Follow the Money: Reporting Public Contributions and Incentives on Research and Development Programs for Agenzia Italiana Del Farmaco (AIFA; ITALIAN MEDICINES AGENCY)

Author(s)

Pourrahmat MM1, Maposa P1, del Aguila M2, Fazeli MS1
1Evidinno Outcome Research Inc., Vancouver, BC, Canada, 2Evidinno Outcome Research Inc., Danville, CA, USA

OBJECTIVES: In October 2020, Italy adopted the Pricing and Reimbursement Decree from AIFA. Pharmaceutical companies seeking reimbursement must provide information about public contributions and incentives received on research and development programs. We identified sources of publicly available information regarding public contributions and incentives for research and development of four medicinal products treating acute myeloid leukemia, multiple myeloma, non-Hodgkin lymphoma, and primary myelofibrosis.

METHODS: A search identified databases with a public repository on contributions and incentives granted by bodies governed by public law. Publicly funded research databases included (region): Consiglio Nazionale delle Ricerche, AIFA, Governo italiano, and Ministero della Salute (Italy), L'Agence nationale de la recherche and scanR (France), Deutsche Forschungsgemeinschaft (Germany), Ministry for Science and Innovation, IIb Sant Pau, Carlos III Health Institute (Spain), Research and Innovation (United Kingdom), Community Research and Development Information Service (European Union [EU]), RePORT (United States [US]), and Grants and Contribution Dataset (Canada).

Across all databases identified above, various terms for drug names, disease area, drug class, manufacturer/sponsor names, and names/registration numbers of pivotal trials were searched. Additional grey literature searches of US and EU clinical trial registry databases identified sponsors of relevant clinical trials. Targeted online searches identified relevant news articles, publications, and press releases. Only information related to public contributions, grants, subsidies, tax rebates as well as other forms of sponsorship were captured.

RESULTS: Information related to the nature of contributions, geographical origin and disburser was available; however, information pertaining to contributions and intellectual property rights or profit-sharing schemes were not uniformly found. Information was most available from the US, particularly for studies funded by governmental agencies. Italy had some funding information, while other EU countries and the United Kingdom reported projects but not funding.

CONCLUSIONS: While difficult and time-consuming, it is possible to identify and provide this information in reimbursement dossiers submitted in Italy.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

HPR33

Topic

Health Policy & Regulatory

Topic Subcategory

Insurance Systems & National Health Care

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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