CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ceritinib (Zykadia) — Coverage Criteria for ALK- and ROS1-positive Tumors

Covers prior authorization and medical necessity criteria for ceritinib (Zykadia) in adults with ALK- or ROS1-positive non-small cell lung cancer and certain other ALK-fusion malignancies; applies to members of Neighborhood Health Plan of Rhode Island per the document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCeritinib (Zykadia) — Coverage Criteria for ALK- and ROS1-positive Tumors

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization including ALK or ROS1 mutation/translocation status; requests are generally authorized for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

ALK+ NSCLCprimary FDA indication

Compendial uses listedadditional covered indications

ALK/ROS1 requiredprior auth documentation

Coverage and Medical Necessity Criteria

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inv-01: NSCLC (initial)

Covered when ALL of the following are met for NSCLC:

NSCLC initial therapy: Member is an adult with recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) with ALK-positive or ROS1-positive tumor as applicable

Includes brain metastases for ALK-positive NSCLC

Documentation of ALK rearrangement/translocation status or ROS1 mutation/rearrangement status is provided (detected by an FDA-approved test or per compendial evidence)

See documentation requirements for required molecular testing

inv-02: Inflammatory Myofibroblastic Tumor (IMT)

Covered when ALL of the following are met for IMT:

IMT eligibility: Member has ALK-positive inflammatory myofibroblastic tumor (IMT) of soft tissue (non-uterine) OR uterine sarcoma that is advanced, recurrent, metastatic, or inoperable

Authorization of 12 months may be granted

inv-03: Erdheim-Chester Disease (ECD)

Covered when ALL of the following are met for ECD:

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

Authorization of 12 months may be granted

All indications for ceritinib (Zykadia) that are not specifically listed as FDA-approved or compendial uses in this policy are considered experimental/investigational and are not medically necessary. Requests for ceritinib for diagnoses outside the enumerated covered indications may be denied on that basis.

Use of ceritinib for indications other than the FDA-approved indication and the compendial uses listed in this policy is not medically necessary. Prior authorization submissions for such off‑label uses do not meet coverage criteria and are subject to denial.

Provider Requirements and Authorization Actions

Prior Authorization

Prior authorization required; typical 12-month approval

Prior authorization is required for ceritinib. When the member meets the specific indication criteria and there is no unacceptable toxicity (or no progression for reauthorization), initial and reauthorization requests are generally authorized for 12 months.

Step Therapy

No step therapy required

No step therapy sequencing requirements are specified in this policy.

Documentation Required

Document ALK or ROS1 molecular status with PA

Prior authorization submissions must include documentation of ALK mutation or translocation status, or ROS1 mutation status where applicable.

Denial Risk

Non‑listed indications are experimental/investigational

Use of ceritinib for indications other than the FDA-approved indication and listed compendial uses is considered experimental/investigational and not medically necessary; such uses may be denied.

Background

Ceritinib (Zykadia) is an oral anaplastic lymphoma kinase (ALK) inhibitor with labeled and compendial activity in ALK‑driven malignancies. The policy’s compendial uses include treatment of recurrent, advanced, or metastatic non‑small cell lung cancer (NSCLC) with ALK or ROS1 rearrangements, ALK‑translocated inflammatory myofibroblastic tumor (IMT), brain metastases from ALK‑positive NSCLC, and Erdheim‑Chester Disease (ECD) with ALK‑fusion. Authorization decisions require that the member’s tumor demonstrates the relevant molecular alteration per the documented indications.

Key Definitions

ALK-positive

DefinitionTumors with anaplastic lymphoma kinase (ALK) rearrangement or translocation as detected by an FDA-approved test.

Alternative evidenceALK rearrangement/translocation may also be documented by accepted compendial sources for covered compendial uses (e.g., IMT, ECD, brain metastases).

Applicable indicationsRelevant for metastatic NSCLC (FDA-approved) and compendial uses including IMT, brain metastases, and ECD with ALK fusion.

ROS1-positive

DefinitionTumors with ROS1 rearrangement (ROS1-positive) documented for consideration of ceritinib therapy.

Documentation requiredPrior authorization submission must include ROS-1 mutation or rearrangement status where applicable.

Covered indicationROS1-positive recurrent, advanced, or metastatic NSCLC is listed as a compendial use and may be covered when documentation is provided.

Line of Therapy / Treatment Setting

inv-15: Salvage — line-of-therapy criteria

Line of therapy: Documented recurrent, advanced, or metastatic disease; specific line of systemic therapy is not specified in the document (salvage setting)

Authorization guidance: initial and reauthorization requests are generally authorized for 12 months when criteria met

Biomarker and Diagnostic Requirements

ALK rearrangement/translocation

Detection methodDetected by an FDA-approved test (per FDA labeling) for ALK-positive tumors.

Compendial documentationALK rearrangement/translocation may be documented per accepted compendia for non‑FDA but compendial covered uses (e.g., IMT, ECD, brain metastases).

Authorization noteDocumentation of ALK rearrangement/translocation status is required for prior authorization review.

ROS1 rearrangement

Documentation requirementPrior authorization submission must include ROS-1 mutation or rearrangement status when ROS1-positive disease is the indication.

Covered settingROS1 rearrangement is required for coverage of ROS1-positive recurrent, advanced, or metastatic NSCLC listed as a compendial use.

ReferenceROS1-positive NSCLC is listed among compendial uses; documentation supports authorization decisions.