Cabometyx

Cabozantinib

• Brand(s): Cabometyx
• Dosage Form/Strength: 20 mg, 40 mg, 60 mg tablet
• Updated: December 29, 2021

Initiation Criteria for Advanced Renal Cell Carcinoma:

Cabozantinib (Cabometyx) will be reimbursed as monotherapy treatment of patients with advanced renal cell carcinoma (RCC) meeting one of the following situations:

1. As monotherapy, second line therapy in a Patient with any risk category (i.e., good, intermediate or poor risk) of advanced RCC after progression on at least one prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy (e.g., Sunitinib, Pazopanib).

   If used in this second line setting, only one of cabozantinib or axitinib or nivolumab will be funded.

2. As monotherapy, third line therapy in a Patient with any risk category (i.e. good, intermediate or poor risk) of advanced RCC after progression on at least one prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy (e.g. sunitinib, pazopanib) in first line and nivolumab in second line.

3. As monotherapy, third line therapy in a Patient with intermediate or poor risk advanced RCC after progression on an ipilimumab-nivolumab combination in first line and a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy (e.g., sunitinib, pazopanib) in second line.

   If used in this third line setting, only one of cabozantinib or axitinib will be funded

Exclusion Criteria:

• Patients who have experienced progression to cabozantinib for advance RCC will not be considered for EAP reimbursement for retreatment with cabozanitinib in a subsequent line.
• Cabozantinib will not be funded in combination with another treatment for advanced RCC.
• Cabozantinib will not be funded as first line therapy.
• Cabozantinib will not be funded for patients when used as in fourth line or later therapy.¹

¹Case-by-case consideration may be provided for patients who have experienced disease progression or intolerance to everolimus or temsirolimus or sorafenib used for advanced or metastatic RCC.

Renewals will be considered until clinically meaningful disease progression or the patient has experienced unacceptable toxicity.

Recommended dose: 60 mg daily.

Requests for 20mg and 40mg tablets should include reasons why the lower dosed tablets are required.

Approval duration for initials and renewals: 1 year

Initiation Criteria for Advanced Hepatocellular Carcinoma:

For the treatment of unresectable, advanced hepatocellular carcinoma (HCC) in adult patients meeting all of the following criteria prior to starting treatment with cabozantinib:

1. Patient is 18 years of age and older; AND

2. Cabozantinib will be used as monotherapy for HCC; AND

3. Cabozantinib will be used as second line therapy in a patient who has experienced disease progression during treatment with sorafenib OR lenvatinib for HCC; AND

4. Patient has good performance status with Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to 1; AND

5. Has a Child-Pugh class A liver function.

Exclusion criteria: Patients meeting any of the following criteria will not be funded:

• Cabozantinib will not be funded in combination therapy with another therapy for HCC.
• Cabozantinib will not be funded in patients with Child-Pugh class status of B or C.
• Cabozantinib will not be funded as first-line therapy.

Notes:

1. Only one of regorafenib or cabozantinib for the treatment of unresectable HCC will be funded in the second line setting.

2. Cabozantinib can be funded in patients who develop intolerances or toxicities to regorafenib and wish to switch to cabozantinib as long as they have not experienced disease progression on regorafenib and meet the initial funding criteria for cabozantinib.

Recommended dose: 60 mg orally once daily

Requests for 20mg and 40mg tablets should include reasons why the lower dosed tablets are required.

Renewal criteria:
Renewals will be considered until clinically meaningful disease progression¹ or the patient has experienced unacceptable toxicity.

Please provide radiographic and/or scan results indicating no progression.

¹Evaluation according to Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria.

Duration of Approval for Initials and Renewals: 3 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests