Risk

Denial risk for dosing/quantity exceedance

Claims may be denied if dosing limits are exceeded. Single dose dosing must not exceed 450 mg and treatment must not exceed the operational monthly maximum of 84 capsules (150 mg strength); applicable billing code: J8999.

Single dose limit: 450 mg
Monthly capsule limit: 84 capsules (150 mg)

Documentation Required

Evidence requirement for off-label use

Off‑label uses require supporting evidence from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards; investigational or insufficient evidence for off‑label indications is an exclusion.

Clinical Evidence & Sources

Key supporting evidence and references include the ASCEND‑1 and ASCEND‑4 clinical trials, cited as primary trials evaluating ceritinib in ALK‑rearranged NSCLC, the Zykadia prescribing information (Novartis, 2021), and compendia such as the NCCN Cancer Guidelines and Drugs and Biologics Compendium (2025). Per the policy, off‑label or non‑FDA‑labeled uses must meet CMS standards (Medicare Benefit Policy Manual Chapter 15) and be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

Background & Definitions

Zykadia (ceritinib) is an anaplastic lymphoma kinase (ALK) inhibitor indicated for monotherapy in adults with ALK‑rearranged metastatic non‑small cell lung cancer. Use must be supported by appropriate evidentiary standards: FDA product labeling, CMS‑recognized compendia (for example NCCN), ASCO/NCCN clinical guidelines, or peer‑reviewed literature that satisfies CMS Medicare Benefit Policy Manual Chapter 15 requirements. The policy also specifies required documentation (e.g., ALK detection by an FDA‑approved test) and defines exclusions and dosing limits that reflect these evidentiary and regulatory standards.

Definitions

Clinically meaningful outcomes (ASCO)Examples include hazard ratio < 0.80 and recommended survival benefit for OS and PFS of at least 3 months.

Revision History

November 2025revisedLatest

Converted to new Evolent guideline template and replaced prior UM ONC_1265 Zykadia (ceritinib). Updated indication section and updated references.

November 2024revised

Updated NCH verbiage to Evolent and added new references; updated maximum dosage form quantities in exclusion criteria noted in prior history.