I have read that from now on, innovative chemotherapy drugs, once approved by AIFA, will be available rapidly in all Italian regions and not "patchy" as it has been up to now. Thus, it will no longer be necessary for patients to wander from one region to another to find the fastest (and most generous) way to update their formulary. However, I still have some doubts: which drugs will be included in the list of innovative ones and with what criteria? And won't the Regions find some new system to drag it out?
Paolo D. Siviero answers
Coordinator of the Aifa Pharmaceutical Strategy and Policies Area
The State-Regions agreement on the direct implementation in the regional hospital therapeutic handbooks of drugs assessed as innovative by the Italian Medicines Agency (Aifa), is essential to guarantee uniform access to drugs throughout the national territory. The agreement provides that all drugs, not only oncological ones, considered innovative by AIFA, are immediately made available in all Regions. This before and independently of their inclusion in the regional therapeutic handbooks. Subsequently, the Regions have 60 days to conclude the procedures for updating the formularies. If a Region does not agree with AIFA's decisions, it can communicate the elements of disagreement to it; AIFA will convene a table with the Regions to evaluate what has emerged: the revised decision will be considered definitive and will be valid for all Regions. Even if conflicting opinions should emerge with respect to what AIFA decided, the innovative products are still made available to patients. In fact, according to the new agreement, immediately after the publication of the Marketing Authorization granted by AIFA, the Regions are required to make available and to reimburse the purchase of innovative medicines to hospitals that request them. The decision on the innovativeness of a drug belongs to the AIFA technical-scientific commission, which evaluates the severity of the pathology being treated, the existence or otherwise of therapeutic alternatives and the expected effect of the new therapy. Two levels of innovation are currently identified which allow direct access to medicines. An important innovation is recognized for all those drugs intended to treat serious pathologies for which a valid therapeutic alternative does not hesitate and the positive result of the treatment has already been proven. In the event that a new drug that complies with the first two points described does not yet have results considered fully conclusive in terms of therapeutic efficacy, or in the event that other elements of innovation are identifiable such as technological or pharmacological innovation linked to the mechanism of action of a drug, a degree of potential innovation is defined, which needs some elements of proof. Finally, a permanent table for monitoring the regional formularies (made up of representatives of the Agency, of all the Regions and Provinces of Trento and Bolzano, and of the Ministry of Health) has been set up at AIFA: it will provide periodic indications for the homogenization and updating of the regional hospital formularies.
January 23, 2011
