Atrial fibrillation (AF) is a chronically progressing arrhythmia and an independent risk factor for stroke, leading to a five-fold increased risk of stroke. The available options for stroke prophylaxis are anticoagulant oral drugs, which include warfarin, used in stroke for several decades, the new generation of anticoagulant drugs (Xa inhibitors and direct thrombin inhibitors), anti-platelet drugs, generally recommended for patients in whom anticoagulants are contra-indicated, and left atrial appendage closure technologies implanted via a catheter-based delivery system, including WatchmanTM.

In Italy decisions concerning drug reimbursement and prices seem that are not based on cost-effectiveness analysis (CEA) results or on the expected impact on health care budget i.e., budget impact analysis (BIA). This study aimed at scrutinizing the reasons of this attitude, anticipating possible future changes, by using a Delphi panel with thirteen experts in economic evaluation and pharmaceutical policy. Politicians’ distaste for explicit rationing, short-term cost-containment pressure and silos budgeting have been identified as the main obstacles to a systematic use of CEA and BIA. Although these obstacles are likely to persist in the future, consensus was reached among the experts for a broader use of CEA results at the national level, should a new drug provide considerable benefits versus a very high price, and of BIA at the regional level to support local sustainability. It is also imperative that both central and regional governments invest in post-marketing studies to evaluate whether the initial decision made when the new product was launched are consistent with a rational use of the scarce resources. Experts also advocated for (i) stronger interactions between the industry and third party payers, both at national and regional levels, especially at the drug market launch, when the industry is required to provide economic evidence and third party payers to assess this evidence, and (ii) an accredited network of research centers and professionals, supporting third party payers in this type of assessment, provided that the conflict of interest is rigorously verified.