WHAT IS THE CANADA’S DRUG AGENCY REIMBURSEMENT RECOMMENDATION FOR VERZENIO?: Canada’s Drug Agency recommends that public drug plans reimburse Verzenio in combination with endocrine therapy for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early-stage breast cancer at high risk of recurrence based on clinicopathological features if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Verzenio, in combination with endocrine therapy, should only be covered in patients whose breast cancer has receptors for the estrogen and progesterone hormones, tests negative for the HER2 protein, has been removed by surgery, and is at high risk of coming back based on clinicopathological features, including 4 or more positive axillary lymph nodes (ALNs), or 1 to 3 positive ALNs plus histologic grade 3 disease, or 1 to 3 positive ALNs plus a tumour size of 5 cm or more, or 1 to 3 positive ALNs plus a Ki-67 score of 20% or more (if tumour size is < 5cm and disease is not grade 3). WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Verzenio, in combination with endocrine therapy, should only be reimbursed if prescribed by clinicians with expertise delivering systemic treatment and if the cost is reduced. WHY DID WE MAKE THIS RECOMMENDATION? • Evidence from a clinical trial demonstrated that patients treated with Verzenio in combination with endocrine therapy experienced a delayed return of cancer. Verzenio, in combination with endocrine therapy, meets patient needs for effective treatments that reduce the risk of their breast cancer coming back, maintain quality of life, and have manageable side effects. Verzenio may also be more accessible because of its oral route of administration. • Verzenio, combined with endocrine therapy, is not considered cost-effective compared to endocrine therapy alone. Economic evidence suggests that a 51% price reduction is needed for Verzenio to ensure that it, in combination with endocrine therapy, is cost-effective at a $50,000 per quality-adjusted life-year (QALY) gained threshold. • Based on public list prices, Verzenio is expected to cost the public drug plans $228,000,000 over the next 3 years.

ADDITIONAL INFORMATION

WHAT IS BREAST CANCER? Breast cancer begins in the cells of the breasts. Invasive early-stage breast cancer without metastases has spread into the surrounding breast tissue but has not spread to different body parts. More than 90% of patients with HR-positive, HER2-negative early-stage breast cancer survive at least 5 years. UNMET NEEDS IN BREAST CANCER: Patients with early-stage breast cancer removed by surgery but at a high risk of coming back need treatment options that prevent or delay the return of the cancer, prolong survival with an acceptable toxicity profile, and maintain quality of life. HOW MUCH DOES VERZENIO COST? Treatment with Verzenio is expected to cost approximately $6,264 per patient per 28 days. The cost per patient of 28-day Verzenio, combined with endocrine therapy, ranges between $6,274 and $6,302.