{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T15:11:06Z","timestamp":1779203466861,"version":"3.51.4"},"reference-count":18,"publisher":"Aboutscience Srl","issue":"1","license":[{"start":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T00:00:00Z","timestamp":1779148800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Grhta"],"abstract":"<jats:p>Introduction: Timely access to new medicines is a key dimension of health system performance. In Italy, pricingand reimbursement decisions are taken by the Italian Medicines Agency (AIFA). In 2024, a reform established theScientific and Economic Commission (CSE), integrating the former Technical-Scientific Committee and Pricing andReimbursement Committee into a single decision-making body. This study evaluates whether the introduction ofthe CSE is associated with changes in the duration of the price and reimbursement process.Methods: An observational pre-post study was conducted using publicly available AIFA regulatory data. Newchemical entities and orphan medicines under negotiation type 1 reimbursed between January 2022 and January2026 were included. Time intervals were reconstructed from official AIFA committee agendas and comparedbetween pre-reform (CTS\/CPR) and post-reform (CSE) periods. Differences were assessed using the Wilcoxonrank-sum test.Results: The sample included 71 medicines (30 pre-reform; 41 post-reform). The median duration of the evaluationand negotiation phase decreased from 195 to 119 days after the introduction of the CSE (p &lt; 0.004). Overalltime to publication also decreased but not significantly. Administrative timelines remained stable.Conclusions: The CSE was associated with a significant reduction in evaluation-negotiation timelines, suggestingimproved efficiency in the phase targeted by the reform. However, no significant reduction was observed in overalltimelines, indicating persistent delays in downstream administrative phases.<\/jats:p>","DOI":"10.33393\/grhta.2026.3736","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T14:42:11Z","timestamp":1779201731000},"page":"125-132","source":"Crossref","is-referenced-by-count":0,"title":["The AIFA reform and evaluation timelines for new drugs: the impact of the Scientific and Economic Commission"],"prefix":"10.33393","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8404-8573","authenticated-orcid":false,"given":"Benedetta","family":"Dal Canto","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9525-258X","authenticated-orcid":false,"given":"Vera","family":"Benedetto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2090-7107","authenticated-orcid":false,"given":"Alma","family":"Martelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanna","family":"Scroccaro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8640-9223","authenticated-orcid":false,"given":"Bruna","family":"Vinci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"18642","published-online":{"date-parts":[[2026,5,19]]},"reference":[{"key":"19751","doi-asserted-by":"crossref","unstructured":"Godman B, Bucsics A, Vella Bonanno P, et al. Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets. Front Public Health. 2018;6:328. https:\/\/doi.org\/10.3389\/fpubh.2018.00328 PMID:30568938","DOI":"10.3389\/fpubh.2018.00328"},{"key":"19752","doi-asserted-by":"crossref","unstructured":"Oortwijn W, Determann D, Schiffers K. Towards Integrated Health Technology Assessment for Improving Decision Making in Selected Countries. Value in Health 2017; 20, 1121-1130 https:\/\/doi.org\/10.1016\/j.jval.2017.03.011","DOI":"10.1016\/j.jval.2017.03.011"},{"key":"19753","doi-asserted-by":"crossref","unstructured":"Kristensen FB, Husereau D, Hui\u0107 M, et al. Identifying the Need for Good Practices in Health Technology Assessment: Summary of the ISPOR HTA Council Working Group Report on Good Practices in HTA. Value Health. 2019;22(1):13-20. https:\/\/doi.org\/10.1016\/j.jval.2018.08.010 PMID:30661627","DOI":"10.1016\/j.jval.2018.08.010"},{"key":"19754","unstructured":"HTA Glossary. Health Technology Assessment. 2025. Online http:\/\/htaglossary.net\/health-technology-assessment (Accessed January 2026)"},{"key":"19755","unstructured":"EUR-Lex. Regulation (EC) No 726\/2004 of the European Parliament and of the Council of 31 March 2004 Laying down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency (Text with EEA Relevance). Vol 136. 2004. Online http:\/\/data.europa.eu\/eli\/reg\/2004\/726\/oj (Accessed January 2026)"},{"key":"19756","doi-asserted-by":"crossref","unstructured":"Folino-Gallo P, Montilla S, Bruzzone M, Martini N. Pricing and reimbursement of pharmaceuticals in Italy. Eur J Health Econ. 2008;9(3):305-310. https:\/\/doi.org\/10.1007\/s10198-008-0114-5 PMID:18566845","DOI":"10.1007\/s10198-008-0114-5"},{"key":"19757","unstructured":"Newton M, Stoddart K, Travaglio M, Troein P. EFPIA Patients W.A.I.T. Indicator 2024 Survey. Online https:\/\/www.efpia.eu\/media\/oeganukm\/efpia-patients-wait-indicator-2024-final-110425.pdf (Accessed January 2026)"},{"key":"19758","doi-asserted-by":"crossref","unstructured":"Lidonnici D, Ronco V, Isernia M et al. Access times to medicines in Italy in the period 2015-2017: Analysis of the evaluation times of the Italian Medicines Agency. Global and Regional Health Technology Assessment. 2018;5(1). https:\/\/doi.org\/10.33393\/grht","DOI":"10.1177\/2284240318792449"},{"key":"19759","doi-asserted-by":"crossref","unstructured":"Raimondo P, Casilli G, Isernia M, et al. AIFA time-to-reimbursement: a comparison between the last two committees from 2015 to 2020. Glob Reg Health Technol Assess. 2020;7(1):109-114. https:\/\/doi.org\/10.33393\/grhta.2020.2173 PMID:36627956","DOI":"10.33393\/grhta.2020.2173"},{"key":"19760","doi-asserted-by":"crossref","unstructured":"Prada M, Ruggeri M, Sansone C, et al. Timeline of Authorization and Reimbursement for Oncology Drugs in Italy in the Last 3 Years. Medicine Access @ Point of Care. 2017;1:maapoc.0000007. https:\/\/doi.org\/10.5301\/maapoc.0000007","DOI":"10.5301\/maapoc.0000007"},{"key":"19761","doi-asserted-by":"crossref","unstructured":"Tedesco A, Bonfanti M, Barugolo A, Luccini F, Berto P. Time to market evaluation for new chemical entities in Italy: a critical analysis of the period 2018-2024. Glob Reg Health Technol Assess. 2025;12(1):141-150. https:\/\/doi.org\/10.33393\/grhta.2025.3422 PMID:40401201","DOI":"10.33393\/grhta.2025.3422"},{"key":"19762","unstructured":"European Parliament. Legislative Decree 219\/2006. Enforcement of Directive 2001\/83\/EC on the Community Code Relating to Medicinal Products for Human Use. Online https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-1_en (Accessed January 2026)"},{"key":"19763","unstructured":"LEGGE 8 novembre 2012, n. 189 - Normattiva. 2012. Online https:\/\/www.normattiva.it\/uri-res\/N2Ls?urn:nir:stato:legge:2012-11-08;189 (Accessed January 2026)"},{"key":"19764","unstructured":"AIFA. Accesso precoce. 2025. Online https:\/\/www.aifa.gov.it\/accesso-precoce-uso-off-label (Accessed January 2026)"},{"key":"19765","unstructured":"AIFA. Lista dei farmaci valutati per inserimento in Classe C(nn). 2025. Online https:\/\/www.aifa.gov.it\/legge-189-2012 (Accessed January 2026)"},{"key":"19766","unstructured":"GALLERY\u00ae - Compendio Farmaceutico WEB - \u00a9Farmadati Italia. 2025. Online https:\/\/gallery.farmadati.it\/Home.aspx (Accessed January 2026)"},{"key":"19767","unstructured":"Linee guida per la compilazione del dossier a supporto della domanda di rimborsabilit\u00e0 e prezzo di un medicinale. 2019. 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