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The Agency has adopted, especially in recent years, a policy of inclusion and openness, as evidenced by the expanding criteria for access to new drugs against Hepatitis C and the increase in the number of drugs have obtained the definition of innovation and can therefore be reimbursed through access to funds allocated to them (Innovative Medicines Fund and funds for innovative cancer) and automatic insertion in regional prontuaries
20 JUL – On pharmaceutical innovation of recent years, the Italian Medicines Agency has set up concrete initiatives: the definition of innovation criteria and their application in the clbadification of new drugs and the promotion of tools that have not yet been valued essential drugs (Fund 5%, Law 648 / 1996 and "compbadionate use") are only some of the most immediate examples.
On access to innovative medicines the goal of the Italian Medicines Agency has been and is very clear: make available and refundable (so free to the citizen) the therapies that actually represent a turning significant for the health and quality of life of patients while ensuring the widest possible acceptance, consistent with the sustainability of the national health service.
The Agency has adopted, particularly in recent years, a policy of inclusion and openness, as evidenced by the expanding criteria for access to new drugs against hepatitis C and the increase in the number of drugs that have reached the definition of innovation and can therefore be reimbursed through access to funds allocated to them (funds for innovative medicines and funds for cancer oncology) and automatic insertion into the regional prontuari.
The 2017 data on the consumption of innovative drugs, in this sense, are very indicative: 13.4 million daily doses of innovative drugs were distributed compared to 12.0 million in 2016 (+ 11.7% ) and to 9.2 million in 2015. Despite the increase in consumption, spending levels have been substantially reduced thanks to the Agency's ability to renegotiate old contracts (even with the write-off of band C in case of no agreement, as in the case of Sovaldi and Harvoni) and to negotiate the new agreements at the least cost. National Health Service.
The constant monitoring of drug use by registries is also a valuable source of information on patient care, prescribing the relevance and effectiveness of treatment in clinical practice, and is an indispensable tool in negotiations and reimbursement agreements, as it allows the periodic re-evaluation of authorized drugs.
The information acquired by clinicians, the therapeutic needs, the patient experience and the know-how of the scientific community are all relevant factors in the decision-making process of the Agency. For this reason, AIFA is also very attentive to the stimuli and requests of the various stakeholders who, in some particular cases, may be promoters of pathways allowing access to an innovative drug, even before & # 39; It is allowed in our country. This is the case of the application for listing on the 648/1996 list, which allows disbursement by the National Health Service, and can also be presented by a patient badociation or a scientific society.
In the thematic working groups, the Agency systematically involves stakeholders, as is currently the case for the geriatric work table, which also includes representatives of citizens, or those of primary care and single-dose drugs. I am also thinking of the valuable contribution made by scientific societies and professional badociations in writing documents on gonadotropins, oral contraceptives and palliative care.
Beyond these tools, AIFA believes in a daily and proactive dialogue with its interlocutors, primarily citizens, and positively considers all such opportunities, such as "the open AIFA," in which it can be generated. a productive comparison to better guide the regulatory activity, always in the priority interest of patients.
Mario Melazzini
General Manager Aifa
July 20, 2018
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