In a long-awaited development, Italy’s Medicines Agency, AIFA, underwent transformative changes on January 30th, 2024.
This has been a recurrent topic of discussion, with talks of merging the Scientific Technical Advisory Committee (CTS) and the Price and Reimbursement Committee (CPR). However, the COVID-19 pandemic delayed these plans, leading to a continuous extension of the current committee members’ tenure.
The road to transforming AIFA into a more streamlined and efficient regulatory and health technology assessment (HTA) body accelerated with the State-Regions Conference agreement on November 15, 2023. Sources from the Ministry of Health (MoH) confirmed that the AIFA CTS and CPR were likely to remain operational for a maximum of 45 days after the 1st of Dec 2023 for a transitional phase.
The CTS and the CPR have continued their work, respectively on technical assessments and pricing and reimbursement negotiations, until mid-January. This extension aligned with the MoH’s assertion that all final steps, including appointments of the AIFA president, scientific and administrative directors, and CSE members, would be completed by mid-January 2024.
So, what can we expect from the new AIFA?
- Elimination of General Director
The General Director position no longer exists, leaving only the President, who becomes the legal representative of the agency.
- Administrative and Scientific-Technical Directors
The President will be supported by an Administrative Director and a Scientific Technical Director.
- Single Commission for Regulatory Activity
A single commission, the Scientific and Economic Commission for Medicines (CSE), consisting of 10 members, will replace the current 20-member strong CPR and CTS. This commission will handle regulatory activities such as approving and determining drug prices.
- Composition of the Scientific and Economic Commission
The commission will comprise of 10 members:
- The Technical-Scientific Director of the agency.
- The President of the Higher Institute of Health (ISS) or a delegate.
- One technician appointed by the Ministry of Economy.
- Three members appointed by the State-Regions Conference.
- Four members designated by the MoH with each having at least 5 years of experience in drug evaluation, pricing, and pharmacoeconomics.
The members can serve for a maximum of 2 terms, each lasting 3 years.
- Appointing System
The president will be chosen by the ministry in agreement with the Regions, providing Regions with a binding opinion. The appointment of administrative and scientific directors will not have a veto from regions but will involve their consultation.
These changes are unlikely to impact the current pricing and reimbursement methodology followed by AIFA, but we can reasonably hypothesize differences in assessment timelines. The new CSE will only have half of the staff that the previous CTS and CPR committees had. At the same time, the current back-and-forth dynamic that happened between the two commissions could be avoided thanks to a more streamlined approach introduced by the unique CSE working group.
In conclusion, the Italian agency stands at a pivotal juncture. It can evolve into a more agile AIFA, harmonizing the technical and economic facets of the CSE to assess a drug’s value holistically and set its price accordingly. OR, it may adopt a slower pace constrained by staff headcounts, and it could be influenced more by CSE’s economic side with factors like budgetary considerations ultimately influencing the drug’s benefit assessment.
The first half of 2024 will be crucial for manufacturers to monitor which route the new AIFA will follow to prepare any launch strategy updates better when considering the Italian market.
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