{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T01:35:09Z","timestamp":1784165709929,"version":"3.55.0"},"reference-count":18,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,11,21]],"date-time":"2019-11-21T00:00:00Z","timestamp":1574294400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>In April 2017 the Italian Medicine Agency (AIFA) developed new criteria to grant any new medicinal product with an innovative designation. The aim of this study is to describe this new model and how it works.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A retrospective descriptive analysis was performed on the results of the assessment process of innovativeness of new medicinal products (or therapeutic indications) based on the AIFA's new innovation criteria (therapeutic need, added therapeutic value and quality of clinical evidence through GRADE methodology) carried out between April 2017 and February 2019 and made publicly available on the AIFA website starting from January 2018.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 37 full reports (22 for oncological indications) explaining the rationale for the AIFA's decision is made publicly available on the agency's website. A total of 12 therapeutic indications (5 oncological) were evaluated as <jats:italic>fully innovative<\/jats:italic>, 13 indications (11 oncological) were evaluated as <jats:italic>conditionally innovative<\/jats:italic>, while 12 indications (6 oncological) as <jats:italic>non\u2010innovative<\/jats:italic>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The new AIFA innovation criteria resulted in a much more flexible and transparent model to define and assess what constitutes a therapeutic innovation. In particular, the choice of AIFA to use the GRADE methodology to evaluate the quality of clinical evidence within a process of drug innovativeness assessment is essential for the early identification of the discrepancy between the need for patients of a rapid access to innovative therapies and the available clinical data needed to make decisions on drug innovativeness.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14138","type":"journal-article","created":{"date-parts":[[2019,10,27]],"date-time":"2019-10-27T07:48:19Z","timestamp":1572162499000},"page":"93-105","source":"Crossref","is-referenced-by-count":21,"title":["Using GRADE methodology to assess innovation of new medicinal products in Italy"],"prefix":"10.1111","volume":"86","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6587-9808","authenticated-orcid":false,"given":"Filomena","family":"Fortinguerra","sequence":"first","affiliation":[{"name":"Italian Medicines Agency (AIFA)  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9283-0153","authenticated-orcid":false,"given":"Giovanni","family":"Tafuri","sequence":"additional","affiliation":[{"name":"Italian Medicines Agency (AIFA)  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Trotta","sequence":"additional","affiliation":[{"name":"Italian Medicines Agency (AIFA)  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Addis","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Lazio Regional Health Service  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,11,21]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.115"},{"key":"e_1_2_10_3_1","first-page":"1413","article-title":"What is a truly innovative drug? New definition from the International Society of Drug Bulletins","volume":"48","author":"Kopp C","year":"2002","journal-title":"Can Fam Physician"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2006.09.009"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd3715"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j1680"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1700446"},{"key":"e_1_2_10_8_1","unstructured":"AIFA \u2013 Italian Medicines Agency Working Group on Innovative Drugs.Criteria for ranking therapeutic innovation of new drugs and elements for supplementing the dossier for admission to the reimbursement system July2007[online]. Available athttp:\/\/www.agenziafarmaco.gov.it\/allegati\/integral_document.pdf. (last accessed 4 September 2019)"},{"key":"e_1_2_10_9_1","unstructured":"AIFA.Criteri per la classificazione dei farmaci innovativi e dei farmaci oncologici innovativi (05\/04\/2017)[online]. Available athttps:\/\/www.aifa.gov.it\/documents\/20142\/241044\/Allegato_1_1.pdf\/66558a13\u2010543c\u20109643\u2010e67b\u201085be01547465(last accessed 4 September 2019)"},{"key":"e_1_2_10_10_1","article-title":"Using systematic reviews in guideline development: the GRADE approach","author":"Zhang Y","year":"2018","journal-title":"Res Synth Methods"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39489.470347.AD"},{"key":"e_1_2_10_12_1","unstructured":"AIFA.Report di valutazione dell'innovativit\u00e0 per indicazione terapeutica (11\/02\/2019)[online]. Available athttps:\/\/www.aifa.gov.it\/farmaci\u2010innovativi(last accessed 4 September 2019)"},{"key":"e_1_2_10_13_1","unstructured":"Legge n. 232 11 Dicembre 2016. Bilancio di previsione dello Stato per l'anno finanziario 2017 e bilancio pluriennale per il triennio 2017\u20132019(Budget Law 2017). GU n. 297 21 Dicembre 2016 \u2013 Suppl. n. 57"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i2016"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i2089"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12961-018-0320-2"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.02.019"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462317000447"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39490.551019.BE"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fbcp.14138","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14138","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bcp.14138","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14138","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T05:31:46Z","timestamp":1694151106000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1111\/bcp.14138"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,21]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,1]]}},"alternative-id":["10.1111\/bcp.14138"],"URL":"https:\/\/doi.org\/10.1111\/bcp.14138","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11,21]]}}}