CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cabozantinib (Cometriq) — Coverage Criteria

Policy governs coverage criteria for cabozantinib (Cometriq) for FDA-approved and compendial indications including medullary thyroid carcinoma, certain differentiated thyroid carcinomas, and RET-rearranged non-small cell lung cancer for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCabozantinib (Cometriq) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of RET gene rearrangement for NSCLC and meet prior‑therapy requirements for differentiated thyroid cancers.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

3primary indication groups

RETbiomarker required (NSCLC)

2023compendia ref year

Coverage Criteria for Cabozantinib (Cometriq)

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inv-01: Covered Indications and Criteria

Covered when ALL of the following are met for each indication group as specified below:

Medullary Thyroid Carcinoma (MTC): Treatment of progressive, metastatic medullary thyroid cancer (MTC). Authorization of 12 months may be granted.

FDA-approved indication.

Differentiated Thyroid Carcinoma (follicular, oncocytic/Hurthle cell, papillary): Disease not amenable to radioactive iodine (RAI) therapy AND disease has progressed after treatment with lenvatinib or sorafenib. Authorization of 12 months may be granted.

Compendial uses; prior therapies required.

Non‑small cell lung cancer (NSCLC) with RET gene rearrangements: Recurrent, advanced, or metastatic NSCLC with documented RET gene rearrangement AND member has not experienced disease progression on therapy with a RET rearrangement–positive targeted regimen. Authorization of 12 months may be granted.

Compendial use; biomarker required.

inv-02: Reauthorization

Reauthorization conditions:

Reauthorization: Continued treatment may be authorized for 12 months if there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Applies to indications listed in covered indications.

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for all indications listed in this policy. Authorization may be granted for up to 12 months when the applicable approval criteria are met.

Authorization duration: up to 12 months when approval criteria are met

Documentation Required

RET Rearrangement Documentation Required

For non‑small cell lung cancer (NSCLC) with RET gene rearrangements, submission of documentation confirming the RET gene rearrangement is required to initiate prior authorization review.

RET rearrangement documentation must be provided with the prior authorization request

Prior Authorization

Required Prior Therapies for Differentiated Thyroid Carcinoma

For follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma, authorization of up to 12 months may be granted when all of the following are met: the disease is not amenable to radioactive iodine (RAI) therapy and the disease has progressed after treatment with lenvatinib or sorafenib.

Required prior therapies: lenvatinib or sorafenib
RAI ineligibility must be documented

Denial Risk

Not Approved Indications

Use of the medication for indications other than the listed FDA‑approved and compendial uses (treatment of progressive, metastatic medullary thyroid cancer; NSCLC with RET gene rearrangements; follicular, oncocytic/Hürthle cell, and papillary thyroid carcinoma, and other compendial uses) is considered experimental/investigational and therefore not medically necessary.

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

Drug	Regimen / Indication	Coverage status
Cometriq (cabozantinib)	Continued treatment for an approved indication when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.	Covered

Line of Therapy Specifications

inv-11: after prior targeted therapy

After prior targeted therapy: Authorization of 12 months may be granted as a single agent for treatment of recurrent, advanced, or metastatic NSCLC with RET gene rearrangements when the member has not experienced disease progression on therapy with a RET rearrangement–positive targeted regimen.

Biomarker (documented RET gene rearrangement) and lack of progression on RET‑targeted therapy required.

inv-12: first-line

First‑line: Treatment for progressive, metastatic medullary thyroid carcinoma (MTC).

FDA‑approved first‑line indication; authorization of 12 months may be granted.

Biomarker Requirements for Use

RET gene rearrangement — biomarker requirement (NSCLC)

Biomarker requiredDocumentation of a RET gene rearrangement is required to support cabozantinib use for NSCLC; submission of this documentation is necessary to initiate prior authorization review.

Clinical contextApplies to recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) with RET gene rearrangements.

Authorization implicationPrior authorization for this indication requires RET rearrangement documentation and may be granted for up to 12 months when criteria are met and there is no disease progression.

Treatment constraintMember must not have experienced disease progression on a RET rearrangement–positive targeted regimen prior to cabozantinib authorization.

Definitions

RET gene rearrangement — definition for NSCLC indication

DefinitionRET gene rearrangement — a genetic alteration (RET gene rearrangement) required to support use of cabozantinib for non-small cell lung cancer in this policy.

Policy applicationRequired for the compendial NSCLC indication; presence of a RET gene rearrangement must be documented for prior authorization consideration.

Related coverage noteNSCLC with RET gene rearrangements is listed as a compendial use; all other non-listed indications are considered experimental/investigational and not medically necessary.

Documentation stepSubmission of RET gene rearrangement documentation is necessary to initiate prior authorization review for NSCLC.

Background

Cabozantinib (Cometriq) is indicated for progressive, metastatic medullary thyroid cancer and is also used in compendial settings for certain thyroid carcinomas (follicular, oncocytic/Hurthle cell, and papillary) and for non‑small cell lung cancer with RET gene rearrangements. All other indications are considered experimental/investigational and not medically necessary.