https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.4297

Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making

This paper aims to provide a review and synthesis of the performance-based contracting (PBC) literature across academic disciplines. It also seeks to examine how the operations and supply management (OSM) discipline in particular relates to PBC studies in other study fields. The research is based on a systematic literature review of 241 peer-reviewed articles across disciplines, published between 1985 and 2014. A classification framework of PBC research is proposed, addressing key aspects of PBC design and management: performance specification and evaluation, the design of incentives and their impact on supplier behaviour and risks allocation depending also on the risk attitudes of buyers and suppliers. The comparative analysis of literature by discipline helps identify current empirical and theoretical limitations of relevant OSM studies. The paper concludes that future OSM research should expand its theoretical framework and empirical focus to better understand PBC design and management. Eight specific suggestions for future OSM research are offered, e.g. examining the potential of PBC as means for managing sustainability and innovation goals of supply chains. The paper helps advance OSM research in this area by providing a structured overview of definitions, theories, conceptual frames, methods and empirical studies from other disciplines.

Performance-based contracting: a literature review and future research directions

Dealing with uncertainty and high prices of new medicines: a comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden.

This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.

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How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Background
National payers across Europe have been increasingly looking into innovative reimbursement approaches – called managed entry agreements (MEAs) – to balance the need to provide rapid access to potentially beneficial orphan medicinal products (OMPs) with the requirements to circumscribe uncertainty, obtain best value for money or to ensure affordability. This study aimed to identify, describe and classify MEAs applied to OMPs by national payers and to analyse their practice in Europe.

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Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries

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

Cergy Pontoise

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