This is why Aifa's approval times for medicines are no longer short

With specific reference to the article signed by Professor Pierluigi Navarra 'After the Aifa reform, shorter approval times for medicinal products' I must express my astonishment at the conclusions indicated in the title of the article, with respect to its text in which only theoretical data, extrapolated data, and in short, methodological hypotheses are reported, and, in short, methodological hypotheses that are in fact circumscribed to these purposes in the very conclusions of the article, where it is stated that the primary objective of this 'study is only the validation of a new methodology of analysis, to be proposed as an alternative to simple descriptive statistics, and the results that have emerged have for us a case-study character and therefore entirely incidental'.

The supreme interest of patients in this case is to know the precise timeframe between the date of EMA approval/application submission by companies and the final date, which for us in Italia coincides with the publication in the Official Gazette of the price and reimbursement determination approved by AIFA's Board of Directors, as is also clearly explained in Prof. Navarra's text. Well, our analysis updated in these days, on the basis of the data reported on the same AIFA website and relating to 71 new drugs (new chemical entities and new orphan drugs, excluding new indications), shows that in the period from June 2024 to January 2026 the average time of the authorisation pathway (from the company's application to publication in the Official Gazette) was 495 days (16.5 months). For a comparison with other public data, in the period 2020-2023 the average time from EMA approval to publication in the Official Journal was 439 days (14.6 months) (source: Patient Wait Indicator): it therefore emerges that the new times lag behind the old ones by about 2 months, aggravated by the fact that in our analysis the times are counted from the submission of the application to AIFA (which takes place, on average, about 30-60 days after the EMA OK). Even with regard to the approval of new indications, our data, again taken from AIFA's reimbursement decree data, do not report very different times. To these times, in our country, must be added the average time taken to access the Regional Registries (between 90 and 150 days) and the time taken to prepare and award tenders, which then allow the approved drugs to actually be made available to all patients.

It is therefore hard to understand what the reduction of 95 days claimed in the text of the article from 483 before the reform to 388 after the reform, which is quoted and emphasised, and the shorter negotiation time (-188 days sic!!) resulting from a methodology that the authors admit 'has the advantage of being able to include procedures that have not yet obtained a price at the time the analysis is carried out' (hence not yet reimbursed) is referring to. It is also difficult to understand the intervention of AIFA's Scientific Director Pierluigi Russo, who expresses on LinkedIn a certain satisfaction with the positive results of AIFA's action rendered through a solid methodological analysis, results 'that independently confirm our initial assessments', but which ones? If our data are the same as AIFA's and certainly do not go in this direction? The data that we have been reporting for some time now and that are being continuously monitored in the current year as well are pragmatic, real and effective and are the only ones that are of interest to patients who want to know how long they will have to wait for the introduction of drugs, the result of the most modern clinical research, which are often decisive for the even long-term control of diseases that are also relevant to their survival. These are therefore solid and real data obtained directly from the official reimbursement decrees, which certify the actual time a patient must wait to have a new therapy available in Italia, and not theoretical or statistical numbers, extrapolated from pure methodological hypotheses, devoid of any concreteness and with origins that have yet to be clarified.

*Coordinator of the Forum of Scientific Societies of Italian Hospital and University Clinicians