Abstract
The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.
Highlights
Governments are committed to controlling increasing healthcare expenditure, contributing to the efficiency and sustainability of healthcare systems, within a context of dwindling budgets, exacerbated by the double impact of the past economic and financial crisis beginning in 2008Downloaded from https://www.cambridge.org/core
Other domains relevant for medical device assessment, such as learning curves for capacity building, organizational issues, or environmental impact, are commonly ignored. This situation calls for additional informational sources such as postlaunch evidence-generation (PLEG) studies, which can provide postmarketing real-world evidence (RWE), enlarging the scope of health technology assessment (HTA) in the lifecycle of technologies according to the new HTA definition [5,6,7]
Despite the value attributed to RWE to inform national decision making in the Spanish National Health System (NHS), the commitment and participation of the Ministry of Health (MoH) and all regional health authorities, and the adherence of the Monitoring Studies (MS) to the essential quality standards for registries recently agreed by EUnetHTA [20], several relevant problems were identified by the DGPSPh, in a recent overall review of the MS processes
Summary
Governments are committed to controlling increasing healthcare expenditure, contributing to the efficiency and sustainability of healthcare systems, within a context of dwindling budgets, exacerbated by the double impact of the past economic and financial crisis beginning in 2008.
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