UK charity Arrhythmia Alliance is warning that hundreds of patients at high risk from suffering an atrial fibrillation (AF)-related stroke could be left without access to potentially life-saving, preventative treatment for months while a decision is made on its funding.
The charity, alongside many of the UK's leading cardiac specialists, is calling on NHS England to secure continued provision of Left Atrial Appendage Occlusion (LAAO) – the only treatment available to prevent AF-related stroke in high-risk patients who can't take oral anticoagulants – in specialist centres while it completes the Commissioning through Evaluation (CtE) process.
LAAO is approved in the US and funded in many European countries, but was put onto the CtE pathway by NHS England as it wanted to collect more evidence on its effectiveness. The move meant that funding for LAAO was limited to 450 patients across 10 specialist centres in the country.
Now the programme is on the verge of entering an 'assessment phase', during which there is a freeze on funding until the outcome of the evaluation is reported and, if approved, the level of funding for the service is agreed. This means that it is unlikely that any LAAO treatment will be funded until April 2018, the charity argues.
"Many of these patients are living with a potential ticking timebomb as they are at seriously high risk of suffering AF-related stroke and the only treatment option open to them is LAAO," stressed Dr Dhiraj Gupta, Consultant Cardiologist, Liverpool Heart and Chest Hospital.
"If each of the current ten centres is 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," he stressed.
"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," added Trudie Lobban MBE, chief executic & founder of the charity.
"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 sub-population of patients to receive this potentially life-saving, and life-improving technology, whilst the data evaluation is completed."