Managed entry agreements
نویسندگان
چکیده
Background New scientific progress in the “precision medicines” direction and a better diagnosis of rare diseases have led Regulators and Payers to focus their vigilance towards the real life setting. Although Regulators and Payers are taking into consideration patient pressures for rapid access to treatment, nevertheless they must balance the difficulties of taking significant decision coping with uncertainties when deciding on pricing and reimbursement processes.
منابع مشابه
Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe
As per the EMA definition, adaptive pathways is a scientific concept for the development of medicines which seeks to facilitate patient access to promising medicines addressing high unmet need through a prospectively planned approach in a sustainable way. This review reports the findings of activities undertaken by the ADAPT-SMART consortium to identify enablers and explore the suitability of m...
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Stretched health care budgets and the increasing availability of high-cost medicines, together with increasing patient expectations, means that manufacturers seeking reimbursement for their products need to demonstrate more than ever that their drugs can provide value-for-money. Due to this complex environment, formal agreements between payers and manufacturers have been developed with the aim ...
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Objectives: The aim of this study is to conduct an analysis on the regulation and application of managed entry agreements (MEA) for oncology drugs across different European countries. Methods: Literature search and document analysis were performed between September 2015 and June 2016 to collect information on the regulatory framework and practice of MEA in Belgium, The Netherlands, Scotland, En...
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BACKGROUND Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. METHOD We conducted a survey on the implementation of MEAs in CEE between January and March 2017. RESULTS Sixteen countries participated in t...
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