ABEMACICLIB

Guidelines for Use

Our guideline named ABEMACICLIB (Verzenio) requires the following rules be met for approval:

1. You have ONE of the following diagnoses:
   1. Early breast cancer (initial stage of breast cancer)
   2. Advanced or metastatic breast cancer (cancer that has progressed or has spread to other parts of the body)
2. If you have early breast cancer, approval also requires:
   1. You are 18 years of age or older
   2. Your cancer is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive (a type of protein)
   3. Verzenio will be used in combination with endocrine therapy (tamoxifen or an aromatase inhibitor such as letrozole, anastrozole, exemestane) for adjuvant (add-on) treatment
   4. You are at high risk of recurrence (disease returning) and has a Ki-67 score of greater than or equal to 20 percent, as determined by a Food and Drug Administration (FDA)-approved test
3. If you have advanced or metastatic breast cancer, approval also requires:
   1. Your cancer is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (a type of protein)
   2. You meet ONE of the following:
      1. You are a postmenopausal female or male AND Verzenio will be used in combination with an aromatase inhibitor (such as letrozole, anastrozole, or exemestane) as initial endocrine-based therapy
      2. You are 18 years of age or older AND Verzenio will be used in combination with fulvestrant, and you have had disease progression following endocrine therapy
      3. You are 18 years of age or older AND Verzenio will be used as monotherapy (one drug) and you have had disease progression following endocrine therapy and prior chemotherapy (drugs used to treat cancer)

Rationale

Promote appropriate utilization of ABEMACICLIB (Verzenio) based on FDA approved indications and dosing.

Indications for Use

Verzenio is a kinase inhibitor indicated:

• 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 and a Ki-67 score ≥20% as determined by an FDA approved test
• In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• 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
• 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

Dosage and Administration

The recommended starting dose in combination with fulvestrant, tamoxifen, or an aromatase inhibitor is 150 mg twice daily.  The recommended starting dose as monotherapy is 200 mg twice daily.

The recommended VERZENIO dose modifications for adverse reactions are provided in the table below.

Dose Level	VERZENIO Dose in Combination with Fulvestrant or an aromatase inhibitor	VERZENIO Dose for Monotherapy
Recommended starting dose	150 mg twice daily	200 mg twice daily
First dose reduction	100 mg twice daily	150 mg twice daily
Second dose reduction	50 mg twice daily	100 mg twice daily
Third dose reduction	Not applicable	50 mg twice daily*

*If further dose reduction below 50 mg twice daily is required, discontinue the treatment.

How Supplied

Tablets: 50 mg, 100 mg, 150 mg, and 200 mg

References

Verzenio [Prescribing Information]. Indianapolis, IN. Eli Lilly and Company; October 2021.