Cracking the European Market: How a US Biotech Navigated HTA and Reimbursement for Its First Launch

For many US-based biotech companies, Europe represents both a tremendous opportunity and a daunting challenge. Unlike the US, where pricing freedom is broader, European markets are fragmented — each with its own health technology assessment (HTA) process, reimbursement hurdles, and clinical practice context. Getting it wrong can mean delayed launches, unfavorable pricing, or missed investor milestones.

This case study shows how one clinical-stage biotech successfully prepared for its first European launch by building a tailored pricing, HTA, and reimbursement strategy across priority markets — on a tight timeline and under investor scrutiny.
The Challenge

The client was a US-headquartered biotech on the brink of a pivotal moment: launching its first product in Europe. Several issues complicated the path forward:

• No in-house European market access expertise: The company lacked dedicated EU pricing and reimbursement strategy.

• Investor pressure: Regulatory and commercialization timelines were non-negotiable, with commitments already made.

• Heterogeneous HTA requirements: Evidence packages that worked for the FDA did not neatly map onto European HTA bodies.

• Competitive landscape: Differentiation from competitors was critical to ensure favorable positioning.

The company needed to define a European-oriented value strategy, align evidence generation with HTA requirements, and execute submissions across multiple countries, all at once.

The Approach

The solution was to act as the biotech’s European Market Access function, combining strategic oversight with practical execution. The engagement was deliberately structured to be focused, flexible, and fast-moving:

• European value proposition: Crafted a continent-wide value story and value-based price, taking into account diverse country-level clinical practices and reimbursement frameworks.

• HTA submissions: Initiated and managed health technology assessment filings across five priority European markets, balancing local customization with European/global consistency.

• Evidence and messaging: Developed a mapped framework of value messages, evidence requirements, and tailored activities, equipping in-country teams with strategies adapted to their markets.

• Real-world insights: Interviewed European prescribers to understand unmet needs, prescribing behavior, and the real-world evidence necessary to strengthen payer and HTA engagement.

• Trusted partnerships: Leveraged a network of in-country partners to ensure local nuance and effectiveness, without losing strategic cohesion at the European level.
  
  The Impact
  
  

  This program delivered more than successful submissions — it set the foundation for sustainable European market access:

  • Optimized positioning: The product’s pricing and value story were fine-tuned to reflect European market realities, strengthening differentiation versus competitors.

  • Regulatory and commercialization success: The company met critical timelines, aligning HTA preparation with regulatory milestones and investor expectations.

  • Cross-country consistency with local flexibility: European-level strategy guided in-country teams, while trusted partners ensured alignment with local payer expectations.

  • Future readiness: By structuring the value framework early, the company built a scalable platform for future European launches.
    
    Why This Matters
    
    

    For US biotechs, Europe can feel like a maze of inconsistent requirements and unpredictable pricing outcomes. This case illustrates the value of building a European-first access strategy, one that:

    • Bridges regulatory and HTA evidence expectations.

    • Anticipates payer demands for real-world effectiveness and economic justification.

    • Balances local flexibility with global consistency.

    The result is not just smoother access, but stronger positioning in one of the world’s most important biotech markets.
    
    The takeaway: If you’re a US biotech preparing for Europe, don’t retrofit your US strategy, build a European one from the start.