Comparison of US and EU Prices for Orphan Drugs in the Perspective of the Considered US Orphan Drugs Act Modifications and Discussed Price-Regulation Mechanisms Adjustments in US and European Union

Bibliographic Data

ID15468487
AuthorsPaweł Żelewski (Kozminski University, corresponding author), Michał Wojna (0000-0002-3869-3215, Kozminski University), Katarzyna Sygit (0000-0001-7173-2266), Elżbieta Cipora (0000-0002-7794-550X, Jan Grodek State Vocational Academy in Sanok), Izabela Gąska (0000-0002-6054-5972, Jan Grodek State Vocational Academy in Sanok), Mateusz Niemiec (0000-0003-1429-8146, Jan Grodek State Vocational Academy in Sanok), Mateusz Kaczmarski (0000-0003-4498-7110, Jan Grodek State Vocational Academy in Sanok), Tomasz Banaś (0000-0002-6656-2490, Jagiellonian University), Beata Karakiewicz (0000-0001-6527-7287, Pomeranian Medical University), Artur Kotwas (0000-0002-6805-4713, Pomeranian Medical University), Paulina Zabielska (0000-0001-8377-7218, Pomeranian Medical University), Olga Partyka (0000-0001-6359-2902, Medical University of Warsaw), Monika Pajewska (0000-0002-7735-5219, Narodowy Instytut Zdrowia Publicznego PZH – Państwowy Instytut Badawczy), Edyta Krzych‐Fałta (0000-0002-9857-7136, Medical University of Warsaw), Ewa Bandurska (Gdańsk Medical University), Weronika Ciećko (0000-0002-1496-1924, Gdańsk Medical University), Aleksandra Czerw (0000-0002-6189-6678, Medical University of Warsaw)
Year2022
Volume19
Issue19
Pages12098-12098
Publication date2022-09-24
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueInternational Journal of Environmental Research and Public Health (JOURNAL)
Journal identifiersISSN: 1661-7827 • E-ISSN: 1660-4601
PublisherMultidisciplinary Digital Publishing Institute (PUBLISHER • CH)
DOI10.3390/ijerph191912098
PMID36231399
OpenAlexW4297236010
LanguageEN
Citations received1
References cited1

The 2019 worldwide sales of Orphan Drugs were estimated at $136 billion USD, which constituted 16% of the global pharmaceutical prescription market and is expected to grow by 12% in the next 5 years. A better understanding of Orphan Drug pricing may contribute to on-going discussions on Orphan Drug Act (ODA) corrections in US or modifications of price setting mechanisms in EU. The objective of the study was comparison and analysis of the prices of Orphan Drugs in US and EU. All drugs with Orphan Drug status were compared in the US and EU. For the US prices, the US Department of Veterans Affairs (VA) was sourced. The EU List Prices came from six EU countries: Denmark, France, Germany, Greece, Poland, Spain. We found US prices to be higher than the six selected EU countries. The average Price Ratio was 1.64. The prices across EU countries were more homogeneous, while the number of the reimbursed and therefore available to patient medicines varied and was correlated with GDP per capita r = 0.87. Considered implementation of the External Reference Price system in US may generate significant savings in the US but may result in upward pressure on pricing of Orphan Drugs in EU. Centralization of the Orphan Drugs pricing negotiations in EU may prevent such development and offer a win-win opportunity for all involved parties

Business · Economics · Environmental health · European union · International economics · International trade · Negotiation · Orphan drug · Per capita · Political science · Population · Public economics · Health Systems, Economic Evaluations, Quality of Life · Intellectual Property and Patents · Law · Medicine · Pharmaceutical Economics and Policy

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