Restrictions have recently increased for the provision of proton pump inhibitors (PPIs) on the Pharmaceutical Benefits Scheme (PBS). The following changes were implemented on 1st May 2019:
- Standard dose PPIs changed from restricted benefit to streamlined authority required;
- Esomeprazole 40mg (30 tablets/capsules + one repeat) changed from restricted benefit to telephone authority required;
- Esomeprazole 40mg requires a trial of standard dose PPI prior to initiation;
- Standard dose PPIs with five repeats prescribed for the long-term maintenance of gastro-oesophageal reflux disease (GORD) may only be used in patients inadequately controlled with a low dose PPI;
- All peptic ulcer indications require Helicobacter pylori testing or failure of eradication therapy prior to initiation of a standard dose PPI; and
- A new clinical indication of initial and short-term maintenance treatment of symptomatic GORD has been added for standard dose PPIs with one repeat.
The terminology used has also been made consistent with the Therapeutic Guidelines: Gastrointestinal. Standard dose PPI therapy now refers to 20mg esomeprazole, omeprazole, and rabeprazole; 30mg lansoprazole; or 40mg pantoprazole. Esomeprazole contained in combination packs (e.g. Nexium® Hp7®) for the eradication of H. pylori remain a restricted benefit. No PPI medicines have been removed from the PBS in this latest update.
The new restrictions were made following the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC agreed that PPIs appear to be overprescribed in Australia and used for excessively long periods, particularly in older people. Four out of the five PPIs available in Australia have consistently appeared in the list of top 50 medications dispensed on the PBS each year over the last decade. A review also found that standard dose and high dose PPIs made up 95% of all PPI prescriptions dispensed under the PBS between 2013 and 2016. Increased restrictions are expected to reduce PBS expenditure on this medication class while also improving the quality use of medicines.
There were a number of tighter restrictions proposed that the PBAC did not adopt. This included the requirement for erosive oesophagitis to be confirmed by endoscopy and the requirement for a gastroenterologist to prescribe PPIs for scleroderma oesophagus, erosive oesophagitis, and all hypersecretory indications. However, if the current restrictions do not change utilisation patterns at the two-year review, these additional restrictions may be reconsidered.
Proton pump inhibitors are potent inhibitors of gastric acid secretion that produce more reliable results than H2 receptor antagonists. While PPIs are well tolerated with an excellent safety profile, they are associated with a number of potential short-term and long-term adverse effects, including:
- Impaired absorption of vitamins and minerals such as calcium, magnesium, and vitamin B12 with the chronic use of high-doses;
- Increased risk of community-acquired pneumonia;
- Increased risk of enteric infections such as Salmonella, Campylobacter jejuni, and Clostridium difficile;
- Possible increased risk of osteoporosis-related fractures with high-dose and long-term therapy; and
- The potential for drug interactions, particularly with omeprazole and esomeprazole which are primarily metabolised by CYP2C19.
While the evidence for many of these adverse effects is limited and the absolute risk considered low, careful use of PPIs is recommended to minimise potential harms. Review of the Therapeutic Guidelines: Gastrointestinal may be useful to guide therapy. For further information on current PBS codes and criteria, please refer to the PBS website. Alternatively, the PBS Code app may be downloaded to smartphones and tablets for mobile access to PBS information.
- Gastrointestinal Expert Group. Therapeutic Guidelines: Gastrointestinal. Version 6. Melbourne: Therapeutic Guidelines; 2016.
- Pharmaceutical Benefits Scheme. Expenditure and Prescriptions Twelve Months to 30 June 2018. Woden: Department of Health; 2018.
- Pharmaceutical Benefits Scheme. March 2018 PBAC Outcomes – Other Matters. Woden: Department of Health; 2018.
- Strand DS, Kim D, Peura DA. 25 years of proton pump inhibitors: a comprehensive review. Gut Liver. 2017; 11(1): 27-37.