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Regulators and payers have placed new demands on industry to provide health economic and epidemiologic evidence, in addition to clinical trials data, to demonstrate the value and safety of a new product. A comprehensive evidence strategy, when created early in the clinical development program, is a key component of successful regulatory and HTA submission planning.
Planning for regulatory and HTA submissions requires strategic foresight into what regulators and payers will consider most influential in their respective reviews. An important step is to identify the health economic and epidemiology evidence that needs to be collected during the clinical development program, and what evidence may already exist. An early landscape assessment can identify evidence sources that may already exist in the published literature.
It is also important to define the aspirational value message for the investigational product in terms of unmet medical need, clinical value, human value, or economic value. By aligning the health economic and epidemiologic evidence strategy with the aspirational value message, the relevance of each piece of evidence becomes clear.
Michael Cook, MSc, MSPH, PhD
Dr. Cook has 15 years of pharmaceutical company experience holding positions of increasing responsibility at Merck, Pfizer and Shire. His area of methodological expertise is in the analysis of large health care databases to conduct real world evidence (RWE) studies.
Dhvani Shah, MS
Lead Health Economist
Dhvani Shah has over 8 years of experience in HEOR, and has led numerous evidence generation activities to demonstrate and communicate product value. At ICON, She is responsible for preparing HEOR research and value strategies, developing economic models for HTA submissions and conducting literature reviews and evidence synthesis activities.
Register today to learn how having a comprehensive health economic and epidemiologic evidence strategy and evidence generation plan can optimise your regulatory and HTA submissions.