Evidence of Value:
Positive HTA assessments from reputable European agencies like NICE (UK), HAS (France), or IQWiG (Germany) provide robust, independent evidence of your therapy’s clinical effectiveness, safety, and cost-effectiveness. This strengthens your value proposition in US negotiations by demonstrating the therapy’s impact on patient outcomes and its value for money.
Reference Pricing
Some US payers consider international pricing and reimbursement decisions when determining their own coverage and reimbursement policies. A favorable price or reimbursement decision in Europe can create a reference point and strengthen your negotiating position in the US. Research by the USC Schaeffer Center for Health Policy and Economics found that nearly half of US commercial insurers use international reference pricing for oncology drugs.
Global Reputation
A successful European launch with positive HTA assessments can enhance your company’s global reputation and credibility, making it easier to engage with US payers and build trust in your therapy’s value. Positive media coverage and recognition from European patient advocacy groups can further amplify this effect.
Designing clinical trials that meet both EMA and FDA requirements can streamline the approval process and avoid costly and time-consuming delays.
Simultaneous submissions to both agencies can lead to faster approvals and patient access in both regions.
Reaching a larger patient population across both markets can significantly increase sales and revenue, which can be reinvested in further research and development.
A diversified market presence can help mitigate risks associated with regulatory or reimbursement challenges in a single market.
Germany offers early access programs that allow patients with unmet medical needs to access promising therapies before formal approval.
Germany has a relatively transparent and predictable reimbursement system, with the potential for high reimbursement rates for innovative therapies.
Germany offers early access programs that allow patients with unmet medical needs to access promising therapies before formal approval.
Early Engagement:
Initiate dialogue with both the EMA and US FDA early in the development process to align expectations and avoid surprises.
HTA Preparedness:
Develop a robust value dossier that aligns with European HTA requirements and demonstrates the
therapy’s value proposition.
Pricing and Reimbursement Strategy:
Craft a global pricing and reimbursement strategy that considers the unique dynamics of both the US and European markets.
Establish a presence in Europe to facilitate engagement with local stakeholders, navigate regulatory processes, and build relationships with key opinion leaders. A presence in Germany can offer significant advantages due to its robust healthcare infrastructure and favourable regulatory environment.
Experienced CEOs:
Individuals who have led successful rare disease companies, offering invaluable insights into strategic decisionmaking and operational excellence.
Government Advisors:
Experts with in-depth knowledge of regulatory frameworks and policy landscapes, ensuring your approach aligns with current requirements.
World-Renowned Professors in Translational Science:
Scientific leaders with a proven track record of translating research into innovative therapies, providing cutting-edge knowledge and guidance.
Life Science Legal Experts:
Legal professionals specializing in the life sciences sector, with extensive experience in European regulations, particularly in Germany, safeguarding your interests, and ensuring compliance throughout the process. This expertise includes establishing European affiliates and navigating the intricacies of the German legal and banking systems.
Entrepreneurs at the Forefront of Drug Repurposing:
Visionaries who identify and champion innovative approaches to repurposing existing medications for rare diseases, accelerating the development of new treatment options.
Keynote Speakers and Patient Advocacy Specialists:
Influential voices who drive awareness, shape policy discussions, and advocate for the needs of patients and families affected by rare diseases.
In the complex world of rare disease therapies, a strategic expansion into Europe and leveraging HTA assessments can significantly bolster a US biotech company’s position in negotiations with US payers. By adopting a dual development and commercialization approach and proactively engaging with European stakeholders, companies can maximize the market potential of their therapies, accelerate patient access, and ultimately improve outcomes for those living with rare diseases.
Partner Rare is uniquely positioned to guide you through this journey, offering a comprehensive suite of services and a deep understanding of the European landscape. With our support, you can confidently navigate the complexities of global market access and ensure your rare disease therapy reaches the patients who need it most.
If you are ready to unlock the vast potential of Europe for your rare disease therapy, contact Partner Rare today to schedule a meeting.
Let’s discuss your specific development and commercialization goals and explore how our expertise can propel your therapy towards success.
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