Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force.

1Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA; 2Office of Health Economics, London, UK; 3Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK; 4ESSEC Business School, Cergy Pontoise, France; 5F. Hoffmann-La Roche AG, Basel, Switzerland; 6Center for Medical Technology Policy, Baltimore, Maryland, USA; 7Institute of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; 8Agenzia Italiana del Farmaco, Rome, Italy; 9Access to Medicines GlaxoSmithKline plc, Brentford, UK

Споразумения за споделяне на риска, основани на представянето - добра практи- ка на дизайна, приложението и оценката: Доклад на работната група на ISPOR Performance-Based Risk-Sharing Arrangements - Good Practices for Design, Implementation, and Evaluation: Report of the ISPOR Good Practices for Performance- Based Risk-Sharing Arrangements Task Force

markdown__Background__ Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. 
__Objectives__ The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. 
__Methods__ An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. 
__Results__ In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. 
__Conclusions__ Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

/pdf/policies-for-biosimilar-uptake-in-europe-an-overview-17befgte9o.pdf

Policies for biosimilar uptake in Europe: An overview.

This paper presents and evaluates pharmaceutical policies in the EU aimed at the rational use of medicines and at keeping pharmaceutical spending under control. Policy makers are growing more aware that by regulating pharmaceutical markets correctly, considerable savings can be achieved without compromising the quality of care. Specifically, the paper makes the case that, by following numerous best-practices in pharmaceutical sector regulations, the value for money of pharmaceutical consumption could be substantially increased. Appropriate regulations can be relevant for pricing, reimbursement, market entry and expenditure control, as well as specific policies targeted at the distribution chain, physicians and patients. Drawing on various initiatives at the EU level related to the pharmaceutical sector, the paper also explores policy options for the EU.

/pdf/cost-containment-policies-in-public-pharmaceutical-spending-1iefgkbqxx.pdf

Cost-containment policies in public pharmaceutical spending in the EU

/pdf/managed-entry-agreements-for-pharmaceuticals-the-european-14kb3xa379.pdf

Managed entry agreements for pharmaceuticals: the European experience

Background
There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes.

https://link.springer.com/content/pdf/10.1186%2F1472-6963-10-153.pdf

Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers.

Background: There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes. Methods: Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes. Results and discussion: A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals. Conclusion: We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.

Gabriella Ofierska-Sujkowska

Papers

Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers.

Correspondencesharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers