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What Is A Managed Entry Agreement

In addition, the payers pointed out that once a product was made available to patients, the removal of the list proved impossible due to the lack of mechanisms to facilitate the removal of the list and low social support for the withdrawal of reimbursement decisions on the basis of economic evidence. These results have an impact on stakeholders in the health sector, because while results-based entry management agreements are needed for adaptive track products to facilitate market access, there is a need to address the lack of infrastructure in many countries, which would facilitate data collection, and to identify practical models and mechanisms. JB and SG were employed by the health authorities at the time of writing and CS is employed by F. Hoffmann La Roche. However, the content of the document and the conclusions are those of each author and cannot be understood as reflecting the content of the organization that employs them. The authors explain that the research was funded by the Innovative Arzneimittel initiative 2 Joint Undertaking under Grant Agreement 115890. This joint venture is supported by the European Union`s Horizon 2020 research and innovation programme and EFPIA. The Cost-Sharing Agreements (CSAs) provide ways for the payer and the pharmaceutical company to share the financial costs associated with the introduction of an innovative drug. CSAs can continue to be subdivided into price volume, budget and usage caps, as well as rebates. Under risk-sharing agreements (RSA), the public payer and the pharmaceutical company share the risks associated with clinical outcomes in patients treated with the innovative drug. RSAs can be defined as “result guarantees,” “guarantees of reimbursement,” “payment by result” or “continuation of conditional treatment.” For the latter, funding for treatment will only be continued for patients with some therapeutic efficacy. In Finland, interest in adapting MEA CONZEPT to the Finnish environment has increased.

In order to achieve this goal, since the beginning of 2017, the Pharmaceuticals Pricing Board has initiated a procedure to accept conditional repayments, resulting in several confidential cost-sharing agreements. While CSAs play a well-established role in Finland`s specialized health system, information on the use of RSA in Finnish hospitals is very limited.

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