Early access programs for medicines: a reform proposal for the Italian National Health Service


  • Patrizia Popoli Centro Nazionale Ricerca e Valutazione Preclinica e Clinica dei Farmaci, Istituto Superiore di Sanità - Italy
  • Giovanni Giuliani Access Chapter, Roche SpA, Monza (MB) - Italy
  • Arturo Cavaliere Servizio Farmaceutico Aziendale, ASL Viterbo e SIFO - Italy
  • Claudio Jommi Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Novara - Italy https://orcid.org/0000-0002-2862-2990




Early access, Italy, Medicines, National Health Service


The present paper illustrates a reform proposal on early access for medicines. In this proposal early access stands for patient’s access, outside of clinical trials and covered by the Italian National Health Service (Servizio Sanitario Nazionale, SSN), to a new medicine or an indication of an already approved medicine before the approval o in between the approval and the decision on price and reimbursement status. The proposal emerged from a multi-stakeholder working group within the Sixth Edition of the “Seminari di Mogliano Veneto”. The reform proposal is aimed at converting the current early access programs (mainly, the programs introduced with Laws 648/96 and 326/03) into a single program inspired by the one introduced in France in 2021. The proposal provides indications on eligibility criteria for drugs and patients, application procedure, evaluation process, economic safeguard clauses, data collection, issues derived from the circumstance that the drug/indication included into the early access program is not reimbursed afterwards and the actions to implement this program.


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How to Cite

Popoli, P., Giuliani, G., Cavaliere, A., & Jommi, C. (2024). Early access programs for medicines: a reform proposal for the Italian National Health Service. Global and Regional Health Technology Assessment, 11(1), 148–153. https://doi.org/10.33393/grhta.2024.3098



Point of View


Received 2024-04-18
Accepted 2024-05-09
Published 2024-06-17


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