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Drug governance, spending caps, tenders: the Regions are back on the attack

After the producers of Farmindustria, which in the public assembly on Wednesday they had called for a profound revision of pharmaceutical governance, it is now the Regions that are pressing for the rules governing the management of the reimbursed drug to be rewritten. In a sense, obviously, far from that desired by companies, which passes from a new reorganization of the ceilings on pharmaceutical expenditure and from more open regional procurement tenders. These are some of the points listed in the document that the Regions delivered to the Minister of Health, Beatrice Lorenzin, in the "summit" organized yesterday by the governors to compile an agenda of the most urgent interventions together with the department.

LRisultati immagini per spesa farmaceuticato list, anticipated by Healthcare24, the website of Il Sole 24 Ore-Sanitàdevotes an entire chapter to pharmaceutical expenditure. In which the Regions complain "the failure to resolve the problems connected to the payback for the years 2013-2016", which is creating "serious suffering for the regional budgets". It should not be forgotten, the document continues, that hospital pharmaceutical spending continues to "significantly" break through the ceiling year after year and in 2016 the overrun should amount to around 1.7-1.8 billion euros. "In this serious situation" the governors continue "the failure to define a new governance is inexplicable and no longer sustainable", because the current one "is completely obsolete and inadequate".

But what forms should the government of the drug that the Regions want have? Certainly not the ones you want Wednesday by Farmindustria, which asked for the exceeding of the expenditure ceilings and of that on hospital care in particular, faster authorizations for new drugs, "European" budgets for the financing of pharmaceutical expenditure and national health policies. The governors' recipe, on the other hand, looks in a completely different direction and takes up the proposals that the health councilors had presented one year ago, when the Government and the Regions began to talk about governance reform (but without arriving at anything concrete, except the reformulation of the ceilings given by the Budget Law for 2017, with the agreement at 7.96% and the direct-dpc-hospital at 6.891 TP3T).
The document presented yesterday succinctly lists those proposals, so to get a complete picture it is necessary to go back to the report from a year ago. From which, for example, stood out the request for a new system of roofs divided not by distribution circuit (territory versus hospital) but by purchase procedure, i.e. affiliated supply chain or centralized tender (the usual method of direct-dpc and hospital). In addition, the Regions are also asking for abundant injections of competition, which for them means the freedom to ban tenders between different active ingredients, on the basis of equivalence grids drawn up by the AIFA Technical-Scientific Commission for therapeutic classes at the fourth level ATC. And with no more differences in the ceiling between contracted and direct, the regional pharmaceutical services will also be able to purchase class A medicines destined for the territory in these tenders, which the pharmacies would then have to distribute at the tariffs of the dpc.

Obviously, the offers don't stop there. In fact, the Regions are also asking for a new price/volume negotiation procedure (the price drops as the number of patients treated increases), which – they wrote a year ago – would sterilize the economic repercussions of phenomena such as combo therapy or the chronicity of some treatments . Finally, the entire system of Aifa registers should be reviewed (in which the Regions and Local Health Authorities should be more deeply involved, said the May 2015 document) and the concept of innovativeness of new drugs should be detailed, which the governors do not want to leave "to the discretion of the Technical-scientific commission» of AIFA.

(AS – Federfarma – 06/23/2017)

Related news: Observations and proposals for discussion with the Minister of Health

Lorenzin: the meeting with the Conference of Regions was very good

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