Objectives The aim was to outline the challenges of implementing outcomes-based contracts (OBCs) in Europe. Methods A scoping review was conducted, building on the searches of a previous systematic review and updating them for December 2017 until May 2021. The combined results were screened, based on inclusion and exclusion criteria. All identified studies published in the English language that described specific OBC schemes for medicines in European countries were included. Insights into the challenges of OBCs were extracted and analysed to develop a conceptual framework. Results Ten articles from the previous systematic review matched our inclusion criteria, along with 14 articles from electronic searches. Analysis of these 24 articles and classification of the challenges revealed that there are multiple barriers that must be overcome if OBCs that benefit all stakeholders are going to be adopted widely across Europe. These challenges were grouped according to five key themes: negotiation framework; outcomes; data; administration and implementation; and laws and regulation. Conclusions If the promise of OBCs is to be fully realised in Europe, there remain major challenges that need to be overcome by all stakeholders working in partnership. The overlapping and interconnected nature of these challenges highlights the complexity of OBC arrangements.
Background: We assessed cost–effectiveness of insertable cardiac monitors (ICMs) in a US cryptogenic stroke population. Materials & methods: We modelled lifetime costs and quality-adjusted life years for three monitoring strategies post cryptogenic stroke: ICM starting immediately, ICM starting after Holter monitoring (delayed ICM) and standard of care involving intermittent ECG and Holter monitoring. Patient characteristics and detection efficacy were based on the CRYSTAL-AF trial. AF detection altered the modelled anticoagulation therapy and subsequent stroke and bleed risks. Results & conclusion: Immediate ICM was found to be cost-effective versus standard of care and cost-saving versus delayed ICM. Results were robust to sensitivity analyses. ICMs are a cost-effective diagnostic tool for the prevention of recurrent stroke in a US cryptogenic stroke population.
Objective: To evaluate the cost-effectiveness of insertable cardiac monitors (ICMs) compared to standard of care (SoC) for detecting atrial fibrillation (AF) in patients at high risk of stroke (CHADS2 >2), in the US. Background: ICMs are a clinically effective means of detecting AF in high-risk patients, prompting the initiation of non-vitamin K oral anticoagulants (NOACs). Their cost-effectiveness from a US clinical payer perspective is not yet known. Methods: Using patient data from the REVEAL AF trial (n= 446, average CHADS2 score= 2.9), a Markov model estimated the lifetime costs and benefits of detecting AF with an ICM or with SoC (namely, intermittent use of electrocardiograms [ECGs] and 24-hour Holter monitors). Ischemic and hemorrhagic strokes, intra- and extra-cranial hemorrhages, and minor bleeds were modelled. Diagnostic and device costs were included, plus costs of treating stroke and bleeding events and of NOACs. Costs and health outcomes, measured as quality-adjusted life years (QALYs), were discounted at 3% per annum. One-way deterministic and probabilistic sensitivity analyses (PSA) were undertaken. Results: Lifetime per-patient cost for ICM was $58,132 vs. $52,019 for SoC. ICMs generated a total 7.75 QALYs vs. 7.59 for SoC, with 34 fewer strokes projected per 1,000 patients. The incremental cost-effectiveness ratio (ICER) was $35,452 per QALY gained. ICMs were cost-effective in 72% of PSA simulations, using a $50,000 per QALY threshold. Conclusions: The use of ICMs to identify AF in a high-risk population is likely to be cost-effective in the US healthcare setting.
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