Outcome Based Risk Sharing Agreement

Value-based contracts (sometimes called risk-sharing agreements or results-based contracts) are a kind of innovative payment model that brings together two important players – health organizations and biopharmaceutical manufacturers – to provide medicines to patients. In value-based contracts, biopharmaceutical manufacturers and payers agree to link coverage and reimbursement levels to the efficacy of a drug and/or drug-rich use. Health authorities should encourage stakeholders to assess the financial and health outcomes of real risk-sharing contracts in order to better understand the variables that influence their use to support the future development of these contracts. In order to facilitate this task and to learn from the experience gained, a national register containing data from these agreements should be created. If health systems are to accelerate the use of these contracts, a clearer legal framework must be developed to simplify the terms of the agreements, which will reduce the burden on health professionals. This management tool, once expanded, is designed to improve patients` access to new technologies. Ferraio A, Kanavos P. Manage uncertainty and high prices for new drugs: A comparative analysis of the use of entry agreements manages in Belgium, England, the Netherlands and Sweden. Soc Sci Med. 2015;124:39-47. Over the past two decades, public health systems have put in place several management tools to cope with the increasing pressure of pharmaceutical companies to introduce new products, usually at high prices, in a context of uncertainty and budgetary constraints. These instruments have been repeatedly identified as fund repayment guarantee systems, managed access agreements, coverage with proof agreements, performance gains, results-based payments or price volume agreements. In this article, we use the concept of risk-sharing agreements to refer to both price volume agreements (mainly to reduce the financial burden) and performance payment agreements (which link drug payments to clinical outcomes).

They are intended to facilitate access to new health technologies where there are uncertainties about clinical outcomes (for example. B the medium-term effectiveness of treatments and potential target groups) and the impact on the budget (for example. B the duration of treatments). In this sense, there are currently major concerns when there are uncertainties as to how efficacy can be generalized to actual medical practice, as has been demonstrated in clinical studies.