@misc{10481/91027,
year = {2023},
month = {11},
url = {https://hdl.handle.net/10481/91027},
abstract = {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.},
organization = {Project PID
2019.105597RA.I00 financed by the Spanish Ministry of Science
and Innovation/National Research Agency MCIN/AEI/10.13039/
501100011033},
publisher = {Frontiers Media},
keywords = {Advanced therapy medicinal products (ATMPs)},
keywords = {Pricing and reimbursement (P&R)},
keywords = {Pharmaceutical policy},
title = {Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries},
doi = {10.3389/fphar.2023.1199500},
author = {Rejón Parrilla, Juan Carlos and Espín, Jaime and Garner, Sarah and Kniazkov, Stanislav and Epstein, David Mark},
}