The case

Early Alzheimer's, drug agency gives 'halt' to first two anti-amyloid monoclonal antibodies

Aifa's Scientific and Economic Commission denies for the time being the reimbursability of lecanemab and donanemab indicated for the treatment of early-stage disease and after rigorous selection of patients to avoid the most serious risks

by Barbara Gobbi

18 March 2026

5' min read

Translated by AI

Versione italiana

Key points

Patients' bitterness
Inadequate care network
The promise: we will not leave patients alone

5' min read

Translated by AI

Versione italiana

Announcing the Italian Medicines Agency's probable 'thumbs down' was AIFA's technical-scientific director Pierluigi Russo in a social media post early on Wednesday morning, 18 March: 'Deciding not to reimburse a medicine is sometimes a terribly complex decision. Many underestimate the scope of this decision, reducing it to a simple technical assessment, others simplify it by reducing it to a generic sustainability. The reality is much more complicated and means knowing how to deal with uncertainty, weighing conflicting risks in an ethical, individual and social dimension that does not contemplate simplistic shortcuts'. Translated, for those who were waiting for a decision considered crucial, especially by the associations of patients and their families: the two monoclonal drugs for the mild forms of Alzheimer's, approved by the US Fda and the European Medicines Agency (Ema) and therefore submitted to the Scientific and Economic Commission for Medicines (CSE) for a check, have not been admitted for reimbursement in Italia for the time being.

A 'halt' - although still awaiting official approval and passage on Tuesday 25 March by the Agency's board of directors - which will be explained to the pharmaceutical companies of reference, i.e. Eisai-Biogen, developers of lecanemab, and Lilly of donanemab, in the letter in which Aifa will detail the reasons behind its choice, as is standard practice.
And it was only late in the evening that Aifa made it known that 'the process of evaluating the two medicines is not yet definitively concluded, and any intermediate negative decisions by the Commission may in any case be subject to subsequent reassessment. At the final conclusion of the process, the Agency will publicly announce the outcome of the procedures'.

The bitterness of the patients

'In other European countries,' Director Russo wrote in his post, 'the same decision was easier, because they do not have an NHS like ours. Let us remember this when we then too lightly and harshly point out errors or inefficiencies, on which we certainly need to work. One really appreciates what one has, when one loses it, or when one cannot have it at all'.
In the meantime, the patients' associations' comment came in a trancing tone: 'I learn through unofficial channels that Aifa has given a negative opinion on the introduction of anti-amyloid monoclonal drugs in the reimbursability band. This decision, if confirmed, scandalises and disconcerts me for many reasons,' begins Patrizia Spadin, president of Aima-Associazione italiana malattia di Alzheimer. 'However small the number of patients eligible for treatment, the possibility of benefit is denied to people who are thus condemned to live the full drama of Alzheimer's disease. In fact, access would remain reserved for those who can pay privately for the entire costly course of treatment, confirming that Alzheimer's is a disease for the rich,' concluded the Aifa president, recalling that 'each drug costs about 26,000 euro a year per patient'.

An inadequate care network

To the scientific societies concerned, such as the Italian Society of Neurology (Sin), Aifa had posed a number of questions concerning the selection pathway, i.e. the early diagnosis and inclusion/exclusion criteria for patients, as well as concerning outcome indicators. That is, how to measure the benefits of therapies, how to guarantee active monitoring for possible side effects, and what requirements for prescribing or infusion centres should be considered to ensure fair access in the regions.

If the reasons for the AIFA Commission's choice - which was not split between 'for' and 'against' but rather between 'against' and 'uncertain' - have yet to be clarified, what is certain is that Italia has a network for taking care of patients that is still inadequate, with serious shortcomings both in the spread of cognitive disorders and dementia centres - the Cdcd that have replaced the old Alzheimer's Assessment Units - and in the availability of adequately trained staff.

Aifa's 'no' to reimbursability could also contain these considerations under wraps. Although for those who look at the glass half full, a green light could on the contrary have given care the acceleration that has been lacking until now. 'We had to wait for the arrival of the new molecules to make it clear that the care network for Alzheimer's patients is inadequate and insufficient,' Spadin comments. 'Aifa's decision, if confirmed, can only reassure local and national institutions that there is no urgency for reorganisation and that the status quo is quietly being maintained, still leaving families with the majority of the burden of managing the disease. We have waited 26 years since the signing of the Cronos project, born when cholinesterase inhibitors appeared, for research to produce some results for Alzheimer's patients as well. After so many disappointments, something concrete has finally arrived and today we are being asked to close our eyes and pretend nothing has happened. Such a negative decision is unacceptable, and what is more, it comes after the confirmation of the note 85 decided by Aifa a few months ago. The lives of Alzheimer's patients and their families are worth very little to our institutions,' the AIMA president concludes, 'if they can ignore their needs and extinguish their hopes.

The promise: we will not leave patients alone

Elias Khalil, President and General Manager of Lilly Italy Hub, speaks of 'serious damage for Italian patients and their families' if the negative opinion on reimbursability is confirmed. "It would mean leaving Italia behind compared to other countries," he warns, "forcing citizens to personally bear the cost of drugs that can represent a real opportunity for treatment, as already defined by the European Medicines Agency (Ema). As a company, we will not leave the Italians alone,' he promises. 'We will continue to guarantee free treatment to the almost 200 patients already undergoing treatment, and we will work with hospitals and individual centres to promote sustainable access models, so as to offer the widest possible possibility of treatment even in the absence of public financial support, and not to leave alone the poorest patients who cannot afford to purchase treatment.

From Eisai they recall that the available data - already positively evaluated by the Ema as part of the process that led to the drug's approval in Europe - indicate that 81% of patients remain in the early stages of the disease after four years of treatment. At the same time, 'the company continues to produce further scientific evidence on the safety profile of the treatment, with a view to full transparency towards the regulatory authorities and the scientific community'. As for the difficulties of the Italian treatment network, the company says it is 'committed to working with institutions, clinicians and the National Health Service to develop treatment paths, organisational models and care networks that can make the introduction of new Alzheimer's therapies as sustainable and appropriate as possible'. Hence the hope 'that the current stage of the regulatory pathway will represent a moment of further discussion and in-depth analysis - and not a setback - in the process aimed at defining the conditions for the reimbursability of new treatments against Alzheimer's in the early stages of the disease'.