EtanerceptBRENZYS
Severe psoriatic arthritis, ankylosing spondylitis, severe active rheumatoid arthritis, severe chronic plaque psoriasis, and severe active juvenile idiopathic arthritis.
Decisions on record
- Meeting Jul 2025 Recommended Severe active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, juvenile idiopathic arthritis
- Meeting Nov 2024 Noted Rheumatoid arthritis; juvenile idiopathic arthritis; psoriatic arthritis; plaque psoriasis; ankylosing spondylitis no PSD
- Meeting Nov 2022 Recommended Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis
- Meeting Nov 2021 Recommended Rheumatoid arthritis; Plaque psoriasis; Ankylosing spondylitis; Juvenile idiopathic arthritis; Paediatric plaque psoriasis
- Meeting Jul 2021 Recommended Rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis, paediatric plaque psoriasis
- Meeting Dec 2020 Not recommended Severe active rheumatoid arthritis Ankylosing spondylitis Severe psoriatic arthritis Severe chronic plaque psoriasis
- Meeting Nov 2018 Deferred Severe active rheumatoid arthritis Ankylosing spondylitis Severe psoriatic arthritis Severe chronic plaque psoriasis
- Meeting Mar 2018 Recommended Rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis (JIA), paediatric plaque psoriasis
18 earlier decisions
- Aug 2017 Recommended Severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis and severe chronic plaque psoriasis
- Jul 2016 Recommended Rheumatoid arthritis; Psoriatic arthritis; Plaque psoriasis; Ankylosing spondylitis;
- Mar 2016 Not recommended Treatment of adults with active non- radiographic axial spondyloarthritis (nr- axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs. Active disease is defined as a Bath Ankylosing Spondylitis Dis
- Mar 2015 Not recommended Indication not stated
- Jul 2014 Recommended injection 50 mg in 1 mL single use auto-injector, injection 50 mg in 1 mL single use pre-filled syringe Enbrel® Pfizer Australia Pty Ltd New listing (Minor submission) Juvenile idiopathic arthritis To request PBS-listing of 50 mg presentations of etanercept for treatment of juvenile idiopathic arthr
- Mar 2012 Recommended Chronic plaque psoriasis.
- Mar 2009 Recommended Chronic plaque psoriasis
- Mar 2009 Recommended Immunomodulating agent
- Jul 2008 Not recommended Psoriasis
- Jul 2008 Not recommended Etanercept is TGA registered for: Active, adult RA in patients who have had inadequate response to one or more disease modifying antirheumatic drugs (DMARDs); severe, active, adult RA to slow progression of disease-associated structural damage in patients at high risk of erosive disease; active poly
- Nov 2007 Recommended Biological disease modifying anti-rheumatic drug no PSD
- Jul 2007 Recommended Plaque psoriasis, rheumatoid arthritis, polyarticular course juvenile chronic arthritis no PSD
- Jul 2007 Recommended Plaque psoriasis, rheumatoid arthritis, polyarticular course juvenile chronic arthritis. no PSD
- Mar 2007 Recommended Psoriatic arthritis and ankylosing spondylitis
- Nov 2006 Recommended Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis. no PSD
- Jul 2004 Recommended A biological disease modifying anti-rheumatic drug for psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis no PSD
- Jul 2004 Deferred A biological disease modifying anti-rheumatic drug for psoriatic arthritis, ankylosing spondylitis rheumatoid arthritis and polyarticular-course juvenile chronic arthritis. no PSD
- Dec 2002 Recommended Treatment for rheumatoid arthritis no PSD
Access path
- TGA registered · BRENZYS
TGA label narrower than the PBS population
- Jul 2005Not recommended
uncertain and unacceptable cost-effectiveness, model subject to considerable uncertainty, high incremental cost per…
- Nov 2005Not recommended
requested restriction did not adequately define a group at high risk of erosive disease with sufficient clarity…
- Nov 2005Not recommended
Requested restriction failed to adequately identify and restrict usage to the intended PBS population; choice of…
- ↻ resubmittedMar 2006Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Mar 2007Not recommended
uncertainty about clinical evidence for proposed model of treatment, inadequate evidence supporting role of continuous…
- ↻ resubmittedJul 2008Recommended
ICER rose $75,000 → $100,000 (+33%)
- Jul 2008Recommended
ICER rose $75,000 → $100,000 (+33%)
- Jul 2008Not recommended
uncertainty in clinical effectiveness for the proposed marginal population based on small patient numbers, long-term…
- ↻ resubmittedJul 2008Recommended
ICER rose $75,000 → $100,000 (+33%)
- Mar 2009Recommended · restricted
Comparator changed: current etanercept PBS regimen (25 mg twice weekly or 50 mg weekly…
- Mar 2012Recommended · restricted
Comparator changed: efalizumab → best supportive care
- Jul 2014Recommended · restricted
Evidence: RCT → Other
- Mar 2015Not recommended
Evidence: Other → RCT
- Mar 2016Not recommended
Comparator changed: placebo with NSAID background treatment → placebo with background…
- ↻ resubmittedJul 2016Recommended
Comparator changed: placebo with background NSAID treatment → etanercept (Enbrel)
- Aug 2017Recommended · restricted
Listing: Restricted → Authority Required
- Mar 2018Recommended · restricted
- Nov 2018Deferred
Evidence: RCT → Other
- Dec 2020Not recommended
authority level change from written to telephone authority considered inappropriate due to complexity of restrictions…
- ↻ resubmittedJul 2021Recommended · restricted
Evidence: Other → Cost-minimisation
- Nov 2021Recommended
Comparator changed: etanercept pre-filled syringes (PFS) → Enbrel
- Nov 2022Recommended · restricted
Comparator changed: Enbrel → Enbrel 50 mg in 1.0 mL solution for pre-filled syringe and…
- Jul 2025Recommended · restricted
Comparator changed: Enbrel 50 mg in 1.0 mL solution for pre-filled syringe and single use…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended General Schedule Authority Required and Section 100 (Highly Specialised Drugs Program) Authority Required listings of a new etanercept biosimilar (Nepexto®) in the form of Injections 50 mg in 1 mL single use pre-filled syringe on a cost-minimisation basis and under the same circumstances as its reference biologic Enbrel® (Injections 50 mg in 1 mL single use PFS).PSD · Jul 2025
5.2 The PBAC advised the equi-effective doses to be Nepexto 50 mg single use PFS = Enbrel 50 mg single use PFS = Brenzys 50 mg single use PFS.PSD · Jul 2025
5.6 The submission did not present an economic analysis as it was a Category 3 submission. The submission proposed Nepexto to have the same approved ex- manufacturer price (AEMP) as Enbrel.PSD · Nov 2022
5.7 Equi-effective doses were not presented in the submission. The equi-effective doses should be: Nepexto 50 mg = Enbrel 50 mg = Brenzys 50 mg. Estimated PBS utilisation and financial implicationsPSD · Nov 2022
5.4 The submission claimed that Nepexto was a biosimilar medicine to Enbrel which was accepted by the PBAC.PSD · Nov 2022
5.5 The PBAC considered that the claims of non-inferior comparative effectiveness and safety were reasonable.PSD · Nov 2022
5.2 The PBAC noted that this item received no consumer comments.PSD · Nov 2021
6.35 As in the March 2015 submission, the re-submission noted that if etanercept received a positive recommendation for PBS listing, a risk sharing arrangement may be required, but did not provide specific details of such an arrangement.PSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as this is a biosimilar with equi-effective dosing to existing PBS-listed etanercept brands.
The PBAC considered that the listing of Nepexto would not result in a net cost to the PBS as it would likely substitute for the other brands of etanercept and not increase the overall market utilisation. PBAC · 2025
Decision context
PopulationAdults and adolescents with severe psoriatic arthritis, ankylosing spondylitis, severe active rheumatoid arthritis, severe chronic plaque psoriasis, and children/adolescents with severe active juvenile idiopathic arthritis weighing 62.5 kg or more.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | Enbrel (reference biologic), Brenzys (other etanercept biosimilar) | — | Cost-minimisation · Cost-minimisation |
| Nov 2022 | Recommended · restricted | Enbrel 50 mg in 1.0 mL solution for pre-filled syringe and single use auto-injector; Brenzys also noted as appropriate c | — | RCT · Surrogate |
| Nov 2021 | Recommended | Enbrel | — | RCT · Comparator |
| Jul 2021 | Recommended · restricted | etanercept pre-filled syringes (PFS) | — | Cost-minimisation · Cost-minimisation |
| Dec 2020 | Not recommended | — | — | Other |
| Nov 2018 | Deferred | — | — | Other |
| Mar 2018 | Recommended · restricted | Enbrel (originator etanercept) | — | RCT · PASI75 |
| Aug 2017 | Recommended · restricted | — | — | — |
| Jul 2016 | Recommended | etanercept (Enbrel) | — | RCT · ACR20 |
| Mar 2016 | Not recommended | placebo with background NSAID treatment | $45k–75k | RCT · ASAS40 |
| Mar 2015 | Not recommended | placebo with NSAID background treatment | — | RCT · ASAS40 |
| Jul 2014 | Recommended · restricted | — | — | Other |
| Mar 2012 | Recommended · restricted | best supportive care | — | RCT · PASI 75 response at 12 weeks |
| Mar 2009 | Recommended · restricted | efalizumab | — | RCT, Cohort studies · PASI 75 response |
| Jul 2008 | Recommended | placebo/standard care | $50k–100k | RCT |
| Jul 2008 | Recommended | current treatment algorithm of etanercept 25 mg twice weekly or etanercept 50 mg weekly administered for 12 weeks initia | $25k–50k | RCT |
| Jul 2008 | Not recommended | placebo/standard care | $50k–100k | RCT |
| Jul 2008 | Recommended | current etanercept PBS regimen (25 mg twice weekly or 50 mg weekly for 12 weeks initially, then intermittently) | $25k–100k | RCT |
| Mar 2007 | Not recommended | etanercept 25mg twice weekly (or etanercept 50mg weekly) administered for 12 weeks initially and then, in responders, ad | $45k–75k | RCT | Other (post-hoc analysis) |
| Mar 2006 | Recommended · restricted | efalizumab | $15k–45k | RCT · PASI 75 at 12 and 24 weeks of treatment |
| Nov 2005 | Not recommended | methotrexate monotherapy | $45k–75k | RCT |
| Nov 2005 | Not recommended | methotrexate monotherapy | $45k–75k | RCT · TSS |
| Jul 2005 | Not recommended | placebo | $45k–75k | RCT · PASI-75 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| GP15-302 (EGALITY) | Ph 3 | 531 | PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted all indications to 'severe' disease and JIA to patients ≥62.5 kg, narrowing the TGA label's broader patient populations.