In accordance with the AIFA Guidelines on the preparation of the Price and Reimbursement (P&R) dossiers, in force since 30 December 2020, Applicants are requested to submit budget impact and possibly also pharmacoeconomic analyses in particular for new drugs, orphan drugs, extensions of indications, new associations of active ingredients, new formulations, variations of posology.
According to the report published by AIFA, 106 P&R applications including pharmacoeconomic and / or budget impact analyses were submitted in 2022. They were related to:
- 20 orphan drugs (19.8%),
- 35 new active ingredients (33.0%),
- 49 new extensions of indications of already reimbursed drugs (46.2%)
- 2 other types of negotiations (1.9%).
The analyses mostly used by Applicants to support the P&R applications were the Cost Effectiveness Analyses in combination with the Budget Impact Analyses (73 CEA + BIA; 68.9%), followed by the Budget Impact Analyses alone (32 BIA; 30.2%).
In addition, in 2022, the availability of the Cost-Effectiveness or Budget Impact model in an open and modifiable electronic format was ensured overall in 93% of cases, compared to 40% observed in 2021 and 8% in 2020.
More details can be found in the report at the following link: Report Valutazioni Economiche 2022 (aifa.gov.it)
Regulatory Pharma Net is ready and available to support pharmaceutical Companies with strategic analyses and advice, development or adaptation of economic models, preparation of the Pricing and Reimbursement dossier in accordance with the AIFA requirements, submission of the P&R application and follow-up of the procedure, including attendance to negotiation meetings with the Authority, up to approval and publication in the Italian Official Journal.
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