L’Agenzia Italiana del Farmaco comunica ai sensi dell’articolo 1, comma 402 della legge 11 dicembre 2016, n. 232:
- L’approvazione dei criteri per la classificazione dei farmaci innovativi, la procedura di valutazione e i criteri per la permanenza del requisito dell’innovatività.
- L’approvazione del modulo per la richiesta del riconoscimento dell’innovatività.
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.