Expert Q&As
First interactions with EMA - Q&A 5
How should we approach pricing
and reimbursement across EU countries?
Access decades of experience
What’s Inside the Q&A:
Country-Specific Value Strategies
Why a one-size-fits-all approach fails in Europe. How to tailor messaging to each market's unique assessment criteria.
Strategic Launch Sequencing
How reference pricing spillover effects impact revenue. The critical importance of launch order planning to avoid pricing pitfalls.
Flexible Pricing Models
Negotiation tactics including outcome-based agreements and risk-sharing models. How these facilitate payer acceptance for expensive therapies.
Early Market Access Planning
When to begin crafting reimbursement strategy and essential payer engagement timelines.
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Expert Q&As
Launching in EU - Q&A 6
How do we ensure compliance with local promotional regulations and get our marketing materials approved in Europe?
Expert Q&As
First interactions with EMA - Q&A 7
What regulatory pathway missteps should we avoid, and how can we streamline our EU dossier preparation?
Expert Q&As
Launching in EU - Q&A 9
Should we launch ourselves in Europe or consider partnering/outlicensing, and how do we decide?
