Edwards Lifesciences, Medtronic score CMS win over TAVR

Edwards Lifesciences (NYSE: EW) and Medtronic (NYSE: MDT) are among the medtech companies praising CMS’s decision to expand Medicare coverage for TAVR to people with asymptomatic severe aortic stenosis.

The finalized national coverage decision, published yesterday evening, also removes the evidence development (CED) requirement for symptomatic cases. In addition, CMS plans to to review the evidence for TAVR for aortic regurgitation.

The Centers for Medicare and Medicaid Services, among other things, drew on data from Edwards Lifesciences’  Early TAVR trial involving 901 people with asymptomatic severe aortic stenosis. Out of the 122 patients who received prompt TAVR, 26.8% ended up experiencing death, stroke, and/or unplanned hospitalization for cardiovascular causes, at a median of 3.8 years. For the 202 patients in the “watchful waiting” group, it was 45.3%.

EW shares were down more than 2% to $84.31 apiece, and MDT shares were down 1% to $90.70 by midday trading today. The S&P 500 was up more than 1%.

In a statement out yesterday, Irvine, California–based Edwards Lifesciences described CMS’s decision as an “important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary heart team.”

Edwards’ statement also said: “Aortic stenosis is a serious, progressive disease, and delays in evaluation, diagnosis and treatment increase the risk of irreversible heart damage and hospitalization, leading to poorer outcomes and higher healthcare costs, as well as an increased risk of death. The modernized policy recognizes the importance of timely care by supporting a more streamlined patient care journey and giving heart teams greater flexibility to apply their expertise to both patient evaluation and treatment based on each patient’s clinical needs.”

Medtronic, in a statement, also welcomed the news: “The TAVR NCD has provided an important framework for supporting patient access, maintaining high standards of care, and advancing the evidence base for the treatment of aortic stenosis. We are encouraged by CMS’ efforts to expand access to TAVR for Medicare beneficiaries while encouraging continued evidence generation. We are also pleased that the final policy continues to recognize the importance of the multidisciplinary heart team”

William Blair analysts led by Brandon Vazquez described CMS’s decision as mostly in line with expectations, keeping their Outperform rating of EW shares. “At a high level, we think inclusion of asymptomatic patients and the streamlining of referral pathways can be meaningful tailwinds to TAVR growth in the coming quarters. Of note, and somewhat debated, the coverage of moderate AS is pushed to local MACs instead of nationally covered. This is not surprising to us since no TAVR devices are cleared for moderate AS, and we think local MACs offer a faster pathway to coverage versus the NCD anyway.”

Marie Thibault and fellow analysts at BTIG also saw CMS’s decision as expected: “We see these as positive changes that can eventually increase TAVR procedure volumes.”