Expert Q&As
First interactions with EMA - Q&A 5
How should we approach pricing
and reimbursement across EU countries?
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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
First interactions with EMA - Q&A 8
What are Early Access Programs (EAPs) in Europe, and how can they help gather real-world data?
Expert Q&As
First interactions with EMA - Q&A 6
What CMC (Chemistry, Manufacturing, and Controls) expectations in the EU might surprise biopharma companies?
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?
