TrastuzumabHerceptin SC
Treatment of metastatic (Stage IV) HER2 positive breast cancer, metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction, early HER2 positive breast cancer, and locally advanced HER2 positive breast cancer. This submission concerns a new 440 mg vial size.
Decisions on record
- Meeting Nov 2021 Recommended Breast cancer (HER2 positive, metastatic and early); Adenocarcinoma of the stomach/gastroesophageal junction
- Meeting Nov 2019 Recommended Human epidermal growth factor receptor-2 (HER2) positive breast cancer HER positive gastric cancer
- Meeting Jul 2019 Recommended Breast cancer Gastric cancer
- Meeting Jul 2019 Recommended Breast cancer Gastric cancer
- Meeting Mar 2019 Recommended Breast cancer Gastric cancer
- Meeting Mar 2019 Recommended Breast cancer Gastric cancer
- Meeting Jul 2015 Recommended Breast cancer
- Meeting Jul 2015 Recommended Gastric cancer
8 earlier decisions
- Nov 2014 Recommended 150 mg injection, 1 × 150 mg vial, 60 mg injection, 1 × 60 mg vial; Herceptin®, Roche Products Pty Ltd. Change to listing (Major submission) HER2+ metastatic breast cancer Section 100 listing for trastuzumab for treatment of a patient with HER2+ metastatic breast cancer (MBC) who has not received pr
- Nov 2012 Deferred Stomach and gastrointestinal cancer
- Jul 2012 Recommended Breast cancer
- Jul 2011 Not recommended Anti-cancer drug
- Jul 2010 Recommended Anti-cancer no PSD
- Jul 2007 Recommended Breast cancer no PSD
- Nov 2006 Recommended Early breast cancer no PSD
- Nov 2006 Deferred Treatment of breast cancer no PSD
Access path
- TGA registered · Herceptin SC
TGA label equal than the PBS population
- Jul 2006Recommended · restricted
vs placebo
- Jul 2006Recommended · restricted
- Nov 2008Recommended
Comparator changed: placebo → taxanes (paclitaxel or docetaxel), aromatase inhibitors…
- Jul 2011Not recommended
unacceptably high and uncertain incremental cost-effectiveness ratios, post hoc rather than pre-specified HER2 subgroup…
- ↻ resubmittedJul 2012Recommended · restricted
Comparator changed: cisplatin plus fluoropyrimidine (CF) → Neoadjuvant chemotherapy…
- Nov 2012Deferred
Comparator changed: Neoadjuvant chemotherapy (without trastuzumab) followed by surgical…
- Jul 2015Recommended · restricted
Comparator changed: cisplatin and either 5-FU or capecitabine (CF) → No HER2 testing…
- Jul 2015Recommended · restricted
Comparator changed: cisplatin and either 5-FU or capecitabine (CF) → No HER2 testing…
- Mar 2019Recommended
Comparator changed: trastuzumab intravenous → trastuzumab (Herceptin)
- Mar 2019Recommended
Comparator changed: trastuzumab intravenous → trastuzumab (Herceptin)
- Jul 2019Recommended
Comparator changed: Herceptin (reference brand trastuzumab) → trastuzumab (Herceptin)
- Jul 2019Recommended
Comparator changed: Herceptin (reference brand trastuzumab) → trastuzumab (Herceptin)
- Nov 2019Recommended · restricted
Comparator changed: trastuzumab (Herceptin) → Herceptin (reference trastuzumab)
- Nov 2021Recommended · restricted
Comparator changed: Herceptin (reference trastuzumab) → trastuzumab 60 mg, 150 mg and 420…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of of a new vial size of 440 mg trastuzumab (Herzuma 440 mg) as S100 EFC Authority Required (STREAMLINED) under the same conditions as the currently trastuzumab 60 mg, 150 mg and 420 mg listings.PSD · Nov 2021
7.2 The PBAC accepted that 1 mg of trastuzumab in Herzuma 440 mg is equivalent to 1 mg of trastuzumab in any other trastuzumab presentation. 4PSD · Nov 2021
4.21 The minor submission proposed listing on the basis of cost-minimisation of Trazimera compared with Herceptin. The equi-effective doses were estimated to be identical based on product information documents for both Trazimera and Herceptin.PSD · Nov 2019
4.22 The submission proposed pricings identical to Herceptin and other currently listed biosimilar trastuzumab medicines.PSD · Nov 2019
5.6 The submission claimed that Herzuma 440 mg was biosimilar to Herceptin. The PBAC considered that Herzuma 440 mg was biosimilar to Herceptin based on the TGA approved Product Information.PSD · Nov 2021
5.7 The submission claimed that on a mg for mg basis Herzuma 440 mg is non-inferior to trastuzumab 60 mg, 150 mg and 420 mg in terms of both clinical efficacy and safety.PSD · Nov 2021
6.2 The PBAC noted and welcomed the input from one organisation via the Consumer Comments facility on the PBS website. The comment described a range of benefits of treatment with trastuzumab SC including greater convenience for patients and clinics in terms of time spent at treatment sites and the ability for patients to be treated in their own homes, reducing the need for travel and time away from family and work.PSD · Jul 2015
6.3 It was also noted that trastuzumab SC may result in increased out of pocket expenses for patients in the private health system, as the appointment with the oncology nurse to administer it will not be covered by private health insurance. The comment states that full financial disclosure should be provided to patients before commencing treatment. 5PSD · Jul 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as this is a new vial size of an existing listed drug assessed on a cost-neutral basis.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because Herzuma 440 mg is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity over currently trastuzumab listings, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 for Pricing Pathway A were not met. PBAC · 2021
Decision context
PopulationPatients with HER2 positive breast cancer (metastatic, early, or locally advanced) and HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction, already eligible for trastuzumab under existing PBS codes.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended · restricted | trastuzumab 60 mg, 150 mg and 420 mg (other vial sizes) | — | Cost-minimisation · Cost-minimisation |
| Nov 2019 | Recommended · restricted | Herceptin (reference trastuzumab) | — | RCT · ORR |
| Jul 2019 | Recommended | trastuzumab (Herceptin) | — | RCT · ORR |
| Jul 2019 | Recommended | trastuzumab (Herceptin) | — | RCT · pCR |
| Mar 2019 | Recommended | trastuzumab (Herceptin) | — | RCT · ORR |
| Mar 2019 | Recommended | Herceptin (reference brand trastuzumab) | — | RCT · ORR |
| Jul 2015 | Recommended · restricted | No HER2 testing followed by cisplatin + 5-fluorouracil (CF) or cisplatin + capecitabine (CX) | $45k–75k | RCT · OS |
| Jul 2015 | Recommended · restricted | trastuzumab intravenous | — | RCT · Pharmacokinetic (serum trough concentration) and pathological complete response |
| Nov 2012 | Deferred | cisplatin and either 5-FU or capecitabine (CF) | $45k–75k | RCT · OS |
| Jul 2012 | Recommended · restricted | Neoadjuvant chemotherapy (without trastuzumab) followed by surgical resection and adjuvant trastuzumab (PBS subsidised) | — | RCT · OS, PFS |
| Jul 2011 | Not recommended | cisplatin plus fluoropyrimidine (CF) | $45k–105k | RCT · OS |
| Nov 2008 | Recommended | taxanes (paclitaxel or docetaxel), aromatase inhibitors, vinorelbine, or placebo | — | RCT · OS | PFS |
| Jul 2006 | Recommended · restricted | placebo | $45k–75k | RCT · DFS, OS |
| Jul 2006 | Recommended · restricted | placebo | $45k–75k | RCT · DFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CT-P6 3.2 (NCT02162667) | Ph 3 | 562 | The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence… | completed |
| Study 283 (LILAC) | Ph 3 | 725 | Percentage of Participants With a Pathologic Complete Response | completed |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| HER2 gene amplification testing (IHC and ISH) for gastric cancer | HER2 gene amplification | supported with conditions | 2012 |
| HER2 ISH testing for neoadjuvant breast cancer | HER2 gene mutation status | supported | 2012 |
Consumer voice
One organisation provided input highlighting the convenience benefits of subcutaneous trastuzumab for patients and clinics, with particular advantages for rural and remote areas, while also raising concerns about potential out-of-pocket expenses in the private health system.
greater convenience for patients and clinics in terms of time spent at treatment sites and the ability for patients to be treated in their own homes, reducing the need for travel and time away from family and work Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation cover identical HER2-positive breast cancer stages and gastric adenocarcinoma indications; 440 mg vial is a strength variant only.