Pharmacy Prior Authorization Criteria

Cabometyx (cabozantinib)

Indications for Prior Authorization

Cabometyx (cabozantinib) tablets

• For diagnosis of Renal cell carcinoma (RCC)
  Indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

• For diagnosis of Renal cell carcinoma (RCC)
  Indicated, in combination with nivolumab, for the first-line treatment of patients with advanced RCC.

• For diagnosis of Hepatocellular Carcinoma (HCC)
  Indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

• For diagnosis of Differentiated Thyroid Cancer
  Indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.

Criteria

Cabometyx

If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Renal Cell Carcinoma (RCC)

• Diagnosis of renal cell carcinoma (RCC)

Cabometyx

*Criterion is part of the FDA-approved label. If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hepatocellular Carcinoma (HCC)

• Diagnosis of hepatocellular carcinoma (HCC)
AND
• Trial and failure, contraindication, or intolerance to Nexavar (sorafenib tosylate)*

Cabometyx

*Criterion is part of the FDA-approved label. If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Differentiated Thyroid Cancer (DTC)

• Diagnosis of differentiated thyroid cancer (DTC) [A, 5]
AND
• Patient is 12 years of age or older
AND
• Disease has progressed following prior VEGFR-targeted therapy (e.g., Lenvima [lenvatinib], Nexavar [sorafenib])*
AND
• Disease or patient is refractory to radioactive iodine treatment or ineligible

Cabometyx

If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications Listed Above

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-09-12, 2024-03-22, 2023-07-05, 2023-05-03, 2022-03-03, 2021-11-02, 2021-09-27, 2021-05-20, 2021-04-08, 2021-02-19, 2020-02-13

References

1. Cabometyx Prescribing Information. Exelixis, Inc. Alameda, CA. September 2023.
2. The NCCN Drugs and Biologics Compendium (NCCN Compendium™). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed February 6, 2024.
3. Patel K, Yip L, Lubitz C et al. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Thyroid Disease in Adults. Ann Surg. 2020;271(3):e21-e93.

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End Notes

1. Differentiated thyroid carcinomas are broadly categorized as papillary thyroid carcinoma (PTC), follicular cancer (FTC), and Hurthle cell carcinoma (HCTC). [3]

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Revision History

• 2024-09-12: No changes to criteria. Added operational note.
• 2024-03-22: 2024 annual review: no criteria changes.
• 2023-07-05: Updated criteria and removed specialist requirement
• 2023-05-03: Annual review: Updated HCC criteria to remove NCCN criteria, updated DTC criteria to include age requirement, updated operational notes for HCC and DTC indications, updated references.
• 2022-03-03: Annual review: updated criteria
• 2021-11-02: Program update to add criteria for new indication of differentiated thyroid cancer.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-08: GPI replication. No change to clinical criteria.
• 2021-02-19: 2021 UM Annual Review.
• 2020-02-13: 2020 UM Annual Review. For Renal Cell Carcinoma criteria, added nephrologist to the existing prescriber requirement. No changes to rest of guideline. Updated indications and references.

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