OBJECTIVES : Innovative therapies, medicinal products targeted at various indications and combination therapies pose challenges to current health care systems. Innovative contracting, such as outcomes-based risk-sharing agreements, are potential solutions to overcome these hurdles. However, in the German context the national association of statutory health insurance funds (GKV-SV - National Association of 111 statutory German health insurances) negotiates the reimbursed price with the submitting company. A core issue within these negotiations is if and how the different data infrastructure of all 111 German insurances could be combined for innovative contracting. This study aims to investigate the availability and quality of necessary data for outcomes-based risk-sharing agreements in the German AMNOG context. Additionally, we discussed how decentralised and centralised accounting systems could be organised to guarantee sustainable data and financial streams.

METHODS : In this qualitative study, semi-structured interviews were conducted. Study participants included experts from pharmaceutical companies, health insurances and service providers in the German statutory health insurance system. Additionally, a targeted literature research on official regulations and laws was conducted.

RESULTS : In Germany, outcomes data for innovative contracting are collected in form of prescription data from pharmacies and medical treatment data from physicians. These can be used for individual agreements between marketing authorization holders and health insurances. On the longer term, a national accounting system would have the potential to enable outcomes-based risk-sharing agreements in the German AMNOG negotiations. The centralized approach would require additional competencies for the GKV-SV and potentially the introduction of a third party as data management organisation.

CONCLUSIONS : This research validated the availability and quality of data for outcomes-based risk-sharing agreements in the German AMNOG context. The results may promote the further application of outcomes-based risk-sharing agreements in Germany. Stakeholders across the German statutory health insurance system have the willingness to cooperate for this purpose.