Indefinite NHS England 'evaluation process' denies access to life-saving treatment for high risk patients

Arrhythmia Alliance is calling on NHS England to reconsider its ‘Commissioning through Evaluation’ (CtE) process, which has left hundreds of patients with AF (Atrial Fibrillation) at serious risk of suffering a debilitating or life-threatening AF-related stroke. The evaluation process 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 highrisk patients who are suitable for LAAO have suffered from previous stroke or transient ischemic attack (TIA), and many have also suffered from intracranial hemorrhage 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.

Mrs L, Surrey:

My husband has had three strokes and two TIAs and was originally considered for LAAO three years ago. Following his most recent stroke he was deemed suitable for LAAO but due to lack of funding has been left on a virtual waiting list. We don’t understand what this means. We now live with the fear of another stroke happening at any time.

A Freedom of Information request made by Arrhythmia Alliance to specialist cardiac centers 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 centers across the UK, NHS England decided in 2014 to put LAAO into the CtE program to carry out further assessment on its effectiveness, limiting funding to a total of 450 patients across ten specialist cardiac centers in the country.

The CtE program 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 centers already in the CtE process to continue to provide LAAO while the wider funding decisions are taken.” Said Trudie Lobban MBE, Founder & Trustee, Arrhythmia Alliance.

“If each of the current ten centers 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 concluded:

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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