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Europe Must address Key Issues

Submitted by on 12 Mar 2012 – 12:19

By Herb Riband, Vice President External Affairs International, Medtronic International; Chair, Eucomed Public Affairs Network

Today Europe is facing the “triple challenge” of ageing populations demanding better healthcare, a growing chronic disease burden and increasing shortages of healthcare workers and professionals – all in an environment of tight budgets.

eHealth innovations have the potential to make significant contributions towards overcoming these challenges, for the benefit of Europe’s patients and healthcare systems. However, three principal issues need to be addressed.

The first issue is a lack of focus on value. Our current healthcare delivery model in Europe does not generate sufficient value from what we spend, and will not enable us to overcome the challenges we face – unless we do things differently.

According to a recent study (LEK, 2009), 80-85% of national healthcare budgets are spent on operating costs, administration, labour, facilities – in other words, delivering healthcare the “same old, same old” ways. But in times of budgetary shortfalls there is a tendency to focus on the perceived “easy targets” by cutting the 2-5% of national HC budgets spent on medical devices, and the 10-15% spent on medicines, instead of rethinking the entire clinical pathway for a given disease and assessing the system’s effectiveness and efficiency on a “total cost of ownership” basis. Such a short term cost-cutting approach will not enable Europe to address the “triple challenge”.

The Commission should use every means possible to promote the need to re-allocate health and healthcare spending to invest in and adopt innovative solutions that will deliver health and quality-of-life gains for patients, and quality and productivity improvements for healthcare systems. It should highlight best practice examples in the EU where this is being done, and champion the need to avoid short-term cost-cutting measures that will generate additional expenses and worse health outcomes in the future.

The second issue concerns barriers to access. Systemic funding, reimbursement, behavioural and other barriers prevent European healthcare providers and patients from getting access to eHealth technologies and services that exist today.

Despite policies designed to promote eHealth, and the growing body of solid “real world” clinical and economic evidence to support the value proposition of eHealth systems such as remote monitoring of cardiac device patients, these systems are used only sporadically across the EU. Systemic barriers — lack of funding and incentives, resistance to change, silo-based funding and delivery systems – continue to impede widespread adoption. As a result patients, clinicians and healthcare systems still generate unnecessary expenses and sub-optimal outcomes by doing things the “same old, same old” ways.

Improvements could be achieved if stakeholders in Europe would collaborate to break down barriers and drive the uptake of innovations that add value to patients, clinicians and healthcare systems. The Commission should use its convening authority to champion the need to do this and highlight where best practices are occurring at Member State, regional or local levels.

The third issue relates to policy frameworks. Europe needs to create and maintain the policies that will incentivize and reward innovation – from concept through to adoption and diffusion – via an appropriate regulatory framework, health technology assessment (HTA) and reimbursement systems, and procurement/purchasing practices.

Many policies in Europe are still focused on approving, assessing, reimbursing and purchasing medical technologies and drugs according to traditional methods. As a result, the use of innovative technologies and services may go unrewarded, or even be penalized. For example, most EU countries still require face-to-face check-ups of cardiac device patients in order for a hospital or physician to be reimbursed for the cost of that service. To address this situation, the following policy improvements are required:

·         European regulators need to be empowered to assess the quality and safety of innovative healthcare delivery systems (as opposed to individual drugs and devices);

·         HTA systems need to be equipped to assess innovative technologies and systems by enabling stakeholder involvement and requiring appropriate types and levels of evidence (i.e., not imposing pharma-style requirements); and

·         Procurement and purchasing authorities must resist the temptation to focus only on lowest initial purchase cost and should instead take into account overall value — which includes quality, essential support services, longevity, etc.

The Commission should ensure that the next-generation EU regulation of medical technologies and systems is appropriately tailored to assessing and approving safe, high-quality innovations as part of healthcare delivery systems, both in terms of methodologies as well as the mindset and capabilities of the regulators. This is critical! The Commission should also champion support for innovation in funding, reimbursement, HTA, procurement and purchasing policies at a Member State level.

But of course it’s not all up to the Commission. Other stakeholders need to step up and play leadership roles. Five recent examples give cause for some optimism.

  • The DBC-Onderhoud in the Netherlands recently issued a guideline establishing a new code for telemonitoring. The guidelines state that any activity that is reimbursed as in-clinic care should also be considered reimbursed when provided through e-health systems. While the exact implementation of this new guideline is not yet clear, it marks an important step towards establishing reimbursement and funding for remote monitoring.
  • The UK Department of Health recently published the results of its “Whole System Demonstrator” (WSD) programme — the largest randomised control trial of telehealth and telecare in the world, involving 6.191 patients, 238 GP practices and 3 sites. The report focused on three conditions: diabetes, COPD and coronary heart disease. It found that telecare solutions for these patient groups resulted in a reduction of: mortality rates ($45%); accident & emergency visits ($15%); emergency admissions ($20%); elective admissions ($14%); bed usage ($14%); and tariff costs ($8%).
  • In 2010, the French Ministry of Health issued a decree related to telemedicine, officially recognizing telemedicine in the law. The decree sets out a clear definition of what constitutes telemedicine, and lays out the conditions for its organization and implementation.
  • The Lombardia region in Italy is currently evaluating next steps towards reimbursing remote monitoring. Following on positive results from a recently concluded clinical trial on remote monitoring in the region, physicians have put forward a concrete proposal to the region on how reimbursement could be put in place.
  • Finally, two prominent physician societies (European Heart Rhythm Association and International Society for Holter & Noninvasive Electrocardiology) recently published a consensus paper on remote monitoring of cardiac device patients (Europace, January 2012). This comprehensive paper demonstrates how physician support for remote monitoring has grown in line with what is now deemed to be a “strong evidence base”. In particular, it highlights that remote monitoring is accepted by patients and caregivers as an acceptable alternative to face-to-face follow-ups; increases patient safety and the feeling of safety; leads to fewer visits to the follow-up clinic; provides greater adherence to the follow-up regiment; provides early detection of clinically-significant events; and reduces hospitalizations. This paper should prove to be very useful for persuading clinics, physicians, payers and other stakeholders to embrace the benefits of remote monitoring of cardiac patients.

Let’s hope that Europe’s healthcare stakeholders, with full support from the Commission, will follow these strong leadership examples so that eHealth innovations can help Europe’s healthcare systems deliver the highest-quality care, with gains in productivity and health outcomes, to Europe’s deserving citiz