CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cabozantinib (Cometriq) — Coverage Criteria for FDA‑approved and Compendial Oncology Indications

Defines prior authorization and coverage criteria for cabozantinib (Cometriq) for FDA-approved and compendial oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage criteria for cabozantinib (Cometriq) for FDA‑approved and specified compendial oncology indications

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization; provide RET gene rearrangement documentation for NSCLC and meet prior‑therapy and RAI criteria for certain thyroid cancers.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

FDA + compendialindications

RET requiredNSCLC documentation

NMNother uses

Coverage Criteria for cabozantinib (Cometriq)

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inv-01: FDA-Approved Indication

Covered when ALL of the following are met:

FDA-approved MTC: Treatment of progressive, metastatic medullary thyroid cancer (MTC)

Authorization of 12 months may be granted when criteria are met (see Authorization)

inv-02: Compendial: Follicular/Oncocytic/Hürthle Cell and Papillary Thyroid Carcinoma

Covered when ALL of the following are met:

Compendial differentiated thyroid cancer: Diagnosis of follicular, oncocytic (Hürthle cell), or papillary thyroid carcinoma

Authorization of 12 months may be granted when criteria are met

Not amenable to RAI: Disease is not amenable to radioactive iodine (RAI) therapy

Prior therapy: Disease has progressed after treatment with lenvatinib or sorafenib

inv-03: Compendial: NSCLC with RET gene rearrangements

Covered when ALL of the following are met:

Diagnosis: Recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) with RET gene rearrangements

RET gene rearrangement documentation must be submitted

Prior targeted therapy: Member has not experienced disease progression on therapy with a RET rearrangement-targeted regimen

Authorization of 12 months may be granted

inv-04: Reauthorization / Continued Treatment

Covered when ALL of the following are met:

No progression or unacceptable toxicity: No evidence of unacceptable toxicity or disease progression while on the current regimen

Authorization of 12 months may be granted for continued treatment

Initial Therapy Requirements

inv-14: Initial therapy for certain thyroid cancers

Initial authorization for differentiated thyroid cancers

Initial differentiated thyroid cancer: Disease not amenable to radioactive iodine (RAI) and progressed after lenvatinib or sorafenib

Authorization of 12 months may be granted

Reauthorization / Continuation Criteria

inv-15: Reauthorization

Criteria for reauthorization/continued treatment

Continued therapy: No evidence of unacceptable toxicity or disease progression while on the current regimen

Authorization of 12 months may be granted

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all approved indications; authorization of up to 12 months may be granted when criteria are met.

Authorization duration: up to 12 months may be granted for covered indications

Documentation Required

RET Rearrangement Documentation

Submit documentation of RET gene rearrangement to initiate the prior authorization review for non-small cell lung cancer (NSCLC) with RET-positive tumors.

Required at submission: laboratory/pathology report confirming RET gene rearrangement (e.g., test name, date, result)

Documentation Required

Prior Therapy Requirement for Certain Thyroid Cancers

For follicular, oncocytic/Hürthle cell, and papillary thyroid carcinoma, the disease must be not amenable to radioactive iodine (RAI) therapy and must have progressed after treatment with lenvatinib or sorafenib to meet prior authorization criteria.

Prior therapy requirement: progression following treatment with lenvatinib or sorafenib, or documented contraindication to these agents
RAI status: documentation that disease is not amenable to radioactive iodine (RAI)

Denial Risk

Unlisted Indications Not Covered

Requests for indications not listed in the policy (including uses outside the compendial/covered uses) are considered experimental/investigational and are not medically necessary.

Unlisted or off-label indications are not covered

Requirement	Details
Prior treatment	Disease has progressed after treatment with lenvatinib or sorafenib.
RAI suitability	Disease is not amenable to radioactive iodine (RAI) therapy.
Coverage label	Compendial indication: follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma (authorization of up to 12 months may be granted when criteria are met).

Definitions and Compendial Uses

Medullary thyroid carcinoma (MTC)

IndicationTreatment of progressive, metastatic medullary thyroid cancer (MTC)

StatusFDA‑approved indication for cabozantinib (Cometriq)

AuthorizationAuthorization of up to 12 months may be granted when criteria are met

Compendial uses

Compendial thyroid cancer usesFollicular, oncocytic (Hürthle cell), and papillary thyroid carcinoma

NSCLC compendial useNon‑small cell lung cancer (NSCLC) with RET gene rearrangements

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

Background

Cabozantinib (Cometriq) is a tyrosine kinase inhibitor with established indications addressed in this policy, including compendial uses for follicular, oncocytic (Hürthle cell), and papillary thyroid carcinoma and for non-small cell lung cancer with RET gene rearrangements. All other uses are treated as experimental/investigational and not medically necessary per this policy.

Revision History

2023-08-17reference_update

NCCN Drugs & Biologics Compendium accessed and cited as a reference for compendial uses.

2020-10reference_updateLatest

Cometriq (cabozantinib) package insert (Exelixis, Inc.) added as a reference.

policy_note

Policy lists FDA-approved and compendial indications with authorization durations and documentation requirements; effective/review dates not specified in document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage criteria for cabozantinib (Cometriq) for FDA‑approved and specified compendial oncology indications

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization; provide RET gene rearrangement documentation for NSCLC and meet prior‑therapy and RAI criteria for certain thyroid cancers.

SourceLink

On This Page

OpenPayer

Cabozantinib (Cometriq) — Coverage Criteria for FDA‑approved and Compendial Oncology Indications

Coverage Criteria for cabozantinib (Cometriq)

Initial Therapy Requirements

Reauthorization / Continuation Criteria

Provider Actions and Documentation Requirements

Step Therapy Requirements

Definitions and Compendial Uses

Background

Revision History