08/04/2013 – AIFA
The assessment of innovativeness is a complex and articulated decision-making process in any field it is applied to. In the case of medicines and the role of a Regulatory Agency, this complexity is particularly evident and relevant, as the risk/benefit ratio of a medicine must be combined with the correct valuation of the benefit/price, i.e., translate into a measurable advantage for patients, for their families and for the National Health System in general.
In doing this, the Agency must account for the principles that inspire it in the evaluation of the dossiers relating to the definition of the reimbursement and the price of drugs, making them transparent and sharing them with all the different interlocutors. AIFA, at the end of a significant development process of a new evaluation structure of the therapeutic innovativeness of medicines, opens to a public consultation reserved for experts in the sector, the elements that make up the preliminary investigation system relating to the definition of any reimbursement and the price of medicines and a simplified model of algorithm for identifying the degree of therapeutic innovation.
It will therefore be possible to request access to the pages hosting the surveys, relating to the domains and questions that make up the medicines evaluation system and an online example of the primary algorithm that the Agency will use in its evaluations.
Access to the algorithms and surveys is reserved for selected users who will ask to participate, logging in using a personal User ID and Password, which will be sent upon incontestable decision by AIFA and which may be suspended at any time.
The Agency, before making these features available to the public, will make them accessible exclusively to its own Advisory Commissions. Therefore requests from external users will be met starting from 8 April.
For intellectual property and development reasons, including international ones, it is forbidden to copy, reproduce in whole and/or in part the nodes and/or the structure of the algorithms and the constituent elements of the survey.
To request strictly individual and non-transferable access, it will be necessary to send an email explaining the reasons for the request together with the applicant's CV, to the Secretariat of the General Management: segreteria.dg@aifa.gov.it
