With this edition, we bring you the two-part installment of the FDA’s Circulatory Systems Devices Panel meeting on June 13 that led to the recommendation to approve Edwards Lifesciences’ Sapien heart valve system for the indication to treat patients with severe, systematic aortic stenosis who are at a high risk for surgery. Now let’s look at who these potential patients may be.
The results that persuaded the panelists came from the PARTNER trial’s Cohort A patient population. Craig R. Smith, MD, principal investigator and a presenter at the panel meeting, and other PARTNER investigators enrolled 699 patients with severe aortic stenosis at 22 centers in the U.S., Canada and Germany.
All patients had to be candidates for conventional surgery to be included in the trial. High risk for surgery was defined as having coexisting conditions associated with a risk of death of at least 15 percent by 30 days after the procedure.
Here is a breakdown of baseline Cohort A characteristics in the transcatheter aortic valve replacement (TAVR) group (348 patients), based on a study published in 2011 (N Engl J Med 2011; 364:2187-2198):
- 94.3 percent were New York Heart Association Class III or IV;
- 74.9 percent had coronary artery disease;
- 26.8 percent had a previous MI;
- 42.6 percent had previous coronary artery bypass surgery;
- 34 percent had previous PCI; and
- 40.8 percent had atrial fibrillation.
These patients were quite elderly, generally in their 80s, and in the U.S. likely would be Medicare beneficiaries. But assuming the FDA follows the recommendation of the panel, what will be the profile of the real-world high-risk patients? Could they be younger, for instance, and possibly hold private insurance coverage?
“With valve replacement, the vast majority of patients have Medicare coverage,” said James C. Robinson, PhD, MPH, a professor of health economics at the University of California, Berkeley in our article on conventional heart valves' value proposition. “It is a problem with the elderly.”
Research by Robinson and others has shown that Medicare pays far less for valve procedures than do private payors. They found that in conventional valve procedures, after adjusting for patient, hospital and market characteristics, the average contribution margin with Medicare paid $30,986 less than private insurance.
The FDA typically adds its stamp of approval on top of its advisory panels’ recommendations. If and when that happens, I hope that it piques the interest of Robinson or one of his colleagues. I am curious to know whether the TAVR financial model ends up mimicking conventional valves or whether this novel therapy breaks the business mold as well.
Cardiovascular Business , editor