Revision of handbooks - Federfarma draws the first conclusions

Fedaisf editorial staff

October 12, 2015

dten drugs, between "on" and "off patent", reclassified in category C with prescription obligation, i.e. at the expense of the assisted persons. Sixty-three reimbursement levels revised downwards, relating to as many equivalence groups of the Aifa Lists. Forty-five "on patent" and 220 "off patent" drugs with new prices, in force since yesterday. And finally, 24 companies that instead of revising the price lists will pay the Regions a pay-back, equal to the share of savings that AIFA counted against them in the September negotiation. These are the figures that summarize the revision of the Handbook implemented by AIFA with the decision published in the Official Gazette on Thursday, in compliance with the provisions of article 9-ter of law decree 78/2015 (the so-called local authorities decree, converted into 125 /2015).

As will be recalled, the measure instructed AIFA to negotiate with the industries farmaceutiche una «riduzione del prezzo di rimborso dei medicinali a carico del Ssn nell’ambito di raggruppamenti di medicinali terapeuticamente assimilabili». Le aziende, in particolare, avrebbero potuto decidere se «ripartire la riduzione di spesa» tra le proprie specialità inserite nei raggruppamenti, restituire alle Regioni «il risparmio atteso» tramite il già citato pay-back, o infine accettare «la riclassificazione in fascia C dei medicinali terapeuticamente assimilabili di cui l’azienda è titolare».
On the basis of these directives, AIFA conducted three weeks of training in September negotiations which had involved about seventy companies for a total of about 580 specialities. For this reason, as the circular issued yesterday to Federfarma members also recalls, "it is presumable to expect spontaneous price reductions by companies in the coming days, to make their drugs more competitive by bringing them closer to the new reference prices". (AS – Federfarma 10/10/2015)

Assogenerici: companies at risk of sustainability

THE price cuts imparted by AIFA "put economic sustainability at risk of generic companies and their role of creating natural competition in the market». This is the complaint that arrives from Assogenerici after the entry into force of the new Transparency Lists, the result of the revision of the Handbook for similar categories negotiated in September by the Medicines Agency and manufacturers. «Once again» explains the president, Enrique Häusermann «the policy of cuts is being used with regard to pharmaceutical expenditure. Only this time generic medicines, which until now had guaranteed savings of hundreds of millions of euros to the public finances, are unbearably compressed".

Furthermore, the maneuver disappoints genericists because it does not touch the pay-back mechanisms, «che impone» continua Häusermann «il ripiano anche a chi genera risparmio». Stesso discorso per «quei vincoli, già vietati e censurati dall’Unione europea», come il Patent Linkage, che in Italia rallentano la commercializzazione dei generici. «Se non si cambia la rotta» è quindi l’avvertimento del presidente di Assogenerici «ci sia avvia a rendere l’Italia un mercato insostenibile per il generico, dove i margini ormai si valutano in centesimi di euro per confezione. E’ possibile che nel breve termine ci sia chi può sostenere questa situazione, ma non a lungo e, soprattutto, si rischia che il Servizio sanitario si trovi a dipendere da uno o due produttori soltanto».

Federfarma 10/10/2015

Part of the provision in graphic format (list)

Revision of the handbook, from today the new Aifa handbook for equivalents