In 2020, AIFA introduced the new simplified P&R negotiation procedures:

• simplified pricing and reimbursement procedure for the negotiation of equivalent/biosimilar drugs prepared in agreement with the AIFA CTS/CPR advisory committees;
• simplified procedure for extending reimbursability of indications already reimbursed to the originator;
• simplified procedure for the reimbursability of new packs due to changes in the primary packaging;
• simplified price negotiation and reimbursement procedure for parallel imported drugs (Determination DG/357/2021);
• simplified procedure for the reimbursability of new packages referring both to changes (increases and reductions) in the number of posological units and to changes (increases and reductions) in the dosages of drugs with a different number of posological units or dosages from those of drugs already reimbursed (December 2021).

Monitoring the competitors of the medicines of the companies we follow is one of our 'business regulatory' activities. Currently, tracking the pricing and reimbursement procedures for equivalent and biosimilar medicines is very complex because they benefit from a simplified procedure that cannot be followed in the AIFA CTS and CPR agendas and only becomes known at the end of the process, at the moment of publication in the Official Journal.

In order to try to predict the Time To Market (TTM) from obtaining the MA of equivalent/biosimilar medicines, we analysed and rendered in graphical format the simplified procedures for the negotiation of medicines and the AIFA report, published in April 2022, on "Effects of the simplified procedures for negotiating medicine introduced in 2020"..

It turned out that:

• There has been an increase in the volume of procedures submitted and a reduction in approval times since the implementation of the simplified procedures.
• Companies have increased their submissions in the case of generic drugs In addition, the area of parallel imported medicines has been unblocked.
• SSN benefited from an economic advantage due to shorter approval times and for citizens the presence of parallel imported drugs also represents an opportunity in terms of reduced cost-sharing.

Knowing the procedures is one way to try to make effective predictions in business regulatory activities.