RituximabRIXIMYO
Biosimilar rituximab for treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and CD20-positive acute lymphoblastic leukaemia.
Decisions on record
- Meeting Nov 2021 Recommended Non-Hodgkin's lymphoma; Chronic lymphocytic leukaemia; Rheumatoid arthritis; Granulomatosis with polyangiitis; Microscopic polyangiitis
- Meeting Sep 2021 Recommended Multiple indications no PSD
- Meeting Mar 2019 Recommended Non-Hodgkin lymphoma
- Meeting Mar 2018 Recommended CD20 positive follicular B-cell non-Hodgkin's lymphoma; CD20 positive non- Hodgkin's lymphoma; Low-grade B-cell non- Hodgkin's lymphoma; Severe active granulomatosis with polyangiitis (Wegeners granulomatosis)(GPA); Microscopic polyangiitis (MPA); Chronic lymphocytic leukaemia; Severe active rheumat
- Meeting Jul 2017 Recommended CD20 positive lymphoma
- Meeting Mar 2017 Recommended Chronic lymphocytic leukaemia (CLL)
- Meeting Nov 2015 Recommended Severe, active granulomatosis with polyangiitis and microscopic polyangiitis
- Meeting Jul 2015 Recommended Severe active granulomatosis with polyangiitis and microscopic polyangiitis
8 earlier decisions
- Mar 2015 Deferred Severe active granulomatosis with polyangiitis and microscopic polyangiitis
- Nov 2014 Recommended 1,400 mg/11.7 mL injection, Mabthera® SC Roche Products Pty Ltd New listing (Minor submission) Non-Hodgkin’s lymphoma Authority Required listing of a new subcutaneously administered formulation of rituximab for patients with non-Hodgkin’s lymphoma.
- Jul 2014 Recommended 100 mg/10 mL injection 500 mg/50 mL injection Mabthera® Roche Products Pty Ltd Change to listing (Minor submission) Non-Hodgkin’s lymphoma Re-submission to review the cost-effectiveness of rituximab for maintenance therapy of follicular lymphoma in patients who have achieved a partial or complete re
- Nov 2011 Recommended Anti-cancer drug no PSD
- Nov 2010 Recommended Anti-cancer drug
- Mar 2010 Deferred Monoclonal antibody for use in leukaemia
- Jul 2008 Recommended Rheumatoid arthritis no PSD
- Jul 2008 Not recommended Rheumatoid arthritis no PSD
Access path
- TGA registered · RIXIMYO
TGA label narrower than the PBS population
- Mar 2006Recommended · restricted
vs placebo in combination with chemotherapy (CVP)
- Mar 2006Recommended · restricted
- Mar 2007Recommended · restricted
Comparator changed: placebo in combination with chemotherapy (CVP) → etanercept and…
- Mar 2010Recommended
Comparator changed: etanercept and adalimumab → fludarabine plus cyclophosphamide (FC)
- Nov 2010Recommended · restricted
ICER rose $45,000 → $75,000 (+67%)
- Jul 2014Recommended · restricted
Comparator changed: fludarabine plus cyclophosphamide (FC) → observation
- Nov 2014Recommended
Comparator changed: observation → rituximab IV infusion
- Mar 2015Deferred
Comparator changed: rituximab IV infusion → cyclophosphamide; salvage therapies (IVIg…
- Jul 2015Deferred
Comparator changed: cyclophosphamide; salvage therapies (IVIg, mycophenolate mofetil…
- Nov 2015Recommended · restricted
Comparator changed: Cyclophosphamide (CYC) for patients with relative contraindications…
- Mar 2017Recommended · restricted
Comparator changed: cyclophosphamide → rituximab intravenous (IV) 500 mg/m2
- Jul 2017Recommended
Evidence: RCT → Other
- Mar 2018Recommended
Evidence: Other → RCT
- Mar 2018Recommended
Evidence: Other → RCT
- Mar 2019Recommended · restricted
Evidence: Other → Single-arm
- Nov 2021Recommended
Comparator changed: MabThera® (rituximab reference brand) → Mabthera (reference biologic)…
- PBS listing · Unrestricted
From the public summary
The PBAC recommended the listing of a new brand of biosimilar medicine rituximab (Ruxience) in the form of solution for I.V. infusion 100 mg in 10 mL and 500 mg in 50 mL under the same conditions as the currently listed biosimilar brands (Riximyo and Truxima).PSD · Nov 2021
• Granulomatosis with polyangiitis (Wegener’s granulomatosis) (GPA) – HSD • Microscopic polyangiitis (MPA) – HSDPSD · Nov 2021
6.18 The submission proposed a cost-minimised price for the fixed-dose rituximab SC formulation (1,600 mg) to the current rituximab IV formulation at a dose of 500 mg/m2 utilising the mean body surface area (BSA) of '''''''''' m2 based on Australian CLL patients.PSD · Mar 2017
6.19 The minor submission presented the following cost minimisation analysis.PSD · Mar 2017
The submission claimed that Ruxience was: • biosimilar to MabtheraPSD · Nov 2021
• non-inferior in terms of comparative effectiveness and safety to Mabthera.PSD · Nov 2021
The PBAC noted that this item received no consumer comments.PSD · Nov 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission presented no economic or financial analysis beyond cost-minimisation to existing biosimilar brands.
As a minor submission, no evaluation of the clinical data was undertaken. PBAC · 2019
Decision context
PopulationPatients with non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and CD20-positive acute lymphoblastic leukaemia (previously untreated or relapsed/refractory).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended | Mabthera (reference biologic) and biosimilar brands Riximyo and Truxima | — | Cost-minimisation · Cost-minimisation |
| Mar 2019 | Recommended · restricted | MabThera® (rituximab reference brand) | — | Single-arm · Efficacy |
| Mar 2018 | Recommended | rituximab (MabThera) | — | RCT · ORR |
| Mar 2018 | Recommended | — | — | Other |
| Jul 2017 | Recommended | — | — | Other |
| Mar 2017 | Recommended · restricted | rituximab intravenous (IV) 500 mg/m2 | — | RCT · Surrogate |
| Nov 2015 | Recommended · restricted | cyclophosphamide | — | RCT · Remission induction |
| Jul 2015 | Deferred | Cyclophosphamide (CYC) for patients with relative contraindications; salvage therapies (IVIg, mycophenolate mofetil, ant | — | RCT · Remission induction |
| Mar 2015 | Deferred | cyclophosphamide; salvage therapies (IVIg, mycophenolate mofetil, anti-thymocyte globulin, alemtuzumab) | — | RCT · Remission induction |
| Nov 2014 | Recommended | rituximab IV infusion | — | RCT · ORR |
| Jul 2014 | Recommended · restricted | observation | $45k–75k | RCT · PFS |
| Nov 2010 | Recommended · restricted | fludarabine plus cyclophosphamide (FC) | $15k–75k | RCT · PFS, OS |
| Mar 2010 | Recommended | fludarabine plus cyclophosphamide (FC) | $15k–45k | RCT · PFS |
| Mar 2007 | Recommended · restricted | etanercept and adalimumab | — | RCT · ACR50 response rate |
| Mar 2006 | Recommended · restricted | placebo in combination with chemotherapy (CVP) | $15k–45k | RCT · OS | PFS | DFS |
| Mar 2006 | Recommended · restricted | placebo in combination with chemotherapy (CVP) | $15k–45k | RCT |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| RAVE (ITN021AI) | Ph 2, PHASE3 | 197 | Disease Remission | completed |
Consumer voice
Lymphoma Australia sought reassurance that biosimilar rituximab will not change patient outcomes, requested that patients be informed of the brand prescribed, and called for tracking of brands used and associated side effects.
seeking reassurance that the introduction of a biosimilar rituximab will not change outcomes for patients with this type of cancer Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC specifies treatment status (previously untreated or relapsed/refractory) not stated in TGA's broad biosimilar indication.