Proton pump inhibitors for complex GORD: New PBS listings March 2021

• On 1 March 2021, the PBS introduced new listings for standard and high dose proton pump inhibitors (PPIs) to allow twice-daily dosing for complex GORD
  These item numbers are additional to existing PBS listings for PPIs. They are intended to cater for patients with gastrointestinal acid-related disorders and inadequate symptom control despite use of a once-daily (or equivalent) standard or high dose PPI.

• Prescription for twice-daily standard and high dose PPIs for complex GORD is Authority Required (immediate assessment) (also known as Telephone Authority)
  The treatment must be the sole PBS-subsidised PPI for this condition.

• Initial treatment with twice-daily standard dose PPIs requires prescription by or in consultation with a specialist (gastroenterologist or upper GI surgeon)
  Continuing treatment may be prescribed by a specialist or general practitioner.

• High dose esomeprazole 40 mg for complex GORD is restricted to prescribing by a specialist (gastroenterologist or upper GI surgeon)
  This facilitates continuing specialist review, an important consideration in this group of patients.

• Patients should be checked for adherence to previous PPI treatment regimens prior to adding twice-daily standard or high dose therapy
  Inadequate symptom control due to non-adherence should not be a reason for accessing treatment.

On 1 March 2021 new PBS listings were added to the PBS General Schedule (Section 85) for standard and high dose proton pump inhibitor medicines (PPIs) to allow twice-daily dosing for complex gastro-oesophageal reflux disease (GORD).¹

The Gastroenterological Society of Australia (GESA) has provided guidance for the purpose of prescribing PPIs on the PBS under the complex GORD listings.²

New listings are described in Table 2 and Table 3 below.

See the PBS website for complete details for each item.

Table 2: Standard dose twice-daily dosing for patients with complex GORD¹

Esomeprazole 20 mg (Items 12275C and 12287Q)

Lansoprazole 30 mg (Items 12284M and 12276D)

Omeprazole 20 mg (Items 12281J, 12270T and 12272X)

Pantoprazole 40 mg (Items 12282K and 12277E)

Rabeprazole 20 mg (Item 12286P)

Table 3. High dose twice-daily dosing for patients with complex GORD¹

Esomeprazole 40 mg (Items 12290W and 12283L)

The new listings were made to address the clinical need of some patients with complex GORD who require more than once-daily standard and high-dose PPI therapy to manage their conditions. In addition, the new listings also aim to improve the quality use of PPI medicines by:^1,4

• maintaining the requirement for specialist involvement in initial prescription of standard and high dose PPIs
• ensuring timely review of patients on long-term high dose PPIs
• supporting stepping down therapy, and/or stopping PPIs where clinically appropriate.

Previous restriction changes

On 1 May 2019, PBS restriction changes were applied to high and standard dose PPI medicines. The changes were intended to improve appropriate prescribing of PPI medicines and included:⁶

• high dose PPI (esomeprazole 40 mg) with 1 repeat, were changed from Restricted Benefit to Authority Required (Telephone)
• all standard dose PPIs (esomeprazole 20 mg, lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg, rabeprazole 20 mg) were changed from Restricted Benefit to Authority Required (Streamlined).
• increases in the maximum quantity or number of units authorised were no longer allowed for GORD.

A RADAR article describing those 2019 changes is available.

Access issues for patients with complex GORD

Analysis of PBS utilisation data for PPI medicines from 1 May 2019 to 31 December 2019 showed an overall 5% reduction in PPI prescriptions compared to the same period in 2018.³

Despite initial concerns raised by the PBAC,⁷ the data showed there was no indication of a shift to high dose PPIs (esomeprazole 40 mg) or to prescriptions for greater quantities of low dose PPIs for patients who were unable to obtain twice-daily standard dose PPIs for GORD.³

These findings were consistent with the intended outcomes of the restriction changes ie, improved quality use of medicines (QUM).³

The PBAC considered collated feedback from patients and prescribers, and input from the Gastroenterological Society of Australia (GESA) and the Royal Australian College of General Practitioners (RACGP), which highlighted the need for additional criteria to include patients requiring twice daily standard or high dose PPIs. Feedback included:

• some patients with difficult to treat, or complex GORD require more than once-daily standard dose PPI therapy to manage their condition.⁴
• prescribers were no longer able to access PBS subsidised twice-daily dosing of standard dose PPIs for their patients with complex GORD.³
• a subset of patients with complex GORD require long term twice-daily high dose PPI therapy eg, those with Barrett’s oesophagus with dysplasia or intramucosal adenocarcinoma who have previously undergone endoscopic (including ablative) therapy.⁴
• 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).⁸
• Australian Therapeutic Guidelines suggest that if high dose therapy is required for symptom control, the standard dose given twice daily is more effective than a high dose (esomeprazole 40 mg) given once daily.⁹

Recommendations

Weighing feedback from clinical groups, prescribers and patients, as well as current guidelines and utilisation data collected since May 2019, the PBAC recommended new PBS restrictions, noting that:⁴

• for standard dose PPIs, initial treatment will require prescribing by, or in consultation with a specialist (gastroenterologist or upper GI surgeon), and continuing treatment may be prescribed by a specialist or general practitioner
• the Authority Required (Telephone) restriction level would distinguish this restriction from the existing once-daily Authority (Streamlined) standard dose PPI listings for GORD, and would maintain the quality use of medicines (QUM) changes achieved since the 1 May 2019 PBS restriction changes
• the inclusion of standard dose PPIs within this restriction enables esomeprazole 20 mg to be given twice daily (as an alternative to high dose esomeprazole 40 mg once daily) as per current guidelines
• twice-daily high dose esomeprazole 40 mg for complex GORD is restricted to prescription by a gastroenterologist or upper GI surgeon for the purposes of PBS subsidy.

• There are no changes to existing restrictions for low, standard or high dose PPIs. Patients obtaining PPIs under existing indications (GORD, peptic ulcer, scleroderma oesophagus, pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion) may continue to do so.
• Prescribers and pharmacists should ensure their prescribing and dispensing software is up to date.
• Services Australia (SA) administers the PBS in accordance with the legislation determined by the Department of Health. Where a PBS restriction does not allow for increased quantities and repeats SA has no delegation to alter these restrictions.

For some patients, complex GORD can be difficult to treat and treatment should be tailored to the individual. Under the new restrictions, esomeprazole 40 mg for complex GORD is restricted to prescribing by a gastroenterologist or upper GI surgeon.⁴

Patients who are unable to travel to a specialist or those living in rural and remote locations should be referred to telehealth services where available.

Applications for authorisation under these restrictions may be made in real time using the Online PBS Authorities system or by phoning Services Australia on 1800 888 333.

Stepping down⁹

Australian guidelines recommend PPI therapy that is providing adequate symptom control may be stepped down and continued at the lowest dose and frequency where symptoms can still be controlled.

Step-down therapy should be individualised, but general principles for stepping down include halving the daily PPI dose or dosing on alternate days, then switching to on-demand therapy, ie, only dosing on days when symptoms occur.

Stopping PPI therapy completely can result in prolonged remission of symptom in 30% of patients, however symptoms such as rebound acid hypersecretion may recur if therapy is stopped abruptly.

Rebound symptoms can be prevented by using the general stepping down principles, or an H₂-receptor agonist or antacid.

Further information is available to support down-titration of PPI doses and deprescribing where clinically appropriate.

Guidance that can be provided to patients includes:^1,9

• there are no changes to existing restrictions for low, standard, or high dose PPIs in standard (PPI-responsive) GORD
• adherence to treatment will be assessed by the treating specialist or general practitioner prior to accessing treatment under the new listings
• before commencing treatment under the new listings, patients must confirm their adherence to PPI therapy was unable to adequately control symptoms
• gradual stepping down and/or stopping treatment may be considered if symptoms are adequately controlled on current PPI therapy
• rebound acid hypersecretion can occur as a result of stepping down PPI therapy
• gradual reduction of PPI dose may reduce the risk of rebound symptoms
• mild rebound symptoms can be managed with antacids or H2 receptor antagonists
• further information is available to support patients where stepping down or deprescribing PPIs is anticipated and clinically appropriate. See below.

• NPS MedicineWise RADAR article: Proton pump inhibitors: PBS changes May 2019
• Managing reflux and heartburn: information for consumers