Verzenio

Abemaciclib

• Brand(s): Verzenio
• Dosage Form/Strength: 50 mg, 100 mg, 150 mg tablet
• Effective date: October 16, 2023

Initiation Criteria:

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 disease recurrence meeting ALL of the following criteria:

1. Patient is 18 years of age or older;
   AND
2. Has documented HR-positive and HER2-negative breast cancer (Note 1);
   AND
3. Has resected invasive early breast cancer without metastases;
   AND
4. Has a documented Ki-67 immunohistochemistry (IHC) test with an index score of at least 20% or higher;
   AND
5. Patient’s breast cancer meets one of the following pathological features;
   a. Pathological tumour involvement in at least 4 ipsilateral axillary lymph nodes;
   OR
   b. Pathological tumour involvement in 1 to 3 ipsilateral axillary lymph node(s) AND patient has a primary tumour at least 5 cm in size or larger or has histologic grade 3 disease OR has both (Note 2 and 3);
   AND
6. Abemaciclib is being used in combination with an endocrine therapy (e.g., tamoxifen, anastrozole, letrozole, exemestane);
   AND
7. Abemaciclib is initiated within 16 months following completion of definitive surgery of primary breast tumour.

Exclusion criteria:

• Patients are not eligible for funding of adjuvant abemaciclib if they have inflammatory breast cancer.
• Patients are not eligible for funding of adjuvant abemaciclib if they have metastatic breast cancer.
• Patients are not eligible for funding of adjuvant abemaciclib if they have received prior treatment with a CDK 4/6 inhibitor (e.g., palbociclib, ribociclib).
• Monotherapy with adjuvant abemaciclib will not be funded.

Notes:

1. Include the following reports with your request application as objective confirmation: HER2 status, hormone receptor status (i.e. estrogen and progesterone receptor status), pathology reports associated with axillary nodal involvement and size of tumours, and the Ki-67 IHC test report.
2. For patients who received neoadjuvant therapy, primary tumour size greater than 5 cm on breast imaging is allowed. If tumour size is needed to meet eligibility criteria, patients with multifocal/multicentric tumours may be eligible based on the addition of diameters of the individual lesions on a case-by-case basis.
3. Histologic grade 3 disease as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system, also known as the Nottingham score or equivalent.
4. Patients who progress early on adjuvant abemaciclib within the first 6 months of treatment will not be eligible for another CDK 4/6 inhibitor in the curative adjuvant or the metastatic state.
5. Patients who have experienced treatment interruptions within the 2 years from starting treatment and have not experienced disease recurrence or disease progression may be considered to resume treatment with abemaciclib on a case-by-case basis to a maximum total of 2 years (i.e., 24 months) of adjuvant treatment with abemaciclib combined with an endocrine therapy.

Discontinuation criteria:

Abemiciclib in the adjuvant setting will be funded until the occurrence of any of the following, whichever occurs first:

• Completion of a total of 2 years of treatment;
  OR
• Until disease recurrence;
  OR
• Until development of unacceptable toxicities from treatment with abemaciclib;
  OR
• If patient meets any of the exclusion criteria.

Renewal Criteria:
Renewals will be considered in patients who do not meet any of the discontinuation criteria for a maximum of 2 years of adjuvant treatment duration. (Note 5)

Approved dose: Up to 150 mg twice daily with dose adjustments as necessary based on the product monograph.

Duration of Approvals: 1 year (A maximum total of 2 years of adjuvant treatment will be funded.)

EAP Drug Request Form:

Standard Form for EAP Drug Requests