Time to reimbursement and negotiation condition in Italy for drugs approved by the European Medicines Agency during the period 2014-2019


  • Mariangela Prada Intexo Società Benefit, Rome - Italy
  • Letizia Rossi Intexo Società Benefit, Rome - Italy
  • Matteo Mantovani Intexo Società Benefit, Rome - Italy




Accessibility, Market access, Regulatory, Reimbursability, Time to market


Introduction: The main purpose of this study was comparing median time (TTR, time to reimbursement) between the first Agenzia Italiana del Farmaco (AIFA) pricing and reimbursement (P&R) dossier’s evaluation and patient access in Italy and to observe the key P&R negotiation results for all new active substances approved by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use between January 2014 and December 2019. We analysed the different factors influencing TTR.

Methods: A panel of medicines for human use approved by the EMA in the period 2014-2019 was considered. All information about authorisation and reimbursement in Italy, including timelines and results from the negotiation, were gathered through EMA and Italian Official Journal databases.

Results: Of 213 new active substances approved from January 2014 to December 2019, 137 obtained reimbursement in Italy, with a median TTR of 7.6 months (228 days). Even if orphan designation, oncology indication, application of Managed Entry Agreements (MEAs; both outcome and financial based) or a discount did not show an impact on TTR, recognition of full innovativeness (n = 27; 20%) was associated with a reduction of 1 month in median TTR. Interestingly, drugs reimbursed with a lower price/daily defined dose showed a reduced TTR (−22%).

Conclusions: Even if the lack of impact of some negotiation conditions was predictable (e.g. oncology indication or orphan status) or the application of a MEA helped to manage possible uncertainties, it did not lead to a quicker completion of the negotiation procedure. Likewise, full innovative drugs showed a shorter TTR underlying the AIFA commitment in recognising, promoting and rewarding innovation.


Download data is not yet available.


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. Available online https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004R0726. [Accessed July 8, 2020].

EUR-Lex. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Available online https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993R2309:EN:HTML. [Accessed July 8, 2020].

European Medicines Agency. Available online https://www.ema.europa.eu/en. [Accessed July 8, 2020].

AIFA. Comunicato alle aziende farmaceutiche relativo agli adempimenti successivi all’entrata in vigore della legge 8 novembre 2012 n. 189, di conversione del decreto legge n. 158/2012 recante “disposizioni urgenti per promuovere lo sviluppo del paese mediante un piu’ alto livello di tutela della salute”. Available online http://www.agenziafarmaco.gov.it/sites/default/files/comunicazione_legge189_12.pdf. [Accessed July 8, 2020].

Gazzetta Ufficiale. LEGGE 8 novembre 2012, n. 189. Available online https://www.gazzettaufficiale.it/eli/id/2012/11/10/012G0212/sg. [Accessed July 8, 2020].

Gazzetta Ufficiale. DECRETO-LEGGE 27 maggio 2005, n. 87. Available online https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2005-05-30&atto.codiceRedazionale=005G0112&elenco30giorni=false. [Accessed July 8, 2020].

AIFA. Criteri di valutazione dell’innovatività. Available online https://www.aifa.gov.it/documents/20142/241044/Allegato_1_1.pdf/66558a13-543c-9643-e67b-85be01547465. [Accessed July 8, 2020].

Gazzetta Ufficiale. Art. 9. Proroghe e disposizioni in materia di farmaci. Available online https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticolo?art.progressivo=0&art.idArticolo=9&art.versione=1&art.codiceRedazionale=08A01632&art.dataPubblicazioneGazzetta=2008-03-18&art.idGruppo=4&art.idSottoArticolo1=10&art.idSottoArticolo=1&art.flagTipoArticolo=0. [Accessed July 8, 2020].

Gazzetta Ufficiale. Art. 10. Modificazioni al decreto legislativo 24 aprile 2006, n. 219, e norme sull’innovatività terapeutica. Available online https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticolo?art.progressivo=0&art.idArticolo=10&art.versione=1&art.codiceRedazionale=12A11988&art.dataPubblicazioneGazzetta=2012-11-10&art.idGruppo=3&art.idSottoArticolo1=10&art.idSottoArticolo=1&art.flagTipoArticolo=0. [Accessed July 8, 2020].

Gazzetta Ufficiale. DECRETO 2 agosto 2019, n. 185. Available online https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2020-07-24&atto.codiceRedazionale=20A03810&elenco30giorni=false[Accessed July 27, 2020]

Villa F, Jommi C, Genazzani A, Antignani S, Montilla S, Melazzini M. Accesso precoce al mercato: dalle approvazioni condizionate di EMA agli accordi negoziali particolari di AIFA. Global & Regional Health Technology Assessment; 2018(5);1. DOI https://doi.org/10.33393/grhta.2018.430

Villa F, Tutone M, Altamura G, et al. Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency. Health Policy. 2019;123(6):595-600. https://doi.org/10.1016/j.healthpol.2019.03.009 PMID:31097207

AIFA. Registri farmaci sottoposti a monitoraggio. Available online https://www.aifa.gov.it/web/guest/registri-farmaci-sottoposti-a-monitoraggio. [Accessed July 8, 2020].

WHO. ATC/DDD Index 2020. Available online https://www.whocc.no/atc_ddd_index/. [Accessed July 8, 2020].

Trotta F, Mayer F, Barone-Adesi F, et al. Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy. BMJ Open. 2019;9(12):e033728. https://doi.org/10.1136/bmjopen-2019-033728 PMID:31826897

Jommi C, Armeni P, Costa F, Bertolani A, Otto M. Implementation of Value-based Pricing for Medicines. Clin Ther. 2020;42(1):15-24. https://doi.org/10.1016/j.clinthera.2019.11.006 PMID:31882225

Villa F, Tutone M, Altamura G et al. Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency, Health Policy 123 (2019) 5 95 –600.

Russo P, Mennini FS, Siviero PD, Rasi G. Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers. Ann Oncol. 2010;21(10):2081-2087. https://doi.org/10.1093/annonc/mdq097 PMID:20335370

Gori S, Di Maio M, Pinto C, et al; AIOM Working Group “Interactions with Regional Sections” (2009-2011). Disparity in the “time to patient access” to new anti-cancer drugs in Italian regions. Results of a survey conducted by the Italian Society of Medical Oncology (AIOM). Tumori. 2011;97(4):442-448. https://doi.org/10.1177/030089161109700405 PMID:21989431

Prada M, Ruggeri M, Sansone C, De Fazio D, Tettamanti A, Mantovani M. Timeline of authorization and reimbursement for oncology drugs in Italy in the last 3 years. Medicine Access @. Point Care. 2017;1(1):e29-e36.

Lidonnici D, Ronco V, Isernia M, et al. Tempi di accesso ai farmaci in Italia nel periodo 2015-2017: Analisi delle tempistiche di valutazione dell’Agenzia Italiana del Farmaco. Global & Regional Health Technology Assessment Volume; 2018(5)1. DOI https://doi.org/10.33393/grhta.2018.433



How to Cite

Prada, M., Rossi, L., & Mantovani, M. (2020). Time to reimbursement and negotiation condition in Italy for drugs approved by the European Medicines Agency during the period 2014-2019. AboutOpen, 7(1), 89–94. https://doi.org/10.33393/abtpn.2020.2184



Original research articles


Received 2020-09-15
Accepted 2020-11-17
Published 2020-12-18