Sapien transcatheter aortic valve. Source: Edwards Lifesciences

Transcatheter aortic valve replacement (TAVR) surgery has created a buzz among the cardiology community and public, and the recent recommendation of an FDA panel to approve TAVR as a less invasive procedure for high-risk patients with aortic stenosis (AS) dialed the volume up even more. But will demand for TAVR break healthcare’s bank? Editorialists in the June 26 issue of Circulation see reasons for concern, but conclude that TAVR may pave the way for new policy and cost models.       

“Simply put, the medical care of 2012 is not the same as care even several years ago; it is better, in some cases substantially so,” wrote Daniel B. Mark, MD, of the Duke Clinical Research Institute, and Robert J. Mentz, MD, of the cardiology division at Duke University Medical Center, both in Durham, N.C. “In the history of medicine to date, better medical care almost always has cost more money.”

The writers examined the clinical and cost-effectiveness results of the PARTNER trial’s two cohorts, cohort B, which included inoperable patients with AS, and cohort A, those patients with severe AS whose present option is standard aortic valve replacement (AVR). The FDA approved the use of the Sapien (Edwards Lifesciences) transcatheter aortic valve for the treatment of inoperable patients with severe symptomatic AS in November 2011. On June 13, the FDA’s Circulatory Systems Devices Panel recommended approval of the Sapien heart valve for patients with severe AS who are at a high risk for surgery.

A cohort B analysis at one year showed that total costs for TAVR patients were on average $52,000 more per patient compared with conservatively treated patients. TAVR added 1.6 years of life expectancy at a cost of $80,000 for an incremental cost-effectiveness ratio of $50,212 per life-year gained, though, and adding quality of life (QoL) to the equation tipped the results even more in favor of TAVR.

“These results confirm that TAVR represents good value for the money, perhaps not a best buy but very respectable when measured against standard benchmarks in health economics,” Mark and Mentz wrote.

Cohort A is a little more problematic, the authors wrote. TAVR had an edge on standard AVR for early mortality and major bleeding but had more strokes at one year and a higher rate of vascular complications. Index admission costs were slightly higher for AVR but procedural costs were much lower in the AVR group compared with the TAVR group. But the additional days needed for intensive and non-intensive care with AVR brought them to a virtual tie. Follow-up costs also were about equal.

“The major economic analysis question posed by the results of PARTNER A is whether to use the small, nonsignificant early differences favoring TAVR (0.065 more life-years and $2,200 lower cost) to conclude that TAVR is the preferable strategy (‘dominant’ in the language of the health economist, meaning better health outcomes and lower costs),” they wrote. “Alternatively, using three-year survival, major complication data, and one-year QoL data, along with the nonsignificance of the cost difference, one could conclude that the choice is a therapeutic and policy toss-up.”

But even if TAVR qualifies as cost-effective, it may not be affordable, they wrote. Affordability depends on the cost of the total healthcare bill and the availability of funds to pay that bill. They pointed to data that suggest only half of eligible AVR patients pursue surgical care who might be more amenable to TAVR.

“What is even less clear is the expected budgetary impact of TAVR on patients currently receiving only palliative care,” they wrote. “Population-based estimates suggest that there may be a million adults in the U.S. with clinically diagnosed AS, and about half of them may be patients 75 years of age or more with severe AS. If 100,000 patients end up getting an AS treatment because of the introduction of TAVR, at an incremental cost of about $80,000, the bill will total $8 billion. Even this may be an underestimate of the total financial impact of TAVR.”

The cost of screening and referral also needs to be folded into the economic equation, Mark and Mentz wrote, but as of now that information is lacking. They argued screening could add days in the hospital and many diagnostic tests to the bill as well as consultations with specialists. “Assuming that this evaluation reveals that two of every three referred patients are ineligible for TAVR, as in PARTNER, substantial additional costs related to TAVR are incurred without a clear increment in benefits,” the authors wrote.

Unlike other expensive technologies, the use of TAVR in the U.S. has been tempered by the cardiology community with the involvement of American College of Cardiology and the Society of Thoracic Surgeons. Mark and Mentz wrote that the societies have taken the lead in making the introduction of TAVR is the U.S. “a model of responsible dissemination.” If this model proves to be successful, they concluded, it will provide a new approach for healthcare policy that fosters innovation while keeping a lid on costs, they concluded.   

The perspective piece is part of a collection of articles focusing on PARTNER studies published in the journal’s Implications of Contemporary Clinical Trials series.