Edwards Lifesciences could see a broader market for its transcatheter heart valves under a new Medicare coverage policy.
The Centers for Medicare & Medicaid Services (CMS) on Sept. 10 finalized a decision to expand coverage for transcatheter aortic valve replacement, or TAVR, to patients with severe aortic stenosis before they have begun to show symptoms. TAVR is a minimally invasive procedure to replace a diseased heart valve without open heart surgery.
CMS also removed a prior coverage requirement for symptomatic aortic stenosis limiting coverage to patients enrolled in a clinical study or data registry.
The decision follows an earlier push by Irvine-based
The decision follows an earlier push by Irvine-based Edwards, which formally petitioned CMS last July to reconsider coverage for symptomatic and asymptomatic patients.
The company reiterated its full-year sales growth guidance of 10% to 11% and said it will provide 2027 and long-term guidance at its investor conference in December.
Shares in Edwards (NYSE: EW) fell 2.7% to $84.37 following the news. They were trading around $85.36 with a $50 billion market cap at press time.
Updated Policy ‘Recognizes Importance of Timely Care’
Updated Policy ‘Recognizes Importance of Timely Care’
The Medicare decision builds on an FDA approval Edwards received last year that expanded use of its Sapien 3 heart valves to patients with asymptomatic severe aortic stenosis.
Severe aortic stenosis occurs when the aortic valve narrows, making it difficult for the heart to pump blood to the rest of the body. It’s the most common type of heart valve disease, affecting as many as 2.5 million Americans over the age of 75. One in 10 are at risk of dying within five weeks without treatment.
Symptoms, however, are often mistaken as normal signs of aging and can be difficult to detect. Treatment options for asymptomatic patients have historically involved close monitoring.
The updated policy recognizes the importance of timely
The updated policy “recognizes the importance of timely care” and gives heart teams “greater flexibility in making treatment decisions,” Edwards said.
In its Progress trial to evaluate the safety and efficacy of the new treatment, Edwards is comparing TAVR versus clinical surveillance in patients ages 65 and older with moderate aortic stenosis. The company is scheduled to present the study’s results on Nov. 3.
Analysts See Upside
The CMS coverage determination aligned with analysts’ expectations, with Raymond James issuing an Outperform 2 rating for Edwards.
While we would have preferred a broader path
“While we would have preferred a broader path to moderate reimbursement, we view the final memo as confirmation of expected positive, de-risking Street estimates that already bake in a benefit from asymptomatic AS expansion,” Raymond James analyst Jayson Bedford wrote in a Sept. 10 note to investors.
Jefferies maintained it Buy rating and raised its price target from $102 to $105, seeing the decision as a “strong catalyst path” for Edwards.
