AtezolizumabTecentriq
Subcutaneous injection formulation for multiple cancer indications including locally advanced or metastatic NSCLC, stage IV metastatic NSCLC, extensive-stage small cell lung cancer, hepatocellular carcinoma, and resected early-stage NSCLC.
Decisions on record
- Meeting Mar 2024 Recommended Locally advanced or metastatic NSCLC, ES-SCLC, advanced hepatocellular carcinoma, resected eNSCLC
- Meeting Jul 2022 Recommended Stage II to IIIA non-small cell lung cancer with PD-L1 expression ≥50% following complete resection and platinum-based chemotherapy
- Meeting Mar 2021 Not recommended First-line metastatic triple-negative breast cancer, PD-L1 positive
- Meeting Jul 2020 Recommended Hepatocellular carcinoma (HCC)
- Meeting Mar 2020 Recommended Small cell lung cancer (SCLC)
- Meeting Mar 2020 Not recommended Breast cancer
- Meeting Nov 2019 Recommended Non-small cell lung cancer (NSCLC)
- Meeting Nov 2019 Recommended Small cell lung cancer (SCLC)
3 earlier decisions
- Jul 2019 Not recommended Small cell lung cancer (SCLC)
- Mar 2019 Recommended Non-small cell lung cancer (NSCLC)
- Nov 2017 Recommended Non-small cell lung cancer (NSCLC)
Access path
- TGA registered · Tecentriq
TGA label narrower than the PBS population
- Nov 2017Recommended · restricted
vs nivolumab
- Mar 2019Recommended · restricted
Comparator changed: nivolumab → platinum-doublet chemotherapy; supplementary comparator…
- Jul 2019Not recommended
Comparator changed: platinum-doublet chemotherapy; supplementary comparator pembrolizumab…
- ↻ resubmittedNov 2019Recommended · restricted
Comparator changed: Carboplatin and etoposide (CE) → carboplatin and etoposide (with…
- Nov 2019Recommended · restricted
Comparator changed: Carboplatin and etoposide (CE) → carboplatin and etoposide (with…
- Mar 2020Not recommended
Comparator changed: atezolizumab 1200 mg Q3W → nanoparticle albumin-bound paclitaxel…
- ↻ resubmittedMar 2020Recommended
Comparator changed: atezolizumab 1200 mg Q3W → nanoparticle albumin-bound paclitaxel…
- Jul 2020Recommended · restricted
Comparator changed: atezolizumab 1200 mg Q3W → sorafenib
- Mar 2021Recommended · restricted
Comparator changed: sorafenib → nab-paclitaxel
- Jul 2022Recommended · restricted
Comparator changed: nab-paclitaxel → best supportive care
- Mar 2024Recommended · restricted
Comparator changed: best supportive care → atezolizumab IV
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the dual Section 85 General Schedule and Section 100 (Efficient Funding of Chemotherapy – Related Benefits) Authority Required listings of atezolizumab SC for locally advanced or metastatic non-small cell lung cancer (NSCLC), stage IV (metastatic) NSCLC, extensive-stage small cell lung cancer (ES-SCLC), advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma and resected early stage (Stage …PSD · Mar 2024
6.2 The PBAC considered that the claim of non-inferior comparative effectiveness and safety to atezolizumab IV was appropriate. The PBAC noted the TGA CER concluded that atezolizumab SC demonstrated similar pharmacokinetics, efficacy and safety assessments to atezolizumab IV.PSD · Mar 2024
5.8 The submission presented a cost-minimisation approach (CMA) of atezolizumab SC compared with atezolizumab IV for its five proposed PBS-listed indications. The CMA specifically examined the drug acquisition costs, fees and mark-ups, and administration costs over a month period for both the atezolizumab SC and IV administration formulations under the HSD and EFC programs in the public and private hospital settings.PSD · Mar 2024
5.9 The submission proposed the equi-effective doses of atezolizumab SC 1875 mg Q3W to be equal to atezolizumab IV 1200 mg Q3W and estimated that 1.45 administrations will be required per average calendar month (30.4375 days).PSD · Mar 2024
5.6 The submission claimed that atezolizumab SC is non-inferior to atezolizumab IV in terms of effectiveness and safety. The TGA CER stated the evaluator was satisfied that atezolizumab SC demonstrated similar pharmacokinetics, efficacy and safety assessments to atezolizumab IV.PSD · Mar 2024
5.7 The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonable.PSD · Mar 2024
5.2 The PBAC noted and welcomed the input from consumer group/organisations (2) via the Consumer Comments facility on the PBS website. Rare Cancers Australia emphasised several benefits of atezolizumab SC compared to atezolizumab IV, including reduced administration time, fewer hospital visits particularly for patients in rural and regional areas, reduced discomfort and thus improved quality of life.PSD · Mar 2024
No risk-sharing arrangements were proposed by the submission. The evaluation noted that the proposed listing of ATZ as adjuvant therapy would affect the extent of use of other PD-1 inhibitors for treatment of advanced or metastatic NSCLC.PSD · Jul 2022
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated as the submission demonstrated cost-neutrality between atezolizumab SC and IV formulations.
The submission estimated that the requested listing of atezolizumab SC to be cost neutral to the PBS/RPBS. PSD · 2024
Decision context
PopulationPatients with locally advanced or metastatic NSCLC, stage IV metastatic NSCLC, extensive-stage small cell lung cancer, advanced hepatocellular carcinoma, and resected early-stage NSCLC requiring atezolizumab treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | atezolizumab IV | — | RCT · Surrogate |
| Jul 2022 | Recommended · restricted | best supportive care | — | RCT · DFS |
| Mar 2021 | Recommended · restricted | nab-paclitaxel | — | RCT · OS |
| Jul 2020 | Recommended · restricted | sorafenib | — | RCT · OS |
| Mar 2020 | Not recommended | nanoparticle albumin-bound paclitaxel (nab-paclitaxel) | — | RCT · OS |
| Mar 2020 | Recommended | atezolizumab 1200 mg Q3W | — | Cost-minimisation · Cost-minimisation |
| Nov 2019 | Recommended · restricted | carboplatin and etoposide (with placebo) | $45k–75k | RCT · OS |
| Nov 2019 | Recommended · restricted | atezolizumab 1200 mg Q3W | — | Pharmacokinetic modelling and exposure-response analysis · Cost-minimisation |
| Jul 2019 | Not recommended | Carboplatin and etoposide (CE) | — | RCT · OS |
| Mar 2019 | Recommended · restricted | platinum-doublet chemotherapy; supplementary comparator pembrolizumab monotherapy for EGFR wild-type/ALK-negative, PD-L1 | — | RCT · OS |
| Nov 2017 | Recommended · restricted | nivolumab | — | Meta-analysis · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| IMbrave150 | Ph 3 | 558 | Overall Survival (OS) in the Global Population | completed |
| IMpower010 | Ph 3 | 1,280 | Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population | active not recruiting |
| IMpassion130 | Ph 3 | 902 | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors … | completed |
| IMpassion131 | Ph 3 | 653 | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumor… | completed |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| PD-L1 immunohistochemistry (IHC) testing for atezolizumab eligibility in triple-negative breast cancer | PD-L1 expression on tumour-infiltrating immune cells | deferred | 2020 |
Consumer voice
Two consumer organisations highlighted benefits of atezolizumab SC including reduced administration time, fewer hospital visits (particularly for rural/regional patients), reduced discomfort, and improved quality of life. Lung Foundation Australia also noted it as an important additional treatment option for NSCLC patients who cannot tolerate the IV formulation.
reduced administration time, fewer hospital visits particularly for patients in rural and regional areas, reduced discomfort and thus improved quality of life Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to subcutaneous formulation and specifies disease stages (locally advanced/metastatic, extensive-stage SCLC, advanced HCC, resected early-stage); TGA label is broader without formulation or stage specifications.