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

Paweł Żelewski (), Michał Wojna, Katarzyna Sygit, Elżbieta Cipora, Izabela Gąska, Mateusz Niemiec, Mateusz Kaczmarski, Tomasz Banaś, Beata Karakiewicz, Artur Kotwas, Paulina Zabielska, Olga Partyka, Monika Pajewska, Edyta Krzych-Fałta, Ewa Bandurska, Weronika Ciećko and Aleksandra Czerw
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Paweł Żelewski: Department of Economics, Kozminsky University, 03-301 Warsaw, Poland
Michał Wojna: Department of Economics, Kozminsky University, 03-301 Warsaw, Poland
Katarzyna Sygit: Faculty of Health Sciences, Calisia University, 62-800 Kalisz, Poland
Elżbieta Cipora: Medical Institute, Jan Grodek State University in Sanok, 38-500 Sanok, Poland
Izabela Gąska: Medical Institute, Jan Grodek State University in Sanok, 38-500 Sanok, Poland
Mateusz Niemiec: Medical Institute, Jan Grodek State University in Sanok, 38-500 Sanok, Poland
Mateusz Kaczmarski: Medical Institute, Jan Grodek State University in Sanok, 38-500 Sanok, Poland
Tomasz Banaś: Department of Gynaecology and Oncology, Jagiellonian University Medical College, 31-501 Cracow, Poland
Beata Karakiewicz: Subdepartment of Social Medicine and Public Health, Department of Social Medicine, Pomeranian Medical University in Szczecin, 70-204 Szczecin, Poland
Artur Kotwas: Subdepartment of Social Medicine and Public Health, Department of Social Medicine, Pomeranian Medical University in Szczecin, 70-204 Szczecin, Poland
Paulina Zabielska: Subdepartment of Social Medicine and Public Health, Department of Social Medicine, Pomeranian Medical University in Szczecin, 70-204 Szczecin, Poland
Olga Partyka: Department of Health Economics and Medical Law, Medical University of Warsaw, Żwirk i Wigury 81 St., 02-091 Warsaw, Poland
Monika Pajewska: Department of Economic and System Analyses, National Institute of Public Health—NIH—National Research Institute, 00-791 Warsaw, Poland
Edyta Krzych-Fałta: Department of Basic of Nursing, Faculty of Health Sciences, Medical University of Warsaw, 01-445 Warsaw, Poland
Ewa Bandurska: Center for Competence Development, Integrated Care and e-Health, Medical University of Gdańsk, 80-204 Gdansk, Poland
Weronika Ciećko: Center for Competence Development, Integrated Care and e-Health, Medical University of Gdańsk, 80-204 Gdansk, Poland
Aleksandra Czerw: Department of Health Economics and Medical Law, Medical University of Warsaw, Żwirk i Wigury 81 St., 02-091 Warsaw, Poland

IJERPH, 2022, vol. 19, issue 19, 1-17

Abstract: 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.

Keywords: orphan drugs; price; pharmacology; economy (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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