Olaparib

Key Messages

• The Formulary Management Expert Committee (FMEC) recommends that olaparib be reimbursed for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated, HER2-negative, unresectable locally advanced or metastatic breast cancer who have been previously treated with chemotherapy provided certain conditions are met.
• Olaparib may be initiated for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated, HER2-negative, unresectable locally advanced or metastatic breast cancer who have been previously treated with chemotherapy. Olaparib should be discontinued if there is disease progression or unacceptable toxicities. The initial prescribing should be limited to medical oncologists with expertise in the management and diagnosis of breast cancer. A price reduction for olaparib may be required.
• FMEC reviewed 1 phase III randomized controlled trial, 2 phase II single-arm cohort studies, and a cost comparison of olaparib versus other treatments used in Canada. Evidence from the randomized controlled trial showed that olaparib provides a clinically meaningful delay in disease progression, no effect on overall survival, and uncertain effects on objective response rate and health-related quality of life (HRQoL) in patients with germline BRCA-mutated metastatic breast cancer. The overall incidence of adverse events was similar between olaparib and chemotherapy, although the adverse event profiles differed. The evidence in patients with somatic BRCA-mutated metastatic breast cancer is very uncertain.
• FMEC concluded that there is a significant clinical need arising from BRCA-mutated, HER2-negative, unresectable locally advanced or metastatic breast cancer. FMEC concluded that olaparib for patients with germline BRCA1 or BRCA2 mutations demonstrates acceptable clinical value versus appropriate comparators in the Canadian setting. FMEC also concluded that it is uncertain whether olaparib for patients with somatic BRCA1 or BRCA2 mutations demonstrates acceptable clinical value versus appropriate comparators in the Canadian setting. Olaparib would potentially address significant nonclinical needs (e.g., treatment burden, travel requirements, impact on family, out-of-pocket costs, access inequities). The recommendation also considered economic considerations and impacts on health systems.