Accessing the risks: A mixed methods study of risk management in Australian pharmaceutical market access

Background: Navigating Health Technology Assessment (HTA) processes presents significant challenges for pharmaceutical companies seeking market access in Australia. While previous research has examined HTA decision-making from payer perspectives, pharmaceutical companies' internal decision-making processes remain understudied.
Objective: To investigate how pharmaceutical companies' market access teams manage uncertainties in the HTA process for medicines in Australia using the ISO 31000 risk management framework to examine decision-making practices.
Methods: A mixed-methods study was conducted involving an online questionnaire and semi-structured interviews with 18 respondents with recent experience with HTA submissions from 14 pharmaceutical companies, representing approximately 50% of PBS expenditure. Data were analysed using a deductive approach that mapped to ISO 31000 risk management process, supported by thematic analysis and descriptive statistics.
Results: Market access teams aim to secure PBS listing by balancing price (45% relative importance), speed (30%), and population coverage (25%) with submission costs. They function as intermediaries between global stakeholders and local market requirements, operating without formal risk management frameworks. Key challenges include managing global-local tensions, navigating increasingly complex stakeholder relationships, addressing rising submission costs (averaging AUD$830,000), and coping with workforce limitations. Risk assessment practices are predominantly informal and experience-based, while communication barriers hinder effective stakeholder engagement.
Conclusions: Through mapping to the ISO 31000 framework, this study established the market access processes of pharmaceutical companies, with focus on uncertainty and decision-making. Enhanced communication may reduce risk and improve HTA system efficiency. Addressing these challenges, as well as improving management of uncertainty, would improve patient access to medicines.