Verzenio - NC Standard

Restricted Product(s)

• Verzenio® (abemaciclib)

FDA Approved Use

• For use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. 
• For use in combination with an aromatase inhibitor as initial endocrine based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. 
• For use in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. 
• For as monotherapy for the treatment of adult patients with (HR)-positive, (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. The patient has a confirmed diagnosis of advanced or metastatic breast cancer; AND 
   1. The patient has hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative breast cancer; AND 
      1. The patient is taking requested agent in combination with an aromatase inhibitor (letrozole or anastrozole) as initial endocrine based therapy; OR 
      2. The patient is taking requested agent in combination with fulvestrant after having disease progression following endocrine therapy; OR 
      3. The patient is taking requested agent as monotherapy after having disease progression following endocrine therapy and prior chemotherapy in the metastatic setting; OR 
4. The patient has a confirmed diagnosis of node-positive early breast cancer at high risk of recurrence; AND 
   1. The patient has hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative breast cancer; AND 
   2. The patient is taking requested agent in combination with endocrine therapy (tamoxifen or an aromatase inhibitor); AND 
5. If the patient is pre/perimenopausal taking requested agent in combination with an aromatase inhibitor or fulvestrant, they will also be treated with a gonadotropin-releasing hormone agonist (GnRH) according to current clinical practice standards; AND 
6. 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 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

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)

References

All information referenced is from FDA package insert unless otherwise noted below

Policy Implementation/Update Information

January 2024: Criteria change: Removed specialist requirement and medical record documentation. Updated language of requirement to use luteinizing hormone releasing hormone agonist to gonadotropin-releasing hormone agonist (GnRH) as stated in package insert.

July 2023: Criteria change: Addition of expanded/broadened indication for early breast cancer to remove the requirement of Ki-67 score. Added duration of approval to quantity limit exception criteria.

Oct 2021: Criteria update: Addition of expanded indication for early breast cancer.

Sept 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).

Mar 2018: Updated criteria in accord with FDA expanded indication for use with aromatase inhibitors as initial endocrine based therapy; Verbiage for “estrogen receptor positive” expanded to “hormone receptor positive.”

Oct 2017: Original utilization management policy issued