Ketogenic diet therapy for epilepsy in Australia: insights from the Pharmaceutical Benefits Scheme

Abstract

Ketogenic diet therapy is an effective non‐pharmacological treatment for drug‐resistant epilepsy. Since the first item was listed on the Pharmaceutical Benefits Scheme (PBS) in 2009, we report a 21.6‐fold increase in annual PBS expenditure on items related to ketogenic diet therapy. This may reflect an increasing utilisation of ketogenic diet therapy for epilepsy nationally.

Anti‐seizure medications are the primary treatment for epilepsy. Although new anti‐seizure medications have become available, with more than 20 now listed on the Australian Pharmaceutical Benefits Scheme (PBS), one‐third of people living with epilepsy are considered drug‐resistant with uncontrolled seizures. ¹ The high‐fat, low‐carbohydrate ketogenic diet is an effective non‐pharmacological treatment for children and adults with drug‐resistant epilepsy and may be considered as first‐line therapy for some metabolic epilepsies. ² , ³ Approximately half of patients treated with ketogenic diet therapy achieve greater than 50% reduction in seizure frequency, with 10%–15% becoming seizure‐free. ⁴

In 2009, KetoCal® 4:1 powder (Nutricia Australia Pty Ltd) was the first item for ketogenic diet therapy for epilepsy listed on the PBS. The aim of this study was to report the trends in PBS expenditure across Australia on ketogenic diet therapy items over the past 15 years.

PBS including Repatriation Pharmaceutical Benefits Scheme expenditure was obtained from the Service Australia Pharmaceutical Benefits Item Reports. The item codes requested were for PBS items listed for the indication ‘intractable seizures requiring treatment with a ketogenic diet’ from 1 January 2009 until 31 December 2024. Expenditure data by state or territory reflected the location where the item was dispensed, not the location of the prescriber. PBS items where the indication was for epilepsy management and other indications were excluded from the analysis.

Over the 15‐year period since PBS items were listed for ketogenic diet therapy for epilepsy, the number of PBS items listed for this indication increased from one to seven (Table S1). Between 2009 and 2024 PBS expenditure totalled AU$12 556 483 on ketogenic diet therapy for epilepsy listed items. From 2009 to 2024, annual PBS expenditure increased from $68 868 to $1 488 140, a 21.6‐fold increase (Fig. 1). In 2024, adjusted for population, the highest expenditure was reported in Victoria, followed by New South Wales and Tasmania (Table 1). No expenditure was reported in the Northern Territory.

Figure 1.

Annual Pharmaceuticals Benefits Scheme (PBS) expenditure on ketogenic diet therapy for epilepsy (2009–2024).

Table 1.

PBS expenditure on ketogenic diet therapy for epilepsy items, by state, per 100 000 population ⁹ , ¹⁰ , ¹¹

Year	New South Wales	Victoria	Queensland	South Australia	Western Australia	Tasmania	Australian Capital Territory	Northern Territory	Total
2009	$533	$282	$2897	$61	$0	$0	$0	$0	$385
2017	$4851	$1878	$2983	$3640	$2471	$5605	$8109	$0	$3407
2024	$9108	$11 068	$2163	$4396	$1677	$6456	$2087	$0	$6141

Discussion

The reported increase in PBS dispensing of items for ketogenic diet therapy for epilepsy likely reflects the growing recognition and utilisation of the role of dietary therapy as a treatment for drug‐resistant epilepsy. Historically, ketogenic diet therapy was used only for children with drug‐resistant epilepsy; however, there is now evidence to support its use also in adult populations. The introduction of variations of the classical ketogenic diet, such as the modified ketogenic diet, modified Atkins diet and the low glycaemic index diet, has improved tolerability and adherence to dietary therapy for epilepsy, with similar efficacy rates. ⁴

Uncontrolled seizures contribute substantially to the personal and economic costs of epilepsy. ⁵ Non‐medication options including dietary therapy, epilepsy surgery and neuromodulation should be considered for people living with drug‐resistant epilepsy. The data highlight a potential inequitable access to ketogenic diet therapy for epilepsy across states and territories. Of particular concern was the absence of any ketogenic diet‐related PBS items dispensed in the Northern Territory, leading to health inequity for Indigenous Australians. This inequity has been reported in other advanced treatments for epilepsy, such as stereotactic EEG. ⁶ It is likely that most patients accessing ketogenic diet therapy for epilepsy are being managed at tertiary referral centres in metropolitan areas. A national clinical trial is under way; the Keto eCoach trial (ACTRN12624000486527) evaluates a novel digital health intervention including remote monitoring of saliva ketone testing and telemedicine, which may reduce barriers to accessing ketogenic diet therapy in regional areas. ⁷

A limitation of this study was the lack of individual patient‐level data. Therefore, we could not determine whether the increase was due to a greater number of patients being treated with ketogenic diet therapy or an increase in PBS expenditure per individual patient. As the prevalence of epilepsy has remained stable over this time period, these data may reflect a true increase in utilisation of these items. ⁸ PBS expenditure may have been underestimated, as four items were excluded because they were listed for multiple indications. These four items were medium chain triglyceride supplements, which may be used as part of ketogenic diet plans.

Over the past 15 years, there has been an increase in the number and total expenditure on PBS items for ketogenic diet therapy for epilepsy. Future research should evaluate the health economic impact of subsidies for ketogenic diet therapy in the context of healthcare expenditure and societal costs related to uncontrolled seizures in people living with epilepsy.

Supporting information

Table S1. Products listed for ketogenic diet for epilepsy on the Pharmaceuticals Benefits Scheme (PBS).

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.