Reforms proposed in 2019, designed to relate Italian pricing and reimbursement decisions to the benefit offered by a medicine, have hit the statute books, but much is still left without clarity.
At the time, the Ministry of Health said:
“The so-called ‘Price Decree’ changes the procedures for the negotiation of the price of drugs by AIFA. Its adoption responds to the need to introduce updated and adequate criteria for the evolution of drug policy and in compliance with the necessary transparency.
“Among the novelties, there is the emphasis placed on the added therapeutic value that the medicine must ensure in relation to the main treatments with which it is compared. In addition, the company is asked for reassurances about its production capacity and management of possible unexpected events, as well as to anticipate the activities it intends to implement to ensure the adequate supply of the drug.”
According to the new regulations, the key feature of Italy’s reimbursement methodology will be requiring manufacturers to show how their product performs compared to treatments currently used in Italy. This move brings Italy into line with Germany and France, whose system also use relative effectiveness in this way. Economic information remains crucial for applications for reimbursement too, and may be the deciding factor in negotiations when a product demonstrates therapeutic equivalence, rather than superiority.
Analysing the Decree, market access commentator Neil Grubert said:
“The decree states that the Director General of AIFA will provide more detailed information on the new pricing and reimbursement procedure within 30 months of the adoption of the decree—a considerable delay.
“In the meantime, the pharmaceutical industry is left to ponder a multitude of critical questions:
- How will AIFA define a significant impact on SNS spending or inappropriate prescribing as the basis for initiating a pricing and reimbursement process?
- What will be the basis for selecting suitable comparator therapies?
- To what extent will AIFA make use of joint HTA conducted at the pan-European level?”
For more details, read the announcement and full text of the Decree in the Gazzetta Ufficiale. The Ministry’s original announcement also offers insights. For a different perspective, read Neil Grubert’s analysis on LinkedIn.