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European Heart Journal, and Professor Nick Linker

Clinical Articles, Lead Article

Patient access to cardiovascular devices delayed by bureaucracy

Patients are experiencing significant delays in access to approved cardiovascular devices due to bureaucratic inefficiencies, reveals a Devices White Paper from the Cardiovascular Round Table published recently in the European Heart Journal.1

The paper provides examples of innovative device technologies that are underused due to inefficiencies in reimbursement, such as transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR).

The authors recommend ways to bring innovation to clinical practice sooner and make investment more attractive. These include:

• Establish a working group of EU and national regulatory authorities and health technology assessment (HTA) agencies, medical professional societies and industry trade associations to speed up clinical adoption of new devices after approval

• National cardiac societies to engage with reimbursement agencies and HTA agencies to create target timescales for allocation of reimbursement codes and agree a process for interim funding of promising new techniques.

Dr Nick Linker (James Cook University Hospital)

Professor Nick Linker (James Cook University Hospital)

The authors state: “Device manufacturers are concerned that their ability to invest in future R&D programmes will be limited by the unintentional side effect of inefficient processes within diagnosis-related group (DRG) systems. Manufacturers are already reporting a significant shortfall in the forecast utilisation of the current generation of cardiovascular devices even when there is clear demand, regulatory approval has been obtained, clinical efficacy has been proven, and the techniques are included within formal guidelines.”

“It is inefficiencies in allocating this code number for the current generation of cardiovascular devices that, surprisingly, represents a major threat to investment in the next generation,” they go on to warn.

Professor Nick Linker (James Cook University Hospital, UK), President of the British Heart Rhythm Society, gave us a UK perspective on the White Paper: “The UK remains well below the European average for implantable cardioverter defibrillator (ICD) implants, although is improving in terms of cardiac resynchronisation therapy (CRT) devices; the latter due to a higher than average implant rate of CRT pacemakers.  However, the rate of implantation of all high energy devices (ICD + CRT-defibrillators) is only slightly more than half the European average”.

“The Cardiovascular Round Table argues for greater involvement of National Societies such as the British Heart Rhythm Society, British Cardiovascular Intervention Society, British Cardiovascular Society and others with healthcare providers and furthermore that the European Commission should establish timescales for the allocation of national funding for new procedures.  Whilst it is unlikely that the European Commission will have a significant influence on the NHS, it is important that clinicians, backed by their National Societies, continue to engage and push to get the funding and support to develop these procedures,” Professor Linker added.*

European Society of Cardiology (ESC) President Professor Fausto Pinto, lead author and Cardiovascular Round Table member, said: “These devices are safe, approved by regulators and included in guidelines but inclusion in reimbursement systems lags behind. Patients may therefore have delayed access to recommended treatments because of bureaucratic delays. The knock-on effect is that return on investment is reduced and companies are scaling back R&D investment for future device therapies.”

He continued: “Innovation in cardiovascular devices is desperately needed to halt an epidemic of cardiovascular disease. Cardiovascular disease is the leading cause of death in Europe but an ageing population plus rapid growth of diabetes and obesity is pushing us towards an even greater problem. Research suggests that 40% of the population will have at least one form of cardiovascular disease by 2030. Novel devices are needed but inefficient DRG systems are putting development at risk.”

“Research has shown a clear correlation between declining death rates from cardiovascular disease and the introduction of novel techniques and devices. However, reimbursement systems in Europe are blunting cardiovascular innovation. Now is the time for regulators, HTA agencies, professional societies, industry and national cardiac societies to speed up clinical adoption of new devices so that patients receive the best treatments now and in the future,” Professor Pinto concluded.

*These are Professor Linker’s personal views, and not necessarily those of the British Heart Rhythm Society or the South Tees Hospitals NHS Foundation Trust


1. Pinto F, Fraser AG, Kautzner J, et al. Barriers to cardiovascular device innovation in Europe. Euro Heart J 2015.

Published on: July 30, 2015

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