Life Sciences Horizons Brochure 2025 - Flipbook - Page 105
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2025 Horizons Life Sciences and Health Care
Italian Medicinal Agency (AIFA) reform and its impact on innovative medicines
In January 2024, the Italian Medicines Agency (AIFA)
underwent a significant restructuring to streamline
drug approval processes and facilitate faster access
to innovative therapies. This reform, introduced by
Ministry of Health Decree No. 3 of 8 January 2024,
represents a pivotal step in modernizing Italy's
pharmaceutical landscape.
The cornerstone of the reform is the unification of AIFA’s two
main decision-making bodies: the Technical Scientific Committee
(CTS) and the Price and Reimbursement Commission (CPR).
Historically, CTS conducted scientific evaluations, while CPR
managed pricing and economic assessments. This bifurcated
structure often led to significant delays in drug approvals due
to divergent perspectives and the need for iterative discussions
between the two bodies.
To address these inefficiencies, the reform merged CTS and CPR
into a single entity: the Scientific and Economic Commission
for Medicines (CSE), which is now tasked with conducting
comprehensive, 360-degree evaluations of medicinal products,
combining clinical and economic perspectives. Additionally, for
the first time, the new CSE Regulation allows patient associations
and scientific societies to be involved in decision-making
processes to provide broader insights. We have identified the
following key impacts on the pharmaceutical market:
Faster access to innovative medicines. By consolidating
evaluations into a single streamlined framework, the reform aims
at reducing significantly approval timelines, particularly for
advanced therapies addressing complex conditions or unmet
medical needs. Indeed, according to AIFA’s President, in the
short time since the reform was implemented, the reformed AIFA
cleared over 150 backlogged dossiers and expedited approval
times for new medicines.
Comprehensive evaluations. The CSE's integrated framework
enables a holistic assessment of innovative therapies by
considering clinical efficacy, safety, cost-effectiveness, and
socioeconomic impacts simultaneously. This approach ensures
that the long-term benefits of high-cost treatments are balanced
against their immediate financial impact, thus ensuring that the
innovative nature of these products is fully recognized while
considering their broader impact on health care systems.
Italy already demonstrated strong performance in efficiency and
accessibility before the reform. According to the EFPIA “Patients
W.A.I.T. Indicator 2023 Survey,” the average timeline for making
new medicines available – measured as the time between
European marketing authorization and inclusion on the public
reimbursement list – was 424 days, below the European average of
531 days. For oncology drugs, the timeline was 417 days compared
to the European benchmark of 559 days. Additionally, 77% of
centrally approved medicines from 2019 to 2022 were made
available in Italy, surpassing the European average of 72%,
with 62% enjoying full NHS coverage.
By building on an already strong foundation, the reform has the
potential to make Italy more and more competitive and a leading
player in Europe’s pharmaceutical sector.
Giuseppe Aminzade
Counsel
Milan
Angelo Forte
Associate
Milan
