Carolina Moreno -

In accordance with the new AIFA Guidelines entered into force on 30 December 2020, the Applicant has to submit pharmacoeconomic and/or budget impact analyses to support the Price and Reimbursement (P&R) application for the following negotiation types: TN1, TN2 and TN3.

According to the report published by AIFA, 90 P&R applications including pharmacoeconomic and / or budget impact analyses were submitted in 2021. They were related to:

  • 18 orphan drugs,
  • 20 new active ingredients,
  • 40 new extensions of indications of already reimbursed drugs
  • 12 other types of negotiations.

The analysis mostly used by Applicants to support the P&R application was the budget impact (41 BIA; 41 CEA + BIA; 91.1%), followed by the cost-effectiveness analysis (3 CEA; 41 CEA + BIA; 48.9%) and other types of analysis (5.6%).

In addition, in 2021, the availability of the cost-effectiveness or budget impact model in an open and modifiable electronic format was ensured overall in 40% of cases, compared to 8% observed in the previous year.

More details can be found in the report at the following link:

Regulatory Pharma Net is ready to support pharmaceutical Companies with strategic analysis and advice, development of economic models, preparation of the Pricing and Reimbursement application, in accordance with the new requirements, submission and follow-up of the procedure, including attendance to negotiation meetings with the Authority.

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