ObinutuzumabGazyva
Treatment of adult patients with active class III or IV lupus nephritis with or without class V disease who are receiving standard therapy with mycophenolate mofetil and corticosteroids.
Decisions on record
- Meeting Mar 2026 Recommended Lupus nephritis
- Meeting Jul 2018 Recommended Chronic lymphocytic leukaemia (CLL)
- Meeting Apr 2018 Recommended CD20 positive follicular lymphoma no PSD
- Meeting Mar 2018 Deferred CD20 positive follicular lymphoma
- Meeting Nov 2017 Not recommended CD20 positive follicular lymphoma
- Meeting Nov 2016 Not recommended Follicular lymphoma (FL)
- Meeting Mar 2015 Recommended Previously untreated CD20 positive chronic lymphocytic leukaemia
- Meeting Jul 2014 Not recommended Gazyva® Roche Products Pty Ltd New listing (Major submission) Chronic lymphocytic leukaemia Section 100 (Efficient Funding of Chemotherapy Program) Authority required listing for the treatment, in combination with chlorambucil, of patients with previously untreated CD20 positive chronic lymphocytic
Access path
- TGA registered · Gazyva
TGA label narrower than the PBS population
- Jul 2014Not recommended
vs chlorambucil monotherapy (primary); rituximab plus…
- ↻ resubmittedMar 2015Recommended · restricted
Comparator changed: chlorambucil monotherapy (primary); rituximab plus chlorambucil…
- Nov 2016Not recommended
Comparator changed: rituximab plus chlorambucil, chlorambucil monotherapy → bendamustine…
- Nov 2017Not recommended
Comparator changed: bendamustine monotherapy (as proxy for best supportive care) →…
- ↻ resubmittedMar 2018Recommended · restricted
- Jul 2018Recommended · restricted
Evidence: RCT → Cost-minimisation
- Mar 2026Recommended · restricted
Comparator changed: ofatumumab, rituximab → standard therapy (glucocorticoids and…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended changing the current S100 Efficient Funding of Chemotherapy (EFC) Program Authority Required (Written) listing for obinutuzumab to a S100 EFC Authority Required (Streamlined) for treatment of CLL.PSD · Jul 2018
5.2 The PBAC recalled that at its March 2015 meeting it had considered a Written Authority listing appropriate for obinutuzumab to help prevent usage outside the population in whom the comparative effectiveness and cost-effectiveness of the medicine have been demonstrated.PSD · Jul 2018
ICER $'''''''''''''''''/QALY. $'''''''''''''''/QALY. Versus previously untreated:PSD · Mar 2018
PBAC considered this was PBAC considered this was highly '''''''''''''''''''''''' “highly uncertain and was uncertain, as the economic model Only changes were reduced likely to be significantly assumed an advantage in survival obinutuzumab price plus updated underestimated” (Para 7.7). based on delayed disease rituximab price (to the 1 Feb progression that is unable to be fully 2018 price). All other parameters tested due to immature OS data unchanged.PSD · Mar 2018
compared to rituximab plus chemotherapy induction therapy and rituximab maintenance monotherapy. The submission also claimed that OS data from obinutuzumab were supportive of the PFS endpoint.PSD · Nov 2017
AEs=adverse events; EQ-5D=EuroQoL five dimension questionnaire; FACT-Lym=Functional Assessment of Cancer Therapy- Lymphoma questionnaire; OS=overall survival; PFS=progression-free survival; QoL=quality of life Source: Table 1.1.1 p2-3 of the submission.PSD · Nov 2017
4.1 The PBAC noted and welcomed the input from individuals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described the fear of relapse as a significant mental and physiological challenge. Lymphoma Australia outlined the importance of having a range of therapeutic options given that patients often experience multiple relapses.PSD · Mar 2018
4.31 The resubmission did not propose a risk sharing arrangement stating that there was no additional impact on PBS budget. However, the PBAC considered that an additional budget impact would be associated with the listing of obinutuzumab in rituximab-refractory follicular lymphoma.PSD · Mar 2018
Cost-effectiveness
ICER value redacted (commercial-in-confidence)
The submission presented a cost-effectiveness analysis of obinutuzumab plus bendamustine compared with bendamustine monotherapy. PSD · 2016
Decision context
PopulationAdult patients with confirmed active class III or IV lupus nephritis with or without class V, eGFR ≥30 mL/min per 1.73 m², UPCR ≥113 mg/mmol, receiving standard therapy with mycophenolate mofetil and corticosteroids.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | standard therapy (glucocorticoids and mycophenolate mofetil) | — | RCT · CRR |
| Jul 2018 | Recommended · restricted | ofatumumab, rituximab | — | Cost-minimisation |
| Mar 2018 | Recommended · restricted | — | — | RCT |
| Nov 2017 | Not recommended | rituximab in combination with chemotherapy for induction treatment and rituximab monotherapy for maintenance treatment | — | RCT · PFS |
| Nov 2016 | Not recommended | bendamustine monotherapy (as proxy for best supportive care) | — | RCT · PFS |
| Mar 2015 | Recommended · restricted | rituximab plus chlorambucil, chlorambucil monotherapy | — | RCT · PFS |
| Jul 2014 | Not recommended | chlorambucil monotherapy (primary); rituximab plus chlorambucil (secondary) | $15k–45k | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CLL11 | Ph 3 | 787 | Progression-free Survival (PFS) | completed |
Consumer voice
One individual and one organisation (Lymphoma Australia) provided input describing the fear of relapse as a significant mental and physiological challenge, and emphasising the importance of having a range of therapeutic options given that patients often experience multiple relapses.
The comments described the fear of relapse as a significant mental and physiological challenge. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with comorbidities/unfitness for fludarabine therapy and specific lab parameters; TGA label has no such restrictions.