Agenzia Italiana del Farmaco
Economic Evaluations guidelines
Guidelines for submitting Health Economic Evaluations to AIFA for pricing and reimbursement of medicines (Section E of the dossier)
The process for pricing and reimbursement of medicinal products begins with the submission to AIFA of an application (P&R dossier) by pharmaceutical companies and ends with the resolution of the AIFA Board of Directors and the subsequent publication in the Italian Official Journal, after consulting the Technical-Scientific Committee (CTS) and the Pricing and Reimbursement Committee (CPR).
According to the Ministerial Decree 2 August 2019, pharmaceutical companies are required to submit a P&R dossier in line with the provisions of the AIFA Guideline to the submission of applications published on the website of the Agency. The following document is an extract from the AIFA Guideline concerning the compilation of Section E of the P&R dossier and the related Appendix 2.
The submission of budget impact analyses and economic evaluations is expressly requested only for new medicinal products, orphan medicines and/or for new therapeutic indications of patented products, which fall within the scope of TN1 procedures (see p.7-8 of the Guideline)."