ContactUnlock Market Access with Robust HTA Strategies
Essential Evidence to Secure MedTech Approval Across Europe
Health Technology Assessments (HTAs) play a crucial role in demonstrating the value of certain medical technologies, particularly in specific countries where HTA evaluations are a prerequisite for reimbursement or market adoption. With the new EU HTA regulation, assessments will become even more central for a subset of high-impact innovations. Robust clinical and economic evidence can make the difference between market approval and delays in access.
At IGES MedTech, we specialise in designing HTA strategies that align with both EU-wide and national requirements. From bridging evidence gaps to developing comprehensive HTA dossiers, we ensure your submission resonates with decision-makers, accelerating approval and supporting long-term market success across Europe’s complex healthcare systems.
Crafting a compelling HTA dossier is crucial for demonstrating the clinical and economic value of your medical device. IGES MedTech combines deep expertise in local requirements with advanced data analysis to deliver dossiers that meet the expectations of regulators and payers. By focusing on clarity, relevance, and robustness, we ensure your submission stands out and accelerates the approval process.
Evidence gaps can delay or complicate the HTA process. Our team identifies these gaps early and provides strategies to address them, ensuring that your device is supported by the data regulators and payers demand. Whether through additional studies, meta-analyses, or real-world evidence, we help you close these gaps efficiently and effectively.
Demonstrating cost-effectiveness is a cornerstone of any successful HTA submission. IGES MedTech develops advanced models that compare your innovation to existing standards of care, highlighting its value in terms of outcomes and cost savings. These models are tailored to local healthcare system requirements, ensuring maximum impact.
Engaging with key stakeholders during the market access process can make or break your submission. IGES MedTech facilitates consultations with local decision-makers, payers, and key opinion leaders to gather critical insights and refine your approach. This proactive engagement ensures that your strategy aligns with stakeholder expectations.
