COVERAGE UNDER EVIDENCE DEVELOPMENT: L’ESPERIENZA DELL’HEALTH POLICY FORUM

[Autom. eng. transl.] The ideal system for generating evidence to inform them has been outlined coverage decisions and directing healthcare pricing and reimbursement decisions in a context of “scarce” resources in which it is necessary to identify objective criteria to understand the real value of the technologies at the time of introduction in the clinical practice in the presence of evidence not considered sufficiently "mature". For medical devices, registries are the fundamental tool for evaluating the potential health benefits deriving from the conditional adoption of a technology. The quality of a register depends on the quality of the data entered and therefore reason it is important to identify the parameters to be monitored in order to obtain results useful, in compliance with the privacy of the data entered. Such registers should be implemented at a national level and the subject of these registers should be the set of high-cost medical devices for which there is insufficient evidence of efficacy. In assessing the impact of a new drug at a central level, the preponderant aspects for each stakeholder in order to support the consequent decision informed. The identified aspects are: • accessibility of technology by patients; • efficiency of the National Health Service, understood as the ability to maximize health produced for the resources invested; • appropriateness, understood as identifying the patient population that can take full advantage of the use of that technology; • efficacy in conditions of real clinical practice; • comparative effectiveness, with respect to the best available alternative for that category of patients; • safety (safety); • control of expenditure with respect to the assigned budget; • health-related quality of life. A weight that identifies the role has been associated with each criterion and for each stakeholder of each stakeholder in the specific phase. The regional level plays an active role in identifying evidence from the moment that it acts as a collector and capillary manager of the flow of information, collects epidemiological, administrative and resource use data. It remains, however, the great difficulty of managing and interpreting such information at a macro level, which they come from highly differentiated systems.