For pharma manufacturers, regulatory approval is only the beginning. True success lies in market access—ensuring that the medicine is not only authorized but also reimbursed and prescribed at scale.
The Pricing and Reimbursement Challenge
Each European country has its own authority to assess clinical value and decide whether to reimburse a drug. For example:
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France (HAS) evaluates therapeutic benefit via SMR/ASMR.
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Germany (G-BA) conducts early benefit assessments.
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UK (NICE) uses cost-effectiveness thresholds.
These evaluations directly influence pricing negotiations and patient access.
Strategic Levers for Success
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Early Health Economics and Outcomes Research (HEOR)
Collecting strong real-world evidence helps demonstrate value beyond clinical trials. -
Stakeholder Engagement
Collaborating with payers, clinicians, and patient advocacy groups can shape favorable outcomes. -
Adaptive Pricing Strategies
Risk-sharing agreements, outcome-based contracts, and country-specific pricing strategies are increasingly critical. -
Speed to Market
Delays in market access can erode revenue potential. Proactive planning shortens time between EMA approval and national reimbursement.
Why Partnering Matters
Asian pharma companies entering Europe face steep learning curves. By partnering with Drugs2Market, manufacturers gain access to an integrated approach: from dossier preparation and payer engagement to negotiation strategies tailored for each country.
👉 In Europe, success is not about approval alone—it’s about market penetration, reimbursement, and long-term sustainability.