NatalizumabTyruko
Recommended NeurologyAuthority Required 💬 consumer voice
Treatment of clinically definite relapsing-remitting multiple sclerosis (RRMS) to delay the progression of physical disability and reduce the frequency of relapse.
8
Submissions
2 resub
2006–25
On the record
$45k–85k
ICER range
4 sourced ICERs · 2006–2007
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2025 Recommended Relapsing-remitting multiple sclerosis (RRMS)
- Meeting Mar 2023 Recommended Relapsing-remitting multiple sclerosis (RRMS)
- Meeting Jul 2022 Recommended Multiple sclerosis, clinically definite relapsing-remitting
- Meeting Jul 2019 Recommended Relapsing-remitting multiple sclerosis (RRMS)
- Meeting Mar 2014 Recommended Tysabri® Biogen Idec Australia Pty Ltd Multiple sclerosis To request that the current Authority Required listing for natalizumab be changed to Authority Required (STREAMLINED). However, the PBAC recommended that the Department review the administrative requirements for all PBS listed treatments for no PSD
- Meeting Jul 2008 Recommended Multiple sclerosis no PSD
- Meeting Nov 2007 Recommended Multiple sclerosis
- Meeting Nov 2006 Not recommended Treatment for multiple sclerosis
Access path
- TGA registered · Tyruko
TGA label narrower than the PBS population
- Nov 2006Not recommended
uncertain indirect comparison due to non-comparable patient populations at baseline (different inclusion criteria…
- ↻ resubmittedNov 2006Recommended · restricted
Evidence: RCT | Single-arm → RCT
- Nov 2007Recommended
ICER dropped $85,000 → $75,000 (-12%)
- Nov 2007Recommended · restricted
ICER dropped $85,000 → $75,000 (-12%)
- Jul 2019Recommended
Evidence: RCT → Registry
- Jul 2022Recommended
Evidence: Registry → Other
- Mar 2023Recommended · restricted
Evidence: Other → RCT
- Mar 2025Recommended · restricted
Comparator changed: natalizumab intravenous infusion (300 mg in 15 mL vial) → Tysabri…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the Section 100 (Highly Specialised Drugs Program) Authority Required (STREAMLINED) listing of a new biosimilar brand of natalizumab 300 mg in 15 mL vial for intravenous infusion (Tyruko®) on a cost-minimisation basis and under the same circumstances as the PBS-listed reference biologic, Tysabri®, for the treatment of clinically definite relapsing-remitting multiple sclerosis (RRMS).PSD · Mar 2025
5.2 The PBAC noted that the TGA has confirmed biosimilarity between Tyruko and the reference product Tysabri.PSD · Mar 2025
Economic analysis
5.7 The submission did not present a formal cost minimisation approach, but assumed, based on the DELIVER and REFINE studies, that the equi-effective doses for natalizumab are: • Natalizumab SC: 2 x 150 mg/mL of PFS (300 mg Q4W) • Natalizumab IV: 1 x 300 mg/15mL vial (300 mg Q4W).PSD · Mar 2023
5.8 Under Section 101(3B) of the National Health Act 1953 (the Act), the PBAC could only recommend listing natalizumab SC at a higher price than the alternative therapy or therapies if it is satisfied that it provides, for some patients, a significant improvement in efficacy or reduction of toxicity over the alternative therapy or therapies. The advice provided by the PBAC applies to each medicine on a case by case basis. In this case, 4PSD · Mar 2023
Clinical claim
5.5 The submission stated that neither trial was specifically designed to confirm non- inferiority.PSD · Mar 2023
5.6 The submission claimed that natalizumab SC administered once every 4 weeks (Q4W) was demonstrated to have a similar PK, PD, efficacy, and safety profile to natalizumab IV Q4W based on evidence from the DELIVER and REFINE studies.PSD · Mar 2023
Consumer comments
5.2 The PBAC noted and welcomed the input from individuals (8), health care professionals (4) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with natalizumab SC including improved convenience and flexibility, reduced stress, reduced time 3PSD · Mar 2023
5.3 The PBAC noted the view received from Multiple Sclerosis Australia clarifying the likely use of natalizumab SC in clinical practice. The PBAC noted the view that the use of natalizumab SC may expand the clinical settings for treatment and reduce the administration and travel time for patients.PSD · Mar 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as Tyruko is a biosimilar with equivalent clinical efficacy and safety to reference product Tysabri.
The PBAC considered that the listing of Tyruko would not result in a net cost to the PBS as it would likely substitute for Tysabri and not increase the overall market utilisation. PBAC · 2025
ICER uncertainICER / price too highCost-effectiveness accepted ×5
Decision context
PopulationAdults with clinically definite relapsing-remitting multiple sclerosis (RRMS).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended · restricted | Tysabri (reference biologic) | — | Cost-minimisation · Cost-minimisation |
| Mar 2023 | Recommended · restricted | natalizumab intravenous infusion (300 mg in 15 mL vial) | — | RCT · PK, PD, efficacy, and safety |
| Jul 2022 | Recommended | — | — | Other |
| Jul 2019 | Recommended | — | — | Registry |
| Nov 2007 | Recommended | interferon beta-1b | $45k–75k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Nov 2007 | Recommended · restricted | interferon beta-1b | $45k–75k | RCT · ARR |
| Nov 2006 | Not recommended | interferon beta-1b | $75k–85k | RCT | Single-arm · OS | PFS | DFS | ORR | QoL | Surrogate |
| Nov 2006 | Recommended · restricted | interferon beta-1b | $75k–85k | RCT · ARR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| REFINE (101MS206) | Ph 2 | 290 | Cumulative Number of Combined Unique Active Lesions | 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 restricts to 'clinically definite' RRMS, whereas TGA label does not specify this diagnostic criterion.