Public consultations on draft reports within the National HTA Program for Medical Devices in Italy

On December 17, 2025, the Ministry of Health published two draft Health Technology Assessment (HTA) reports developed under the National HTA Program for Medical Devices (PNHTA-DM) and opened a public consultation. The assessments are coordinated by the National Agency for Regional Health Services (AGENAS).

The first draft HTA provides a systematic, multidisciplinary, and multidimensional evaluation of continuous glucose monitoring (CGM) systems compared with self-monitoring of blood glucose in patients with type 1 and type 2 diabetes mellitus receiving insulin therapy. The systematic review reached the following key conclusions:

• Evidence indicates that both real-time CGM (rtCGM) and intermittently scanned CGM (isCGM, also known as flash glucose monitoring, FGM) are more effective than traditional self-monitoring of blood glucose in improving metabolic control in patients with diabetes treated with insulin.
• In adult patients with type 1 diabetes, CGM use is associated with reductions in HbA1c, increased time in range (TIR), and decreased glycaemic variability, with clinical benefits closely linked to improved metabolic stability and the prevention of complications.
• In type 2 diabetes, although fewer studies are available, CGM use similarly demonstrates reductions in HbA1c and increases in TIR, with more pronounced benefits observed for rtCGM systems.

The second draft HTA concerns the UroLift and Rezum systems for the treatment of benign prostatic hyperplasia compared with standard surgical techniques - transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). The assessment focuses on clinical effectiveness, safety, organizational implications, and economic impact.

Stakeholders and the public may submit comments on the draft reports by January 16, 2026, via email.

See the more details in Italian here.

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