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Value & Access

Value Strategy to Support CMS Engagement and Coverage Expansion in Cardiology

image of pharmacy community engagement activities
Client Profile

Large MedTech

Key Stakeholders

HEOR, Market Access, Clinical, Marketing

Asset

Launched

Disease Area

Cardiology

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Client Profile

Large MedTech

Key Stakeholders

HEOR, Market Access, Clinical, Marketing

Asset

Launched

Disease Area

Cardiology

Situation

A large medical device company sought to expand U.S. payer access for an established cardiovascular intervention.

Coverage policies were shaped by an outdated national determination, despite a growing body of new clinical and real-world evidence.

With limited time before engagement with CMS, the client engaged Alkemi to synthesize CMS-relevant evidence, clarify the value story, and support a structured coverage expansion strategy.

Approach

1. Conducted a rapid literature assessment, screening 1,000+ publications and reviewing key full-text studies across clinical and real-world domains.

2. Identified and synthesized evidence most relevant to CMS priorities, including safety, efficacy, and real-world outcomes.

3. Facilitated a cross-functional alignment workshop to refine the value narrative, messaging, and payer engagement strategy.

4. Developed a comprehensive evidence summary report to support discussions with CMS and other U.S. payers.

The focus throughout:

Translate a growing evidence base into a clear, CMS-ready value story.

Deliverables

1
Targeted literature review identifying CMS-relevant studies and evidence themes.
2
Stakeholder alignment workshop to clarify value messaging and strategic priorities.
3
Evidence summary report articulating value messages, strength of evidence, and engagement roadmap.
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6

Impact

“I have used the report several times now with leadership and colleagues, and it has been fantastic. I really want to congratulate you on how organized and comprehensive it is.” - HEOR Leader

Stronger CMS Engagement:

Equipped teams with a structured value story and objection-handling framework for discussions with CMS and other payers.

Clearer Strategic Direction:

Provided a roadmap for future evidence generation and coverage expansion priorities.

Internal Alignment:

Enabled leadership alignment on messaging, priorities, and next steps.

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