Global Trends in Device Regulation and Reimbursement

The fourth session of the FDA Town Hall Meeting at the Transcatheter Cardiovascular Therapeutics (TCT) conference was titled “Regulation and Reimbursement: Global Imperatives and Trends.” It began with the keynote address, “The Intersection of Innovation, Payment and Regulatory Approval in the Future of Interventional Cardiology,” delivered by Jack L. Lewin, MD, CEO of the Cardiovascular Research Foundation. He discussed 5 critical trends affecting innovation: progression of science, information technology and big data, changing politics and public scrutiny of healthcare quality and costs, regulatory expansion, and healthcare payment reform. According to Dr Lewin, getting involved in payment reform is critical during this transition of payment models toward value-based models. He stated that adaptation is necessary as changes take place. He concluded with predictions, including the following: big data impacts will be huge, regulators will be more empowered with more data, products will come to market more quickly, regulatory strategies will change, and the United States will not see a decline in innovation.

Next, Alan G. Fraser, MD, professor at the Cardiff University School of Medicine in the United Kingdom, presented “Status Update on European Medical Device Regulatory Reform Initiatives.” He referred the audience to a paper from the European Society of Cardiology published 2 years ago which details a review of the current regulatory system in Europe and some suggestions for reform. According to Dr Fraser, new legislation, involving over 700 amendments, has recently moved through the European Parliament regarding medical devices. A decision was made last week, but a public statement has not been made. Most changes are aimed at increasing transparency, efficacy, and patient safety. Dr Fraser concluded by calling for greater international collaboration.

The final presentation of the session, “Enlightened Perspectives from NICE,” was presented by Amanda I. Adler, chair of the Technology Appraisals Committee at the National Institute for Health and Care Excellence (NICE) in Cambridge, United Kingdom. According to Ms Adler, any new technology in the United Kingdom must go through regulators first, followed by NICE, which then determines if the National Health System should adopt it. NICE uses the quality-adjusted life-year (QALY) as a measure of health effectiveness, and it heavily weighs the cost and value of a new technology. Ms Adler also stated that NICE makes an effort to be timely, transparent, and up-to-date. Lastly, she reviewed CV devices that have been considered in the past 2 years.

Following the presentations, there was a brief discussion regarding regulation and reimbursement in countries outside the United States. Takeshi Kimura, MD, of the Kyoto University Hospital in Sakyo-ku, Japan; Dr Ashkoth Seth from Fortis Escorts Heart Institute in New Delhi, India; and Ross Prpic, MD, of the Pacific Clinical Research Group in North Sydney, Australia, were asked: “How does the cost of a device affect its access at the bedside in your country?” In Japan, there is a public insurance system, so essentially, there is no effect. When a device is approved, reimbursement is guaranteed. In India, device cost and approval cost are not related. In Australia, the approval process is separate from reimbursement.