PNS38 PROPOSING AND EVALUATING A DESIGN FOR GDPR-COMPLIANT, SCALABLE TECHNOLOGY FOR AUTOMATIC ADJUDICATION OF RISK-SHARING AGREEMENTS

Abstract

Risk-sharing agreements (RSAs) between biopharma manufacturers and payers are increasingly being adopted in European markets, either as managed entry schemes or for marketed products. Such agreements may, according to the literature, control expenditures on higher cost medicines while linking payment to a clinical, economics, or administrative outcome. Documented hurdles to RSA implementation include the costs associated with data collection and adjudication. GDPR and European country-specific privacy laws in some cases restrict the ability of health care data to be entered into a system that could facilitate more scalable, lower-cost adjudication of RSAs; RSA implementation in some jurisdictions has necessitated employing clinical professionals as data managers in hospitals and clinics for a specific contract. Payers and manufacturers have reported in the literature that these cost and logistic hurdles may negate the potential savings of specific RSAs or limit their growth and scale. We previously built and tested a technology approach using blockchain databases to automatically adjudicate a theoretical RSA for a high cost cancer product. Building on the results of this initial testing, we designed a model that used encrypted data signatures across a private, distributed architecture to demonstrate how this technology could be implemented across multiple participating hospital sites at the local level to calculate whether terms of an RSA have been met based on locally held data, and how an encrypted output signal could be sent to a remote node with the ability to interpret whether RSA contract terms had been met or not met in any particular instance. We theorize that building and implementing such a system would significantly reduce the administrative costs associated with RSA adjudication and would provide a method for easier audit and management of RSAs.