CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cabometyx (cabozantinib) — coverage criteria for oncology indications

Criteria and prior authorization requirements for coverage of cabozantinib (Cabometyx) across FDA-approved and compendial oncology indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCabometyx (cabozantinib) — coverage criteria for oncology indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation (including RET gene rearrangement when applicable); prior authorization of up to 12 months may be granted when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration (typical)

FDA + compendialcovered indications

>=4GIST prior therapies required

12 yrsmin age (thyroid indication)

Coverage Criteria for Cabometyx (cabozantinib)

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FDA‑Approved Indication — Thyroid Carcinoma

Covered FDA‑approved indications — Authorization may be granted when ALL approval criteria are met and no exclusions to therapy exist.

{

"operator":"all",

"children":[

{

"text":"Member has locally advanced or metastatic differentiated thyroid carcinoma (including follicular, oncocytic/Hurthle cell, or papillary histologies)",

"operator":"","children":null

{

"text":"Disease has progressed following prior VEGFR‑targeted therapy (e.g., lenvatinib or sorafenib)",

"operator":"","children":null

{

"text":"Disease is radioactive iodine (RAI)‑refractory or the member is ineligible for RAI therapy",

"operator":"","children":null

"note":"Examples of RAI ineligibility include absence of sufficient iodine uptake or prior maximal cumulative RAI dose with lack of response."

{

"text":"Member is at least 12 years of age",

"operator":"","children":null

{

"text":"Therapy is requested as subsequent‑line single‑agent treatment after progression on prior VEGFR‑targeted therapy",

"operator":"","children":null

"note":"Authorization duration: up to 12 months for single‑agent subsequent therapy; renewal requires documentation of clinical benefit or lack of unacceptable toxicity."

}

"label":"Thyroid carcinoma — subsequent therapy criteria"

}

Compendial Indications — GIST (subsequent therapy)

Compendial / subsequent‑line indications — Authorization may be granted when documentation and criteria are met.

{

"operator":"all",

"children":[

{

"text":"Member has histologically or cytologically confirmed gastrointestinal stromal tumor (GIST) with disease progression or intolerance to standard therapies",

"operator":"","children":null

{

"operator":"any",

"label":"ONE of the following must be met:",

"children":[

{

"text":"Member has received and progressed on or is intolerant to approved first‑line and subsequent standard GIST therapies (e.g., imatinib, sunitinib, regorafenib)",

"operator":"","children":null

{

"text":"There is clinical rationale documented by the treating clinician for use of cabozantinib as subsequent therapy in the setting of limited options or molecular profile supporting benefit",

"operator":"","children":null

}

]

{

"text":"Authorization duration: up to 12 months for subsequent‑line single‑agent therapy; renewal requires documentation of clinical benefit or lack of unacceptable toxicity.",

"operator":"","children":null

"note":"This criteria group covers GIST as a compendial/subsequent‑line indication."

}

"label":"GIST — subsequent therapy criteria"

}

Line of Therapy Specifications

first-line | second-line | salvage

Specify initial vs subsequent/salvage therapy rules:

Line of therapy entries: First-line: advanced renal cell carcinoma in combination with nivolumab. Subsequent-line/salvage: single-agent use in hepatocellular carcinoma after sorafenib, relapsed or stage IV renal cell carcinoma, non-small cell lung cancer with RET rearrangement, sarcomas (Ewing, osteosarcoma), GIST, and recurrent endometrial carcinoma as listed.

Document lists both first-line and subsequent-line settings

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior authorization required; up to 12-month authorization when criteria met

Prior authorization is required for Cabometyx; when approval criteria are met for a listed indication, authorization of up to 12 months may be granted.

Step Therapy

GIST: failure of ≥4 FDA‑approved therapies required

For GIST, the member must have failed at least four FDA‑approved therapies before Cabometyx will be authorized; examples provided include imatinib, sunitinib, regorafenib, and ripretinib.

Member has failed ≥ 4 FDA‑approved therapies (examples: imatinib, sunitinib, regorafenib, ripretinib)
Medication will be used as a single agent (per GIST criteria)

Documentation Required

Provide RET gene rearrangement documentation to initiate review

Submission of documentation confirming RET gene rearrangement is required to initiate prior authorization review for the non‑small cell lung cancer indication.

Provide documentation verifying RET gene rearrangement to start PA review for NSCLC with RET rearrangement

Denial Risk

Non‑covered indications — requests will be denied

Requests for Cabometyx for indications not listed in the policy are considered experimental/investigational and not medically necessary; such requests will be denied.

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

Coding and Related Numeric Requirements

GIST — Prior therapies threshold

Required number of prior FDA‑approved GIST therapiesMember must have failed at least four FDA‑approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib)

Examples of therapies countedImatinib; sunitinib; regorafenib; ripretinib

Use settingRequirement applies for authorization of Cabometyx for GIST when used as single‑agent subsequent therapy

Biomarker and Genetic Testing Requirements

RET gene rearrangement — biomarker summary

Biomarker requiredRET gene rearrangement must be documented for non‑small cell lung cancer indication

Documentation requirementSubmission of RET gene rearrangement documentation is necessary to initiate prior authorization review

Authorization detailsAuthorization of up to 12 months may be granted for RET‑rearranged NSCLC when criteria are met (single‑agent use)

Covered Regimens and Dosing Configurations

Regimen component	Dose / Administration (documented in source)	Clinical notes / Authorization details	Coverage status
Cabometyx (cabozantinib) — single agent
Refer to prescribing information for dosing — used as single agent for advanced/relapsed/stage IV RCC
Authorization of 12 months may be granted for treatment of advanced, relapsed, or stage IV renal cell carcinoma (including brain metastases)
Covered

Regimen component	Dose / Administration (documented in source)	Clinical notes / Authorization details	Coverage status
Cabometyx (cabozantinib) — single agent
Refer to prescribing information for dosing — used after progression on VEGFR-targeted therapy for differentiated thyroid carcinoma
Authorization of 12 months may be granted when disease has progressed after VEGFR-targeted therapy, patient is ≥12 years, and disease is not amenable to radioactive iodine
Covered

Continuation / Reauthorization Criteria

Continuation of therapy

Continuation/Reauthorization criteria

Reauthorization: Continuation may be authorized for up to 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen for an indication listed in the policy.

From continuation of therapy section

Definitions and Compendial Use

Compendial use — supported indications

Definition of compendial useUses supported by recognized compendia (e.g., NCCN) that are considered covered when approval criteria are met

Examples of compendial indicationsNSCLC with RET rearrangement; relapsed or stage IV RCC; HCC as subsequent treatment; osteosarcoma; Ewing sarcoma; GIST; endometrial carcinoma

Coverage linkageCompendial uses are covered only when documentation and indication‑specific criteria are met

Background

Cabozantinib (Cabometyx) has recognized uses across multiple solid tumor types, including compendial support for indications such as non-small cell lung cancer with RET rearrangement, relapsed or stage IV renal cell carcinoma, hepatocellular carcinoma as subsequent treatment, osteosarcoma, Ewing sarcoma, gastrointestinal stromal tumor (GIST), and endometrial carcinoma. Coverage under this policy is limited to the FDA-approved indications and the compendial uses listed; all other uses are considered investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCabometyx (cabozantinib) — coverage criteria for oncology indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation (including RET gene rearrangement when applicable); prior authorization of up to 12 months may be granted when criteria are met.

SourceLink

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