Restrictions are not in line with international guidelines, despite hypertension being the leading risk factor for death in Australia.
A new study adds to the large body of evidence for the use of single pill combinations as first-line treatment for hypertension, a widely accepted international practice which has not yet been adopted in Australia.
Researchers from the George Institute for Global Health found the therapies brought substantial cost savings to patients and the Australian government.
These therapies, known as single pill combinations (SPCs) or fixed dose combinations (FDCs), have also been shown to improve treatment adherence and reduce cardiovascular events and all-cause mortality in patients with hypertension.
All major international guidelines recommend starting hypertension with dual SPCs and progressing to triple SPCs as needed.
The study explained that most patients need multiple drugs for effective control of hypertension and that affordable generic SPC options are widely available in Australia.
According to a statement from the George Institute, one in three Australians have hypertension, but only half are diagnosed. Of those being treated, only 30% have their blood pressure controlled to a healthy range.
A 25% reduction in the prevalence of hypertension could save around 37,000 lives annually, the institute said.
So, why are we still using monotherapy as first-line treatment?
A spokesperson for the Department of Health, Disability and Ageing told The Medical Republic that the PBS did not allow patients to initiate hypertension treatment with FDCs.
In late 2024, the PBAC recommended lifting the PBS restrictions on dual FDCs. The proposed changes would likely result in cost savings for the PBS and consumers, the recommendation stated, but the savings were considered to have been overestimated.
“Before making this change, the PBAC asked the Department to revise the financial estimates,” the spokesperson said.
“Once the financial estimates are finalised, other steps are required before the listings can be changed, including consideration and approval by the Australian Government.”
The recommendation also stated that prescriber behaviour was likely to be in line with clinical practice guidelines, which do not currently recommend FDCs as first-line therapy.
“The Department is aware that the Heart Foundation and Stroke Foundation are currently updating the Australian Hypertension Guidelines, which are expected to be finalised later in 2025,” the spokesperson said.
“The Department has kept the National Hypertension Taskforce informed of PBAC’s recommendations, so that the anticipated changes to the PBS listings for dual therapy antihypertensives can be reflected in the revised guidelines.”
The PBAC recommendation did not extend to triple therapy SPCs.
This latest study added to the overwhelming evidence for SPCs as first-line treatment, said Professor Alta Schutte, co-director of the Global Cardiovascular Program at The George Institute.
She told media that the research confirmed what international guidelines have long recommended and making first-line SPCs standard practice in Australia would be a win-win for consumers and the health system alike.
“Now is the time for the government to act by updating PBS restrictions so clinicians can follow global best practice,” she said.
“Starting treatment with single-pill combinations is safer, more effective, and more economical than multiple pills of equivalent dose.”
“This is a real opportunity to improve policy, cut costs, and most importantly, save lives.”
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The study included 57 possible combinations of brand and dose as listed on the PBS, to compare the cost to both patients and the government if SPCs were used in place of single pills.
SPCs overall cost less than multiple pills for patients, with the largest average saving of 30% seen for non-concession patients before reaching the safety net of $1648.
They found that there was a mean saving for patients independent of subsidy eligibility, and that only in general patients before reaching the safety net was there a slight cost increase to the government.
The cost-minimisation analysis was conducted based on PBS prices as of March 2024, and accounted for ex-manufacturer price, wholesale markup, the Administration, Handling and Infrastructure fee and the Dispensing fee.
They calculated the per-pill cost for all available pack sizes, and lowest-cost options were compared to SPCs of equivalent doses.
A key reason for using SPCs as initial treatment, researchers explained, was to combat treatment inertia. Monotherapy practices require adequate up-dosing and the addition of drug classes in follow-up visits.
Treatment inertia remains one of the most important blood pressure control problems in general practice and a likely contributor to the poor blood pressure control in Australia, they said.
The researchers cited a 2018 study which found that nearly 40% of hypertension patients in Australia aged 45-74 years had not been prescribed medication in the past six months, including 40% of those at moderate-to-high cardiovascular risk.
