Presentation (CTI)

OBJECTIVES: Pharmaceutical companies navigate significant uncertainty when pursuing market access. In Australia, this primarily relates to making health technology assessment (HTA) submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the statutory authority that advises the Minister for Health on which medicines should be included for public subsidy on the Pharmaceutical Benefits Scheme. This study explored how market access professionals manage complexities and uncertainty in the HTA process. Risks and contemporary topics, such as the place for real-world evidence (RWE), were examined.
METHODS: A mixed-methods approach comprising 90-minute semi-structured interviews and surveys with 18 market access professionals from 14 companies was conducted between January 2023 and January 2024 to examine the market access process and the management of uncertainty. Qualitative data were analysed thematically, using a deductive approach mapped to key elements of ISO 31000 Risk Management Guidelines (e.g. identifying, assessing, and communicating uncertainties) to organise reported practices.
RESULTS: Market access professionals pursued patient access to medicine by employing strategies balancing price (via economic evaluation), speed, and population coverage, while managing uncertainties based on the evidence and market experience. Respondents highlighted the attentiveness of the PBAC to the uncertainty of clinical and economic evidence. Respondents discussed the limitations of conventional clinical data and contexts where RWE might influence submission planning and PBAC recommendations. Participants identified market size constraints in Australia as a limiting factor for generating additional clinical evidence to address uncertainty, suggesting a potential role for RWE—contingent upon methodological acceptance. Key challenges included managing stakeholder expectations, external communications, and policy context, while operating under resource constraints.
CONCLUSIONS: Australian market access professionals utilise various strategies to manage uncertainty. The risks faced by the industry in this monopsony market may reflect similar evidence-related challenges across Asia Pacific (and other HTA-focused) healthcare systems, where centralised decision-making significantly shapes market access strategies.