Cabometyx - NC Standard

• Cabometyx® (cabozantinib)

• For the treatment of patients with advanced renal cell carcinoma (RCC) 
• For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 
• For the treatment of advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. 
• For the treatment of adults and pediatric patients 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. 

1. The patient is currently taking the requested medication for a cancer diagnosis; AND

a. The patient will utilize the generic formulation of this product (if available); OR

2. The patient is being managed by or in consultation with an oncologist; AND

3. ONE of the following:

a. The patient has been diagnosed with advanced renal cell carcinoma (medical record documentation required); AND

i. The patient is 18 years of age or older; AND

ii. iii. The patient has received at least one prior anti-angiogenic therapy; OR The patient has not received prior therapy; AND

1. The patient will take the requested agent in combination with nivolumab (Opdivo®); OR 

b. The patient has been diagnosed with hepatocellular carcinoma (medical record documentation required); AND

i. The patient is 18 years of age or older; AND

ii. The patient has previously been treated with sorafenib (Nexavar®); OR

c. The patient has been diagnosed with locally advanced or metastatic differentiated thyroid cancer (medical record documentation required); AND

i. The patient is 12 years of age or older; AND

ii. The patient’s disease has progressed following VEGFR-targeted therapy; AND

iii. The patient’s disease is refractive to radioactive iodine; OR

1. The patient is radioactive iodine ineligible; AND

4. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND

5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:  365 days (1 year) 

 quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND

2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND

3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR

4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:  365 days (1 year) 

all information referenced is from FDA package insert unless otherwise noted below. 

August 2022: Criteria change: Added medical record documentation required for diagnosis.  September 2021: Criteria update: Addition of new indication for differentiated thyroid cancer. February 2021: Criteria update: Addition of new indication: first line treatment of renal cell carcinoma.

July 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and using generic (if available).

Mar 2019:  Updated policy with expanded indication of hepatocellular carcinoma

Feb 2018: Revoked trial of prior antiangiogenic therapy in accord with FDA expanded indication; added prescriber requirement; added nonFDA approved indication criteria.

May 2016: Original utilization management criteria issued