Innovative pricing agreements: using Danish registries as ‘on-demand’ real world evidence for clarification of cost-benefit on new medicine

Healthcare spending on prescription medicine is increasing, leading to a focus on value for money based on real-world effects. The implication is that innovative new medicine with low evidence struggle with reimbursement. Innovative pricing agreements (IPAs) based on actual treatment performance can accommodate the likelihood of reimbursement, as financial risk is shared between payer and medicine company. However, IPAs need access to systematically gathered data, such as Danish registry data,. The objective is to explore if Danish registry data can be used ‘on-demand’ to support IPAs in terms of economic benefit, validity, and workload—thus supporting financial risk sharing? This retrospective, hypothetical performance-based risk-sharing agreement (PBRSA) uses Danish registry data to estimate survival time after treatment with ipilimumab between 2014 and 2015. The non-discounted list price was used as full payment upfront, with partial (80%, 40%, and 20%) refunds for the fraction of deceased patients within 1, 2, or 3 years after initiation of treatment. Three models were tested. In model 1 (assumption of full treatment) the estimated cost was 144.7 million DKK. In model 2 (total number of identified administrations) the estimated cost was 113.4 million DKK. Model 3 (the actual procurement cost) adds up to 164.5 million DKK. The potential savings in the PBRSA were 44% of full upfront payment in all models. PBRSAs based on Danish ‘on-demand’ registries have potential in providing possible financial risk-sharing between payer and pharmaceutical company. IPAs can be conducted with acceptable validity on Danish Health Care data.