OlaparibLynparza Tablets
Recommended OncologyAuthority RequiredLater-line line 💬 consumer voice
Treatment of HER2-negative metastatic breast cancer in patients with a confirmed germline BRCA1 or BRCA2 mutation who have received prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
15
Submissions
10 resub
2016–24
On the record
$45k–75k
ICER range
2 sourced ICERs · 2016
Redacted
Cost basis
Decisions on record
- Meeting Nov 2024 Recommended Metastatic castration-resistant prostate cancer with BRCA mutations
- Meeting Jul 2024 Recommended HER2-negative metastatic breast cancer with BRCA1 or BRCA2 mutation
- Meeting Nov 2023 Not recommended First-line metastatic castration-resistant prostate cancer (BRCA1/BRCA2 mutation) with abiraterone
- Meeting Nov 2023 Recommended HER2- high-risk early breast cancer with gBRCA1/gBRCA2 mutation (post-chemotherapy)
- Meeting Jul 2023 Recommended Ovarian cancer no PSD
- Meeting Mar 2023 Not recommended Breast cancer; HER2-negative high-risk early breast cancer with germline BRCA1 or BRCA2 mutation
- Meeting Nov 2022 Deferred Newly diagnosed HRD positive BRCA wild type advanced epithelial ovarian, fallopian tube or primary peritoneal cancer
- Meeting Jul 2022 Not recommended Newly diagnosed HRD positive BRCA wild type advanced epithelial ovarian, fallopian tube or primary peritoneal cancer maintenance therapy with bevacizumab
9 earlier decisions
- Nov 2021 Recommended Prostate cancer (metastatic castration resistant)
- Mar 2021 Not recommended Metastatic castration resistant prostate cancer with BRCA1/2 variants
- Jul 2020 Recommended Ovarian, fallopian tube or primary peritoneal cancer
- Mar 2020 Recommended High grade serous ovarian cancer High grade serous fallopian tube cancer High grade serous primary peritoneal cancer
- Nov 2019 Not recommended Ovarian, fallopian tube or primary peritoneal cancer
- Mar 2018 Recommended High-grade serous ovarian, fallopian tube and primary peritoneal cancer
- Nov 2016 Recommended BRCA-mutated (BRCAm) platinum- sensitive relapsed (PSR) ovarian, fallopian tube or primary peritoneal cancer with high- grade serous features or a high-
- Jul 2016 Not recommended Ovarian, fallopian tube or primary peritoneal cancer
- Mar 2016 Deferred Ovarian, fallopian tube or primary peritoneal cancer
Access path
- TGA registered · Lynparza Tablets
TGA label narrower than the PBS population
- Mar 2016Deferred
vs standard follow-up care (placebo)
- Jul 2016Not recommended
- ↻ resubmittedNov 2016Recommended · restricted
Listing: Restricted → Authority Required
- Mar 2018Recommended · restricted
Comparator changed: standard follow-up care (placebo) → olaparib 50 mg capsules
- Nov 2019Not recommended
Comparator changed: olaparib 50 mg capsules → watch and wait (placebo) followed by…
- ↻ resubmittedMar 2020Recommended
Comparator changed: watch and wait (placebo) followed by second-line platinum-based…
- Jul 2020Recommended
Comparator changed: standard follow-up care → placebo (watch and wait following…
- Mar 2021Not recommended
Comparator changed: placebo (watch and wait following platinum-based chemotherapy) → best…
- ↻ resubmittedNov 2021Recommended
Comparator changed: best supportive care (mixed comparator: BSC 75%, docetaxel 15%…
- Jul 2022Not recommended
Comparator changed: best supportive care (75%) and cabazitaxel (25%) → placebo plus…
- Mar 2023Not recommended
Comparator changed: placebo plus bevacizumab (with bevacizumab monotherapy as primary…
- ↻ resubmittedJul 2023Recommended
Comparator changed: placebo (watch and wait) → bevacizumab monotherapy
- Nov 2023Recommended
Comparator changed: bevacizumab monotherapy → placebo (watch and wait)
- Nov 2023Not recommended
Comparator changed: bevacizumab monotherapy → placebo (watch and wait)
- ↻ resubmittedJul 2024Recommended · restricted
Comparator changed: novel hormonal agent (NHA) monotherapy with either abiraterone or…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of olaparib for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer and a confirmed BRCA1 or BRCA2 pathogenic variant. The PBAC is satisfied that olaparib provides, for some patients, a significant improvement in efficacy compared with chemotherapy in terms of progression free survival.PSD · Jul 2024
7.2 The PBAC recalled that olaparib was recommended for patients with HER2-negative BRCAm breast cancer in the high risk eBC setting in November 2023 and the Committee had previously noted that patients with de novo metastatic disease would not be able to access olaparib under the proposed listing, but that cost-effectiveness 44PSD · Jul 2024
Economic analysis
6.47 The submission presented a cost-utility analysis comparing olaparib with chemotherapy in patients with HER2-negative, BRCAm mBC who had not previously received chemotherapy in the metastatic setting based on the corresponding subgroup in the OlympiAD trial (hence referred to has the subgroup model). The submission also presented an additional cost-utility analysis reflective of the whole trial population (hence referred to as the ITT model).PSD · Jul 2024
6.48 Table 11 presents a summary of the overview, key inputs and rationale of the submission’s economic evaluation.PSD · Jul 2024
Clinical claim
• In the whole trial population, which included patients with HER2-negative mBC with a confirmed BRCA1 or BRCA2 mutation who had previously received up to two lines of chemotherapy for mBC, olaparib was superior in terms of effectiveness compared with chemotherapy based on PFS and non-inferior in terms of safety compared with chemotherapy.PSD · Jul 2024
• In the subgroup of patients with HER2-negative mBC with a confirmed BRCA1 or BRCA2 mutation who had not previously received chemotherapy for mBC, olaparib was superior in terms of OS and PFS compared with chemotherapy.PSD · Jul 2024
Consumer comments
6.2 The PBAC noted and welcomed the input from health care professionals (1) and organisations (4) via the Consumer Comments facility on the PBS website. The comments described the benefits of treatment with olaparib as superior to chemotherapy in terms of efficacy and tolerability and noted the benefit of an oral treatment in allowing patients to travel, without need to return to hospital for chemotherapy infusion.PSD · Jul 2024
6.3 The PBAC noted the advice received from So Brave in support of the submission, highlighting the need for advancements in treatments and access for patients to targeted treatments that can provide hope of prolonged survival and quality of life.PSD · Jul 2024
Cost-effectiveness
ICER values are redacted in the public document; economic analysis performed but commercially sensitive.
The PBAC considered that the incremental cost-effectiveness ratio (ICER) was highly uncertain and unacceptably high. PBAC · 2023
ICER uncertain ×5ICER / price too high ×3Economic model disputed ×3Price cut / RSA needed ×4Indirect comparison
Decision context
PopulationAdult patients with HER2-negative metastatic breast cancer with a confirmed germline BRCA1 or BRCA2 mutation (class 4 or 5 variant) who have received prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, with WHO performance status 0-2.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended · restricted | chemotherapy | — | RCT · PFS |
| Nov 2023 | Recommended | placebo (watch and wait) | — | RCT · IDFS |
| Nov 2023 | Not recommended | novel hormonal agent (NHA) monotherapy with either abiraterone or enzalutamide | — | RCT · PFS |
| Jul 2023 | Recommended | bevacizumab monotherapy | — | RCT · PFS |
| Mar 2023 | Not recommended | placebo (watch and wait) | — | RCT · Invasive disease-free survival |
| Jul 2022 | Not recommended | placebo plus bevacizumab (with bevacizumab monotherapy as primary comparator) | — | RCT · PFS |
| Nov 2021 | Recommended | best supportive care (75%) and cabazitaxel (25%) | — | RCT · OS |
| Mar 2021 | Not recommended | best supportive care (mixed comparator: BSC 75%, docetaxel 15%, cabazitaxel 10%) | — | RCT · OS |
| Jul 2020 | Recommended | placebo (watch and wait following platinum-based chemotherapy) | — | RCT · PFS |
| Mar 2020 | Recommended | standard follow-up care | — | RCT · PFS |
| Nov 2019 | Not recommended | watch and wait (placebo) followed by second-line platinum-based chemotherapy at relapse | — | RCT · PFS |
| Mar 2018 | Recommended · restricted | olaparib 50 mg capsules | — | RCT · PFS |
| Nov 2016 | Recommended · restricted | standard follow-up care (placebo) | $45k–75k | RCT · PFS |
| Jul 2016 | Not recommended | standard follow-up care (placebo) | $45k–75k | RCT · PFS |
| Mar 2016 | Deferred | standard follow-up care (placebo) | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| OlympiA | Ph 3 | 1,837 | Invasive Disease Free Survival (IDFS) | active not recruiting |
| OlympiAD | Ph 3 | 302 | Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According … | completed |
| PAOLA-1 | Ph 3 | 806 | Efficacy by progression free survival (PFS1) | completed |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| BRCA mutation testing for olaparib eligibility in platinum-sensitive relapsed ovarian cancer | germline BRCA mutation | supported | 2016 |
| Somatic BRCA1/BRCA2 mutation testing in advanced ovarian, fallopian tube or primary peritoneal cancer | somatic BRCA1 or BRCA2 mutation | supported with conditions | 2020 |
| Testing of tumour prostate tissue to detect BRCA1/2 pathogenic gene variants in people with metastatic castration-resistant prostate cancer | BRCA1/2 pathogenic gene variants | supported | 2021 |
| HRD testing of ovarian tumour tissue | homologous recombination deficiency (HRD) status and BRCA1/2 status | not supported | 2022 |
| Germline BRCA mutation test (HER2-negative high-risk early breast cancer) | germline BRCA1 or BRCA2 pathogenic or likely pathogenic gene variants | deferred | 2023 |
| BRCA1/2 mutation testing in patients with metastatic castration-resistant prostate cancer (amendment to MBS items 73303 and 73304) | BRCA1/2 pathogenic or likely pathogenic gene variants | supported | 2024 |
Consumer voice
Healthcare professionals and consumer organisations (So Brave, Pink Hope, BCNA, MOGA) supported olaparib access, highlighting superior efficacy and tolerability compared to chemotherapy, the convenience of oral administration, and equity concerns regarding access for patients with metastatic breast cancer and BRCA variants.
the benefits of treatment with olaparib as superior to chemotherapy in terms of efficacy and tolerability and noted the benefit of an oral treatment in allowing patients to travel, without need to return to hospital for chemotherapy infusion Consumer comments · PSD
treatment efficacyquality of lifetreatment burdenunmet needaccess barriersequity concerns
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to confirmed BRCA1/2 mutations (class 4-5) and WHO performance status 0-2; TGA allows suspected deleterious mutations.