The Italian Medicines Agency communicates pursuant to article 1, paragraph 402 of the law of 11 December 2016, n. 232:
- The approval of the criteria for the classification of innovative drugs, the evaluation procedure and the criteria for maintaining the requirement of innovation.
- Approval of the innovativeness recognition request form.
AIFA press release – 05/04/2017
AIFA believes that the innovativeness assessment model must be unique for all drugs but that it may provide for the use of further specific indicators, if necessary. The proposed model envisages a multidimensional approach, which takes into account three fundamental elements:
1. the therapeutic need;
2. the added therapeutic value;
3. the quality of the evidence or the robustness of the clinical studies.
Drugs for which both a "Maximum" or "Important" level of therapeutic need and added therapeutic value and a "High" quality of evidence have been recognized can be considered innovative. On the other hand, innovativeness cannot be recognized in the presence of a therapeutic need and/or an added therapeutic value judged as "Poor" or "Absent", or of a quality of the evidence judged as "Low" or "Very low". Intermediate situations will be evaluated on a case-by-case basis, taking into account the relative weight of the individual elements considered.
At the end of the process, the CTS will prepare a brief report, in which the assessments relating to each of the three areas considered will be described, and the relative final judgment will be expressed.
As established by article 1, paragraph 402, of Law 11 December 2016, n. 232 (2017 Budget Law), the recognition of innovativeness and the consequent benefits have a maximum duration of thirty-six months. The permanence of the innovative character attributed to a drug will be reconsidered if evidence emerges that justifies its reevaluation. In any case, for drugs with conditional innovation, at least one re-evaluation will be mandatory 18 months after its granting.
In the presence of evidence that contradicts that which had justified its recognition or reduces its effect, the innovativeness cannot be confirmed, and the benefits associated with it will cease, with the consequent start of a new negotiation of the price and the conditions of reimbursement.
