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HEOR

Global HTA Modeling Strategy to Reduce Pre-Launch Access Risk

image of pharmacy community engagement activities
Client Profile

Mid-size Biopharmaceutical

Key Stakeholders

Market Access, HEOR, Medical Affairs

Asset

Pre-Launch

Disease Area

Rare Disease

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Client Profile

Mid-size Biopharmaceutical

Key Stakeholders

Market Access, HEOR, Medical Affairs

Asset

Pre-Launch

Disease Area

Rare Disease

Situation

A mid-size biopharmaceutical company was entering pivotal development for a rare disease therapy.

As competitors emerged, the team faced uncertainty around how to demonstrate differentiated value and how HTA requirements and modeling expectations would vary across markets.

Without early alignment, differences in evidence thresholds, comparators, and economic assumptions created risk for both access outcomes and launch sequencing.

The client engaged Alkemi to evaluate global HTA requirements, identify gaps, and align HEOR and modeling plans with country-level expectations.

Approach

1. Benchmarked HTA processes and evidence requirements across priority markets using competitive analogues.

2. Reviewed evidence and modeling plans to identify gaps, risks, and anticipated payer objections by country.

3. Conducted advisory boards with HTA experts, payers, economists, and KOLs to pressure-test assumptions.

4. Synthesized insights into an aligned HEOR, value modeling, and launch sequencing strategy.

The focus throughout:

Make modeling decisions early that hold up across markets.

Deliverables

1
HTA requirements assessment defining evidence and modeling expectations across priority markets.
2
Early evidence and modeling readout identifying country-level gaps and risks.
3
HEOR statistical analysis plan (SAP) to support Phase III HTA submissions.
4
Value modeling and launch sequencing strategy aligning comparators, scenarios, and timelines.
5
6

Impact

“The Alkemi team refined our HEOR plans and ensured alignment with HTA requirements. This prepared us to tackle payer objections and strengthened our launch strategy.” - Head of Medical Affairs

Strong HEOR Alignment:

HEOR plans were refined to reflect priority HTA outcomes and beyond-launch evidence needs.

Clear Modeling Direction:

Confirmed key comparators and country-specific requirements, including the need for ITC modeling in priority markets.

Improved Launch Planning:

HTA timelines and process insights informed launch sequencing and forecasting assumptions.

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