CHARACTERISTICS OF RISK-SHARING SCHEMES IN EUROPE

Author(s)

Dominic Muston, BSc, MSc, Scientific Officer1, Rodolphe Perard, PharmD, MSc, Health Outcomes Analyst1, Frances Nixon, BSc, Health Outcomes Analyst21Heron Evidence Development Ltd, Letchworth Garden City, Hertfordshire, United Kingdom; 2 Heron Evidence Development Ltd, Letchworth Garden City, United Kingdom

Objective: The characteristics of attractive conditional reimbursement settlements such as risk-sharing agreements (RSA) to manufacturers and healthcare payers have previously been discussed (Sculpher et al 2007). Mutual trust between the two parties is a pre-requisite. Manufacturers should prefer: minimal pre and post launch burden; clarity in the link between reimbursement, access, sales and retrospective/future revenue; clarity on timing of decisions; clarity in agreements on data sharing. Payers aim to maximise net health benefit and should prefer RSAs in which proposed research agendas are expected to most improve knowledge of clinical effectiveness and economic value. Methods: We reviewed the qualities of RSAs in several European countries for which sufficient detail had been published. The qualities compared were: financial burden; relationship between reimbursement decision, access, sales and revenue; validity of treatment effectiveness metric; clarity of decision timing; and data-sharing agreement type. Results: Four RSA schemes were considered. The beta interferons in multiple sclerosis and proposed Velcade (bortezomib) in multiple myeloma schemes in England and Wales were compared with the conditional reimbursement scheme operated by the Netherlands Health Care Insurance Board and the prospective price fixing regulations operated by the Economic Committee of Health Products (CEP) in France. Relationships between reimbursement, access, sales and revenues were clearest in the Velcade scheme. The effectiveness metric used in the beta-interferons scheme was unconventional, but reflective of quality of life improvements. The 3-year reassessment timeframe of the Netherlands scheme provided greatest decision timing clarity. The financial burden to manufacturers and payers of the RSAs was difficult to assess. Data-sharing agreements varied. Conclusion: The nature of risk-sharing schemes in Europe is developing and highly variable. Risk-sharing is clearly an area of policy development where innovative proposals by manufacturers that address the concerns of payers can lead to earlier, wider market access.

Conference/Value in Health Info

2008-05, ISPOR 2008, Toronto, Ontario, Canada

Value in Health, Vol. 11, No. 3 (May/June 2008)

Code

PHP68

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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