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?
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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.

Meet an Expert
Our People
Elvira Müller, PhD VP HTA and Evidence Development

Elvira is an expert in HTA engagements with substantial experience in health technology assessment, reimbursement strategy and early dialogues, both national and multi-HTA via the EUnetHTA collaboration.

Roman Casciano General Manager and SVP Evidence & Access

Roman Casciano is the General Manager of Certara’s Evidence and Access Business Unit. As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the international 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.

Matthew Brougham Sr. Expert Consultant

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.


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