A Simplified Decision-Support Framework for Estimating the Financial Benefits of Cycle-Capping Patient Access Programs

Abstract

Objective: To develop a simplified decision-support framework for estimating the financial benefits of cycle-capping Patient Access Programs (PAPs) in settings where a dedicated cost-effectiveness analysis is unavailable. Methods: The framework was developed through lessons learned from four hypothetical case studies of cycle-capping PAPs involving high-cost targeted anticancer drugs that were not included in National List of Essential Medicines. Four key questions were used to guide the assessment of financial benefits across PAP case studies: (1) whether the drug included in the PAP demonstrated superior clinical effectiveness compared with standard treatment; (2) the extent to which PAP participation reduced drug costs compared with a scenario without PAP participation; (3) the degree to which the remaining treatment costs after PAP participation approached affordability thresholds; and (4) how PAP conditions could be modified to further improve affordability and patient access. Lessons learned from these case studies were synthesized into a simplified decision-support framework. Results: A simplified decision-support framework was developed as a four-step process for estimating the financial benefits of cycle-capping PAPs: (1) assessing clinical evidence of the PAP drug compared with standard treatment; (2) analyzing drug cost reductions associated with PAP participation versus non-participation; (3) evaluating the remaining treatment costs against affordability thresholds; and (4) exploring modifications to PAP conditions to improve affordability. The findings indicate that failure to weight drug costs by progression-free survival rate can lead to overestimation of cost savings. Although PAP participation substantially reduces drug costs—the primary cost component—it often remains above cost-effectiveness and affordability thresholds. Adjustments to PAP design, including price reductions, increased support cycles, and modifications to payment schedules, can influence the incremental cost-effectiveness ratio and serve as practical options for improving affordability while maintaining negotiation feasibility. Conclusion: A simplified decision-support framework can support decision-making regarding cycle-capping PAPs and provide a practical approach to improving affordability and access to high-cost medications through modifications of PAP design.