Economic evaluation alongside the PAOLA-1 /ENGOT-ov25 trial: cost of ovarian cancer and cost-effectiveness of olaparib plus bevacizumab first-line maintenance

The PAOLA-1 trial randomized 806 patients with newly diagnosed advanced ovarian cancer to olaparib plus bevacizumab or placebo plus bevacizumab and demonstrated a progression-free survival (PFS) and overall survival (OS) benefit when maintenance olaparib was added to bevacizumab in patients with a positive tumor homologous recombination deficiency (HRD) test. We conducted an economic evaluation based on patient-level data from the PAOLA-1 trial. Costs were assessed from the French health care system perspective with a 60-month time horizon. Individual healthcare consumptions were collected from the case report forms. Survival analysis was conducted using restricted mean survival time (RMST). Health-related quality of life (HRQoL) was measured using the EQ-5D-5L questionnaire. Costs and HRQoL were discounted at 2.5% rate. Incremental cost-effectiveness ratios (ICERs) were calculated. Sensitivity analyses were performed. Mean costs per patient were €90,972 (SD: 55,229) in the ITT population ( N = 806) and €96,054 (SD: 56,270) in the HRD-positive population ( N = 387). In the latter, mean costs per patient were €109,895 (SD: 49,234) in the olaparib plus bevacizumab group (255/387) and €69,316 (SD: 59,468) in the placebo plus bevacizumab group (132/387). Mean Progression-free survival (PFS) were 3.375 (SD: 0.108) and 2.058 (SD: 0.140) years, respectively, leading to an ICER of €30,750 per Progression-free life-year gained (PF-LYG). Mean Overall survival (OS) were 4.208 (SD: 0.080) in the olaparib plus bevacizumab group and 3.875 (SD: 0.124) years in the placebo plus bevacizumab group. ICER was €121,088 per Life-year gained ( LYG). Mean quality-adjusted life-year (QALY) were 3,775 (SD: 1,101) and 3,442 (SD: 1,094) years, respectively, leading to an ICER of €121,577 per QALY gained. The probability of olaparib plus bevacizumab being cost-effective was 29.9% at €100,000 level of willingness to pay per LYG and 24.3% per QALY gained. In the HRD-positive population the ICER is exceeding international standards at the usually accepted willingness to pay thresholds. However, it can be considered acceptable in light of the statistical value for QALY that has been calculated in the French setting or based on a threshold amounting to two to three times the gross domestic product (GDP) per capita per QALY gained. NCT02477644 (date of registration: 2015-06-18).