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The technical document for the AIFA calculation of the budget assigned to each pharmaceutical company

The Finance law changes the regulation of the pharmaceutical sector, in particular in the revision of the expenditure ceilings and in the allocation of a part of the budget for the remuneration of the pricing of innovative drugs. The resources available remain the same, increased in proportion to the increase in the fund for the NHS, but are distributed differently, between "hospital" and "contracted" and within the latter. The ceiling for agreed expenditure, including the direct distribution of class A medicines, and that of hospital expenditure which includes the direct distribution of non-class A medicines, rises to 14% and 2.4%. The 20% of incremental resources is allocated to the attribution of a higher price to drugs considered innovative. Any overruns of the 14% ceiling will be borne by the supply chain, i.e. distributed among industries, wholesalers and pharmacies. The compensation by the industries will take place through direct payback and the quota to be compensated will be calculated with the new budget system. In fact, for each company, AIFA will establish an annual budget calculated on the basis of the previous year's turnover, correcting for any loss of revenue due to drugs that have come out of patent protection in the meantime and separating the amount of the payback paid the previous year. Exceeding the ceiling of 2.4% will be borne exclusively by the Regions, only when the Regions themselves spend more than what was foreseen for the entire health care. The company budget The Law of 29/11/2007 n. 222, in art. 5 paragraph 2 lett. c) provides that AIFA "shall allocate a provisional budget to each marketing authorization holder company by 31 January 2008 on the basis of the rules for allocating the budget defined by the same letter a)". For this year, the cost containment is therefore based on the assignment to each company (based on the volumes and prices of the last 12 months) of an annual budget, separate for equivalent drugs and for those still covered by patent. In calculating the budget, AIFA deducts the amount of the minor expense that that company will foreseeably achieve as a result of the expirations of the patents in its possession. For the purposes of attributing the total figure on an annual basis, AIFA partially takes into account (60%) additional resources, which derive from the increase in the expenditure ceiling compared to the previous year and from the reduction in total expenditure due to the forfeiture of patents. A further 20% of these resources is set aside to cover the expense generated by innovative drugs that will be authorized during the year (see attached tables). The requirement of innovation, however, does not refer to new authorizations in general but is recognized by the agency, having heard the opinion of the technical-scientific advisory commission, in specifi c cases and for a limited period of time (3 years). This particular provision is in line with one of the objectives expected from the introduction of equivalent medicines: the freeing up of resources to invest in research and development, especially for those diseases that are not yet adequately treatable. The budget system is not very flexible, even though it maintains a certain amount of room for competition between companies, albeit within the overall spending ceiling. Expenditure control takes place by controlling companies, anchoring them to the previous year's turnover and forcing them to settle for the share by which they have grown. The legislator did not choose to control spending by therapeutic areas, a methodology which would have led companies to compete with each other and to greater freedom of strategic choice in securing market shares n

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