– Marco Marchetti, Director, UVT
– Americo Cicchetti, Scientific Director, UVT
History and Structure
The Unità di Valutazione delle Tecnologie (UVT) (also known as the Health Technology Assessment (HTA) Unit) was established in 2001 at Agostino Gemelli University Hospital, a private, not-for-profit hospital accredited by the National Health System (NHS) that provides health care services in the Italian NHS. The HTA Unit has been created with the scope to introduce a scientific sounded tool which is able to provide all the information required to hospital management and clinical practice. The HTA Unit is part of the General Directorate and is overseen by the General Director. The HTA Unit’s activities are managed by an Executive Chief and by a Scientific Chief (responsible for the innovation are – research area); a technical staff is employed with expertise in epidemiology, health economics, biomedical engineering, quality systems, risk management, biostatistics and management.
The UVT mission is:
- To counsel top management in decisions making on resource allocation, using transparent, fair and consistent evaluation process;
- To support clinical practice by promoting the implementation and utilization of Clinical Governance logics and tools within the clinical care units;
- To conduct research projects and training activities in the HTA and Clinical Governance areas.
How UVT Works
The main Areas of Activities performed by the UVT are:
- Health technologies assessment;
- Quality management;
- Strategic Control;
- Research and Development (R&D);
- Education and Training.
The HTA Unit is part of a network of diverse competencies and information flows, within the hospital. As regards to the health technology assessment process, once a request has been submitted by clinicians, the HTA Unit identifies and synthesizes the evidence and incorporates local health and economic data collected from the hospital’s clinicians and administrative/clinical offices. Specifically, the HTA Unit has the task to synthesize information about the scientific evidence in a systematic review and to measure the economic impact, the organizational impact and the logistics component involved with the new technology. The results of the analyses are presented in a HTA report submitted to the Internal Commission in charge to make a decision on the introduction or use of the technology. In relation to Quality Management activity, different methods and tools have been adopted and standardized; in particular, guidelines on the standard clinical pathways, target pathways, responsibilities and clusters matrix were defined and approved by Health Care Directorate. A Risk Management Committee was created, and meetings have been scheduled with Technical Service (Institutional accreditation) and Joint Accreditation Committee-ISCT & EBMT (JACIE working group – Certification/Accreditation). HTA Unit’s Strategic Control activity aims to produce valuable information to General Directorate decision making body in order to support the governance strategy of “A. Gemelli” University hospital through a steering dashboard (based on the management and control of internal relevant information flows and sources and data analyses), internal auditing (based on a grid of indicators that measure the hospital performance), external benchmarking (based on a grid of indicators to compare the hospital performance with national and international hospitals), and horizon scanning.
Full HTA reports are disseminated internally only (i.e., hospital). A summary of the HTA reports are available on the net. The principal methods of distribution are the hospital’s intranet and direct distribution to health care professionals in the hospital. Research-based and quality and risk management reports are delivered to the funding organizations and are also disseminated through publication in national and international scientific journals, workshops, presentation at meetings or conferences.
All reports produced by the HTA Unit are written in Italian; an English version of these reports will be soon available.
Current Projects (A Selection)
Evaluation of medical devices:
- HydroSurgery System to simultaneously ablate, cut, and remove targeted tissue.
- Cochlear Implants
- Radiofrequency (RF) ablation system designed to maximize clinical outcomes and completely remove the Barrett's epithelium without significant injury to the underlying tissue.
- Bipolar energy device,
- Artificial urinary sphincter
- Generator for transdermal electromotive administration of chemiotherapy
- Bone Graft Substitute Silicate Substituted Calcium Phosphate
- System of intramedullary (IM) nails, screws
- Minimally invasive device for the treatment of gastroesophageal reflux disease
- Endoscopic stapling devices and coaxial endosurgical hand instrumentation for
- Selective internal radiation therapy using Yttrium-90 glass (liver cancer)
- Cements for vertebroplast
- Percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation
- One-step nucleic acid amplification (OSNA) for intraoperative detection of lymph node metastases in patients with breast cancer
- Hospital Acquired Infections: clinical and cost evaluation
- EUnetHTA projects: WP4- Core HTA, WP5- Relative Effectiveness Assessment of Pharmaceuticals, WP8- Strategy and business model development
- Daparox (paroxetina)
- Survey on stakeholder involvement and perception of the Pricing & Reimbursement process in Italy
- Evaluation of the impact of Vernakalant on the patient’s pathway of care
Education activities in HTA
- The Ulysses program – International Master Program in HTA and Management (5th Edition – 2009/2011)
- Master in Health Technology Assessment & Management (2nd edition- 2010-2011)
- Education activities on HTA targeted to scientific associations (short course)
- To support the development of clinical practice guidelines and to monitor their implementation in order to foster the transferring of the scientific knowledge into the clinical practice
- To increase the collaboration with Hospital clinicians through the spread of HTA knowledge, principles and culture
- To carry out primary studies related to research topics of particular interest
- To contribute to the development and standardization of methods for the assessment of health technologies like Medical Devices, Drugs, Biomedical equipments, etc.
Description of population served:
Population served (mil):
Current HTA budget (mil USD):
Permanent staff: 10
Consultants: variable (clinicians interested and involved in specific assessment projects)
Ongoing TA projects:
Director: Marco Marchetti
Contact person: Marco Marchetti (firstname.lastname@example.org)
HTA Unit in A. Gemelli Teaching Hospital
Largo Agóstino Gemelli
8-00168 Roma Italy