Metastatic stage IV HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction

The PBS subsidises trastuzumab for patients with metastatic stage IV HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.

Patients with human epidermal growth factor receptor 2 (HER2) positive metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction can receive subsidised treatment with trastuzumab (Herceptin®). This is subsidised through the PBS under Section 100 (Special Authority) item of the National Health Act 1953.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing trastuzumab (Herceptin®).

Schedule item details

Dose

You must specify on the prescription the dose to be administered in milligrams per infusion. The prescription must be written for 1 dose plus the approved number of repeats, if applicable.

Initial application

The dose depends on the patient's weight. The loading dose is calculated as follows:

  • for dosing once a week: 4 mg per kg
  • for dosing every 3 weeks: 8 mg per kg

The maximum dose which can be approved is 1000 mg.

Continuing treatment

The dose depends on the patient's weight. The dose is calculated as follows:

  • for dosing once a week: 2 mg per kg
  • for dosing every 3 weeks: 6 mg per kg

The maximum dose that can be approved is 750 mg.

Up to 3 repeats can be requested.

Authority approval will be granted for a new loading dose up to a maximum of 1000 mg is a patient has had a break in trastuzumab (Herceptin®) therapy. The break must be more than 1 week and less than 6 weeks from when the last dose was due.

Test requirements

All patients seeking initial PBS subsidised treatment must meet the criteria as:

  • an initial patient, or
  • a patient who has received treatment with trastuzumab (Herceptin®) for this condition before 1 January 2016

You must provide a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 positivity as detailed in the relevant initial, or initial grandfathered, treatment criteria.

Cardiac function must be tested before seeking the initial authority approval and then every 3 months during treatment. This testing must be undertaken by a suitable method, such as:

  • echocardiography (ECHO), or
  • multigated acquisition (MUGA)

You must not give treatment to patients with a left ventricular ejection fraction (LVEF) of less than 45% or with symptomatic heart failure, or both.

Lodging an application

All initial application requests must be made in writing. Send all written applications to the Complex Drugs address via the contact us page.

All written applications for initial PBS authorisation must include:

Applications for continuing treatment for patients who do not have progressive disease may be made in writing by phone or by contacting us on the Complex Drugs enquiry line.

Further information

For more information contact us on the Complex Drugs enquiry line.

Page last updated: 8 November 2016

This information was printed Sunday 4 December 2016 from humanservices.gov.au/health-professionals/enablers/metastatic-stage-iv-her2-positive-adenocarcinoma-stomach-or-gastro It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.