Accesso precoce ai farmaci: una proposta di riforma per il Servizio Sanitario Nazionale

Glob Reg Health Technol Assess. 2024 Jun 17:11:148-153. doi: 10.33393/grhta.2024.3098. eCollection 2024 Jan-Dec.
[Article in Italian]

Abstract

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.

Grants and funding

Conflict of interest: PP and AC have no conflict of interest to declare; GG is an employee of Roche; CJ reported serving as an advisory board member and a paid speaker for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, CSL Behring, Gilead, Incyte, Merck Sharp & Dohme, Roche, Sanofi, Takeda, outside the submitted work.