OBJECTIVES:The market launch of biosimilars may induce price competition and allows selecting the most cost-effective option from a range of therapeutically equivalent biologics. Hence, payers across Europe have experimented with benefit-sharing programs, which are incentive schemes established through the collaboration of stakeholders (e.g., health authorities/payers, hospital administrators, and healthcare professionals) to support the use of the most cost-effective biologics and to share resulting savings among stakeholders involved. However, little is known about the conditions for the implementation of benefit-sharing programs. This study aims to conduct a comparative analysis of the design and implementation conditions for benefit-sharing programs across Europe.

METHODS:Our approach was based on a literature review and on semi-structured interviews with payers/insurers, policy makers, healthcare professionals and industry representatives in England, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania and Scotland.

RESULTS:Our analysis revealed very variable design characteristics for benefit-sharing programs, depending on the organisation of the healthcare system, the specific time frame, the care setting and the policy environment. We also noted a generalised lack of transparency regarding the distribution of savings and how they are reinvested. This has raised questions on how to properly engage all stakeholders and on how to optimally implement benefit-sharing in the future.

CONCLUSIONS:To realise the full potential of benefit-sharing programs we identify the importance of 1) setting-up and timely monitoring success indicators for these programs; 2) including quality of care parameters as success indicators; 3) establishing clear pathways for the transparent distribution of savings; 4) transparently communicating with patients about the outcomes of benefit-sharing programs.