Generic drugs, Osmed: the Italians are starting to convince

I dati dell’ultimo Osmed report dell’Agenzia italiana del farmaco (Aifa), accendono i riflettori in particolar modo sul consumo dei farmaci non “griffati”. Il 70,4% delle dosi di farmaci consumate ogni giorno dagli italiani è infatti costituita da prodotti a brevetto scaduto, che rappresentano anche oltre la metà della spesa.

L’utilizzo di questi medicinali continua dunque a crescere: Molise (+21,9%) e la Provincia Autonoma di Trento (+17,3%) sono le Regioni con i maggiori incrementi rispetto al 2013. I generici fanno risparmiare lo Stato: sono in vendita a un prezzo inferiore, circa il 20-50% in meno rispetto al medicinale originale e dal 2000 a oggi hanno permesso allo Stato di risparmiare ben 4 miliardi di euro. Una cifra considerevole che potrebbe tendere verso l’aumento se non ci fossero ancora forme di scetticismo circa l’efficacia degli effetti.

Ad avere meno dubbi di tutti, sono gli abitanti dell’Emilia Romagna (73,9%), Umbria (73,6%) e Provincia Autonoma di Bolzano (73,1%), mentre Lazio (67,4%), Provincia Autonoma di Trento (68,1%) e Calabria (68,6%) sono le Regioni con i livelli più bassi di consumo. Il pantoprazolo supera il lansoprazolo tra i principi attivi a brevetto scaduto a maggior spesa (entrambi inibitori di pompa protonica contro l’ulcera e il reflusso).

Solo il 12% dei farmaci dispensati in Italia è oggi generico, mentre nei mercati farmaceutici principali dei più grandi Paesi europei, i farmaci generici rappresentano in media circa il 50% delle unità vendute (con punte del 70% in Paesi come la Germania) e contribuiscono per il 20% alla spesa. In tema di “equivalenti” si è espressa anche l’Agenzia europea per i medicinali, Ema, che si dichiara pronta a condividere le sue valutazioni di richieste di autorizzazioni di medicinali equivalenti in tempo reale con gli enti regolatori di Paesi al di fuori dell’Unione europea. Questa iniziativa mira a favorire l’autorizzazione e la tempestiva disponibilità di generici sicuri, efficaci e di alta qualità in tutto il mondo.

Rossella Gemma – 28 gennaio 2015 – Farmacista33

Related news: Drugs: Aifa, purchases unchanged in 2014; 23 packs each. The use of drugs in Italy - OsMed Report (January - September 2014)

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NOTE

What AIFA says in the OsMed Report: “Anche nel 2014 è stata riscontrata una crescente incidenza del 13,6% -sulla spesa convenzionata – della compartecipazione a carico del cittadino (comprensiva del ticket per confezione e della quota a carico del cittadino eccedente il prezzo di riferimento sui medicinali a brevetto scaduto) rispetto al 12,7% registrato nel 2013. L’ammontare complessivo della spesa per compartecipazioni a carico del cittadino sui medicinali di classe A è risultata pari a 1.121 milioni di euro, in aumento rispetto allo stesso periodo dell’anno precedente del +4,4%, attribuibile principalmente all’incremento della quota a carico del cittadino eccedente il prezzo di riferimento per i medicinali a brevetto scaduto (+8,7%), mentre è stata osservata una riduzione del ticket fisso per ricetta (-2,4%). Il ticket per confezione, con un valore di spesa pari a 411 milioni di euro, ha pesato per il 36,7%, mentre la quota a carico del cittadino eccedente il prezzo di riferimento per i medicinali a brevetto scaduto, con 710 milioni di euro, ha inciso per il residuale 63,3%”

( … )

“Expired patent medicines now represent more than half (51.1%) of approved pharmaceutical expenditure, up on 2013 by +6.6%, and 70.4% of total DDDs, up on 2013 by +11.9% . The percentage spent on generic medicines (drugs based on active ingredients with expired patents, excluding those that have enjoyed patent protection) was equal to 28.8% of the total of expired patent medicines (Table 12). Overall, the top twenty patent-expired active ingredients represent approximately 50% of the consumption, in terms of DDD, of all patent-expired drugs; pantoprazole and lansoprazole, which dropped to second position in 2014, were the active ingredients with expired patents at the highest expense, with respectively 217.5 and 189.2 million euros”

From the 2012 Osmed Report: The regulation of medicines not covered by a patent has had a significant boost in Italy, above all in light of the legislative interventions enacted since 2000. In particular, with article 85, paragraph 28, of Law no. 338/2000 the current transparency lists were established, ie the lists that group expired patent drugs and the corresponding reimbursement prices, which are published monthly on the AIFA website. Various aspects relating to the regulation of the supply of these drugs were then strengthened and further clarified with the issuing of the Law 405 of 2001, which established some main points: • for the purposes of patent protection, only patents on the active principle are considered valid; • all medicines based on the same active principle, with the same route of administration, pharmaceutical form and unit dosage, whether they are with a common denomination or with a fancy denomination, upon expiry of the patent protection are considered mutually substitutable; • the package with the lowest price among the equivalent and mutually replaceable ones constitutes the reimbursement price (reference price 1 ) which is charged to the NHS; any difference between the medicine dispensed and the reference price is to be paid by the patients (with the exception of war invalids receiving life pensions); • the Regions are empowered to adopt suitable provisions on the basis of the effective availability of equivalents in the regional distribution circuit. It should be noted that in Italy the establishment of the Complementary Certificate of Protection (CCP), which took place in 1991, allowed the extension of patent coverage (established at 20 years for medicinal products) initially up to a maximum of 18 years beyond the expiry of the patent, thus extending the exclusivity of the exploitation of the molecule up to a maximum of 38 years. The EEC Regulation n. 1768 of 1992 has, in fact, passed the national legislation on the CCP, establishing the Supplementary Protective Certificate (SPC), the maximum duration of which cannot exceed 5 years. Nonetheless, since the entry into force of the CCP in Italy took place earlier than that of the SPC, a large part of the active ingredients present on the Italian market (about 80%), having obtained the CCP, benefited in Italy from a significantly longer coverage than in other European countries. Consequently, even the possible savings for the NHS, deriving from the loss of patent coverage, have been delayed over time precisely in the face of the impossibility of marketing in Italy those generic medicines which have already been present for some time in other European countries. Subsequently, in order to mitigate the negative effects mentioned above, a measure was introduced to progressively adjust the duration of the SPC to that present in other European countries (Law n. 112 of 2002), according to a reduction procedure established in six months for each calendar year starting from 1 January 2004. With Legislative Decree 39/2009, converted, with amendments, by Law 24 June 2009, n. 77, some rules have been introduced which regulate the economic aspects relating to this area of the pharmaceutical market, which can be described as follows:

1. 12% reduction in the public price of equivalent medicines;

2. the NHS deducts from the pharmacist's remuneration, by way of recovery of the value of the extra discounts applied by pharmaceutical companies during the year 2008, 1.4% on the gross expense;

3. reduction of the margins of the supply chain relating to drugs equivalent to 58.65% for pharmaceutical companies (the shares of pharmacists and wholesalers were then modified by Law 122/2010 - see section 1.4). The remaining share of 8% (at 66.65%) is redistributed among wholesalers and pharmacists.

4. the owner of a medicine whose patent has expired, in the 9 months following the date of authorization of a first equivalent medicine, can reduce the price to the public of his medicine, provided that the difference between the new price and that of the corresponding medicine equivalent is greater than €0.50 for drugs whose cost is less than or equal to €5, or, in the case of medicines in single-dose packages, provided that the difference is greater than €1 for drugs whose cost is greater than €5 € and less than or equal to €10, or is greater than €1.50 for drugs whose cost is greater than €10 (this rule was subsequently repealed by Legislative Decree No. 179 of 18 October 2012, converted with amendments by Law December 17, 2012, no. 221).

Subsequently, the Law 30 July 2010 n. 122 (conversion of Law Decree 31 May 2010 n. 78) again reduces the price to the public of equivalent medicines by 12.5%, from 1 June to 31 December 2010, with the exclusion of medicines originally covered by patents or which have benefited from licenses deriving from this patent. Finally, with Determination of 8 April 2011, the AIFA, in application of the provision referred to in paragraph 9, of article 11 of the Legislative Decree 78/2010, carried out a reduction in the reference prices of the medicines included in the transparency lists, on the basis of a survey of the prices in force in the countries of the European Union. The description of the methodology followed in setting the new reference prices is available on the AIFA website (http://www.agenziafarmaco.gov.it/it/content /elenco-dei-farmaci-lista-di-trasparenza-aifa -effective-from-15-April-2011). The “Balduzzi” Decree Law (Law 189/2012) has established a relevant principle in the regulation of the market for medicines with expired patents, i.e. such medicines cannot be classified as medicines paid by the NHS with effect prior to the expiry date of the patent or of the complementary protection certificate, published by the Ministry of Economic Development in accordance with current legal provisions. The active ingredients that lost their patent coverage during 2012, or the new packs of active ingredients that previously lost their patent protection and which entered the AIFA transparency lists following the authorization of equivalent generics, are listed in table 1.7 .1.

Expired patent medicines, in particular, and more generally medicines paid for by the NHS dispensed under conventional assistance have been the subject of an evolution of the provisions on the subject of filling in the prescription, providing for the possibility for the doctor to indicate exclusively the active ingredient of the medicinal product and its packaging. This regulation originates from the combined application of article 11, paragraph 12 of the Legislative Decree January 24, 2012, n. 1 (so-called Liberalization Decree) and article 15, paragraph 11-bis of the Law Decree of 6 July 2012 n. 95, converted with amendments by Law 7 August 2012 n. 135 (so-called Spending Review Decree); the latter subsequently replaced by article 13-bis, paragraph 1, of Legislative Decree 18 October 2012, n. 179, converted, with modifications, from law 17 December 2012, n. 221. Per ulteriori approfondimenti sul tema si consiglia di consultare la linea guida per l’adeguamento delle procedure informatiche della ricetta elettronica (http://sistemats1.sanita.finanze.it/). Al fine di consentire l’attuazione della normativarelativa, l’AIFA pubblica ogni mese gli elenchi dei medicinali di fascia A e H con evidenza del gruppo di equivalenza, ovvero dei codici di raggruppamento di medicinali a base del medesimo principio attivo e con lo stesso confezionamento (stessa via disomministrazione,stesso numero di unità posologiche, stesso peso dell’unità posologica). Nel corso del 2012 il legislatore è intervenuto anche con norme finalizzate ad accelerare l’accesso al mercato di medicinali generici equivalenti. Nello specifico l’articolo 12, comma 6, del D.L. 13 settembre 2012, n. 158, convertito con modificazione dalla Legge 8 novembre 2012, n. 189, delimita la possibilità per un medicinale generico di ottenere l’automatica classificazione a carico del SSN, saltando l’iter della negoziazione del prezzo, qualora l’azienda titolare proponga un prezzo di vendita di evidente convenienza per il SSN. Il successivo Decreto del Ministero della Salute 4 aprile 2013, attuativo della norma, definisce le fasce di riduzione del prezzo di vendita – rispetto a quello del medicinale di riferimento – in rapporto ai volumi di vendita previsti (Tabella 1.7.3).

An area of emerging importance in the context of patent-expired drugs is that of biosimilars. In order to promote correct information on biosimilar drugs at the various levels of the healthcare organization, as well as citizens, the Agency has since July 2012 launched a shared process of synthesis on three relevant points of the debate:

1. Definition and main characterization criteria of biological and biosimilar medicines;

2. Framework of the regulatory provisions in force in the EU regarding biosimilar medicinal products;

3. Role of biosimilars in the economic sustainability of the national health service (SSN).

The process was completed on 28 May 2013 with the publication of the Position paper (for further information, it is advisable to download the document at the following link: http://www.agenziafarmaco.gov.it/sites/default/files/AIFA_POSITION_PAPER_FARMACI_ BIOSIMILARI. pdf). The Position paper clarifies the Agency's position on the subject of the substitutability of biological medicines previously covered by patent with biosimilars, providing the evaluation elements both with respect to the implications in terms of economic sustainability, and with respect to the priority ones in terms of health protection. For further information on the expenditure and consumption of off-patent medicines and biosimilars, please refer to section 7.3 of this Report.

For theand active substances imported from non-EU countries That "they will be able to enter Italy to be used in the production of medicines for human use” underlines Isabella Marta, AIFA Raw Materials Inspection Management Unit, “only if accompanied by a certification from the competent authority of the country of production, which certifies its equivalence to the quality standard valid in Europe, or if accompanied by a GMP certificate from a European country. This measure is to protect the quality of medicines produced and marketed in Italy. Furthermore, AIFA will be able to inspect producers or importers of excipients, in case of suspected non-compliance with the expected quality requirements and, possibly, if deemed appropriate in the context of collaboration with the Ministry of Health, distributors of active substances located in the territory national or established in third countries” ( Guide to the implementation of Legislative Decree n. 17 of 19 February 2014, as regards active substances and excipients )

OsMed report January-September 2014, extract pag. 43, Table 12.

Expenditure and consumption under class A-SSN approved assistance regime of expired patent drugs included in the AIFA transparency lists*: comparison between the first 9 months of 2014 and 2013

Italy

Total consumption

DDD//1,000 inh. Die: 1.035,9

Δ%: 0.0

You use expired patent medicines

DDD/1,000 in ab day: 728,9

% on total DDD: 70,4

Δ% 14/13: 11,9

Gross expenditure on expired patent drugs

€ per capita: 69,2

% on the total expenditure: 51,1

Δ% 14/13: 6,6

% Equivalent expenditure**:  28,8

*The analysis was performed using the transparency lists published monthly by AIFA

** Calculated on the total expense for expired patent medicines. Equivalent drugs are medicines based on active ingredients with an expired patent, with the exception of those that have enjoyed patent coverage, pursuant to art. 1 bis, dated Legislative Decree 27 May 2005, n. 87, converted, with modifications, from Law 26 July 2005, n. 149.