Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries
Introduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers. While there are many theoretical papers on pricing and reimbursement...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-11-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1199500/full |
| _version_ | 1827631470921908224 |
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| author | Juan Carlos Rejon-Parrilla Jaime Espin Jaime Espin Jaime Espin Jaime Espin Sarah Garner Stanislav Kniazkov David Epstein |
| author_facet | Juan Carlos Rejon-Parrilla Jaime Espin Jaime Espin Jaime Espin Jaime Espin Sarah Garner Stanislav Kniazkov David Epstein |
| author_sort | Juan Carlos Rejon-Parrilla |
| collection | DOAJ |
| description | Introduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers. While there are many theoretical papers on pricing and reimbursement (P&R) options, original empirical research is very scarce. This paper aims to provide a comprehensive international review of regulatory and P&R decisions taken for all ATMPs with centralized European marketing authorization in March 2022.Methods: A survey was distributed in July 2022 to representatives of 46 countries.Results: Responses were received from 20 countries out of 46 (43.5%). 14 countries reimbursed at least one ATMP. Six countries in this survey reimbursed no ATMPs.Conclusion: Access to ATMPs is uneven across the countries included in this study. This arises from regulatory differences, commercial decisions by marketing authorization holders, and the divergent assessment processes and criteria applied by payers. Moving towards greater equality of access will require cooperation between countries and stakeholders, for example, through the WHO Regional Office for Europe’s Access to Novel Medicines Platform. |
| first_indexed | 2024-03-09T14:22:27Z |
| format | Article |
| id | doaj.art-31e19f289e864cbba9290ea03a90ef4d |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-09T14:22:27Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-31e19f289e864cbba9290ea03a90ef4d2023-11-28T09:45:52ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.11995001199500Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countriesJuan Carlos Rejon-Parrilla0Jaime Espin1Jaime Espin2Jaime Espin3Jaime Espin4Sarah Garner5Stanislav Kniazkov6David Epstein7Health Technology Assessment Area (AETSA), Andalusian Public Foundation Progress and Health (FPS), Seville, SpainAndalusian School of Public Health, Granada, SpainInstituto de Investigación Biosanitaria ibs, Granada, SpainCIBER of Epidemiology and Public Health (CIBERESP), Madrid, SpainCátedra de Economía de la Salud y Dirección de Organizaciones Sanitarias (Esalud2), Granada, SpainWorld Health Organization Regional Office for Europe, Copenhagen, DenmarkWorld Health Organization Regional Office for Europe, Copenhagen, DenmarkDepartment of Applied Economics, University of Granada, Granada, SpainIntroduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers. While there are many theoretical papers on pricing and reimbursement (P&R) options, original empirical research is very scarce. This paper aims to provide a comprehensive international review of regulatory and P&R decisions taken for all ATMPs with centralized European marketing authorization in March 2022.Methods: A survey was distributed in July 2022 to representatives of 46 countries.Results: Responses were received from 20 countries out of 46 (43.5%). 14 countries reimbursed at least one ATMP. Six countries in this survey reimbursed no ATMPs.Conclusion: Access to ATMPs is uneven across the countries included in this study. This arises from regulatory differences, commercial decisions by marketing authorization holders, and the divergent assessment processes and criteria applied by payers. Moving towards greater equality of access will require cooperation between countries and stakeholders, for example, through the WHO Regional Office for Europe’s Access to Novel Medicines Platform.https://www.frontiersin.org/articles/10.3389/fphar.2023.1199500/fulladvanced therapy medicinal products (ATMPs)pricing and reimbursement (P&R)pharmaceutical policysurveyhealth technology assessment (HTA) |
| spellingShingle | Juan Carlos Rejon-Parrilla Jaime Espin Jaime Espin Jaime Espin Jaime Espin Sarah Garner Stanislav Kniazkov David Epstein Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries Frontiers in Pharmacology advanced therapy medicinal products (ATMPs) pricing and reimbursement (P&R) pharmaceutical policy survey health technology assessment (HTA) |
| title | Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries |
| title_full | Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries |
| title_fullStr | Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries |
| title_full_unstemmed | Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries |
| title_short | Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries |
| title_sort | pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries |
| topic | advanced therapy medicinal products (ATMPs) pricing and reimbursement (P&R) pharmaceutical policy survey health technology assessment (HTA) |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1199500/full |
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