PertuzumabPerjeta
Recommended OncologyAuthority RequiredFirst-line line 💬 consumer voice
Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early stage (>2 cm in diameter or node positive) early breast cancer, in combination with trastuzumab and chemotherapy.
5
Submissions
3 resub
2014–25
On the record
$45k–105k
ICER range
2 sourced ICERs · 2014–2018
Redacted
Cost basis
Decisions on record
- Meeting Mar 2025 Recommended HER2+ locally advanced, inflammatory or early stage breast cancer, neoadjuvant treatment
- Meeting Mar 2020 Not recommended Breast cancer
- Meeting Mar 2019 Not recommended PERTUZUMAB is indicated for: Early Breast Cancer: Perjeta is indicated in combination with trastuzumab and chemotherapy for: the neoadjuvant treatment of patients with human epidermal growth factor receptor-2 positive (HER2+) inflammatory; or locally advanced, or early stage (either > 2 cm in diam
- Meeting Mar 2019 Not recommended Indication not stated
- Meeting Jul 2018 Not recommended Human epidermal growth factor receptor-2 positive (HER2+) early breast cancer (EBC)
- Meeting Nov 2014 Recommended 420 mg/14 mL injection, 1 x 14 mL vial; Perjeta® Roche Products Pty Ltd. New listing (Major submission) HER2+metastatic breast cancer Section 100 listing for pertuzumab in combination with trastuzumab and docetaxel for treatment of a patient with HER2+ metastatic breast cancer who have not received
- Meeting Mar 2014 Deferred Perjeta® Roche Products Pty Limited Breast Cancer To request Section 100 (Efficient Funding of Chemotherapy) Authority Required listing of pertuzumab for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2 positive metastatic breast cancer who have not received
Access path
- TGA registered · Perjeta
TGA label equal than the PBS population
- Mar 2014Deferred
vs trastuzumab administered in combination with a taxane
- Jul 2018Not recommended
ICER rose $75,000 → $105,000 (+40%)
- Mar 2019Not recommended
Listing: Restricted → Authority Required
- Mar 2020Not recommended
Comparator changed: trastuzumab in combination with chemotherapy → trastuzumab in…
- ↻ resubmittedMar 2025Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of pertuzumab for the neoadjuvant treatment of human epidermal growth factor receptor 2 positive (HER2+) high risk early breast cancer, on the basis that it should be available only under special arrangements under Section 100.PSD · Mar 2025
The PBAC considered that adjuvant treatment with pertuzumab would also be appropriate for a proportion of patients, consistent with international guidelines and the Australian Product Information (PI) for pertuzumab.PSD · Mar 2025
Economic analysis
6.51 The resubmission presented a modelled economic evaluation comparing P+T+Chemo versus T+Chemo in the neoadjuvant setting for patients with HER2-positive high-risk eBC. The type of economic evaluation presented was a cost-effectiveness and cost- utility analysis.PSD · Mar 2025
6.52 Table 13 summarises the key components of the economic evaluation.PSD · Mar 2025
Clinical claim
6.47 The resubmission described P+T+Chemo as superior in terms of efficacy compared to T+Chemo for patients with high risk eBC, when added to trastuzumab and chemotherapy in the neoadjuvant setting. The efficacy claim was unchanged from the March 2020 submission. The evaluation considered this claim was adequately supported but the magnitude of the effect was uncertain.PSD · Mar 2025
6.48 The resubmission described P+T+Chemo as inferior, yet manageable, comparative safety to T+Chemo. The March 2020 submission made a claim of non-inferior safety.PSD · Mar 2025
Consumer comments
6.2 The PBAC noted and welcomed the input from health care professionals (3) and organisations (5) via the Consumer Comments facility on the PBS website. The comments from health care professionals described equity of access issues, noting that many patients are currently self-funding pertuzumab.PSD · Mar 2025
6.3 The PBAC noted the advice received from Breast Surgeons ANZ who also noted that pCR is a valuable surrogate for survival endpoints and commented on the reduction in the extent of surgery and impacts on cosmetic outcomes and quality of life, citing several publications demonstrating the increase in breast conserving surgery associated with neoadjuvant pertuzumab.PSD · Mar 2025
Cost-effectiveness
ICER value is redacted/not published in the public text
ICER uncertain ×2Economic model disputed ×2Price cut / RSA needed
Decision context
PopulationAdults with HER2-positive, locally advanced, inflammatory or early stage (>2 cm in diameter or lymph node positive) early breast cancer receiving neoadjuvant treatment in combination with trastuzumab and chemotherapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended · restricted | trastuzumab in combination with chemotherapy (T+Chemo) | — | RCT · pCR |
| Mar 2020 | Not recommended | trastuzumab in combination with chemotherapy (T+Chemo) | — | RCT · ORR |
| Mar 2019 | Not recommended | trastuzumab in combination with chemotherapy | — | RCT · iDFS |
| Jul 2018 | Not recommended | trastuzumab in combination with chemotherapy | $45k–105k | RCT · iDFS |
| Mar 2014 | Deferred | trastuzumab administered in combination with a taxane | $45k–75k | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CLEOPATRA | Ph 3 | 808 | Progression-Free Survival (PFS) Determined by an Independent Review Facility | completed |
| APHINITY | Ph 3 | 4,804 | Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Sec… | completed |
| PEONY | Ph 3 | 329 | Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by t… | completed |
Consumer voice
Healthcare professionals and consumer organisations provided strong support for PBS listing of pertuzumab, highlighting improved pathological complete response rates, survival benefits, reduced surgical extent, improved quality of life through breast-conserving surgery, and equity of access issues for patients currently self-funding the treatment.
The comments from health care professionals described equity of access issues, noting that many patients are currently self-funding pertuzumab. Consumer comments · PSD
unmet needaccess barriersequity of accessquality of lifesurvival benefittreatment burden
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts describe identical neoadjuvant HER2-positive early breast cancer populations with same size/node criteria and treatment regimen.