Table 2

Access restrictions to HER2-targeted therapies in Australia

(a) Subsidy restrictions: trastuzumab for HER2+ metastatic breast cancer
2001–2005	2006–2015	2015—present*
Treatment qualification: patients must have HER2 overexpression by
▸ IHC 3+ or ISH	ISH	No change
Trastuzumab treatment
In combination with taxanes in patients not previously receiving chemotherapy for MBC As monotherapy in patients previously receiving chemotherapy for MBC Weekly dosing regimen	As per 2001–2005 plus weekly or 3-weekly dosing regimen	As per 2001–2015 plus in combination with any chemotherapy except nab-paclitaxel
Cardiac monitoring
▸ None required	None required	ECHO or MUGA at baseline then at 3-monthly intervals
(b) Subsidy restrictions: trastuzumab for HER2+ early breast cancer
2006–2015		2015—present
Treatment qualification: patients must have…
HER2 overexpression demonstrated by ISH Undergone surgery for breast cancer		No change
Trastuzumab treatment
Started in combination with chemotherapy Patients are eligible for 52 weeks of treatment		No change
Cardiac monitoring
ECHO or MUGA at baseline then at 3-monthly intervals Left ventricular ejection fraction (LVEF) > 45% No symptomatic heart failure		No change
(c) Subsidy restrictions: lapatinib for HER2+ metastatic breast cancer
2008–2010	2010–2015	2015—present
Treatment qualification: patients must have…
HER2 overexpression demonstrated by ISH Prior taxane for ≥3 cycles; or intolerance to taxane Disease progression while receiving trastuzumab for MBC	No change	No change
Lapatinib treatment
As sole PBS-subsidised anti-HER2 treatment In combination with capecitabine Patients CANNOT receive trastuzumab subsequent to receiving lapatinib	As sole PBS-subsidised anti-HER2 treatment In combination with capecitabine Patients CAN receive trastuzumab subsequent to receiving lapatinib	No change
Cardiac monitoring
▸ ECHO or MUGA at baseline then at discretion of clinician	No change	ECHO or MUGA at baseline then at 3-monthly intervals
(d) Subsidy restrictions: trastuzumab for HER2+ neoadjuvant therapy
2012—present
Treatment qualification: patients must have…
HER2 overexpression demonstrated by ISH Not undergone surgery for breast cancer
Trastuzumab treatment
In combination with chemotherapy Patients are eligible for 52 weeks of treatment
Cardiac monitoring ECHO or MUGA at baseline then at 3-monthly intervals LVEF >45% No symptomatic heart failure
(e) Subsidy restrictions: pertuzumab for HER2+ metastatic breast cancer
2015—present
Treatment qualification: patients must have…
HER2 overexpression demonstrated by ISH WHO performance status of 0 or 1 No prior HER2 therapy for MBC
Pertuzumab treatment
In combination with trastuzumab and a taxane (not nab-paclitaxel)
Cardiac monitoring
ECHO or MUGA at baseline then at 3-monthly intervals
(f) Subsidy restrictions: Trastuzumab emtansine (T-DM1) for HER2+ metastatic breast cancer
2015–2016		2016—present
Treatment qualification: patients must have
HER2 over expression demonstrated by ISH WHO performance status of 0 or 1 Progressed while receiving pertuzumab and trastuzumab for MBC or while receiving or within 6 months of completing adjuvant trastuzumab Not received prior treatment with lapatinib or developed an intolerance to lapatinib		As per 2015–2016 but patients may have received prior treatment with lapatinib or developed an intolerance to lapatinib
T-DM1 treatment
Treatment as monotherapy		No change
Cardiac monitoring
ECHO or MUGA at baseline then at 3-monthly intervals		No change

*Herceptin Programme ceased and trastuzumab for MBC was listed on the PBS.
ECHO, echocardiography; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ISH, in situ hybridisation; MBC, metastatic breast cancer; MUGA, multiple gated acquisition scan; PBS, Pharmaceutical Benefits Scheme.