We are, once again, in a transition process towards a harmonization of the HTA (High Technology Assessment) regulation. The new regulation aims to establish a framework that allows an efficient, transparent, predictable evaluation capable of accelerating access to innovation.
We see the creation of two operating modes: the Joint Scientific Consultation and Joint Clinical Assessment. The first favors an early engagement between the company and the regulatory bodies on the clinical development program and on the package of tests necessary for the purposes of the assessment. The second favors obtaining consensus on technical aspects of clinical evaluation.
Although the regulation came into force in 2021, its applicability will be progressive, the deadline for medicinal products with oncological indications and ATMPs is for 2025; 2028 for medicinal products with orphan indications and 2030 for all other medicinal products.
The adoption of the regulation was accompanied by a remodeling of the network of HTA bodies involved in the preparation of the infrastructure and future evaluation methods. The two main bodies are the HAG (responsible for the HTA agency group) whose Italian partners include AIFA, AGENAS and RER which are also part of Eunethta. Thanks to the great commitment of these Italian authorities, our country is already in full implementation of the HTA regulation, and from which Italy and the other member countries will be positively affected and will have a single clinical evaluation body at European level.
Dr. Ponzianelli’s invitation is to actively participate in the session of the symposium dedicated to this topic because it will certainly be a profitable place for comparison and discussion.