Posted on decree implementing the rules of the Balduzzi decree. The objective is to ensure that the prices of equivalent and biosimilar medicines are changed automatically with reference to the lowest price and to the average annual value of NHS expenditure for the medicine covered by patent in the three years preceding the reimbursement request.
13 JUN – The decree of 4 April 2013 of the Ministry of Health was published in the Official Gazette, in force since 1 July next, containing the "Criteria for identifying the brackets for the automatic negotiation of generics and biosimilars".
Fofi informs in a circular how article 1 of the ministerial decree established that "the selling price of a generic medicine or a biosimilar medicine which presents a percentage discount, compared to the price of the reference medicine, at least equal to that indicated in the table in Annex A for each of the turnover brackets indicated in the same table is considered «obviously convenient for the National Health Service».
To this end, the price of the reference medicinal product in force at the time of the application and the average annual value of the total expenditure incurred by the National Health Service for the medicinal product covered by patent protection, including any licensees, in the three calendar years preceding the reimbursement application are taken into consideration.
If the average turnover of the last three calendar years of marketing of the reference medicinal product prior to the expiry of the patent protection falls within a different expenditure level bracket in table A, starting from the aforesaid deadline, the discount referring to this bracket is automatically applied, if more favorable to the National Health Service, instead of the discount originally proposed in the reimbursement request.
The proposal, by the holder of the marketing authorization for the generic or biosimilar medicinal product, of a price higher than that of obvious convenience for the National Health Service, as defined on the basis of article 1, paragraph 1, of the decree, involves the start of the ordinary procedure
