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Risky federalism of medicines.

After the presentation of the repayment plans of Liguria, Calabria and Lazio, the recourse to a regionalization of pharmaceutical assistance is spreading, despite the clarifications of AIFA. An analysis by CERM – Competitiveness, Regulation, Markets – is now intervening on the subject
The most salient feature of the current scenario of pharmaceutical assistance is undoubtedly the use of a sort of regional reference price, based not on chemical equivalence (same active ingredient, same reimbursed price) but on ATC classes. For now, in the regions mentioned, the measure has only been implemented in the case of proton pump inhibitors or PPIs, with the decision to fully reimburse only the price of the only generic available, and to charge the citizen the difference compared to the other drugs in the class.
AIFA had already intervened on the subject, with note number 50 of 9 February 2007, in which "deep concern was expressed as the adoption of reference prices established by the individual regions for the purposes of reimbursement of medicines, introduce differentiations from Region a Region regarding the reimbursement prices and the free accessibility of medicines". Now comes an analysis by CERM, an independent research centre, which takes up the matter in rather alarming tones. Assuming that a certain variability between the regions may be due to discrepancies in the distribution of drugs in the different realities, which should in any case be remedied, "what is happening" reads the editorial by Fabio Pammolli and Chiara Bonassi "is something much more risky , or a distorted use of the reference price instrument by some Regions through an autonomous redefinition of the equivalence groups on which to apply the maximum reimbursement price”. According to the authors, this trend translates into the multiplication of pressures to differentiate the rules of reimbursement and the functioning of the markets between Regions. "This heterogeneity not only casts, in some cases, doubts on the therapeutic equivalence of some products, but produces further distorting effects".
These effects are, in the first place, those indicated by the Medicines Agency, which concern the lack of uniformity of treatment of citizens in the various Regions, therefore of the very concept of LEA. But CERM also reports other, higher transaction, administrative and programming costs to be borne by companies. There is a risk, for example, of determining additional costs also in terms of finding and adequately managing information relating to the different regulation of regional sub-markets. Furthermore, as already complained by organizations of general practitioners (FIMMG), it could be "limited the assessments of prescribing appropriateness by doctors, giving more weight to assessments of cost containment rather than those relating to the improvement of patients' health /consumers". With regard to the reference price based on the ATC classification, the experience of Germany is often cited, which has actually adopted this criterion, but keeping the cases of drugs with expired patents separate from those for which the patent is still in force.
From “pharmacist33”

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco