Italy

Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA. The steering committee will produce policy recommendations about the use of the assessed technologies and monitor implementation by procurement organizations. Read about the scope of the framework in our blog post.

A list of scientific societies and technical and scientific medical associations appointed to release national guidelines will be defined in the next months by the Ministry of Health, following its decree issued on 2nd August 2017.

The previous regional guidelines on brain stimulation therapy for advanced Parkinson’s disease, drug-resistant chronic migraine, and drug-resistant epilepsy, published in 2014, have been updated by the Regional Technical Commission for Medical Devices considering the new evidence on the specific groups of patients and some modifications in the indications for use of some devices. Check out indications for different neurostimulator technologies. These recommendations will form the foundation for reimbursement of devices in the region.

Assessments were directed by national HTA body AGENAS. They cover renal denervation for hypertension, next generation sequencing in oncology, robotic surgery, sling operation for urinary incontinence and vertebral disc replacement.

For 19 of the surgical procedures in which laparoscopic techniques are more common, such approach is used in less than 4 out of 10 cases. Differences in levels of use emerged between Northern, Central, and Southern Regions in which the laparoscopic procedures were used less often.

New publication in Obesity Facts provides insights into cost-effectiveness of bariatric surgery in Italy ("Cost-Utility Analysis of Bariatric Surgery in Italy: Results of Decision-Analytic Modelling"). Bariatric surgery was found to be cost effective at 10-year and cost saving at lifetime time horizon.

An updated form for notification of medical technology to Italian national health technology assessment program has been released in May. Any stakeholder, including industry, can make notification, which will be reviewed and prioritize every six months.