Integrating HTA Principles into Procurement of Medical Devices: The Italian National HTA Programme for Medical Devices

Managing the adoption and diffusion of technological innovation is a key challenge for healthcare systems. In 2015, Italy has started designing and implementing a National Health Technology Assessment (HTA) Programme for Medical Devices (MDs), a network aimed at promoting the use of HTA tools, and safety, effectiveness and cost-effectiveness principles in the decision-making process of medical technologies. Since 2017, all the relevant stakeholders involved in HTA (i.e., patients and citizens’ representatives, scientific organizations, industry, healthcare organizations, academic researchers) are supporting a Steering Committee active at the Ministry of Health in the design and implementation of the Programme. Several working groups were established, one of them - based on a review of best practices - was instructed (i) to develop methods and procedures to integrate the results of HTA into decisions of procurement and clinical pathways and (ii) to propose a purchase request form template to be used by health care professionals. The final goal of the HTA Program is to reduce the heterogeneity across practices which translate into uneven access to innovative health technologies. This work provides an overview of the rationale and participatory process undertaken in Italy, and illustrates the working group main findings and recommendations.