Italy’s medicines agency AIFA has taken a significant step forward in how health technology assessment bodies engage with stakeholders—and it’s excellent news for patients with Alzheimer’s disease.
For the first time since the agency’s restructuring, AIFA’s Board of Directors convened an audition with patient associations alongside leading neurology societies to discuss newly authorised monoclonal antibodies for early-stage Alzheimer’s treatment. The Italian Neurology Society, the Italian Society of Neurology of Dementia, and the Society of Hospital Neurologists presented a joint position, while the Italian Alzheimer’s Association and Alzheimer’s Italy Federation represented the patient perspective.
This marks a meaningful shift in how regulatory and reimbursement decisions are made. Historically, HTA bodies have operated behind closed doors, with limited patient or clinical society input during critical assessment phases. AIFA is now embedding stakeholder consultation directly into its governance processes, with formal mechanisms like “AIFA Ascolta” (for patient associations) and “AIFA Incontra” (for scientific and industry stakeholders) launching in early May.
For patients with Alzheimer’s and other serious conditions, this development is profoundly important. It means their voices—and those of the clinicians treating them—are heard before reimbursement decisions are finalised, not after. This improves the likelihood that access decisions reflect real-world clinical need, treatment burden, and patient priorities, not just economic modelling.
It’s also a signal to other European HTA bodies that transparent, participatory decision-making strengthens the legitimacy and quality of assessments. When patients and clinicians are consulted early, you reduce the risk of denying access to treatments that could meaningfully improve lives, particularly in areas of high unmet need like neurodegeneration.
This is how modern HTA should function—collaborative, transparent, and patient-centred.
https://www.aifa.gov.it/-/alzheimer_audite_in_cda_societa_scientifiche_e_associazioni
