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HEOR, Market Access

Medicare RWE Protocol to Address Priority Evidence Gaps

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Client Profile

Mid-Size Biopharmaceutical

Key Stakeholders

Outcomes Research, Market Access, Real-World Evidence

Asset

Phase III

Disease Area

Oncology

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Client Profile

Mid-Size Biopharmaceutical

Key Stakeholders

Outcomes Research, Market Access, Real-World Evidence

Asset

Phase III

Disease Area

Oncology

Situation

A mid-size biopharmaceutical company wanted to maximize insights from existing RWE analyses while strengthening future evidence generation for a Phase III oncology therapy.

Existing datasets required review to determine data quality, publication feasibility, and their ability to support priority value messages.

The client engaged Alkemi to assess the current analyses, identify credible publication opportunities, and develop an adaptable Medicare RWE protocol for future claims research.

Approach

1. Assessed existing datasets against the evidence landscape and future value objectives.

2. Evaluated data quality, limitations, and the messages that could be supported credibly.

3. Identified priority publication opportunities and evidence gaps.

4. Aligned cohort, treatment-line, and outcome definitions to develop an execution-ready Medicare RWE protocol.

The focus throughout:

Turn existing evidence into a clear plan for credible, future-ready RWE generation.

Deliverables

1
Publication feasibility assessment identifying supportable insights, evidence gaps, and priority publication opportunities from historical data.
2
Adaptable Medicare RWE protocol defining treatment cohorts and approaches to evaluate treatment patterns, healthcare utilization, costs, and outcomes.
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Impact

“Alkemi translated our evidence needs into a clear, execution-ready Medicare protocol that can support future real-world research.” - VP, Global Outcomes Research & Real-World Evidence

Clearer Evidence Priorities:

Clarified the strategic value and limitations of existing RWE, helping the client focus publication efforts on the most credible opportunities.

Stronger Research Foundation:

Established a rigorous, adaptable framework to accelerate future Medicare claims research.

Improved Value Demonstration:

Created a practical foundation for generating evidence on treatment patterns, utilization, costs, and outcomes.

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