According to the AIFA Determination n. 1372 of 30 December 2020, companies that intend to negotiate the price for pharmaceuticals in Italy, must submit the P&R application through the new e-platform of the Italian Agency.
The digital template is split into 6 sections (A to F), some of which are strictly inter-related, directly via tables and/or sections that automatically pop-up during submission, or indirectly through an invisible but necessary thread of logic.
The aim of these connections is to correlate the clinical sections to the economic ones, thus ensuring a logical flow of information aimed at supporting AIFA’s decision-making process.
According to the AIFA Guidelines the development of economic analysis must be shaped on the local target population and in line with the Italian healthcare environment. Therefore, sections B and C of the dossier, relating to the clinical condition, epidemiology and product’s value, supported by clinical studies, do intersect with sections D and E, in which the company needs to accurately present the proposed price (also, in comparison with the existing alternatives), the expected NHS’ costs, cost-effectiveness (related to clinical efficacy) and budget impact for the NHS (before-after the introduction of the drug subject of the price and reimbursement request). The pharmaco-economic analysis must ultimately be modelled on the clinical and epidemiological scenario, the unmet medical need and the value of the new drug in comparison with the technologies already approved/reimbursed within the NHS.
In conclusion, the management of the flow and consistency of information within the sections of the dossier is extremely important for the purposes of devising an accurate pharmaco-economic analysis in view of a positive evaluation by AIFA.
RPN is available to provide full P&R support:
- strategic analysis and advice;
- development and adaptation of economic models;
- preparation of the Pricing and Reimbursement application in accordance with AIFA requirements;
- e-dossier creation and submission;
- follow-up of the procedure, including attendance to negotiation meetings with the Authority.
Do not hesitate to contact us at info@regulatorypharmanet.com