Mai 2021

Managed Entry Agreement Germany

Ando G, Kowal S, Reinaud F. Payer blocks risk-sharing agreements around the world: where, when and how? Health value. 2010;13 (7):A241. The list of relevant keywords and databases was identified in a three-step process. A number of keywords used to define RSAs were identified by the first literature review mentioned above. Then we compiled a list of databases that were searched only for verified items. The keywords were then entered individually into each database to verify the selection of the keyword and database. For pre-defined filters (see example „Annex“), the number of results was taken into account when selecting keywords and databases. The following keywords and terms have been retained and used in research: patient access scheme, pharmaceutical risk sharing, risk sharing, risk-sharing system, risk-sharing agreement, entry-management agreement, profit-based payment, performance-based risk-sharing agreement, coverage with data development and agreement on price volume. 66 payers completed the survey.

Interviewees expected that the use of innovative price agreements would remain slow or increase in the future. Overall, they felt that the new rules were positive and that innovative agreements would likely be used if they reduce total costs or reduce uncertainty. Petrov M, Hubenov P. Introduction of formal risk-sharing agreements (RSA): a promising solution for sustainable and predictable pharmaceutical spending in Bulgaria. Health value. 2015;18 (7):A571-2. Costello S, Haynes S, Kusel J. Innovative price agreements in UK NICE Submissions. Health value. 2010;13 (3):A96. Morel T, Arickx F, Befrits G, Siviero P, van der Meijden C, Xoxi E, et al.

Compatibility of cost and outcome insecurity with the need for access to orphan medicines: a comparative study on entry agreements managed in seven European countries. Orphanet J Rare Dis. 2013;8:198. doi:10.1186/1750-1172-8-198. Historically, Germany has left behind other important European markets when using managed entry agreements (AMA). However, in recent months, influential interest groups have become increasingly interested in the potential of AMEs and several new performance payment (P4P) contracts have been announced. Given the many potentially expensive new drugs in the pipeline, including very expensive single therapies, it would be easy to use MEAs as a panacea to impede market access. However, pharmaceutical companies need to be aware of the challenges posed by P4P as a market access strategy. Innovative drug price agreements have been used in European markets for more than 20 years and offer payers and pharmaceutical companies the opportunity to focus on value, optimize speed for patients and share risks. The development of successful agreements requires consultation among key stakeholders, but there is no synthetic data on how current innovative agreements are used in the real world (for example. B the level of access to medicines, as well as discounts and discounts, often opaque).

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