Accessing the Risks: A Mixed Methods Study of Risk Management in Australian Pharmaceutical Market Access

• Companies’ decision-making and risk management in HTA remains under-investigated • Mixed-method study applied ISO 31000 risk framework to pharmaceutical market access • Global needs, submission costs, and the market access triangle are in tension • HTA was seen more as a strategic negotiation rather than a technical evaluation • Enhanced communication may reduce risk and improve HTA system efficiency 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. 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. 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. 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 AUD830, 000), and coping with workforce limitations. Risk assessment practices are predominantly informal and experience-based, while communication barriers hinder effective stakeholder engagement. 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.