Accessing the risks
A mixed methods study of risk management in Australian pharmaceutical market access
Bibliographic Data
| ID | 21467196 |
|---|---|
| Authors | Zachary Tirrell (0000-0003-0394-3090, Macquarie University, corresponding author), Sean Lybrand (0000-0001-8293-7910, Macquarie University), Neil Soderlund (0009-0001-0557-499X), Neli Soderlund (Macquarie University), Bonny Parkinson (0000-0002-2137-0962, Macquarie University) |
| Year | 2026 |
| Volume | 168 |
| Pages | 105608 |
| Publication date | 2026-06-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Health Policy (JOURNAL) |
| Journal identifiers | ISSN: 0168-8510 • E-ISSN: 1872-6054 |
| Publisher | Elsevier BV (PUBLISHER) |
| DOI | 10.1016/j.healthpol.2026.105608 |
| PMID | 41865727 |
| OpenAlex | W7135413883 |
| Language | EN |
| References cited | 40 |
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
Access to medicines · Market access · MEDLINE · Pharmaceutical industry · Risk management · Risk Management in Financial Firms · Risk Perception and Management · Securities Regulation and Market Practices
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| Highly cited | No |
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