CurrentNeighborhood Health Plan of Rhode IslandPolicy 2212-A

Cabometyx

Defines covered FDA-approved and compendial indications for cabozantinib (Cabometyx), documentation requirements, and authorization durations (typically 12 months) when approval criteria are met and no therapy exclusions exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCabometyx

Policy CodePolicy 2212-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required; submit RET gene rearrangement documentation to initiate review for NSCLC with RET rearrangement.

SourceLink

POLICY UPDATE CHANGES

No material changes — has_material_change=false.

7FDA-approved indications listed

9Compendial uses listed

12Typical authorization duration (months)

Coverage Summary & Covered Indications

Cabometyx (cabozantinib) is an anti-cancer agent with multiple FDA-approved and compendial indications. Coverage is provided when indication-specific criteria and documentation requirements are met. The policy defines covered FDA-approved and compendial indications for cabozantinib (Cabometyx), documentation requirements, and authorization durations (typically 12 months) when approval criteria are met and no therapy exclusions exist.

Covered Indications and Authorization

Cabometyx is considered a covered benefit for the indications below when all listed approval criteria are met and the member has no exclusions to the prescribed therapy.

Covered FDA-approved indications (any one)

Advanced renal cell carcinoma (RCC)
Advanced renal cell carcinoma (RCC), as a first-line treatment in combination with nivolumab
Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligibleadult and pediatric patients >= 12 years
Previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET)adult and pediatric patients >= 12 years
Previously treated, unresectable, locally advanced or metastatic, well-differentiated extrapancreatic neuroendocrine tumors (epNET)adult and pediatric patients >= 12 years

Compendial uses (any one)

Relapsed or stage IV renal cell carcinoma
Non-small cell lung cancer with RET gene rearrangement
Hepatocellular carcinoma as subsequent treatment
Ewing Sarcoma
Osteosarcoma
Gastrointestinal Stromal Tumor (GIST)
Endometrial carcinoma

General requirement for coverage (all)

Member has no exclusions to the prescribed therapy
All indication-specific criteria below are met

Documentation requirement for NSCLC with RET rearrangement (all)

Submission of RET gene rearrangement documentation is necessary to initiate the prior authorization review for the indication of non-small cell lung cancer
Requested use is for recurrent, advanced, or metastatic non-small cell lung cancer following progression on first-line pralsetinib (Gavreto) or selpercatinib (Retevmo)

GIST specific criteria (all)

Member has residual, unresectable, tumor rupture, or recurrent/metastatic disease
Member has failed at least four FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib)Failed at least 4 therapies
The requested medication will be used as a single agent

Thyroid carcinoma specific criteria (all)

Member has locally advanced or metastatic disease
Disease has progressed after VEGFR-targeted therapy (e.g., lenvatinib and sorafenib)
Disease is not amenable to radioactive iodine therapy (RAI)
Member is at least 12 years old>= 12 years

Authorization duration rules (any one applies)

Authorization of 12 months may be granted for treatment of advanced, relapsed, or stage IV renal cell carcinoma (including brain metastases) when used as a single agent or in combination with nivolumab12 months
Authorization of 12 months may be granted as a single agent for subsequent treatment of hepatocellular carcinoma12 months
Authorization of 12 months may be granted as a single agent for treatment of recurrent, advanced, or metastatic non-small cell lung cancer with RET gene rearrangement following progression on first-line pralsetinib or selpercatinib12 months
Authorization of 12 months may be granted for treatment of Ewing sarcoma as a single agent for subsequent therapy12 months

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

Prior Authorization, Documentation, and Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization is required to initiate coverage for cabozantinib. For non-small cell lung cancer with RET gene rearrangement, submission of documentation confirming the RET gene rearrangement is necessary to begin the prior authorization review.

Affected indication: non-small cell lung cancer with RET gene rearrangement

Documentation Required

Document prior VEGFR-targeted therapy for DTC

For locally advanced or metastatic differentiated thyroid cancer (DTC), document that disease has progressed after prior VEGFR-targeted therapy and that the disease is not amenable to radioactive iodine (RAI) therapy. Ensure the member is at least 12 years of age.

Threshold: member must be >= 12 years old

Documentation Required

Document prior therapies for GIST

For gastrointestinal stromal tumor (GIST), document that the member has residual, unresectable, tumor rupture, or recurrent/metastatic disease and that they have failed at least four FDA-approved therapies prior to use of cabozantinib.

Examples of prior FDA-approved therapies: imatinib; sunitinib; regorafenib; ripretinib

Prior Authorization

Authorization duration

When approved, authorization is typically granted for up to 12 months. Reauthorization (continued treatment) may be granted for up to 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen. Many listed indications have 12-month authorization per the criteria group.

Many listed indications (e.g., RCC, HCC, NSCLC with RET rearrangement, GIST, thyroid carcinoma, sarcomas, neuroendocrine tumors) have 12-month authorization described in the criteria

Denial Risk

Experimental/Investigational exclusion

Requests for uses not listed among the FDA-approved indications or compendial uses will be considered experimental or investigational and are not medically necessary, which may result in denial of the request.

Background

Cabometyx (cabozantinib) is an anti-cancer agent with multiple FDA-approved and compendial indications. Coverage is provided when indication-specific criteria and documentation requirements are met.

FDA-approved indications include: advanced renal cell carcinoma (including first-line in combination with nivolumab); hepatocellular carcinoma previously treated with sorafenib; locally advanced or metastatic differentiated thyroid cancer (progressed after prior VEGFR-targeted therapy and radioactive iodine-refractory or ineligible) and certain pediatric indications (patients 12 years of age and older for DTC, pNET, and epNET); previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic and extrapancreatic neuroendocrine tumors.

Compendial uses include: relapsed or stage IV renal cell carcinoma; non-small cell lung cancer with RET gene rearrangement; hepatocellular carcinoma as subsequent treatment; Ewing sarcoma; osteosarcoma; gastrointestinal stromal tumor (GIST); endometrial carcinoma; soft tissue sarcoma; and neuroendocrine and adrenal gland tumors.

Documentation and prior authorization requirements include submission of RET gene rearrangement documentation for NSCLC with RET rearrangement. Authorization of 12 months may be granted for many indications when specific criteria are met and there is no evidence of unacceptable toxicity or disease progression. All other indications not listed are considered experimental/investigational and not medically necessary.

Key Thresholds

Age threshold for certain indications>= 12 years for DTC, pNET, and epNET

GIST prior therapy requirementFailed at least 4 FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib)

OpenPayer

Cabometyx

Coverage Summary & Covered Indications

Prior Authorization, Documentation, and Authorization Rules

Referenced Product / Codes

Evidence and References

Background

Revision History