Gaining reimbursement for established technologies is hard enough, but solving the coding, coverage, and payment puzzle for a pioneering product area raises the degree of difficulty to a new level. Dirksen Lehman, who heads Edwards Lifesciences’ public affairs organization, including global health economics and reimbursement, takes us through the company’s strategy to break new ground in transcatheter valves using an approach that continues to drive innovation in this growing space.
In 2000, when Edwards Lifesciences spun out of Baxter International, the notion that the new company would emerge as one of the leaders (along with Medtronic) in creating not only a ground-breaking device sector—transcatheter heart valves—but a sector that would become one of only two true blockbuster product categories in the modern medical technology era (along with coronary stents) was seen as highly unlikely largely for two reasons. First, the achievement was considered improbable because of the technological hurdles inherent in converting a complex open surgical procedure to one performed percutaneously. Second, even if product companies could overcome the technological hurdles, from a commercial standpoint Edwards was one of the last firms that most industry executives would have predicted as the one to make that happen. At the time, Edwards was largely a surgical products (including valve surgery) company that had built close ties with the surgeon community, who were its primary customers. Traditional heart valve procedures were not only the exclusive province of surgeons, they were their bread and butter. Transitioning this practice from one focused on surgeons to one geared to their competitors at the time—interventional cardiologists—was a risky strategy for a company like Edwards and not one that many in the industry saw the firm adopting lest it risk alienating its longstanding, largest customer base. (For an in-depth look at Edwards’ history and how it evolved into a leader in transcatheter valves, see “Edwards Lifesciences: 20 Years After,” Medtech Strategist, March 9, 2022.)
Fast forward to today with Edwards’ having successfully completed that unforeseen transformation to a market leader in transcatheter valves through both innovative technologies and equally innovative customer-facing approaches, most notably championing the utilization of heart teams that include both surgeons and interventionalists. But developing the innovative technology is only part of the story. Transcatheter valves could not have achieved their current level of adoption if that advanced technology was not accompanied by advances in reimbursement policy, which encompasses the coding, coverage, and payment processes necessary to drive the ultimate growth of these products.