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Title: Enzymatic replacement therapy for lysosomal storage disorders: Drug evaluations review in Spain
Author: Darbà, Josep
Ascanio, Meritxell
Keywords: Terapèutica
Anàlisi enzimàtica
Enzymatic analysis
Issue Date: Mar-2019
Publisher: Elsevier
Abstract: In the European Union companies only need to demonstrate that the risk-benefit balance of the new drug is favourable to obtain the authorization to sell new drugs. Hence a comparison with available treatments, a cost-effectiveness analysis and the place in the therapy of the new drug are not required. Therefore, it is necessary to carry out these analyses in an additional study. In Spain there is no national government agency, which conducts a centralized evaluation and makes decisions on funding and are the Pharmacy and Therapeutics committees that take mandatory decisions for the entire region.
Note: Versió postprint del document publicat a:
It is part of: Health Policy and Technology, 2019, vol. 8, num. 1, p. 14-23
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ISSN: 2211-8837
Appears in Collections:Articles publicats en revistes (Economia)

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