WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR TRODELVY?: CADTH recommends that Trodelvy should be reimbursed by public drug plans for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting, if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Trodelvy should only be covered to treat adult patients with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have been previously treated with at least 1 taxane, at least 1 prior anticancer hormonal treatment, and at least 1 cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting, have experienced treatment failure after 2 to 4 prior systemic chemotherapy regimens for metastatic disease, and have good performance status. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Trodelvy should only be reimbursed if it is prescribed by clinicians with expertise and experience in treating breast cancer in approved centres, and if the price of Trodelvy is reduced. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial demonstrated that Trodelvy was better than treatment of physician’s choice (TPC) (including eribulin, capecitabine, gemcitabine, or vinorelbine) in allowing patients to live longer and improving quality of life. Based on CADTH’s assessment of the health economic evidence, Trodelvy does not represent good value to the health care system at the public list price. A price reduction is therefore required. Based on public list prices, Trodelvy is estimated to cost the public drug plans approximately $129 million over the next 3 years. However, the actual budget impact is uncertain and may be lower depending on the initiation criteria required for reimbursement.

ADDITIONAL INFORMATION

WHAT IS HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER? Breast cancer can be classified by proteins (receptors) expressed by the cancer cell. The HR-positive and HER2-negative subtype is the most prevalent breast cancer in Canada. Moreover, a breast cancer is considered unresectable and locally advanced or metastatic when the cancer spreads to other parts of the body or cannot be removed by surgery. UNMET NEEDS IN HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER: For many patients, their cancer does not respond to available treatment options. Even in patients whose cancer does respond to treatment, the cancer may still return. Patients with advanced HR-positive, HER2-negative breast cancer who do not benefit from endocrine therapy or additional chemotherapy regimens need other treatments that prevent or delay cancer from returning, prolong survival with an acceptable toxicity profile, and maintain quality of life. HOW MUCH DOES TRODELVY COST? Treatment with Trodelvy is expected to cost approximately $15,765 per patient per 28-day cycle, assuming a patient weight of 70 kg.