COST-UTILITY ANALYSIS AND BUDGET IMPACT ANALYSIS FOR PIRTOBRUTINIB VERSUS IDELALISIB PLUS RITUXIMAB AS THIRD-LINE TREATMENT IN RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKAEMIA PATIENTS IN THE NETHERLANDS
Author(s)
Sai Siddharth Kolluru, MSc1, Nicolas Xander, MSc2.
1Erasmus School of Health Policy & Management, Rotterdam, Netherlands, 2Erasmus University Rotterdam, Rotterdam, Netherlands.
1Erasmus School of Health Policy & Management, Rotterdam, Netherlands, 2Erasmus University Rotterdam, Rotterdam, Netherlands.
OBJECTIVES: Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia in the Netherlands. Following progression on covalent Bruton tyrosine kinase inhibitors, few third-line treatment options remain for relapsed/refractory CLL. This study evaluated the cost-utility and three-year budget impact of pirtobrutinib versus idelalisib plus rituximab (IdelaR) using the Dutch societal perspective.
METHODS: A three-state partitioned survival model (progression-free survival, progressed disease, death) was developed. Clinical inputs were sourced from the BRUIN CLL-321 phase 3 randomised controlled trial. Pseudo-individual patient data were reconstructed using the Hoyle-Henley algorithm. Inverse probability of censoring weighting (IPCW) was used to adjust the 76% treatment crossover in the comparator arm. For survival extrapolation, seven parametric survival distributions were fitted to identify the best fit based on lowest AIC/BIC, visual inspection, and long-term plausibility. Cost data were based on Dutch unit prices as per the 2024 Dutch Healthcare Institute (ZIN) guidelines. EQ-5D health state utilities were derived from published literature. Deterministic sensitivity analysis, probabilistic sensitivity analysis, eight ZIN-mandated scenario analyses, three-year budget impact analysis, and a value-of-information analysis involving the expected value of (partially) perfect information (EVPI/EVPPI) were conducted.
RESULTS: The base-case ICER was estimated at €262,702/QALY (pirtobrutinib: €306,907, 2.66 QALYs; IdelaR: €212,322, 2.30 QALYs), exceeding the Dutch cost-effectiveness threshold of €80,000/QALY. This result held across deterministic, probabilistic and scenario analyses. EVPI was €3,177 per patient, and EVPPI identified survival curve extrapolation as the dominant driver of decision uncertainty. A 45% reduction of pirtobrutinib’s list price (from €320 to €176 per day) would be required to reach the cost-effectiveness threshold. The budget impact was approximately €19 million at the current list price.
CONCLUSIONS: Pirtobrutinib is not cost-effective compared with IdelaR for relapsed/refractory CLL at the current Dutch list price. The scale of the ICER and the budget impact support an outcome-based managed entry agreement pending overall survival data maturity.
METHODS: A three-state partitioned survival model (progression-free survival, progressed disease, death) was developed. Clinical inputs were sourced from the BRUIN CLL-321 phase 3 randomised controlled trial. Pseudo-individual patient data were reconstructed using the Hoyle-Henley algorithm. Inverse probability of censoring weighting (IPCW) was used to adjust the 76% treatment crossover in the comparator arm. For survival extrapolation, seven parametric survival distributions were fitted to identify the best fit based on lowest AIC/BIC, visual inspection, and long-term plausibility. Cost data were based on Dutch unit prices as per the 2024 Dutch Healthcare Institute (ZIN) guidelines. EQ-5D health state utilities were derived from published literature. Deterministic sensitivity analysis, probabilistic sensitivity analysis, eight ZIN-mandated scenario analyses, three-year budget impact analysis, and a value-of-information analysis involving the expected value of (partially) perfect information (EVPI/EVPPI) were conducted.
RESULTS: The base-case ICER was estimated at €262,702/QALY (pirtobrutinib: €306,907, 2.66 QALYs; IdelaR: €212,322, 2.30 QALYs), exceeding the Dutch cost-effectiveness threshold of €80,000/QALY. This result held across deterministic, probabilistic and scenario analyses. EVPI was €3,177 per patient, and EVPPI identified survival curve extrapolation as the dominant driver of decision uncertainty. A 45% reduction of pirtobrutinib’s list price (from €320 to €176 per day) would be required to reach the cost-effectiveness threshold. The budget impact was approximately €19 million at the current list price.
CONCLUSIONS: Pirtobrutinib is not cost-effective compared with IdelaR for relapsed/refractory CLL at the current Dutch list price. The scale of the ICER and the budget impact support an outcome-based managed entry agreement pending overall survival data maturity.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE398
Topic
Economic Evaluation, Health Technology Assessment
Topic Subcategory
Budget Impact Analysis, Value of Information
Disease
Biologics & Biosimilars, Oncology