PMD82 - 3-D PRINTING IS REVOLUTIONIZING THE MEDICAL DEVICES WORLD, BUT ARE PAYERS READY?

Abstract

3D printed medical devices have the potential for significant innovation and clinical advantages in addressing unmet needs, such as the ability to create customized implants fit-for- purpose tailored to meet patient’s individual anatomy. In this research, we explore the challenges in reimbursing 3D printed devices and what manufacturers can do to address them. We have undertaken desk research and 10 telephone interviews with payers, surgeons, and industry experts in the US and several European markets (France, Germany, Belgium, Sweden, Spain, and Switzerland) in late 2014 and early 2015. 3-D printing is not on payers’ radar yet, as it is mostly reimbursed via DRG. 3-D printed medical devices with a higher price premium vs. conventional devices will face a higher degree of scrutiny, as budget impact and safety profile (in light of frequent medical device safety scandals) are primary payer concerns. Where cost is less of an issue, on a hospital-level the “hassle factor,” financial incentives, and P4P schemes may significantly affect the uptake of 3D printed medical devices for the mainstream patient. Market access success of 3D printed devices will depend on balance between consolidated surgeon workload (pre and during surgery) and safety aspects of the device (wear and tear). The commercial problem is the current lack of regulations for in-hospital printed devices, which threatens the 3D industry and the patient (as quality control cannot be on same level as industrial-made). Payer interests will depend on pricing vs. not 3D printed devices (from no interest if within same DRG, to high interest if with additional budget, or need for higher DRG). The key point is to find out cost effectiveness (or efficiency) of 3D printed medical devices versus standard devices, e.g., impact on direct medical cost, and length of surgery.