Risk-sharing instruments in the drug reimbursement system in Poland and the world

The report was commissioned by INFARMA and conducted by HTA Consulting and Sequence HC Partners in cooperation with the Law Firm Ryś and Associates.

INFARMA considers risk-sharing instruments (RSA - risk sharing agreements) a very important and prospective method of introducing innovative medicines to the drug reimbursement system in Poland. Introduction of such instruments requires specific organizational, procedural and legal solutions related, for example, with records of patients. As Stefan Bogusławski wrote, on behalf of the research team, in the introduction to the report (Sequence): "Spending on healthcare in Poland is very low compared to European Union countries including “the new" Union. However, patients and doctors expect widest possible access to new diagnostics and therapies as soon as possible. The significant gap between the financial capacity of the system and the expectations of the society imposes on us an obligation to urgently seek solutions allowing sharing new technologies with the people in need.

Risk-sharing instruments (RSA) are one of the ways of meeting such needs. They allow reimbursement of new medical technologies, leading to a situation in which the payer pays for health benefits, saving expenses when they do not see the effects or if the effects are not sufficient. RSA, however, are complex tools that require a well-regulated and transparent cooperation of the payer, drug manufacturers, service providers (typically hospitals), doctors and pharmaceutical distribution. The process of implementation and conducting the RSA cannot be implemented without a good plan”.

We hope that this report - as a compendium of knowledge on RSA - will become a useful instrument in the work of people related to healthcare in Poland.


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