Atrial fibrillation--not so NICE in Ireland!

Atrial fibrillation is arguably the biggest cardiovascular challenge facing us in Ireland. The TILDA longitudinal study shows that up to 11% of our 80 years+ population have atrial fibrillation 1 . International data shows the prevalence of atrial fibrillation (paroxysmal and persistent) in western populations to be 5% over the age of 65 2 . The relative risk of stroke is the same irrespective of type of atrial fibrillation, with a 5-7 fold increased risk of stroke 3 . While atrial fibrillation accounts for 20% or so of all strokes internationally, local stroke databases suggest atrial fibrillation to be a causative factor in almost 1/3 of strokes in Ireland and associated with 55% of the more severe strokes 4 . A stroke from atrial fibrillation is associated with 60% chance of significant disability and almost 20% mortality 5 . A condition with such a high prevalence and such a high stakes should warrant a concerted preventative programme and public education. The WHO criteria used for validation of screening programmes are applicable to atrial fibrillation and Irish GPs know how to diagnose and treat atrial fibrillation 6,7 . The technology however to monitor, analyse and interpret cardiac rhythm unobtrusively and for periods of up to 5 days is needed in primary care and the remuneration of GPs for identifying and screening those at risk (perhaps those over 65 with hypertension initially) from proper patient registers needs to worked out. While this may seem ‘rich’ in the current economic climate, a principle in stroke prevention however, is that ‘we must invest to save’. Antiplatelets are of little efficacy for stroke prevention in atrial fibrillation and have largely been abandoned as a recommended strategy by European Society of Cardiology guidelines even for those at a modest risk on CHA2DS2Vasc scoring systems 8 . While oral anticoagulation is now the gold standard for stroke prevention, Warfarin is underutilised in Ireland as elsewhere 9,10 and Time in Therapeutic Ratio (TTR) achieved in clinical practice low 11 . Atrial Fibrillation is an age-related disease and physicians are reluctant to use warfarin where they perceive risks of bleeding may outweigh benefit of stroke prevention. The same risks that increase our risk of stroke as we age are those that increase our risk of bleeding with warfarin (CHADS2 is as good a predictor of risk of bleeding on anticoagulation as ischaemic stroke in atrial fibrillation for example). In addition because of its’ origins as a rodenticide, the need for monitoring and relative contraindication with alcohol, patients often refuse Warfarin or have to, as they are unable to access monitoring services due to mobility problems, living in remote areas etc. The advent of the newer anticoagulants offers new hope in greater treatment rates of those at risk with more effective and safer drugs. Dabigatran a direct thrombin inhibitor, Rivaroxaban and Apixaban both factor Xa inhibitors should individually and variably address many of the problems associated with Warfarin. All agents have fixed dosing, short half-lives, little interaction with other drugs and foodstuffs and do not need coagulation monitoring. All agents have demonstrated at least a similar efficacy to warfarin in preventing ischaemic stroke and a reduced incidence of intracranial bleeding 12-14 . The trial evidence is strong in appropriately aged, at-risk populations. It should lead to improved prevention and less stroke in atrial fibrillation. There are concerns however about the efficacy and availability of strategies, such as dialysis (in the case of dabigatran) or Prothrombin Complex (with the Xa factor inhibitors) to restore normal coagulation in the event of severe bleeding or where urgent surgery might be indicated. The main obstacle however to wider uptake of anticoagulation in atrial fibrillation is that the drugs are not reimbursed currently in Ireland, as in many other countries. The UK’s National Institute for Clinical Excellence (NICE) recently approved both Dabigatran and Rivaroxaban for use in the UK. Analysis by our own National Centre for Pharmacoeconomics (NCPE) failed to reach the same affirmative conclusions on cost effectiveness regarding Dabigatran, although importantly it recognises there are broad assumptions in its model; that the two drugs analysed were more likely than not to be cost effective at the pre-specified QUALY of €20-30,000, and their recommendation was in part based on the perceived ‘value for money’ for the HSE. There are of course differences in methodological analysis and scale of population sizes between national analyses, but not included in our any analysis was the almost 40% of people with atrial fibrillation not currently anticoagulated in Ireland, due in a large part to the nature of warfarin. A 66% reduction of incidence of stroke in this population would make appreciable savings to a health service where the average direct acute costs alone of a stroke is €20,000 approx., and particularly as atrial fibrillation-related stroke is likely to be at the more severe end of the spectrum 14 . The indirect costs of monitoring clinics and presentations to emergency departments due to high INRs or excess bleeding are also significant and indeed when the direct drug costs are stripped away there is evidence for probable significant savings with all three agents over warfarin in other economies 15 . We have a moral imperative as doctors to recommend best treatment to patients. Where we have evidence for superior drug treatment for an individual, in terms of either efficacy and/ or safety, then our advice must be honest irrespective of all re-imbursement considerations. There maybe an uncomfortable discussion of a ‘ second best ‘ treatment for those who cannot afford the new drugs but there is an ethical and medico legal obligation to recommend what is best treatment for individual patients and that is likely to be one of the newer anticoagulation agents in a substantial number of patients with atrial fibrillation. DR Collins, T CoughlanDepartment of Age-Related Health Care and Stroke Medicine, AMNCH, Tallaght, Dublin 24Email: [email protected] References1. Finucane C, Frewen J, Cronin H, Kearney P, Rice C, O’Regan C, Harbison J, Kenny RA. Low Awareness of AtrialFibrillation in a Nationally Representative Sample of Older Adults. Circulation. 2011;124:A156612. Rietbrock S, Heeley E, Plumb J, van Staa T. Chronic atrial fibrillation: Incidence, prevalence, and prediction ofstroke using the Congestive heart failure, Hypertension, Age >75, Diabetes mellitus, and prior Stroke or transientischemic attack (CHADS2) risk stratification scheme. 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Medical Cost Reductions Associatedwith the Usage of Novel Oral Anticoagulants vs. Warfarin Among Atrial Fibrillation Patients, Based on the RE-LY,ROCKET-AF and ARISTOTLE Trials. J Med Econ .2012 Mar 27. Atrial Fibrillation – not so NICE in Ireland!2