Metastatic breast cancer

The Pharmaceutical Benefits Scheme subsidises pertuzumab, lapatinib ditosylate, trastuzumab emtansine and trastuzumab for patients with metastatic breast cancer.

Patients must have human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (Stage IV).

For patients with HER2-positive metastatic breast cancer, treatment is subsidised through the Pharmaceutical Benefits Scheme (PBS) as follows:

Under section 85 of the National Health Act 1953 for:

  • lapatinib (Tykerb®)
  • trastuzumab subcutaneous (Herceptin®)

Under section 100 (efficient funding of chemotherapy) of the National Health Act 1953 for:

  • pertuzumab (Perjeta®)
  • trastuzumab intravenous (Herceptin®)
  • trastuzumab emtansine (Kadcyla®)

Under section 100 (efficient funding of chemotherapy – related benefits) of the National Health Act 1953 for:

  • trastuzumab subcutaneous (Herceptin ®)

Schedule restriction details

Restrictions apply for use of the following PBS subsidised medicines in the treatment of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer:

  • pertuzumab (Perjeta®)
  • lapatinib ditosylate (Tykerb®)
  • trastuzumab (Herceptin®)
  • trastuzumab emtansine (Kadcyla®)

Read more about the restrictions for each medicine by searching the A-Z medicine listing on the PBS website.

Treatment

If you want to start initial treatment with pertuzumab (Perjeta®) your patients must:

  • have demonstrated HER2 positivity by in situ hybridisation
  • have a World Health Organization (WHO) performance status of 0 or 1
  • not have received prior anti-HER2 therapy or chemotherapy for this condition
  • receive treatment in combination with trastuzumab (Herceptin®) and a taxane, and
  • have their cardiac function tested by a suitable method, such as echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan

Pertuzumab (Perjeta®) is not PBS subsidised when used in combination with nab-paclitaxel.

If you want to start initial treatment with lapatinib (Tykerb®) your patients must:

  • have demonstrated HER2 positivity by in situ hybridisation
  • receive lapatinib (Tykerb®) treatment in combination with capecitabine
  • have received prior therapy with a taxane for at least 3 cycles - or developed an intolerance to treatment
  • have disease progression despite treatment with pertuzumab (Perjeta®) and trastuzumab (Herceptin®) in combination for metastatic disease
  • receive treatment with lapatinib (Tykerb®) as the sole PBS subsidised anti-HER2 therapy for this condition, and
  • have their cardiac function tested by a suitable method, such as ECHO or MUGA

If you want to start initial treatment with trastuzumab emtansine (Kadcyla®) your patients must:

  • have demonstrated HER2 positivity by in situ hybridisation
  • have disease progression despite treatment with pertuzumab (Perjeta®) in combination with trastuzumab (Herceptin®) or have disease progression during or within 6 months of completing adjuvant therapy with trastuzumab (Herceptin®)
  • have a WHO performance status of 0 or 1
  • receive treatment as monotherapy, and
  • have their cardiac function tested by a suitable method, such as ECHO or MUGA

If you want to start initial treatment with trastuzumab (Herceptin®) your patients must have:

  • demonstrated HER2 positivity by in situ hybridisation, and
  • cardiac function tested by a suitable method, such as ECHO or MUGA

Trastuzumab (Herceptin®) is not PBS subsidised when used in combination with nab-paclitaxel.

Continuing treatment

Your patients are eligible for continuing treatment until there is evidence of disease progression.

Applications for continuing treatment may be made by phone or in writing.

Test requirements

A copy of the pathology report confirming the presence of HER2 gene amplification by in situ hybridisation must be provided from an approved pathology authority.

Cardiac function must be tested by a suitable method, such as ECHO or MUGA, before seeking the initial authority approval, and then at 3 monthly intervals during treatment.

Schedule item details

Dose - Pertuzumab (Perjeta®) prescriptions should be written for a maximum quantity up to 840 mg with no repeats, or 1 repeat for grandfathered patients.

Dose - Lapatinib (Tykerb®) is available as 250 mg tablets taken as a daily dose of 1250 mg.

Prescriptions should be written for a quantity of 140 tablets with 2 repeats.

Dose - The recommended dose of trastuzumab emtansine (Kadcyla®) is 3.6 mg/kg, administered as an intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity.

Prescriptions should be written for a maximum quantity up to 450 mg with 8 repeats.

Dose - Trastuzumab (Herceptin®) is available as an IV infusion or subcutaneous (SC) injection.  The prescription must clearly specify whether the IV or SC route of administration is requested.

For patients receiving intravenous trastuzumab

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

Initial application

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

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

Prescriptions should be written for a maximum quantity up to 1000 mg with no repeats, or 3 repeats for grandfathered patients.

Continuing treatment

The continuing treatment dosage depends on the patient's weight. It is calculated as follows:

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

Up to 3 repeats may be requested.

For patients receiving subcutaneous trastuzumab

Initial application

The dose for patients is 1 SC injection every 3 weeks. The prescription must be written for one 600 mg injection - as dose is irrespective of weight - and no repeats may be requested.

Continuing application

The continuing dose is 1 SC injection every 3 weeks. The prescription must be written for one 600 mg injection, as dose is irrespective of weight, and up to 3 repeats may be requested.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the PBS.

Lodging an application

All initial applications must be in writing. Send written applications to the Complex Drugs address on the contact us page.

Complete the Metastatic breast cancer Initial PBS authority application Supporting information form (PB099) for your patient starting initial PBS subsidised treatment with:

  • pertuzumab (Perjeta®)
  • lapatinib ditosylate (Tykerb®)
  • trastuzumab emtansine (Kadcyla®), or
  • trastuzumab (Herceptin®)

The patient and prescriber acknowledgements must be completed.

Further information

For more information contact the Complex Drugs Programs enquiry line.

Page last updated: 4 May 2016

This information was printed Sunday 4 December 2016 from humanservices.gov.au/health-professionals/enablers/metastatic-breast-cancer 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.