New PBS listings have been introduced for proton pump inhibitors (PPIs) to allow twice-daily standard and high dose therapy for complex GORD initiated by a gastroenterologist.
The new items, which come into effect from 1 March are for treatment of GORD patients who have inadequate symptom control despite use of a once-daily (or equivalent) standard or high dose treatment with esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole.
The changes, which are in addition to existing PBS items, reverse some of the restrictions on the use of high dose PPIs imposed by the PBS in May 2019 in response to concerns about over prescribing of high dose PPIs.
Following complaints from clinicians and patients about the inability to access high dose PPI therapy, the PBS has created items that allow prescriptions for twice-daily standard and high dose PPIs for complex GORD as Telephone Authority items.
The criteria for prescribing state that initial treatment with twice-daily standard dose PPIs must be by or in consultation with a specialist (gastroenterologist or upper GI surgeon). Continuing treatment may be prescribed by a specialist or GP.
The PBS has also restricted prescribing of high dose esomeprazole 40 mg for complex GORD to a specialist only.
The new items also specify that high dose treatment must be the sole PBS-subsidised PPI and only dose for the condition, and that patient adherence to lower dose PPI must be checked to exclude non-adherence as a reason before ‘step-up’ therapy.
In March 2020 the Pharmaceutical Benefits Advisory Committee (PBAC) reviewed the impact of the previous year’s restrictions on PPIs and found that they had achieved their intended purpose of reducing overall PPI prescribing – by 5% compared to the previous year.
However the PBAC also acknowledged feedback from the Gastroenterological Society of Australia (GESA) and the RACGP, which highlighted that GORD was a heterogeneous condition and could be difficult to treat.
“GESA indicated that in addition to patients with complex GORD symptoms requiring twice daily standard doses of PPIs there is a subset of patients who require long term high dose PPI therapy,” the committee noted.
In an article published by NPS MedicineWise, the PBAC said feedback from groups such as GESA stated that prescribers were no longer able to access PBS subsidised PPI therapy for patients with Barrett’s oesophagus with dysplasia or intramucosal adenocarcinoma who have previously undergone endoscopic (including ablative) therapy.
“This subset did not meet the criteria for whom increased quantities or repeats of high dose esomeprazole are currently allowed (eg, hypersecretory conditions such as Zollinger Ellison Syndrome),” it said
The PBAC also noted that Australian Therapeutic Guidelines suggested that if high dose PPI therapy was required for symptom control, the standard dose given twice daily was more effective than a high dose given once daily.
In its advice, the PBAC also highlighted the importance of stepping down PPI therapy, noting that stopping PPI therapy completely can result in prolonged remission of symptom in 30% of patients.