LIFE SCIENCES | New AIFA guidelines for the reimbursement and pricing dossier approved

On 23 December 2025, the Italian Medicines Agency (AIFA) approved Determination No. 88, which sets out guidelines for preparing the dossier in support of applications for reimbursement and pricing of medicinal products. Through these Guidelines, AIFA introduces an update to the procedural and methodological framework governing the access of medicinal products to the reimbursed market in Italy.

The reimbursement dossier is now conceived as a document aimed at providing an integrated representation of the medicinal product’s overall value, taking into account not only the therapeutic benefit, but also the overall impact on the healthcare system.

The Guidelines reflect the new institutional framework of AIFA, following the abolition of the Technical Scientific Commission and the Pricing and Reimbursement Committee and the concentration of their respective competences within the Scientific and Economic Commission for Medicinal Products. The assessment of the dossier is now carried out according to a unitary approach, integrating clinical, economic and financial aspects, overcoming a fragmented view of competences and requiring companies to ensure greater consistency and completeness in the presentation of data. From an economic perspective, the dossier must now provide a clear representation of the relationship between the proposed price, expected usage volumes and consequences for public pharmaceutical expenditure, in accordance with transparent and standardized methodologies.

A further significant innovation introduced by the Guidelines concerns the integration of Health Technology Assessment (HTA) principles into the reimbursement and pricing process. In line with the European regulatory framework on HTA, the dossier is required to reflect a multidimensional assessment of the medicinal product. This approach reinforces the role of HTA, aimed at supporting public authorities in assessing the overall value of medicinal products.

The entry into force of the Guidelines as of 1 April 2026 is accompanied by the provision of an adjustment period for pharmaceutical companies, which are required to reorganize their internal processes and the documentation supporting negotiation applications. Ordinary reimbursement and pricing procedures will be fully subject to the new framework, while for simplified procedures, such as those relating to equivalent and biosimilar medicinal products, AIFA has announced the preparation of specific documents.

Newsletter n. 114 – January 2026