Seek advice from HTA bodies for your clinical development program
Early dialogue/scientific advice from health technology assessment bodies (HTABs) is an opportunity to increase the probability of obtaining timely reimbursement at the target price in the appropriate patient population by generating the appropriate evidence. It is recommended to seek HTA advice prior to initiation of Phase III or pivotal trials and for real world evidence (RWE) generation.
The need for better alignment between evidence generation strategy and HTABs’ requirements calls for early engagement
Why should early advice from HTA bodies be considered?
Compared with regulatory agencies, HTA bodies have different mandates and methodologies and are focused on understanding the value and consequences of making a new treatment available, including how it will perform in the real world, its economics, and impact within the local organizational and social context. Early HTA engagement has become a vital part of market access strategy and planning.
Discuss with experts key aspects of early advice:
- Risks in seeking advice?
- Financial implications and resource needs?
- Which agencies to go to?
- Ready for real world evidence generation?
- Ready for early value proposition and early economic modelling plan?
- Impact on market access/reimbursement strategy?
Expert training on early HTA engagement
Meet with our experts to receive background information on early HTA advice and general considerations as well as information on stakeholders, processes, timing and requirements. We can discuss case studies and potential critical questions that might come up.
Be prepared for your next face-to-face or virtual meeting.
Our People
Elvira Müller, PhD, MPH VP, HTA Strategy and Access
Roman Casciano, PhD, MEng SVP, Evidence & Access
Matthew Brougham Sr. Expert Consultant
Elvira Müller, PhD, MPH VP, HTA Strategy and Access
Roman Casciano, PhD, MEng SVP, Evidence & Access
Matthew Brougham Sr. Expert Consultant
Elvira Müller is Vice President within Certara’s Evidence & Access group, responsible for HTA and Evidence Development while managing Certara’s consulting team base in Germany. Besides numerous HTA engagements, she has substantial experience 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 market access, applying her senior expertise in providing high-quality scientific advice to optimize the value of pharmaceuticals and medical technologies. Elvira holds an MSc and PhD in Biology and Toxicology from Würzburg University and an MPH from Ulm University.
Roman Casciano is a Senior Vice President within Certara’s Evidence and Access group. 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.
He held senior public sector positions in Canada and New Zealand including 3 years as Vice President of CADTH and 5 years as Chief Executive of PHARMAC He is an expert in assessing value and value for money of health technologies.
Elvira Müller is Vice President within Certara’s Evidence & Access group, responsible for HTA and Evidence Development while managing Certara’s consulting team base in Germany. Besides numerous HTA engagements, she has substantial experience 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 market access, applying her senior expertise in providing high-quality scientific advice to optimize the value of pharmaceuticals and medical technologies. Elvira holds an MSc and PhD in Biology and Toxicology from Würzburg University and an MPH from Ulm University.
Roman Casciano is a Senior Vice President within Certara’s Evidence and Access group. 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.
He held senior public sector positions in Canada and New Zealand including 3 years as Vice President of CADTH and 5 years as Chief Executive of PHARMAC He is an expert in assessing value and value for money of health technologies.
