Establishing a national HTA program for medical devices in Italy: Overhauling a fragmented system to ensure value and equal access to new medical technologies.

Differing contexts have greatly influenced HTA development in various countries, with considerable effort recently made by international HTA networks (e.g., EUnetHTA) and the European Union (EU) to make HTA a more coherent, equal, and efficient process. Medical devices (MDs) present particular challenges for HTA because of frequent, rapid innovation, outcomes influenced by end-user competence, dynamic pricing and often low-quality scientific evidence. Our objective is to describe the development, structure and governance of a National HTA Program for MDs (PNHTADM) in Italy, a highly participatory, stakeholder-engaged, evidence-based process to reform a fragmented system of appraisal and approval. Based largely on EUnetHTA methods, the resulting process delineates a standardized system for proposing MDs by any stakeholders, accrediting HTA producers, setting criteria for prioritization and appraisals, and innovatively linking recommendations with coverage, reimbursement and procurement of MDs. Expected benefits include reduced disparities in pricing and reimbursement policies and improved access to new technologies across 21 regional healthcare systems in Italy's decentralized, universal system, complete with provisions to require additional evidence collection and centrally monitor diffusion. Though devised for Italy, the design, resources and underlying analysis provide a framework for other nations seeking to consolidate HTA initiatives, particularly in light of new EU regulation.

Cost-Utility of Intermediate Obstetric Critical Care in a Resource-Limited Setting: A Value-Based Analysis.

Background: Sierra Leone faces among the highest maternal mortality rates worldwide. Despite this burden, the role of life-saving critical care interventions in low-resource settings remains scarcely explored. A value-based approach may be used to question whether it is sustainable and useful to start and run an obstetric intermediate critical care facility in a resource-poor referral hospital. We also aimed to investigate whether patient outcomes in terms of quality of life justified the allocated resources. Objective: To explore the value-based dimension performing a cost-utility analysis with regard to the implementation and one-year operation of the HDU. The primary endopoint was the quality-adjusted life-years (QALYs) of patients admitted to the HDU, against direct and indirect costs. Secondary endpoints included key procedures or treatments performed during the HDU stay. Methods: The study was conducted from October 2, 2017 to October 1, 2018 in the obstetric high dependency unit (HDU) of Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Findings: 523 patients (median age 25 years, IQR 21-30) were admitted to HDU. The total 1 year investment and operation costs for the HDU amounted to €120,082 - resulting in €230 of extra cost per admitted patient. The overall cost per QALY gained was of €10; this value is much lower than the WHO threshold defining high cost effectiveness of an intervention, i.e. three times the current Sierra Leone annual per capita GDP of €1416. Conclusion: With an additional cost per QALY of only €10.0, the implementation and one-year running of the case studied obstetric HDU can be considered a highly cost-effective frugal innovation in limited resource contexts. The evidences provided by this study allow a precise and novel insight to policy makers and clinicians useful to prioritize interventions in critical care and thus address maternal mortality in a high burden scenario.