Bridging East with West of Europe – a comparison of orphan drugs policies in Poland, Russia and the Netherlands

Abstract

The goal of this article is to provide an in-depth review of rare disease policies and the reimbursement of ODs in 3 European countries, two EU members (Poland, the Netherlands) and a non-EU one (Russia). A review of publicly available information on rare disorder policies and HTA processes was performed. Experts were consulted in case of unclear or scarce information. Russia has a five times higher frequency threshold for its rare disease definition than Poland and the Netherlands (both using the EU definition). The Netherlands has vastly increased its disease registries by instituting 300 expert centers via its National Plan, in Poland there are only 6 registries while in Russia one central registry exists. All 3 countries have an HTA process in place, however, the Russian one is relatively undeveloped. Access to ODs in the Netherlands is the broadest with 80 out of 83 EMA approved ODs reimbursed in 2015; Poland reimbursed 49, whereas Russia reimbursed 4 on the federal level and 43 in Moscow region. In all countries, new rare disease policies are under development. The availability of healthcare system solutions and the reimbursement of ODs differs greatly between all 3 countries. Even though both states are EU member with common regulations and access to EMA approved drugs, marked differences exist between Poland and the Netherlands in the range of policies, access to treatments and screening programs.

Application of Managed Entry Agreements for Innovative Therapies in Different Settings and Combinations: A Feasibility Analysis

“…Our literature review yielded only a few papers specifically describing MEAs in a non-high-income setting. Though theoretically most MEAs could be applied in any setting, and it is very likely that countries with more limited resources could benefit more from applying them, previous research has shown that some MEAs are actually used less in lower-income settings [ 1 , 30 ]. Particularly the more complex MEAs that require more resources, such as pay-per-outcome schemes (that need monitoring of treatment effects) and value-based pricing agreements (that require an extensive health technology assessment process to be completed), are more difficult to implement in countries with fewer resources.…”