The Italian Medicines Agency (AIFA) has given details of the implementation of a major new information system set for introduction in 2013 which will result in greater regulatory transparency.
IHS Global Insight perspective | |
Significance | AIFA has given details of a new information system which it will start to introduce in 2013, which will result in a greater degree of transparency across the pharma regulatory sector in Italy. |
Implications | The implementation of a major new information system has been an important goal of AIFA for several years, in its pursuit of more efficiency in pharmaceutical reimbursement. |
Outlook | The implementation of the system is likely to have a significant impact on innovative pharmaceutical companies, with a more efficient information system set to help achieve savings targets, and the opening of the work of AIFA's committees to the wider public is also likely to help it achieve a more efficient reimbursement system. |
AIFA announces launch of major new information system
The Italian Medicines Agency (AIFA) has published details of new arrangements for interactions with pharmaceutical companies, doctors, and pharmacists for the period during which its new information system will be in the process of implementation, including important details of administrative procedures that will be in place during this period. The new information system will involve the placing online of all information relating to decision-making processes, any conflicts of interest, and also the work of all AIFA's commissions, as reports the website of Osservatorio Malattie Rare, a news agency dedicated to rare diseases. As the source reports, AIFA's director Luca Pani announced that all such information will be made available to the public, in the interest of transparency, emphasising that transparency is a "duty" of regulatory agencies to citizens.
In its own press release providing information to the various stakeholders regarding the new system, AIFA states that it is designed to automate the flow of administrative, accounting-related and medical technology information, which will simplify procedures and optimise resources. As well as integrating all the agency's services, it will also mean greater potential for interfacing with external systems, in particular those of the European Medicines Agency (EMA). The press releases published by AIFA relating to the new information system – which is aimed at each professional group separately – can be accessed here, in Italian.
As the new system's implementation phase is beginning from 1 January 2013, a transition phase in which the migration of existing systems and the reorganisation of documents, services and data is now in effect, in which it will not be possible to use certain AIFA applications which are currently in use. The most significant part of this transition relates to the system of registers operated by AIFA for high-cost medicines. As AIFA specifies, under the new system, the registers of some drugs will remain accessible in the same way as on the current site, while others will be made available on the new platform on the basis of a schedule which will be announced in due course. During the period in which the registers for these latter drugs are not available, a simplified data collection system will be in place. The drugs concerned are detailed below.
Drug registers set to be added to new system
Cancer drugs
Afinitor (everolimus; Novartis, Switzerland)
Atriance (nelarabinw, GlaxoSmithKline, United Kingdom)
Avastin (bevacizumab; Roche, Switzerland)
Erbitux (cetuximab; Merck Serono, Germany)
Halaven (eribulin mesylate; Eisai, Japan)
Herceptin (trastuzumab; Roche)
Javlor (vinflunine; Pierre Fabre, France)
Jevtana (cabazitaxel; Sanofi, France)
Mabthera (rituximab; Roche)
Mepact (mifamurtide; Takeda, Japan)
Nexavar (sorafenib; Bayer, Germany)
Revlimid (lenalidomide; Celgene, United States)
Sprycel (dasatinib; Bristol-Myers Squibb, U.S.)
Sutent (sunitinib; Pfizer, U.S.)
Tarceva (erlotinib; Roche)
Tasigna (nilotinib; Novartis)
Thalidomide (Celgene)
Torisel (temsirolimus; Pfizer)
Vectibix (panitumumab; Amgen, U.S.)
Vidaza (azacitidine; Celgene)
Yondelis (trabectedin; Zeltia, Spain)
Zevalin (ibritumomab tiuxetan; Bayer)
Multiple Sclerosis drugs
Gilenya (fingolimod; Novartis)
Tysabri (Elan, Ireland)
Ophthalmology drugs
Lucentis (ranibizumab; Novartis)
Macugen (pegaptanib; Pfizer)
Rheumatoid arthritis drugs
Cimzia (certolizumab pegol; UCB Pharma, Belgium)
RoActemra (tocilizumab; Roche)
Orphan drugs
Elaprase (idursulphase; Shire, UK)
Ilaris (canakinumab; Novartis)
Kuvan (sapropterin hydrochloride; Merck KGaA, Germany)
Nplate (romiplostim; Amgen)
Revolade (eltrombopag; GlaxoSmithKline)
Soliris (eculizumab; Alexion Pharma, US)
Asthma drugs
Xolair (omalizumab; Novartis)
Management of cost/risk-sharing agreements, payment-by-result arrangements discontinued
Also very significantly for the pharma industry, mechanisms related to the management of cost and risk-sharing agreements, as well as payment-by-result arrangements, are to be discontinued, while basic data relating to them will continue to be collected. The management of these mechanisms will be started again, with retrospective effect, when the new system is up and running.
Outlook and implications
This is a highly significant development in the regulation of the pharmaceutical sector in Italy, and is the culmination of years of work and planning in AIFA, where the system of registers for the management of high-cost drug use has reached a stage of advanced development and has received widespread praise – although it is not without its own administrative challenges. The reports regarding the new system suggest that all the information regarding the work of the committees in AIFA – including the Technical-Scientific Committee and the Pricing and Reimbursement Committee – will be made available to the public, in the interests of transparency. Until now, the details of the deliberations of these committees have not been widely available in the public domain, so that the reasoning behind pricing and reimbursement decisions has not been readily available. For this information to be made available would mark a significant change. Additionally, the transfer of the drugs listed above to a new information system is likely to have important implications regarding the efficiency of their use, as AIFA seeks to streamline the pharmaceutical expenditure of the Italian state at a challenging time for the country economically.