CurrentNeighborhood Health Plan of Rhode IslandPolicy 1668-A

Ceritinib (Zykadia) — Coverage Criteria and Prior Authorization

This policy governs prior authorization and coverage criteria for ceritinib (Zykadia) for Neighborhood Health Plan of Rhode Island members, covering FDA-approved and compendial oncologic indications when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCeritinib (Zykadia) — Coverage Criteria and Prior Authorization

Policy CodePolicy 1668-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit ALK mutation or translocation status to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

ALK-positivebiomarker required

FDA + compendiacovered indications

NCCNcompendia cited

Coverage Criteria for ceritinib (Zykadia)

NSCLC coverage: Member has recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test

Includes brain metastases from ALK rearrangement-positive NSCLC

Authorization period: Authorization of 12 months may be granted12 months

Reauthorization may be granted when no evidence of unacceptable toxicity or disease progression

Anaplastic Large Cell Lymphoma (ALCL)

Covered when ALL of the following are met:

ALCL coverage: Member has relapsed/refractory or requires initial palliative therapy for ALK-positive anaplastic large cell lymphoma (ALCL)

Authorization of 12 months may be granted as a single agent

Inflammatory Myofibroblastic Tumor (IMT)

Covered when ANY of the following are met:

IMT coverage: Member has ALK-positive inflammatory myofibroblastic tumor (IMT) and either (1) uterine sarcoma that is advanced, recurrent, metastatic, or inoperable, or (2) a soft tissue sarcoma (not including uterine sarcoma)

Authorization of 12 months may be granted

Erdheim-Chester Disease (ECD)

Covered when ALL of the following are met:

ECD coverage: Member has symptomatic or relapsed/refractory ALK-positive Erdheim-Chester Disease (ECD)

Authorization of 12 months may be granted as a single agent

All indications not explicitly listed in the FDA-approved indications or the compendia-supported uses are considered experimental/investigational and not medically necessary. Coverage is limited to the specific tumor types and scenarios described in this policy; requests for ceritinib (Zykadia) for other diagnoses or uses will be denied as not medically necessary.

Uses of ceritinib (Zykadia) that fall outside the listed FDA-approved indications and the compendial (NCCN-supported) uses in this policy are considered not medically necessary because they are experimental or investigational. Providers should document that the requested use matches an approved or compendia-supported indication to support coverage.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Reauthorization

Authorization of 12 months may be granted for listed indications when approval criteria are met.

Prior authorization may be granted for 12 months for approved indications.
Reauthorization may be granted for 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Documentation Required

Required Documentation

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

Denial Risk

Provider Notice — Experimental/Not Medically Necessary

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

Note

Provider Action

Definitions

inv-13: ALK-positive — Tumors with anaplastic lymphoma kinase (ALK) rearrangement or translocation as detected by an FDA-approved test or as documented in compendia.

DefinitionTumors with anaplastic lymphoma kinase (ALK) rearrangement or translocation as detected by an FDA-approved test or as documented in compendia-supported indications

Detection methodsALK-positivity may be established by an FDA-approved diagnostic test (for NSCLC) or by documentation of ALK translocation/fusion in compendial sources for other tumor types (e.g., IMT, ECD)

Related coverage noteBrain metastases from ALK rearrangement–positive NSCLC are included under ALK-positive indications

Biomarker Requirements

inv-15: ALK (anaplastic lymphoma kinase) — as detected by an FDA-approved test or documented ALK translocation/status

BiomarkerALK (anaplastic lymphoma kinase)

Requirement for coverageAs detected by an FDA-approved test (for NSCLC) or documented ALK translocation/status in supporting compendia for listed indications

When requiredSubmission of ALK mutation or translocation status is necessary to initiate prior authorization review

ScopeRequired for NSCLC and other ALK-positive listed indications (e.g., ALCL, IMT, ECD)

Line of Therapy / Treatment Setting

salvage

line of therapy notes: May be used for relapsed/refractory disease and for initial palliative therapy in ALCL

Authorization decisions may grant up to 12 months; documented ALK-positivity required

Background

Ceritinib (Zykadia) is an anaplastic lymphoma kinase (ALK) inhibitor used to treat ALK-positive malignancies. Coverage under this policy follows FDA approvals and compendia-supported indications for ALK-rearranged tumors, including metastatic non-small cell lung cancer (NSCLC) and certain rare tumor types such as inflammatory myofibroblastic tumor (IMT) and Erdheim-Chester Disease (ECD). Authorization may be considered when the member’s disease is documented as ALK-positive and the indication matches the FDA or compendial uses listed in this policy.