This may come as a shock to many of you, but the proposed new medical device regulation “will not change market access to new devices appreciably,” according to an article published this week in the BMJ. Moreover, “the proposals fall short of what is required to prevent high-risk devices being used without reliable evidence on their safety and efficacy—as is required for new drugs.”
In “Trials are needed before new devices are used in routine practice in Europe,” a trio of German consultants argue that the German experience with transcatheter aortic valve heart implantation (TAVI) and intracranial stents illustrate how German patients would have been better served under more restrictive regulatory and reimbursement systems. It may be telling that the authors cite the pharmaceuticals regulatory framework as something of a benchmark.
Philipp Storz-Pfennig, Mechtild Schmedders and Matthias Dettloff write that EU member states would lack sufficient evidence to steer funding decisions related to new medical technologies, even if the scrutiny procedure and other proposed changes to the device regulation are adopted. The unrestricted use of TAVI and intracranial stents in Germany, which have much narrower approvals for use in the United States, “underline the case for tighter regulation of new technologies based on better evidence,” they write. In the absence of more rigorous safety and efficacy data, the use of devices such as these “should be restricted to appropriate trials until sufficient evidence is available for general reimbursement decisions,” they argue.
Pfennig, Schmedders and Dettloff are employees of the German National Association of Statutory Health Insurance Funds.
The full article is available on the BMJ website.Norbert Sparrow