The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines
Background: The duration of price&reimbursement (P&R) procedures is taken as a key performance indicator of Regulatory Agencies in Europe. In this study we have tested the hypothesis that the price of medicines may have negatively affected the duration of P&R negotiations in Italy in the...
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AboutScience Srl
2025-01-01
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| Series: | Global & Regional Health Technology Assessment |
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| Online Access: | https://journals.aboutscience.eu/index.php/grhta/article/view/3259 |
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| author | Raffaella Cocciolo Paola Turella Daniela Pilunni Pierluigi Navarra |
| author_facet | Raffaella Cocciolo Paola Turella Daniela Pilunni Pierluigi Navarra |
| author_sort | Raffaella Cocciolo |
| collection | DOAJ |
| description | Background: The duration of price&reimbursement (P&R) procedures is taken as a key performance indicator of Regulatory Agencies in Europe. In this study we have tested the hypothesis that the price of medicines may have negatively affected the duration of P&R negotiations in Italy in the period 2021-2023.
Methods: Data were retrieved from the Intexo database, which included all medicines with EC approval within the period 2021-2023. Biosimilars, generics, gene therapies, Sars-Cov-2 vaccines and medicines with no negotiated price at the datalock of December 2023 were excluded from the analysis. The ex-factory price of the most expensive package was taken as the price of each reimbursed medicine, whereas the time between the publication of EC decision in the European GU and the publication of P&R AIFA decision in the Italian GU (gazette-to-gazette time) as well as the time between the submission of P&R dossier and the publication of AIFA decision in the Italian GU (AIFA negotiation time) were taken as the procedure duration.
Results: Sixty-seven EC approved medicines completed the P&R procedure in Italy within the study period, and had a reimbursed price. The median and mean gazette-to-gazette times were 395 and 442.6 days, respectively, whereas the mean and median AIFA negotiation times were 389.5 and 434.7 days, respectively. The mean price was 10,942 euros. The analysis of correlation between the duration of procedure and the negotiated price showed that there is no correlation whatsoever between the length of procedures and the price of medicines.
Conclusions: We can reasonably exclude that the price of medicines negatively affected the duration of P&R negotiation procedures.
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| format | Article |
| id | doaj-art-a9a4c47bc844464d9fa3b5d2f69a955b |
| institution | Kabale University |
| issn | 2284-2403 2283-5733 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | AboutScience Srl |
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| series | Global & Regional Health Technology Assessment |
| spelling | doaj-art-a9a4c47bc844464d9fa3b5d2f69a955b2025-01-15T14:02:59ZengAboutScience SrlGlobal & Regional Health Technology Assessment2284-24032283-57332025-01-0112110.33393/grhta.2025.3259The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicinesRaffaella Cocciolo0Paola Turella1Daniela Pilunni2Pierluigi Navarra3Intexo Società Benefit, a ProductLifeGroup Company, Roma - ItalyIntexo Società Benefit, a ProductLifeGroup Company, Roma - ItalyFarmacia Prodotti Sperimentali, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma - ItalyDipartimento di Sicurezza e Bioetica, Sezione di Farmacologia, Facoltà di Medicina e Chirurgia, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma - ItalyBackground: The duration of price&reimbursement (P&R) procedures is taken as a key performance indicator of Regulatory Agencies in Europe. In this study we have tested the hypothesis that the price of medicines may have negatively affected the duration of P&R negotiations in Italy in the period 2021-2023. Methods: Data were retrieved from the Intexo database, which included all medicines with EC approval within the period 2021-2023. Biosimilars, generics, gene therapies, Sars-Cov-2 vaccines and medicines with no negotiated price at the datalock of December 2023 were excluded from the analysis. The ex-factory price of the most expensive package was taken as the price of each reimbursed medicine, whereas the time between the publication of EC decision in the European GU and the publication of P&R AIFA decision in the Italian GU (gazette-to-gazette time) as well as the time between the submission of P&R dossier and the publication of AIFA decision in the Italian GU (AIFA negotiation time) were taken as the procedure duration. Results: Sixty-seven EC approved medicines completed the P&R procedure in Italy within the study period, and had a reimbursed price. The median and mean gazette-to-gazette times were 395 and 442.6 days, respectively, whereas the mean and median AIFA negotiation times were 389.5 and 434.7 days, respectively. The mean price was 10,942 euros. The analysis of correlation between the duration of procedure and the negotiated price showed that there is no correlation whatsoever between the length of procedures and the price of medicines. Conclusions: We can reasonably exclude that the price of medicines negatively affected the duration of P&R negotiation procedures. https://journals.aboutscience.eu/index.php/grhta/article/view/3259ItalyPrice&Reimbursement procedures |
| spellingShingle | Raffaella Cocciolo Paola Turella Daniela Pilunni Pierluigi Navarra The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines Global & Regional Health Technology Assessment Italy Price&Reimbursement procedures |
| title | The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines |
| title_full | The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines |
| title_fullStr | The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines |
| title_full_unstemmed | The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines |
| title_short | The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines |
| title_sort | length of price reimbursement negotiation procedures in italy in the period 2021 2023 was independent from the price of medicines |
| topic | Italy Price&Reimbursement procedures |
| url | https://journals.aboutscience.eu/index.php/grhta/article/view/3259 |
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