There list of innovative drugs published by the Italian Medicines Agency (AIFA) at the end of December 2010 creates confusion: out of 19 medicines classified as innovative, only four represent important therapeutic innovations. The drugs must be present in the Hospital Therapeutic Handbooks of the Italian Regions and Autonomous Provinces. But of the list, which should only contain hospital drugs, more than half are intended for pharmacies. And there is also confusion about the criterion by which innovation is evaluated. Result: pharmaceutical expenditure will increase without real benefits for patients.
This is what the "Innovative Medicines" dossier made by Drug dialogue, bimonthly independent health information and update. "The list of 19 innovative drugs published by the Medicines Agency, and which by law will end up in the Hospital Therapeutic Handbooks of all Regions and Autonomous Provinces, has no scientific rigor - say the magazine's managers - If only because it is not accompanied, as it should, from a document that motivates the selection criteria".
Step back. According to a 2006 study, innovation is divided into 'therapeutic' when the drug brings new benefits compared to medicines available with the same indication, 'pharmacological' when there are new mechanisms of action but the therapeutic advantage compared to other medicines is not documented, and 'technological' when there is they are new industrial processes, therefore the molecules are obtained through biotechnological techniques or have a new system for releasing the active ingredient. According to this approach, effectively accepted by AIFA in 2007, only therapeutic innovation represents an important objective for public health.
That said, the authors of the dossier state, in the list "AIFA equates the value of a therapeutic novelty to that of a pharmacological or technological innovation of exclusively "commercial" and only potentially therapeutic value. Moreover, out of 19 medicines only 4 are important therapeutic innovations. While the other 15 are classified as potentially innovative, therefore with clinical efficacy and safety yet to be demonstrated. Of the latter, 10 are pharmacological innovations, but the remaining 5 are neither pharmacological nor technological innovations, but simply belong to already known therapeutic classes. Furthermore, according to the State-Regions agreement, only drugs that are used in hospitals should appear on the list. But of the 19 active ingredients, 13 are intended for pharmacies and only 6 are for hospitals". The list does not even include orphan drugs, generally used to treat rare diseases. In short, the list has been attributed the degree of potential therapeutic innovation to the pharmacological or technological innovation, and the criterion, in this case, risks becoming at least ambiguous.
Strong words are spent by Silvio Garattini, who accompanies the dossier with a editorial on the topic "What does innovation mean?"
