Aims: As one of the three pillars of Australia’s universal public health system, the Pharmaceutical Benefits Scheme (PBS) provides equitable access to medicines for all Australians. Cancer is now the leading cause of death of Australians (18% in 2020).1 Hence, timely availability of new treatments on the PBS has become more critical than ever to more Australians. This retrospective review of the listing and use of cancer pharmacotherapies on the PBS considers whether the current scheme is meeting the needs of Australian clinicians and patients.
Methods: Publicly available sources providing information (Annual Reports, Budget papers) and data (PBS item statistics) regarding the operation of the PBS over time will be used to identify patterns of utilisation by therapeutic area, where possible. Agendas and Outcomes of Pharmaceutical Benefits Advisory Committee (PBAC) Meetings will be reviewed to identify treatments for oncology indications. Significant changes to access and pricing policies over the same period will be examined using source documents, such as the PBAC Guidelines, Strategic Agreements and enabling legislation to understand influences on the scheme. The duration between marketing approval by the Therapeutic Goods Administration (TGA) and PBS listing of advances in treatments for breast and non-small cell lung cancer (NSCLC) will be determined and, where possible, compared to timing of inclusion in local treatment guidelines.
Results: Statistical data for services and Government expenditure on the PBS are available for the thirty-year period, July 1992 to June 2022. Medicines to treat cancers represent an increasing proportion of total Government expenditure on the PBS over time. The introduction of Section 100 High-Cost Drugs to reimburse States for in-hospital usage of certain therapies, and agreements between the Commonwealth and some States/Territories to permit PBS out-patient dispensing have added service volume to the scheme. Increased costs have been offset by pricing policy changes, mostly directed at manufacturers, such as splitting into Formularies by molecule patent status, Price Disclosure and Efficient Funding of Chemotherapies (EFC). Lack of timely access, especially for first-in-class molecules, introduces a lag between local treatment practices and transition to internationally accepted standards of care. Delays in PBS listing of effective innovative therapies may be filled by access programs.
Discussion: Subsidised access to cancer pharmacotherapies via the PBS is an integral part of clinician decision making when designing treatment plans for their patients. Challenges and potential improvements to providing timely access to innovative medicines via the PBS are identified and discussed.