European Cardiovascular Round Table Finds Bureaucracy Is Delaying Patient Access to New Devices

July 16, 2015—The European Society of Cardiology (ESC) recently announced the publication of a Devices White Paper from the Cardiovascular Round Table that states that patients in Europe are experiencing significant delays in access to approved cardiovascular devices, including transcatheter aortic valve replacement and fractional flow reserve technology, because of bureaucratic inefficiencies. The Cardiovascular Round Table, which is composed of cardiologists and representatives of the pharmaceutical, device, and equipment industries, is an independent forum established by the ESC. The paper by ESC President Prof. Fausto Pinto, MD, et al is available online in the European Heart Journal.

The paper states that there is a clear correlation between declining death rates from cardiovascular disease and the introduction of innovative techniques and devices. In the ESC press release, Prof. Pinto commented, “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 research and development investment for future device therapies.”

Prof. Pinto 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 aging 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 diagnosis-related group (DRG) systems are putting development at risk.”

The Devices White Paper states,  “Device manufacturers are concerned that their ability to invest in future research and development programs will be limited by the unintentional side effect of inefficient processes within DRG systems. Manufacturers are already reporting a significant shortfall in the forecast utilization 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.”

As characterized by ESC, cases under the DRG system are categorized into diagnosis groups. Hospitals claim a standard tariff for each inpatient stay against the code for a treatment. When a new device is developed, a code has to be raised so that it can be reimbursed. Before this, devices are awarded a CE Mark that certifies proven safety and performance. Individual countries then carry out a health technology assessment (HTA) that again evaluates safety and clinical effectiveness. Assigning a reimbursement code nationally should be purely an administrative step but can take 6 years or more. The heterogeneity and need for repeated HTA assessment in various European countries could also represent another limiting step in the introduction of clinically proven technologies, explained the ESC announcement. 

The White Paper advises, “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.”

The CRT Devices White Paper recommendations to bring innovation to clinical practice sooner and make investment more attractive include:

• Establishing a working group of European Union and national regulatory authorities and HTA agencies, medical professional societies, and industry trade associations to speed up clinical adoption of new devices after approval.
• Fostering engagement of national cardiac societies with reimbursement agencies and HTA agencies to create target timescales for allocation of reimbursement codes and agree on a process for interim funding of promising new techniques.

Prof. Pinto concluded in the ESC press release, “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.”