Hundreds of patients with Atrial Fibrillation (AF) in the UK have been left at risk of suffering a life threatening AF-related stroke, thanks to NHS England’s flawed ‘Commissioning through Evaluation’ (CtE) process, according to the charity, Arrhythmia Alliance. The evaluation process, which should be reviewed, has meant patients being denied access to potentially life-saving treatment with no guarantee when the process will be completed to allow access.
The evaluation process, which should be reviewed, has meant patients being denied access to potentially life-saving treatment with no guarantee when the process will be completed to allow access.
Left atrial appendage occlusion (LAAO) is the only treatment available to prevent an AF-related stroke in hundreds of patients in whom oral anticoagulant drugs are contra-indicated. Many of these high risk patients who are suitable for LAAO have suffered from previous stroke or transient ischaemic attack (TIA), and many have also suffered from intracranial haemorrhage or major bleeds at other sites.
“Many of these patients are living with a potential ticking time-bomb as they are at seriously high risk of suffering an AF-related stroke and the only treatment option open to them is LAAO,” stated Trudie Lobban MBE, Founder & Trustee, Arrhythmia Alliance.
A Freedom of Information request made by Arrhythmia Alliance to specialist cardiac centres across England uncovered that many patients suitable for LAAO are unable to receive treatment on the NHS due to funding constraints, while the CtE evaluation process is completed. Some of the most high risk patients are now being offered the treatment privately as the only means to receive this potentially life-saving treatment.
A recent survey undertaken by the charity of 800 people with AF found that over 10 percent had previously suffered an AF-related stroke and nearly 4 percent were unable to take anticoagulant medication. Despite having a large body of evidence to support its use, including FDA approval and full reimbursement in a number of EU countries, and having been used successfully by a number of centres across the UK, NHS England decided in 2014 to put LAAO into the CtE programme to carry out further assessment on its effectiveness, limiting funding to a total of 450 patients across ten specialist cardiac centres in the country.
The CtE programme is now in its ‘assessment phase’, which means no more funding is available for any patient until the evaluation has been reported and, if approved, the level of funding agreed.
The CtE programme is now in its ‘assessment phase’, which means no more funding is available for any patient until the evaluation has been reported and, if approved, the level of funding agreed.
This means no access to LAAO on the NHS for these very high-risk patients until the financial year commencing in April 2018 – at the earliest. “Although we believe in the concept of CtE, we cannot accept such high-risk patients with AF being unable to receive this often life-saving treatment.
“The Arrhythmia Alliance together with many UK Cardiac Specialists is urging NHS England to allow those centres already in the CtE process to continue to provide LAAO while the wider funding decisions are taken,” says Trudie Lobban MBE, Founder & Trustee, Arrhythmia Alliance.
“If each of the current ten centres was able to continue providing LAAO implants over the coming 12 months – as they were during the CtE process – this would reduce the number of inevitable AF-related strokes that many patients are likely to suffer during this time period,” added Dr Dhiraj Gupta, Consultant Cardiologist, Liverpool Heart and Chest Hospital.
Ms Lobban concludes, “The cost of an LAAO as used by NHS England for CtE was £7,470 – however, the first-year cost per patient that suffers an AF-related stroke is calculated at well over £13,000. We believe it makes sense both clinically and economically for NHS England to allow this specific subpopulation of patients to receive this potentially life-saving, and life-improving technology, whilst the data evaluation is completed.”
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