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.
专家团队
Elvira Müller, PhD, MPH HTA 和证据开发副总裁
Roman Casciano, MEng 证据和准入高级副总裁
Matthew Brougham Sr. Expert Consultant
Elvira Müller, PhD, MPH HTA 和证据开发副总裁
Roman Casciano, MEng 证据和准入高级副总裁
Matthew Brougham Sr. Expert Consultant
Elvira 是 HTA 方面的专家，在卫生技术评估、报销战略和早期对话方面拥有丰富的经验，既包括国家层面的经验，也包括通过 EUnetHTA 合作进行的多次 HTA 经验。
Roman Casciano 是 Certara 证据和准入集团的高级副总裁。作为一名应用卫生经济学家和市场准入战略家，Roman 亲自领导了数百项与产品价值展示相关的国际市场准入、HEOR 和实际证据方面的工作，并在与支付方和 HTA 机构的正式和非正式交流中积累了丰富的经验。
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 是 HTA 方面的专家，在卫生技术评估、报销战略和早期对话方面拥有丰富的经验，既包括国家层面的经验，也包括通过 EUnetHTA 合作进行的多次 HTA 经验。
Roman Casciano 是 Certara 证据和准入集团的高级副总裁。作为一名应用卫生经济学家和市场准入战略家，Roman 亲自领导了数百项与产品价值展示相关的国际市场准入、HEOR 和实际证据方面的工作，并在与支付方和 HTA 机构的正式和非正式交流中积累了丰富的经验。
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.
