Olaparib

Key Messages

• The Formulary Management Expert Committee (FMEC) recommends that olaparib be reimbursed for the maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy, provided certain conditions are met.
• Olaparib may be reimbursed for the maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy, provided the following conditions are met: no progression after at least 16 weeks of first-line systemic chemotherapy and good performance status. Olaparib should be discontinued if there is disease progression or unacceptable toxicities. Olaparib should be priced no higher than the least costly therapy available for this population.
• FMEC reviewed 1 trial of olaparib versus placebo and a cost comparison of olaparib versus other treatments used in Canada. Overall, the evidence demonstrates that, compared to placebo, olaparib maintenance therapy provides a clinically meaningful improvement in progression-free survival (PFS), does not contribute to a decline in health-related quality of life (HRQoL), and has a tolerable safety profile.
• FMEC concluded that there is a significant unmet need in BRCA-mutated pancreatic adenocarcinoma, given the rarity of BRCA mutations and poor prognosis of this condition. FMEC also concluded that it is uncertain whether olaparib demonstrates acceptable clinical value versus appropriate comparators; however, olaparib would potentially address significant nonclinical needs (e.g., treatment burden, travel requirements, out-of-pocket costs, access inequities). FMEC noted that economic considerations are important to address when implementing olaparib.