Following the provisions of the Ministerial Decree of 2 August 2019 “Criteria and methods by which the Italian Medicines Agency determines, by negotiation, the prices of drugs reimbursed by the National Health Service” (OJ n. 185 of 24-Jul-2020) and the subsequent Guidelines published 30-Dec-2020, adopted with AIFA Determination n. 1372 of 30-Dec-2020 , companies that intend to negotiate the price for pharmaceuticals, must necessarily submit the P&R Dossier application through the new platform of the regulatory agency.
The “Prices and Reimbursement e-dossier Portal” is the new AIFA’s online service, through which companies are required to submit the Dossier supporting the price and reimbursement request.
The digital template is split into 6 sections A to F, that are (or are not) to be filled depending on the negotiation type (and sub-type) that the Applicant submits; text areas and pop-up content follow one another in more or less articulated tables.
After a transition phase, the e-dossier became mandatory starting from 1 December 2021.
The aim of new AIFA platform is to digitize and harmonize information, with a focus on the strict connection between the clinical and economic aspects of the disease/drug, also keeping in mind the issues of innovativeness and the ongoing evolution of economic knowledge. But above all, the scope is to encourage transparency between EU Member States and their Regulatory Agencies.
After the entry into force of the mandatory use of the new AIFA portal for the submission of the P&R applications, some additional functions have been implemented and currently the platform is still being updated and an improved version will be released.
The preparation of the e-dossier is an activity that must be planned in due time in order to be successfully completed in a timely manner considering the technical problems that could arise related to a new portal in continuous evolution.
RPN available to provide full P&R support:
- strategic analysis and advice;
- development of economic models
- preparation of the Pricing and Reimbursement application in accordance with the new requirements;
- e-dossier creation, submission and follow-up of the procedure, including attendance to negotiation meetings with the Authority.
Do not hesitate to contact us at info@regulatorypharmanet.com