Abemaciclib (Verzenio)

Key Messages

• Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
• The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
• This review assesses abemaciclib (VERZENIO), 50 mg, 100 mg, 150 mg oral tablets.
• Indication: VERZENIO is indicated in both early breast cancer and advanced breast cancer or metastatic breast cancer. In the advanced breast cancer or metastatic breast cancer setting the following indications were issued NOC by Health Canada on April 5, 2019:
  VERZENIO (abemaciclib) is indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer as follows:
  • in combination with an aromatase inhibitor in post-menopausal women as initial endocrine-based therapy;
  • in combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone agonist;
  • as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens. At least 1 chemotherapy regimen should have been administered in the metastatic setting, and at least 1 should have contained a taxane.