Healthcare reimbursement is a hot topic as governments devise ever more creative ways to parse out ever more tighter budgets. This is seen in the variety of reimbursement systems for medical devices across Europe. A recent article by the European Society of Cardiology and The Cardiovascular Round Table, a collection of pharmaceutical and medtech companies, sees this hodgepodge as a serious problem.
The authors state the often lengthy and unpredictable results of each government's reimbursement approval process is a threat to R&D spending: ?there is anecdotal evidence that some companies are already cutting R&D budgets as a response to time-to-market delays and low adoption rates of important techniques.? Lower R&D spending means fewer innovative products that the authors cite are correlated to improved life expectancy.
One example used is transcatheter aortic valve implantation (TAVI). This expensive technology is meant to be used in aortic valve stenosis patients who cannot undergo heart surgery. How TAVI is reimbursed varies between countries and the paper cites research that finds a correlation between the amount paid and the frequency of the procedure.
Having studied the European TAVI market I can attest to the primary influence of reimbursement on the use of this device. Easy and lucrative reimbursement has the effect of altering physician behaviour as is the case in Germany and Switzerland where the interdisciplinary ?heart team? approach is collapsing as hospitals want to realize the margins of performing more TAVI procedures. In contrast, in the UK, physicians have to apply to a commissioner for each TAVI procedure they wish to perform. The commissioner controls a fund that is used for a range of new devices. And as the authors recommend, all UK TAVI patients are enrolled in a registry to track clinical and cost effectiveness data. As a result, the TAVI procedures per capita is lower in the UK.
But examining the R&D budgets of large public cardiovascular medical device companies seems to tell a different story. Boston Scientific, Edwards LifeSciences, Medtronic, St Jude Medical and Sorin Group have all had fairly flat or increasing R&D budgets over the past 5 years. Even if the anectdotal evidence of R&D cuts comes to fruition, will difficult reimbursement stop these players from acquiring small companies with promising technology?
Frankly, the authors seem to take a short sighted view by focusing on devices that have turned out to be clinically worthwhile. There is no mention of patent foramen ovale closure devices, a stroke prevention technology that has consistently shown lackluster efficacy compared to pharmaceutical therapy. Nor of renal denervation, which crashed and burned with poor clinical trial results last year. A contrarian would say more industry-friendly reimbursement systems would accelerate the collection of clinical and cost effectiveness data to determine if new devices are worthwhile. However, this shifts the financial burden of evidence collection from companies, who pay for clinical trials, to stressed governments.
Governments have already tried to come up with equitable and hopefully financially sustainable ways to pay for healthcare. Perhaps it is the turn for medtech companies to show some flexibility. For example, price according to the economic conditions of each national health care system. Pushing for a value-based system, where payment is made only if patient outcomes are positive, is also a worthwhile step.
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