Tab. I.

Experts’ opinion.

General comments of expert panel	The following points were shared and appreciated by the panel of experts: the proposal to evaluate from different points of view the intermittent catheterization (IC) procedure, commonly used in people suffering from neurological and non-neurological pathologies, associated with complications and with an increased risk for patients of contracting urinary tract infections (UTIs) the need to answer the questions indicated and which have not yet been answered (e.g. which pathological conditions require intermittent catheterization and which of these are most associated with urinary tract infections, which type of catheter is most associated with UTIs, etc.), in particular “what are the real needs of patients who need intermittent catheterization” the “value based” approach of patient management with IC, in the various declinations of personal, allocative, technical and social value the project objective of identifying the main health needs of catheterized patients and action priorities for value-based management the applied methodology and the feasibility analysis which focused on the domains of the EUnetHTA core model HTA (CUR, ECO and TEC) The experts stressed the importance of a multidisciplinary approach for the management of IC with the active involvement of both clinicians and nurses. The experts underlined the heterogeneity and complexity of the various clinical conditions that may require catheterization as well as the variability of their clinical-epidemiological burden, especially in Italy. The experts also underlined the importance of greater prevention of UTIs related to IC. The importance of greater patient involvement was emphasized. In Italy, the actions of patient Associations but also of citizens are very strong. With regard to the medical device under study, the potential characteristics and opportunities to enhance patient safety and improve their quality of life should be considered (as reported in: Cittadinanzattiva. Carta della qualità e della sicurezza delle cure per pazienti e operatori sanitari. 2020. Available at: https://www.cittadinanzattiva.it/multimedia/import/files/progetti/salute/CARTA_della_qualit%C3%A0_e_della_sicurezza_delle_cure_per_pazienti_e_operatori_sanitari_1.pdf). Experts have highlighted the need to: collect information directly from patients with IC and caregivers on the needs of these patients, differentiated from each other being a very heterogeneous population, in order to reduce the risk of complications and UTIs but also to improve the patients’ quality of life produce an evaluation that includes the point of view of patients and caregivers on the IC procedure and on the most suitable devices to manage it provide patients with information on the IC and on the correct use of the device, with attention to the aspects of hygiene and infection prevention, accurately manage informed consent, taking into account the specificities of the person and the different context of life of the patient (hospital, home, nursing home, etc.)
Comments on review of the literature	According to the experts, the literature review was performed correctly from a methodological point of view and was fundamental to highlight the epidemiological gap on the number of patients with IC in Italy as well as on the prevalence of UTIs related to IC. This gap can be filled with further ad hoc studies aimed at producing scientific evidence on this health topic. The epidemiological data on the UTIs burden are heterogeneous in relation to the target population studied, the size of the sample, the study design, the definition of UTIs and the basic disease considered. Studies on the burden of IC-related UTIs in patients with multiple sclerosis and benign prostatic hyperplasia are still limited and more studies are needed to define the clinical-epidemiological burden. However, UTIs are also present in these target populations and underline a health need that must also be taken into account in these patients.
Comments on economic model	The members of the Advisory Board believe that the economic assessment presented is consistent. However, they underlined the need to build economic models that evaluate the cost-effectiveness of the different types of available catheters and that take into account the complications avoided (e.g. UTI), even with head-to-head comparisons. Furthermore, it would be useful to build ad hoc models on specific target populations and specific diseases that require catheterization.
Final comments	All the experts expressed particular interest in the contents proposed during the meeting, underlining the importance of working and producing evidence in this area in a perspective of value-based healthcare. The problem of IC-related UTIs is a serious problem and, unfortunately, underestimated. It deserves to be evaluated, deepened and disclosed in order to identify real and, where possible, innovative solutions. Finally, the panel expressed particular interest in the proposed study and the pre-assessment of the new technology under study, underlining the importance of the HTA evaluation of medical devices.