Early Health Technology Assessment (HTA) engagement is a critical step in optimizing market access for new therapies. By obtaining early scientific advice from Health Technology Assessment Bodies (HTABs), you can align your clinical evidence generation strategy with payer requirements. This proactive approach increases the probability of achieving timely reimbursement at the target price for the appropriate patient population. Early HTA advice is especially valuable prior to Phase III trials or pivotal studies and when planning real-world evidence (RWE) collection.
Early HTA Engagement
Early health technology assessment services
Obtain timely reimbursement through early HTA engagement
Generate appropriate evidence for timely reimbursement
Align evidence generation with HTA requirements
Demonstrated expertise engaging with HTA and regulatory bodies
Strategic guidance on appropriate reimbursement, development of submission documents and meeting participation
Tactical support for strategic considerations
Provide client support by development required documentation including value proposition, questions and rationale and modeling plans in an assortment of therapeutic areas
Strategic decision-making support
Leverage expert insights to optimize your market access strategy and resource allocation.
Enhanced reimbursement success rates
Early advice helps reduce risks and improve outcomes in securing payer support.
Better align evidence generation with HTA bodies’ requirements
Explore Certara’s early HTA and regulatory engagement offerings
Early dialogue strategy
Review of key questions when engaging with HTA and regulatory bodies
HEOR and modeling plans
Strategies for the use of RWE to address evidence gaps and demonstrate value
Documentation development
Support on value proposition and other submission documents
Post-guidance planning
Advice on next steps upon receipt of guidance
Collaborate with global leaders in market access
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Experts
Elvira Müller, PhD, MPH
VP, HTA Strategy and Access
Elvira is responsible for HTA and Evidence Development while managing Certara’s consulting team based in Germany. Besides numerous HTA engagements, she has substantial expertise in EUnetHTA collaboration as well as in European Joint Clinical Assessments (JCA) and Joint Scientific Consultation (JSC). She has 20+ years of experience in global m...
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Experts
Roman Casciano, PhD, MEng
SVP, Evidence & Access
As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the global market access, HEOR and real-world evidence context related to product value demonstration and has deep experience in both formal and informal exchanges with payers and HTA bodies.
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Connect with Certara’s experts to align your evidence generation strategy with HTA requirements and optimize your market access success. Our team is ready to provide tailored solutions, actionable insights, and training on early HTA engagement.
Gain insights into risks and resources for HTA advice.
Prepare for early value proposition and economic modeling.
Discuss alignment with global HTA bodies.
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FAQs
What is early health technology assessment (HTA) advice?
Early health technology assessment (HTA) advice, also called scientific advice, is a formal process that allows manufacturers to gain nonbinding feedback from HTA bodies on clinical trials prior to the launch of a product or service.
What is the primary benefit of early HTA engagement?
Before initiating Phase III/pivotal trials or planning real-world evidence collection.
Does Certara offer training on HTA engagement?
Yes, Certara provides expert-led training to prepare for HTA consultations.
