CurrentNeighborhood Health Plan of Rhode IslandPolicy 1668-A

ceritinib (Zykadia) coverage

Criteria and prior authorization requirements for coverage of ceritinib (Zykadia) for ALK-positive malignancies for members of Neighborhood Health Plan of Rhode Island, including FDA and compendial indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyceritinib (Zykadia) coverage

Policy CodePolicy 1668-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit ALK mutation or translocation test results to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration for covered indications

1FDA-approved indication (ALK-positive metastatic NSCLC)

4Compendial uses listed

Coverage Criteria

Indication-specific coverage criteria

Covered when ALL of the following are met for each indication below

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NSCLC (FDA): Adult patient with metastatic non-small cell lung cancer (NSCLC) whose tumor is ALK-positive as detected by an FDA-approved test

Authorization of 12 months may be granted for recurrent, advanced, or metastatic disease including brain metastases

NSCLC reauthorization: No evidence of unacceptable toxicity while on the current regimen for continued treatment of NSCLC

Authorization of 12 months may be granted for continued treatment

ALCL: Initial palliative therapy or treatment of relapsed/refractory ALK-positive anaplastic large cell lymphoma (ALCL)

Authorization of 12 months may be granted

IMT: ALK-positive inflammatory myofibroblastic tumor (IMT) in a member who either has uterine sarcoma that is advanced, recurrent, metastatic, or inoperable OR has a soft tissue sarcoma (excluding uterine sarcoma)

Authorization of 12 months may be granted

ECD: Symptomatic or relapsed/refractory ALK-positive Erdheim-Chester Disease (ECD)

Authorization of 12 months may be granted

Compendial coverage: Uses recognized in compendia: recurrent/advanced/metastatic ALK-positive NSCLC; IMT with ALK translocation; brain metastases from ALK-positive NSCLC; ECD with ALK-fusion

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

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

Any indication not listed among the FDA-approved indications or the compendial uses below is considered experimental/investigational and not medically necessary.

Indication	Covered Regimen	Authorization Duration / Notes
Non-Small Cell Lung Cancer (NSCLC)
ceritinib (Zykadia) — single-agent therapy for ALK-positive disease
Authorization of 12 months may be granted for treatment of recurrent, advanced, or metastatic ALK-positive NSCLC (including brain metastases)
Anaplastic Large Cell Lymphoma (ALCL)
ceritinib (Zykadia) — single-agent therapy for ALK-positive disease
Authorization of 12 months may be granted for initial palliative therapy or treatment of relapsed/refractory ALK-positive ALCL as a single agent
Inflammatory Myofibroblastic Tumor (IMT)
ceritinib (Zykadia) — single-agent therapy for ALK-positive disease
Authorization of 12 months may be granted when either: the member has uterine sarcoma that is advanced/recurrent/metastatic/inoperable, or the member has a soft tissue sarcoma (excluding uterine sarcoma)
Erdheim-Chester Disease (ECD)
ceritinib (Zykadia) — single-agent therapy for ALK-positive disease
Authorization of 12 months may be granted for treatment of symptomatic or relapsed/refractory ALK-positive Erdheim-Chester Disease as a single agent

Coding

Covered drugNDC | drugCovered

ceritinib (Zykadia)

listed drug — brand and generic, all dosage forms and strengths unless otherwise stated

Provider Actions & Authorization

Prior Authorization

NSCLC authorization — Authorization may be granted

Authorization of 12 months may be granted for treatment of recurrent, advanced, or metastatic ALK-positive non-small cell lung cancer (NSCLC), including brain metastases; prior authorization required.

Prior Authorization

ALCL authorization — Authorization may be granted

Authorization of 12 months may be granted for initial palliative therapy or treatment of relapsed/refractory ALK-positive anaplastic large cell lymphoma (ALCL) as a single agent.

Prior Authorization

IMT authorization — Authorization may be granted

Authorization of 12 months may be granted for treatment of ALK-positive inflammatory myofibroblastic tumor (IMT) as a single agent when either 1) the member has uterine sarcoma that is advanced, recurrent, metastatic, or inoperable, or 2) the member has a soft tissue sarcoma (not including uterine sarcoma).

Prior Authorization

ECD authorization — Authorization may be granted

Authorization of 12 months may be granted for treatment of symptomatic or relapsed/refractory ALK-positive Erdheim‑Chester Disease (ECD) as a single agent.

Prior Authorization

Reauthorization — Authorization may be granted

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for covered indications when therapy remains clinically beneficial (no unacceptable toxicity or disease progression).

Documentation Required

Required documentation — ALK testing required

Submission of ALK mutation or translocation status is necessary to initiate the prior authorization review.

Denial Risk

Experimental/Investigational exclusions — Not medically necessary

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

Note

(reserved)

Line of Therapy

Line of therapy

Initial or subsequent therapy: Indication-specific use of ceritinib (Zykadia) as a single agent for treatment of advanced, recurrent, metastatic, or relapsed/refractory disease per indication

Authorization typically granted for 12 months

Biomarker Requirements

ALK rearrangement/translocation — Biomarker requirement (FDA indication) "inv-16"

BiomarkerALK rearrangement or translocation

Required test resultDetected by an FDA-approved test

Applies toAll covered NSCLC and other ALK-positive indications (per policy)

Documentation neededSubmission of ALK mutation or translocation status to initiate prior authorization review

Definitions

Anaplastic lymphoma kinase (ALK) rearrangement or translocation detected by an FDA-approved test — 'ALK-positive' definition "inv-14"

DefinitionAnaplastic lymphoma kinase (ALK) rearrangement or translocation detected by an FDA-approved test

SynonymALK-positive

Context — FDA indicationDefines tumors qualifying for Zykadia in metastatic NSCLC when detected by an FDA-approved test

Context — Compendial usesAlso relevant for compendial ALK-positive conditions (IMT with ALK translocation; brain metastases from ALK-positive NSCLC; ECD with ALK-fusion)

Required submissionALK mutation or translocation status must be submitted for prior authorization review

Background

Ceritinib (Zykadia) is an anaplastic lymphoma kinase (ALK) inhibitor indicated for ALK-positive metastatic non–small cell lung cancer (NSCLC). The policy also recognizes compendial uses for ALK-positive malignancies including NSCLC, recurrent/advanced/metastatic ALK rearrangement‑positive tumors; inflammatory myofibroblastic tumor (IMT) with ALK translocation; brain metastases from ALK rearrangement‑positive NSCLC; and Erdheim‑Chester Disease (ECD) with ALK‑fusion.

Revision History

2025-03-07policy_reviewLatest

References and compendia citations updated (NCCN Drugs & Biologics Compendium and NCCN NSCLC Guidelines accessed March 7, 2025).

2021-10label_update

FDA package insert for Zykadia (ceritinib) cited (October 2021).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyceritinib (Zykadia) coverage

Policy CodePolicy 1668-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit ALK mutation or translocation test results to initiate prior authorization review.

SourceLink

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