heart rhythmPatients are experiencing significant delays in accessing approved cardiovascular devices due to bureaucratic inefficiencies, a Devices White Paper from the Cardiovascular Round Table (CRT) has revealed.

The White Paper said there was a clear correlation between declining death rates from cardiovascular disease and the introduction of innovative techniques and devices.

However, the authors of the paper said that issues around reimbursement and the scaling back of R&D investment meant many people were not getting access – or experiencing delayed access – to the innovative devices.

For example, under the diagnosis related group (DRG) system, cases are categorised 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. Prior to this, devices are awarded a CE Mark which certifies proven safety and performance. Individual countries then carry out a health technology assessment (HTA) which evaluates safety and clinical effectiveness. Assigning a reimbursement code nationally should be purely an administrative step but can take six years or more.

ESC President Professor Fausto Pinto, lead author and CRT 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.”

Examples of innovative device technologies that are underused due to inefficiencies in reimbursement include 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:

  • Establishing a working group of EU and national regulatory authorities and HTA agencies, medical professional societies and industry trade associations, which would speed up clinical adoption of new devices after approval
  • Encouraging 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.

The CRT is an independent forum established by the European Society of Cardiology (ESC) and comprised of cardiologists and representatives of the pharmaceutical, device and equipment industries. The White Paper was published in the European Heart Journal.