Pertuzumab (Perjeta) – Changes to listing

Initial application — (metastatic breast cancer)

only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 12 months for application meeting the following criteria:

All of the following:

1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
2. Either:
   1. Patient is chemotherapy naïve; or
   2. Patient has not received prior treatment for their metastatic disease and has had a treatment-free interval of at least 12 months between prior (neo)adjuvant chemotherapy treatment and diagnosis of metastatic breast cancer; and
3. The patient has good performance status (ECOG grade 0-1); and
4. Pertuzumab to be administered in combination with trastuzumab; and
5. Pertuzumab maximum first dose of 840 mg, followed by maximum of 420 mg every 3 weeks; and
6. Pertuzumab to be discontinued at disease progression. 

Renewal — (metastatic breast cancer)

only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both Either:

1. Both:
   1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
   2. The cancer has not progressed at any time point during the previous 12 months whilst on pertuzumab and trastuzumab; and
2. All of the following:
   1. Patient has previously discontinued treatment with pertuzumab and trastuzumab for reasons other than severe toxicity or disease progression; and
   2. Patient has signs of disease progression; and
   3. Disease has not progressed during previous treatment with pertuzumab and trastuzumab.