BlinatumomabBlincyto
B-cell precursor acute lymphoblastic leukaemia (B-ALL) in complete haematological remission following induction chemotherapy, regardless of measurable residual disease (MRD) status, in the consolidation phase.
Decisions on record
- Meeting Dec 2025 Recommended Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL) no PSD
- Meeting Nov 2024 Recommended Measurable residual disease (MRD)-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL)
- Meeting Jul 2024 Deferred Measurable residual disease-negative B-cell precursor acute lymphoblastic leukaemia after induction chemotherapy no PSD
- Meeting Mar 2023 Recommended Acute lymphoblastic leukaemia (ALL); residual disease testing no PSD
- Meeting Jul 2019 Recommended Acute lymphoblastic leukaemia (ALL)
- Meeting May 2019 Recommended Acute lymphoblastic leukaemia (ALL)
- Meeting Mar 2019 Deferred Acute lymphoblastic leukaemia (ALL)
- Meeting Jul 2018 Not recommended Acute lymphoblastic leukaemia (ALL)
3 earlier decisions
- Nov 2016 Recommended Relapsed or refractory Philadelphia- chromosome negative B- precursor acute lymphoblastic leukaemia
- Jul 2016 Recommended Acute lymphocytic leukaemia
- Nov 2015 Not recommended Philadelphia chromosome-negative relapsed or refractory B- precursor acute lymphoblastic leukaemia
Access path
- TGA registered · Blincyto
TGA label narrower than the PBS population
- Nov 2015Not recommended
vs Standard of care chemotherapy (FLAG ± anthracycline)
- ↻ resubmittedJul 2016Recommended · restricted
Comparator changed: Standard of care chemotherapy (FLAG ± anthracycline) → standard care…
- Nov 2016Recommended · restricted
Comparator changed: standard care chemotherapy (FLAG with or without anthracycline, high…
- Jul 2018Not recommended
Comparator changed: standard care chemotherapy (FLAG with or without anthracycline, high…
- Mar 2019Deferred
Comparator changed: standard of care chemotherapy, i.e. consolidation/maintenance…
- May 2019Recommended
Comparator changed: consolidation chemotherapy – post-induction → inotuzumab ozogamicin
- Jul 2019Recommended · restricted
Comparator changed: inotuzumab ozogamicin → standard of care chemotherapy (post induction…
- Nov 2024Recommended · restricted
Comparator changed: standard of care chemotherapy (post induction consolidation) →…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred blinatumomab for the treatment of patients with B-cell precursor acute lymphoblastic leukaemia (B-ALL) who are measurable residual disease (MRD)- negative following induction chemotherapy. The PBAC was of a mind to recommend blinatumomab, pending advice from the Therapeutic Goods Administration Delegate.PSD · Nov 2024
The PBAC noted that blinatumomab plus standard of care consolidation chemotherapy provided a significant improvement in overall survival and relapse-free survival over standard of care consolidation chemotherapy alone but considered the magnitude of benefit in the proposed PBS population was uncertain.PSD · Nov 2024
6.47 The submission presented a cost-utility analysis of blinatumomab in combination with standard of care consolidation chemotherapy compared to standard of care consolidation chemotherapy alone for the treatment of patients with B-ALL in complete haematological remission without minimal residual disease. The economic evaluation was based on E1910 trial data as well as other modelled variables. 25PSD · Nov 2024
Health state distribution Kaplan-Meier estimates for the two sets of OS and RFS curves were derived from a post hoc analysis of E1910 trial data and were used directly up to the extrapolation point of 4.5 years. Mixture cure models (weighted curves based on statistically cured and uncured fractions) were used to extrapolate each outcome to 30 years.PSD · Nov 2024
inferior in terms of safety compared to standard of care consolidation therapy alone Source: Table 1-1, p21 of the submission.PSD · Nov 2024
Abbreviations: ASCT, allogeneic stem cell transplant; B-ALL, B-cell precursor acute lymphoblastic leukaemia; MRD, measurable residual disease.PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from health care professionals (2) and organisations (2) via the Consumer Comments facility on the PBS website. The comments from health care professionals described the efficacy of blinatumomab as a frontline therapy in the treatment of B-ALL based on the E1910 trial.PSD · Nov 2024
6.92 The sponsor did not propose a risk sharing arrangement (RSA), but noted that the existing Deed of Agreement, which includes an RSA for blinatumomab and inotuzumab ozogamicin in the treatment of B-ALL, reached the end of its term onPSD · Nov 2024
Cost-effectiveness
ICER value(s) redacted in the public document; numeric values not stated
Decision context
PopulationNewly diagnosed patients with B-cell precursor acute lymphoblastic leukaemia in haematological complete remission, ECOG performance status 0 or 1, with or without measurable residual disease, without CNS or testicular involvement, following intensive combination chemotherapy for initial treatment or salvage therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | standard of care consolidation chemotherapy alone | — | RCT · Relapse-free survival |
| Jul 2019 | Recommended · restricted | standard of care chemotherapy (post induction consolidation) | $45k–75k | Single-arm · OS |
| May 2019 | Recommended | inotuzumab ozogamicin | — | Cost-minimisation |
| Mar 2019 | Deferred | consolidation chemotherapy – post-induction | $75k–105k | Single-arm · Relapse-free survival |
| Jul 2018 | Not recommended | standard of care chemotherapy, i.e. consolidation/maintenance chemotherapy | — | RCT · Relapse-free survival |
| Nov 2016 | Recommended · restricted | standard care chemotherapy (FLAG with or without anthracycline, high dose methotrexate in combination with pegylated-asp | $45k–75k | RCT · OS |
| Jul 2016 | Recommended · restricted | standard care chemotherapy (FLAG with or without anthracycline, high dose methotrexate, vinca alkaloids, steroids, etopo | $45k–75k | Single-arm · OS |
| Nov 2015 | Not recommended | Standard of care chemotherapy (FLAG ± anthracycline) | — | Single-arm · OS |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| Measurable residual disease (MRD) testing in acute lymphoblastic leukaemia using quantitative molecular assays | patient-specific genetic variant in acute lymphoblastic leukaemia | supported | 2023 |
| Measurable residual disease (MRD) testing by flow cytometry and next-generation sequencing in acute lymphoblastic leukaemia | measurable residual disease (MRD) | supported | 2022 |
Consumer voice
Health care professionals and patient advocacy organisations provided input highlighting blinatumomab's efficacy as a frontline therapy with lower toxicity than chemotherapy and suitability for outpatient delivery. They advocated for age-agnostic access, particularly for patients unable to tolerate conventional chemotherapy and those with early-onset severe treatment-related toxicity.
blinatumomab as less toxic than chemotherapy and noted that it can be delivered in an outpatient setting in the majority of cases Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to newly diagnosed patients in consolidation phase; TGA label includes relapsed/refractory disease without consolidation phase specificity.