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Pharmaceutical companies have a good understanding of the needs and requirements of regulatory bodies, but the evidence expectations of health technology assessment (HTA) and coverage/payer bodies are less well understood and addressed. This paper seeks to improve this understanding by providing an overview of the expectations of HTA and coverage/payer bodies, explaining how and why these differ from those of regulators, and describing the extent and limitations of work on harmonization. The article goes on to describe ways in which HTA and coverage/payer bodies' expectations can be addressed, and to encourage industry to interact with HTA and coverage/payer bodies to increase mutual understanding and hence promote more efficient development of and access to innovative medicines.

Health technology is a term widely used to refer to different areas of health, including prevention, diagnosis, and therapy. It includes all products used in health services delivery, procedures, and systems (1-3). Health technology assessment (HTA) is a multidisciplinary process for the systematic evaluation of properties, effects, ABSTRACTObjective.

This case study intends to draw useful lessons for policymakers in emerging settings interested in the adoption of the HPV vaccine supported by evidence-informed processes, such as those offered by institutionalized HTA. Future studies are also recommended to elucidate the specific roles that social values and uncertainties play in vaccine decision-making across different societies.

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