PBS restriction changes for antihypertensive dual therapy fixed dose combinations
Page last updated: 1 April 2026
Summary
On 1 April 2026, PBS restrictions were changed to allow fixed dose combinations (FDCs) for dual therapy antihypertensives to be used as a first-line treatment for hypertension in line with international clinical guidelines and with the recommendations of the National Hypertension Taskforce of Australia. 30-day prescription items for antihypertensive dual therapy FDCs were changed to Unrestricted Benefit listings. 60‑day prescription items for antihypertensive dual therapy FDCs were changed to Restricted Benefit listings for patients whose condition is stable.
These changes implement recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in December 2024 following its consideration of an analysis of antihypertensive utilisation through the PBS, which included a costing analysis and literature review.
Background
In September 2023, the PBAC supported a proposal to undertake a research project on antihypertensives as part of the Post-market Review workplan. The project was to focus on quantifying the potential underuse of antihypertensive FDCs, and potential savings to consumers and the Australian Government from addressing underuse of FDCs. The PBAC noted that the PBS restrictions do not allow patients to initiate subsidised antihypertensive therapy with an FDC as recommended in international clinical guidelines.
Report
In February 2024, the Department contracted the University of South Australia to provide a report on antihypertensive utilisation, including a costing analysis and literature review of the comparative effectiveness of commencing antihypertensive therapy with ‘standard care’ (i.e. low dose monotherapy, followed by the addition of a second low dose therapy, then titrating up the doses) versus commencing low-dose dual FDC therapy.
The ‘Utilisation analysis of antihypertensives’ Report is available below.
The Report contains the original financial estimates presented to the PBAC in December 2024. The financial estimates were revised following PBAC consideration.
Key Findings
The Report’s key findings were:
Utilisation of antihypertensives
- In 2023, there were almost 59 million antihypertensive prescriptions dispensed through the PBS to 5.0 million people (around 19% of the Australian population).
- In July 2023, around half of the antihypertensive prevalent population were dispensed multiple classes of antihypertensives: 35% were supplied two concurrent antihypertensive classes, and 15% were supplied three or more concurrent classes. Of those supplied multiple antihypertensive classes, around 60% were dispensed at least one FDC.
- In 2023, an estimated 378,000 Australians were using multiple antihypertensive classes that could have been using at least one FDC (i.e. the classes being used were available in an FDC).
- In 2023, around 400,000 patients initiated antihypertensive therapy, of which approximately 90% started with monotherapy, 6% commenced multiple therapies (not as an FDC) and 4% commenced an FDC.
- In 2023, within 12 weeks of commencing antihypertensive monotherapy, around 8% of patients were being supplied multiple therapies and 17% had ceased all antihypertensive treatment. At 12-months follow-up, around 19% were supplied multiple antihypertensive therapies, while 54% had ceased all antihypertensive treatment.
- Four-year persistence to any antihypertensive therapy based on patients initiating therapy between 2015-2019 was similar between those initiated on combination treatment (FDC or multiple single-drug products) or monotherapy. For patients commencing therapy with an angiotensin-converting enzyme inhibitor (ACE) or angiotensin II receptor blocker (ARB), persistence to the initial (or index) therapy was slightly better for those commencing an FDC than for those who commenced multiple single-drug therapies.
- Adherence rates were relatively high for all classes, ranging from 79% to 87% across the classes. Adherence was measured as the proportion of days covered (PDC) from initiation of a class(es) to last dispensing for that class(es).
Quality use of medicines
- For people with diabetes, caution is advised on the use of beta blockers (BBs) and thiazides due to potential adverse effects on glucose metabolism. The analysis found that 32% of people with diabetes were supplied BBs and 20% were supplied thiazides.
- For people with airways disease, one in four were dispensed selective BBs. Selective BBs should be used with caution in those with airways disease due to the high risk of bronchospasm. Additionally, 3% of those with airways disease were taking contraindicated non-selective BBs.
- For people with chronic kidney disease (CKD), only 53% were using the preferred antihypertensive agents (ACE or ARB), noting that some patients may be unable to use ACE or ARB due to contraindications or adverse effects.
Literature review – Initiating antihypertensive therapy with standard care versus dual therapy FDC
- A literature review found no systematic reviews of studies specifically comparing the safety and effectiveness of commencing antihypertensive treatment with standard care (monotherapy followed by add-on therapy) versus low dose dual FDC. Two individual randomised controlled trials (RCTs) found that initiating antihypertensive treatment with a low dose dual FDC was associated with a more rapid reduction in blood pressure (BP) in the short term, but at an increased risk of hypotension.
PBAC consideration
The Report was considered by the PBAC in December 2024. The outcome for this item was published as part of the December 2024 PBAC Outcome.
The PBAC considered that the recommended restriction changes, which would allow antihypertensive dual therapy FDCs to be used as a first-line treatment for hypertension, were likely to result in cost savings for the PBS and consumers but considered the reported savings to be overestimated. The financial estimates were subsequently revised by the University of South Australia and the Department.
The PBAC highlighted several quality use of medicines issues identified in the Report and considered that it would be valuable to communicate the report findings to prescribers and consumers through relevant publications and peak bodies.
The PBAC Minutes for this item are available below.
- PBAC Minutes – Antihypertensives December 2024 (Word 119 KB)
- PBAC Minutes – Antihypertensives December 2024 (PDF 3.2 MB)
Useful Resources
This section contains links to websites that provide information on hypertension and consumer support.
