In brief
On 28 February 2023, the Italian Medicines Agency (AIFA) published on its website the updated version of the “Simplified Pricing and Reimbursement Procedure for Generic and Biosimilar Drugs”.
The mentioned update extends the possibility of benefiting from the simplified procedure to generic and biosimilar drugs whose originator has a registry and/or one or more indications included in the lists referred to in Law 648/1996. If the marketing authorization holder opts for this procedure and the proposed reimbursement price is in line with the reductions provided for by Ministerial Decree 21/07/2022, the generic or biosimilar drug will then be submitted to the evaluation of the Technical Scientific Committee (CTS), which will express its opinion on whether or not to confirm the same reimbursement conditions (class and supply regime) of the originator, without the involvement of the Pricing and Reimbursement Committee (CPR).
By contrast, generic and biosimilar drugs whose originator includes in its negotiation conditions a Managed Entry Agreement remain excluded from the simplified procedure; indeed, the standard negotiation procedure involving both the CTS and the CPR shall apply to these products even if the marketing authorization holder agrees to the reductions provided for by Ministerial Decree 21/07/2022.
