Health technology assessment

Insights and updates for more productive and successful HTA submissions

As healthcare treatments and interventions evolve, Health Technology Assessment bodies are continually adjusting their evidence requirements and negotiation frameworks. Our health economic, market access and regulatory teams can guide clients to understand the latest updates and prepare for successful access.

Ensuring scientific rigor in external control arms

Randomized controlled trials are the gold standard for determining the efficacy of a new therapy or evaluating its comparative effectiveness against the standard of care. Yet there are situations, such as in rare or orphan diseases, with breakthrough therapies, or in areas of high unmet medical need, when RCTs are either unfeasible or unethical.

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Comparative clinical study

Seeking parallel consultation from regulators and HTAs in Europe

Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help. Read the whitepaper for key factors to ensure that parallel consultation meetings are well prepared, productive and informative.

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Early scientific regulatory consultation