The Italian Medicines Agency has published their annual AIFA Activity Report in 2025, outlining the key facts and figures regarding pharma and biotech market access in Italy for 2024. It offers a comprehensive overview of last year that marked a historic turning point for the Italian Medicines Agency, as in 2024 the AIFA reform came into force, reshaping the Agency’s governance and organizational structure.
The New AIFA Organisational Model – A Reformed Approach to Market Access
The AIFA reform, introduced by the Ministerial Decree no. 3 of 8 January 2024, brought profound changes to the Agency’s structure and functioning. Among the most significant updates:
- The role of General Director was abolished and legal representation of the Agency was transferred to the President
- The Agency was reorganized into two main Directorates, comprising six areas and 43 offices
- The former Technical-Scientific Commission (CTS) and Pricing and Reimbursement Committee (CPR) were replaced by the new Scientific and Economic Commission (CSE), which now oversees both technical-scientific assessments and economic negotiations for medicines.
This comprehensive restructuring has led to a more integrated approach to drug evaluation, combining scientific and economic perspectives within a single body. However, it also led to non-negligeable delays in medicine assessment timelines.
Italian pharma and biotech approvals in numbers for 2024
In 2024, AIFA authorized 889 medicines, of which 228 reimbursed by the National Health Service (SSN), while the rest (661) remains at the citizen’s expense.
The Agency also recorded total revenues of €159.52 million, with profits amounting to €31.5 million.
Italian early and compassionate access programmes in numbers for 2024
Ensuring early access to promising therapies remains one of AIFA’s core missions. In 2024:
- 80 requests were managed under Law 648/1996 (+3.9% vs 2023), allowing SSN reimbursement for drugs not yet authorized in Italy or for unapproved indications
- 18 new compassionate use programs were approved (-5.3% vs 2023), involving 1,642 patients, with treatment costs covered by manufacturers
- 79 authorizations were granted for the non-repetitive use of advanced therapies (ATMPs) in exceptional clinical cases (+21.5% vs 2023)
- 468 requests were processed through the AIFA National Fund (5% Fund, Law 326/2003), supporting access to orphan drugs awaiting commercialization (-15.2% vs 2023).
Italian pathway for innovative medicines – 2024 numbers
Promoting pharmaceutical innovation remains central to AIFA’s mission. The Agency participates in the European Innovation Network (EU-IN) and offers Scientific Advice and Innovation Meetings at both national and EU levels. It also published the Horizon Scanning Report – Scenario of Upcoming Medicines 2024, identifying new therapeutic options with potential impact on public healthcare spending.
In 2024, full innovation status (innovatività piena) was granted to IMCIVREE (setmelanotide) for obesity and hunger control associated with Bardet-Biedl syndrome. Six other medicines received conditional innovation status, while twelve applications were not approved.
Italy’s participation in the EU HTA and Joint Clinical Assessments
AIFA continues to play an active role in European initiatives such as the implementation of the EU Regulation on Health Technology Assessment (HTA), coordinating Joint Clinical Assessments (JCA) and contributing to a harmonized European approach to evaluation. At the time of writing, AIFA is yet to be an assessor/co-assessor for an HTA.
JSC Market Access Consulting Firm – Over 10 years of expertise
Justin Stindt Consultants is a seasoned market access consultancy with over 10 years of expertise. Our market access consulting experts support clients through every step of the Italian market access journey — from early strategy to post-launch optimization. Learn more about our core expertise:
- Italian Market Access Strategy
- AIFA HTA Dossier Development and Negotiation Support
- Early access programs Italy
- Pricing & Reimbursement strategies
- Strategic advice on Pricing & Reimbursement Pathways Italy
- Analogue research & Price Benchmarking
- Market Access Landscape Assessments
Why Choose Justin Stindt Consultants as your market access consulting partner
- Proven Expertise: With years of experience in global pricing and reimbursement, our team offers unparalleled expertise and strategic insights.
- Tailored Solutions: We understand that each client and market is unique, and we provide customized solutions that address specific needs and challenges.
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- Regulatory Mastery: Our deep understanding of regulations, requirements and processes, including extensive experience with AIFA, positions us to effectively advocate for your products.
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