Edwards Lifesciences: TAVR NCD expectations ahead of June 15th

研报英文原文证据摘录

Edwards Lifesciences: TAVR NCD expectations ahead of June 15th

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Edwards Lifesciences

TAVR NCD expectations ahead of June

15th

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TAVR NCD proposal expected on June 15th 09 June 2026

The TAVR NCD proposal is expected on June 15th. We outline the key topics expected in Equity

the proposal, Edwards Lifesciences (EW’s) latest public commentary, societies/ KOL

public comments, and doc expectations from our recent TAVR survey. See inside for more. Travis Steed

Research Analyst

BofASOur base case expectation for proposed TAVR NCD +1 404 607 3251

As a result of our survey and public comments analysis, we expect the TAVR NCD travis.steed@bofa.com

proposal to likely include sunsetting CED requirements (reduce administrative burden Stephanie Elghazi

and barriers to treatment), mirroring FDA label indications (include asymptomatic), and Research Analyst BofAS

decreasing center volume requirements (opens more capacity). We assign a lower +1 646 855 4568

probability to the elimination of heart team requirement given that is the largest debate stephanie.elghazi@bofa.com

amongst societies and KOLs we speak to (see our note on the: public comments). But Gracia Mahoney Research Analyst

any expansion of the NCD will still likely be a positive tailwind for EW. BofAS

+1 646 855 1136

EW’s proposal for reopened TAVR NCD and latest message gracia.mahoney@bofa.com

Enjia Cao

EW formally requested CMS reconsider the NCD for TAVR in late July 2025. EW Research Analyst

presented evidence and requested that the NCD 1) expand indications to include BofAS

+1 646 743 9861

asymptomatic patients, 2) remove coverage with evidence development (CED), and 3) enjia.cao@bofa.com