Thanks to Giulia Conforto for collaborating on this article
On December 23, 2020, the Italian Agency of Medicines (Agenzia Italiana del Farmaco – the “AIFA”) issued Guidelines for the compilation of the dossier to support the request for reimbursement and pricing of a medicine (“Guidelines”), pursuant to the Ministerial Decree of August 1, 2019 (“Decree”). The Decree set out new criteria for the price negotiation procedure between the AIFA and the marketing authorization holder (“MAH”) to establish the price for a medicine to be reimbursed by the National Health Service (NHS).1
The AIFA Guidelines aim to support the applicant in the correct and complete compilation of the dossier to be filed with the AIFA, according to the Decree. Specifically, the Guidelines indicate which information the AIFA considers necessary and how such information shall be provided for each section in the dossier outline.
According to the provisions of the Decree (Art. 3.1), the negotiation procedure must be concluded within 180 days, between the day it begins and the date of the last opinion delivered by the Price and Refund Committee (Comitato Prezzi e Rimborso). However, for “orphan drugs” of exceptional therapeutic importance or for medicinal products that can be used exclusively in a hospital environment, the duration of the negotiation procedure may be reduced to 100 days (“fast-track”) upon specific request of the MAH. Such terms may be suspended by the AIFA when further documents are to be collected.
Interestingly, with specific reference to Cnn class medicines, the Guidelines specify that, if the MAH does not submit a request for reimbursement and price within 30 days of the issue of the marketing authorization, the AIFA will send by e-mail to the MAH a reminder to submit this application, assigning a term of 30 days for the transmission of the related application and necessary documentation. If the MAH then sends the request within this deadline, the procedure corresponding to the specific type of negotiation will be started; otherwise, the AIFA will order the medicine suspended from the Cnn class, with the consequence that the medicine — with temporary exceptions for reasons of public health and/or therapeutic continuity — cannot be further marketed in the national territory until the ordinary procedure is reactivated by the applicant or the AIFA.
The Guidelines will be applied as of March 1, 2021 in order to provide operators a suitable transition period for compilation of the new dossiers. Moreover, the AIFA expressly reserves the right to revise the Guidelines through December 2021 as a result of their real-world application.
Furthermore, a dedicated interface is currently being developed for on-line compilation and filing of dossiers. Until this interface is ready, which will be announced on the AIFA website, it is suggested that applicants prepare any dossiers in Italian and submit them with the relevant documentation in electronic format (Word and PDF) by e-mail (email@example.com and firstname.lastname@example.org).