Key points

  • On 1 May 2019, changes were made to all PPIs listed on the PBS General Schedule
    Changes apply to esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole. They affect restriction levels, terminology, clinical criteria and number of repeats.
  • The PBAC considered advice from a utilisation review of PBS-listed GORD medicines
    The PBAC agreed that high dose PPIs appear to be overprescribed in Australia.
  • Restriction levels were increased to improve awareness of PPI strengths
    Esomeprazole 40 mg has a higher therapeutic relativity compared with standard dose PPIs.
  • Terminology was revised to align with Therapeutic Guidelines and NPS MedicineWise
    PPI dose terminology has changed from highest, high and low, to high, standard and low.
  • The changes are intended to improve the appropriate prescribing of PPIs
    High dose PPIs should be limited to patients with gastrointestinal acid-related disorders and inadequate symptom control despite use of a standard dose PPI.
 

What's changed?

On 1 May 2019, changes were made to the restriction levels, terminology, criteria and number of repeats for proton pump inhibitors (PPIs) listed on the PBS General Schedule (Section 85).1-5

The changes will apply to all listed PBS items for esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole.1-6

They apply to people with gastro-oesophageal reflux disease (GORD), peptic ulcers, and hypersecretory conditions including Zollinger-Ellison Syndrome and scleroderma oesophagus.1-5

The changes are described in the tables below.

In summary:6

  • Terminology for PPI doses has changed from highest, high and low, to high, standard and low.
  • Restriction level for esomeprazole 40 mg (1 repeat) has increased from Restricted Benefit to Authority Required (Telephone).
  • Restriction levels for all standard dose PPIs have increased from Restricted Benefit to Authority Required (Streamlined).
  • New item numbers have been added for standard dose PPIs for long-term maintenance treatment of GORD in patients with symptoms inadequately controlled by a low dose PPI.
  • The GORD indication has been removed from item numbers for standard dose PPIs used to treat patients with other gastrointestinal acid-related disorders.

See the PBS website for complete details for each item, under A02B – Drugs for peptic ulcer and gastro-oesophageal reflux disease.

Changes to terminology

Table 1. Changes to dose terminology for PPIs for gastrointestinal acid-related disorders

Medicine

Before 1 May 2019

After 1 May 2019

Esomeprazole 40 mg

Highest dose

High dose

Esomeprazole 20 mg

High dose

Standard dose

Lansoprazole 30 mg

High dose

Standard dose

Omeprazole 20 mg

High dose

Standard dose

Pantoprazole 40 mg

High dose

Standard dose

Rabeprazole 20 mg

High dose

Standard dose

Lansoprazole 15 mg

Low dose

Low dose

Omeprazole 10 mg

Low dose

Low dose

Pantoprazole 20 mg

Low dose

Low dose

Rabeprazole 10 mg

Low dose

Low dose

Changes to PBS items for PPIs for gastrointestinal acid-related disorders

Notes about medicine equivalence have not been described in the tables below. For example, esomeprazole 40 mg items also contain the note, ‘Pharmaceutical benefits that have the form esomeprazole tablet 40 mg and pharmaceutical benefits that have the form esomeprazole capsule 40 mg are equivalent for the purposes of substitution.’ Go to the PBS website to view these notes.

Table 2a. High dose PPIs

Esomeprazole 40 mg (Items 3401B and 10331R)1


PBS criteria

Before 1 May 2019

After 1 May 2019

Indication

Scleroderma oesophagus

Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

No change

Restriction level

Authority Required

Authority Required (Telephone)

Clinical criteria

None

Patient must have symptoms which are inadequately controlled using a standard dose PPI

Number of repeats

5

No change

Notes

For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner

Check patient adherence to lower dose PPI before ‘stepping-up’ therapy

Standard dose PPIs are appropriate step-down therapy from high dose PPIs

For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner

Table 2b. High dose PPIs

Esomeprazole 40 mg (Items 8601Q and 10330Q)1


PBS criteria

Before 1 May 2019

After 1 May 2019

Indication

GORD

No change

Restriction level

Restricted Benefit

Authority Required (Telephone)

Clinical criteria

The treatment must be for the healing of GORD

Patient must have symptoms which are inadequately controlled using a standard dose PPI

Number of repeats

1

No change

Notes

No increase in the maximum quantity or number of units may be authorised

No increase in the maximum number of repeats may be authorised

Check patient adherence to lower dose PPI before ‘stepping-up’ therapy

Standard dose PPIs are appropriate step-down therapy from high dose PPIs

No increase in the maximum quantity or number of units may be authorised

No increase in the maximum number of repeats may be authorised

Table 3a. Standard dose PPIs

Esomeprazole 20 mg (Items 11687D and 11692J)

Lansoprazole 30 mg (Items 11669E and 11697P)

Omeprazole 20 mg (Items 11682W, 11677N and 11683X)

Pantoprazole 40 mg (Items 11678P and 11681T)

Rabeprazole 20 mg (Item 11670F)1-5


PBS criteria

Before 1 May 2019

After 1 May 2019

Indication

N/A. These are new item numbers, effective from 1 May 2019

GORD

Restriction level

N/A. These are new item numbers, effective from 1 May 2019

Authority Required (Streamlined)

Clinical criteria

N/A. These are new item numbers, effective from 1 May 2019

The treatment must be for long-term maintenance of GORD in a patient with symptoms inadequately controlled using a low dose PPI

Number of repeats

N/A. These are new item numbers, effective from 1 May 2019

5

Notes

N/A. These are new item numbers, effective from 1 May 2019

Check patient adherence to lower dose PPI before ‘stepping-up’ therapy

Low dose PPIs are appropriate step-down therapy from standard dose PPIs

A low dose PPI includes:

  • lansoprazole 15 mg,
  • omeprazole 10 mg,
  • pantoprazole 20 mg, and 
  • rabeprazole 10 mg

No increase in the maximum quantity or number of units may be authorised

No increase in the maximum number of repeats may be authorised

Table 3b. Standard dose PPIs

Esomeprazole 20 mg (Items 8600P and 10343J)

Lansoprazole 30 mg (Items 9478W and 2241Y)

Omeprazole 20 mg (Items 8333N, 9110L and 1327W)

Pantoprazole 40 mg (Items 8008L and 9424B)

Rabeprazole 20 mg (Item 8508T)1-5


PBS criteria

Before 1 May 2019

After 1 May 2019

Indication

All: GORD, scleroderma oesophagus

Esomeprazole: Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

Omeprazole, pantoprazole: Zollinger-Ellison syndrome

All: Scleroderma oesophagus

Esomeprazole: Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

Omeprazole, pantoprazole: Zollinger-Ellison syndrome

Restriction level

Restricted Benefit

Authority Required (Streamlined)

Clinical criteria

Esomeprazole: The treatment must be maintenance therapy

And, the condition must be healed

None

Number of repeats

5

No change

Notes

Esomeprazole: No increase in the maximum quantity or number of units may be authorised

Check patient adherence to lower dose PPI before ‘stepping-up’ therapy

Low dose PPIs are appropriate step-down therapy from standard dose PPIs

A low dose PPI includes: 

  • lansoprazole 15 mg
  • omeprazole 10 mg
  • pantoprazole 20 mg, and
  • rabeprazole 10 mg

Esomeprazole: No increase in the maximum quantity or number of units may be authorised

Table 3c. Standard dose PPIs

Esomeprazole 20 mg (Items 8886Q and 10295W)

Lansoprazole 30 mg (Items 9477T and 2240X)

Omeprazole 20 mg (Items 8331L, 9109K and 1326T)

Pantoprazole 40 mg (Items 8007K and 9423Y)

Rabeprazole 20 mg (item 8509W)1-5


PBS criteria

Before 1 May 2019

After 1 May 2019

Indication

Esomeprazole: Gastric ulcer

Lansoprazole, omeprazole, pantoprazole, rabeprazole: Peptic ulcer

GORD, peptic ulcer

Restriction level

Restricted Benefit

Authority Required (Streamlined)

Clinical criteria

None

GORD: The treatment must be for initial treatment of symptomatic GORD

Or, the treatment must be for the short-term maintenance treatment of GORD

Peptic ulcer: Patient must have tested negative for helicobacter pylori infection

Or, patient must have failed treatment with helicobacter pylori eradication therapy

Number of repeats

Esomeprazole, lansoprazole, omeprazole: 1

Pantoprazole, rabeprazole: 2

1

Notes

All: Helicobacter pylori eradication therapy should be considered

All: No increase in the maximum number of repeats may be authorised

Esomeprazole: No increase in the maximum quantity or number of units may be authorised

Check patient adherence to lower dose PPI before ‘stepping-up’ therapy

Low dose PPIs are appropriate step-down therapy from standard dose PPIs

A low dose PPI includes: 

  • lansoprazole 15 mg
  • omeprazole 10 mg
  • pantoprazole 20 mg, and 
  • rabeprazole 10 mg

No increase in the maximum quantity or number of units may be authorised

No increase in the maximum number of repeats may be authorised

Table 4. Low dose PPIs

Lansoprazole 15 mg (Items 9331D and 8198L)

Omeprazole 10 mg (Item 8332M)

Pantoprazole 20 mg (Item 8399C)

Rabeprazole 10 mg (Item 8507R)2-5


PBS criteria

Before 1 May 2019

After 1 May 2019

Indication

All: GORD, scleroderma oesophagus

Omeprazole, pantoprazole: Zollinger-Ellison syndrome

No change

Restriction level

Restricted Benefit

No change

Clinical criteria

None

No change

Number of repeats

5

No change

Notes

None

Check patient adherence to lower dose PPI before ‘stepping-up’ therapy

 

Why were the changes made?

At the March 2018 PBAC meeting, the PBAC considered advice from the Drug Utilisation Sub-Committee following a PBS utilisation review of all PBS-listed medicines for GORD.6-8

The PBAC agreed that high dose PPIs appear to be overprescribed in Australia, for excessively long periods of time, and particularly among older people.8

A large number of standard (previously termed ‘high’) and high (previously termed ‘highest’) dose prescriptions were dispensed (95%) relative to low dose PPIs (5%) over 2013–16.8

The PBAC subsequently considered amendments to PPI listings at the July 2018 PBAC meeting.7

The PBAC recommended:

  • revision of PBS terminology for PPI oral doses to align with terminology used by Australian Therapeutic Guidelines9 and NPS MedicineWise (see Managing GORD with PPIs in primary care)6
  • revision of PPI restriction levels to increase awareness of the higher therapeutic relativity of esomeprazole 40 mg compared with standard dose PPIs6
  • reduction of the standard dose pantoprazole and rabeprazole PBS items for peptic ulcer from two repeats to a single repeat to be consistent with the other standard dose PPIs for this indication6
  • revision of clinical criteria for high and standard dose PPIs to distinguish between patients requiring long-term (5 repeats) or short-term (1 repeat) treatment for GORD6

PPI utilisation review in 2 years6

The PBAC did not recommend restrictions for the GORD indication to include additional clinical criteria requiring erosive oesophagitis to be confirmed by endoscopy for treatment with esomeprazole 40 mg (1 repeat) or long-term treatment with a standard dose PPI (5 repeats).

The PBAC noted stakeholder concerns that this was clinically unnecessary and burdensome for patients.

It also did not recommend the addition of criteria requiring treatment to be prescribed by a gastroenterologist or in consultation with a gastroenterologist for hypersecretory, scleroderma oesophagus and erosive oesophagitis indications.

However, the PBAC suggested that PPI utilisation should be reviewed in 2 years, and these additional restrictions should be considered if PPI prescribing has not improved.

 

Will the changes affect current prescribing?

The changes are intended to improve the appropriate prescribing of PPIs, in line with recommendations in Australian Therapeutic Guidelines.8,9

The same PPI medicines are PBS subsidised, at the same doses, before and after 1 May 2019.

However, terminology and restriction levels have been revised and additional criteria have been added to clarify PPI therapeutic equivalence and confirm conditions for stepping up or stepping down treatment.

The need to check patient adherence and confirm inadequate symptom control with standard and low dose PPIs before stepping up therapy has been recognised.

Recommendations for starting, stepping down or stopping PPI treatment for GORD are summarised in NPS MedicineWise’s Reviewing PPIs for GORD algorithm (found under Resources and below). 

Reviewing PPIs for GORD

Date published : 27 June 2018

 

Impact on administrative processes

Prescriptions for PPIs written before 1 May 2019 will still be valid for PBS subsidy, for the life of the prescription.

However, to prepare for the new and amended PPI listings, prescribers and pharmacists should ensure their prescribing and dispensing software is up to date.

The Department of Human Services (DHS) administers the PBS in accordance with legislation determined by the Department of Health. Where a PBS restriction does not allow for increased quantities and repeats the DHS has no delegation to alter these restrictions.

Information for prescribers

For PBS subsidy for Authority Required (Telephone) listings, prescribers need to complete an authority prescription form and gain prior approval from the DHS by calling 1800 888 333.

However, there is no need to telephone for most authority approvals.10

For PBS subsidy for Authority Required (Streamlined) listings, prescribers need to complete an authority prescription form and endorse the prescription with the valid streamlined code.

Prescribers can also request authority approval for most PBS items through the Online PBS Authorities System. This includes increased quantities and repeats – when permitted.10

The online system can be used to:

  • request a new PBS authority approval to prescribe an authority item
  • cancel or change a request submitted for PBS authority approval (if not already dispensed) within 1 year of being prescribed
  • enquire about approved, cancelled or rejected PBS authority approvals within 2 years of being prescribed.

Authority approvals can be requested online at any time through upgraded clinical or prescribing software (when available) or through Health Professional Online Services (HPOS).10

Information for pharmacists

Because PBS-subsidised PPIs are frequently prescribed medicines, pharmacists are reminded to select the PBS item code corresponding to the streamlined authority code selected by the prescriber.

Patients are required to meet specific PBS restriction criteria to receive an item, and a streamlined code will reflect the indication for which a PPI is prescribed. PBS prescriptions must be endorsed with the correct streamlined authority code to ensure patients receive subsidy for the medicine.

A factsheet on streamlined authorities is available on the PBS website.

If a warning or rejection code is displayed when a claim is being processed, pharmacists are required to resolve any issues prior to supplying pharmaceutical benefits, including PPI items.

The DHS website has information for pharmacists on PBS reason and rejection codes.

 

What else should health professionals know?

Gastro-oesophageal reflux (not GORD) is characterised by mild and intermittent reflux symptoms (no more than one episode per week). Diet and lifestyle modifications may be sufficient in people with these symptoms.9

In contrast, GORD is characterised by frequent reflux (at least two episodes per week), or episodes of reflux that are severe enough to significantly impair quality of life.9

People with GORD will also need initial treatment with a PPI. When starting treatment, a PPI is recommended at the standard dose (see Table 1).9

The appropriate use of PPIs depends on only starting a standard dose PPI for 4–8 weeks in patients who have been diagnosed with GORD, and regularly reviewing patients with the aim of reducing or stopping PPI treatment if symptoms are well controlled.9

There are different options for stepping down PPI treatment, and the approach should be individualised in consultation with the patient.9

These options can be viewed in the Reviewing PPIs for GORD algorithm (above).

Endoscopy is not routinely recommended for patients with typical reflux symptoms, and should only be considered when red flags are present (such as difficult or painful swallowing, weight loss or persistent vomiting).9

High dose PPIs (esomeprazole 40 mg) should be limited to patients with GORD who have inadequate symptom control despite use of a standard dose PPI for 4–8 weeks.9

Before prescribing a high dose PPI for these patients, check adherence and then consider referring for endoscopy if required to exclude other conditions.9

Read more in the Medicinewise News: Stepping the appropriate path with GORD medicines.

The NPS MedicineWise topic Managing GORD with PPIs in primary care has further information on the use of PPIs for GORD, including a practice review, summary of key references and CPD options.

 

What should patients know?

Patients should be advised that acid reflux and heartburn are common conditions. Symptoms are often caused by high-fat meals, alcohol, coffee, chocolate, citrus fruit, tomato products, spicy foods and carbonated drinks.9

Foods that trigger symptoms should be avoided, but patients should avoid unnecessary food restrictions.9

If symptoms are particularly regular or severe, patients need to speak with a health professional, as they may have GORD.9

For GORD, a PPI should be taken 30–60 minutes before a meal. It can be taken in the morning or evening, depending on when symptoms mainly occur.9

Making lifestyle changes may help reduce reflux symptoms, even while patients are taking their GORD medicines.9

Changes include losing weight (if appropriate), stopping smoking, avoiding lying down after eating, eating smaller meals, and avoiding food before vigorous exercise and 2–3 hours before bedtime.9

However, not all changes will work for all people.9

Patients can read Managing reflux and heartburn on the NPS MedicineWise website to find out more.

NPS MedicineWise has also developed a patient action plan (found under Resources and below) to help health professionals and patients discuss starting, stepping down, or stopping a PPI for GORD.11

PPI therapy for managing GORD

Date published : 26 June 2018

 

References

  1. Pharmaceutical Benefits Scheme. PBS Schedule: Esomeprazole. Canberra: Australian Government Department of Health, 2019 (accessed 26 April 2019 and 1 May 2019).
  2. Pharmaceutical Benefits Scheme. PBS Schedule: Lansoprazole. Canberra: Australian Government Department of Health, 2019 (accessed 26 April 2019 and 1 May 2019).
  3. Pharmaceutical Benefits Scheme. PBS Schedule: Omeprazole. Canberra: Australian Government Department of Health, 2019 (accessed 26 April 2019 and 1 May 2019).
  4. Pharmaceutical Benefits Scheme. PBS Schedule: Pantoprazole. Canberra: Australian Government Department of Health, 2019 (accessed 26 April 2019 and 1 May 2019).
  5. Pharmaceutical Benefits Scheme. PBS Schedule: Rabeprazole. Canberra: Australian Government Department of Health, 2019 (accessed 26 April 2019 and 1 May 2019).
  6. Pharmaceutical Benefits Scheme. PBAC Outcomes: Recommendations made by the PBAC (July 2018). Canberra: Australian Government Department of Health, 2019 (accessed 14 February 2019).
  7. Pharmaceutical Benefits Scheme. PBAC Agendas: PBAC Meeting Agenda (July 2018). Canberra: Australian Government Department of Health, 2019 (accessed 14 February 2019).
  8. Pharmaceutical Benefits Scheme. PBAC Outcomes: Recommendations made by the PBAC (March 2018). Canberra: Australian Government Department of Health, 2019 (accessed 29 March 2019).
  9. Gastrointestinal Expert Group. Therapeutic Guidelines: Gastrointestinal. Version 6. West Melbourne: Therapeutic Guidelines Ltd, 2019 (accessed 1 April 2019).
  10. Department of Human Services. PBS for prescribers: PBS Authorities. Canberra: Australian Government Department of Human Services, 2019 (accessed 2 April 2019).
  11. NPS MedicineWise. Patient action plan: PPI therapy for managing GORD. Sydney: NPS MedicineWise, 2019 (accessed 14 February 2019).