Financing medical devices in Italy and Spain

This study reports on the first comparative analysis of regulation and funding of medical devices in the two European countries: Italy and Spain. The research was articulated in two parts with their distinctive objectives. The objectives of the first part were: (i) to provide an in-depth description of the contents and structure of existing national/regional services/benefit baskets; (ii) to identify actors involved in the decision-making process related to benefits baskets; (iii) to describe the decision-making process related to benefits baskets. In the second part, an in-depth analysis on selected medical technologies was conducted across three dimensions: (i) coverage status and access to technology (inclusion/exclusion of device in the national/ regional benefit basket); (ii) procurement mechanisms, conceived as the financing arrangements between producers (medical device industry) and providers (hospitals) concerning acquisition price; (iii) reimbursement status (type of reimbursement, decision makers and criteria adopted). Six medical devices/procedures were selected, belonging to three different categories of medical devices: i) artificial body parts (i.e. medical devices implanted in the patient: knee endoprostheses, implantable cardiac defibrillators (ICDs), coronary stents), ii) medical aids (i.e. products given to or prescribed for selected categories of patients: urinary incontinence pads, wound care) and iii) assistance for professionals (i.e. technical equipment supporting professionals: laparoscopic colorectal surgery).