Carolina Moreno -

On 27 April 2023, the Italian Medicines Agency (AIFA) published a report on the timelines of “Pricing and Reimbursement” procedures for medicinal products in the period 2018-2022.

The following three indicators have been analyzed: (i) the administrative assessment time; (ii) the overall duration of the procedure; and (iii) the time for the publication in the Italian Official Journal.

The results of the analysis are summarized below:

– The time between the date of the CHMP opinion and the date of the European Commission (EC) decision, over the 2018-2022 period, averaged around 2 months for non-generic drugs and between 2-3 months for generic drugs, with greater variability for non-generic drug procedures.

– The time between the date of the European Commission (EC) decision and the date of submission of the P&R application by the pharmaceutical company was observed to be, from 2018 to 2022, on average 6 to 12 months for non-generic drugs and 7 months to over a year for generic drugs, showing a strong variability over time for both pharmaceutical categories.

– The time for the administrative assessment was found to be the most optimal indicator, with an average value in the period 2018-2022 of 8 days and decreasing more and more over time to 2 days for generics and 4 days for non-generics in 2022.

– The overall duration of the procedure – from the date of initiation to the date of conclusion, including the evaluation time by the Agency’s advisory committees (HTA Secretariat, Technical Scientific Committee and Pricing and Reimbursement Committee) – decreased from 2018 to 2021 from 10 to 8 months on average for non-generic drugs and around 2-3 months for generic drugs.

– Lastly, the time for the publication in the Italian Official Journal, calculated from the date of conclusion of the relevant procedure, decreased over time from just over 2 months in 2018 to 2 months in 2021, for both generic and non-generic medicines.

Regulatory Pharma Net is pleased to provide further updates on this topic and to offer end-to-end support, from strategic analysis and advice to the full preparation of the Pricing and Reimbursement application with Health Economic models development or adaptation, up to the negotiation with the Authority.

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