OcrelizumabOcrevus
Treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS). Ocrelizumab SC provides an alternative subcutaneous administration route to the currently listed intravenous formulation.
Decisions on record
- Meeting Jul 2025 Recommended Relapsing-remitting multiple sclerosis
- Meeting Jul 2020 Not recommended Ocrelizumab is indicated for the treatment of patients with primary progressive multiple sclerosis (PPMS) to delay the progression of physical disability. Ocrelizumab is also indicated for the treatment of patients
- Meeting Nov 2017 Not recommended Primary progressive multiple sclerosis (PPMS)
- Meeting Jul 2017 Recommended Relapsing-remitting multiple sclerosis (RRMS)
Access path
- TGA registered · Ocrevus
TGA label narrower than the PBS population
- Jul 2017Recommended · restricted
vs fingolimod, natalizumab, alemtuzumab (indirect comparisons…
- Nov 2017Not recommended
Requested PBS restriction broader than trial eligibility criteria and does not restrict access to PPMS patients most…
- Jul 2020Not recommended
- ↻ resubmittedJul 2025Recommended · restricted
Comparator changed: best supportive care → ocrelizumab IV (intravenous infusion 300 mg in…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of a new form of ocrelizumab (solution for subcutaneous injection 920 mg in 23 mL; ocrelizumab SC) under the same circumstances as the PBS-listed ocrelizumab solution concentrate for intravenous infusion 300 mg in 10 mL (ocrelizumab IV), for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS), on the basis that it should be available only under special arrangements under Section 100 …PSD · Jul 2025
6.2 The PBAC recommended listing ocrelizumab SC on a cost-minimisation basis to ocrelizumab IV. The PBAC considered ocrelizumab IV an appropriate comparator. The PBAC noted that ocrelizumab SC provides an alternative option to ocrelizumab IV currently listed on the PBS and that evidence demonstrated that ocrelizumab SC has non-inferior comparative effectiveness and safety compared to ocrelizumab IV.PSD · Jul 2025
5.17 As a Category 4 submission, the economic analysis was not independently evaluated.PSD · Jul 2025
5.18 The submission presented a cost-minimisation approach of ocrelizumab SC compared with ocrelizumab IV. The equi-effective doses were estimated as a single dose of ocrelizumab SC 920mg in 23 mL, to ocrelizumab IV 300mg in 10mL, two vials as a single infusion (600 mg), administered every six months.PSD · Jul 2025
5.13 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of ocrelizumab SC 920 mg administered every 6 months compared with ocrelizumab IV 600 mg (2 x 300 mg) administered every 6 months for RRMS.PSD · Jul 2025
5.14 The submission cited the OCARINA II study to support the claim that ocrelizumab SC 920 mg administered every 6 months is equally effective and safe as ocrelizumab IV 600 mg administered every 6 months for patients with RRMS.PSD · Jul 2025
5.2 The PBAC noted and welcomed the input from individuals (14), health care professionals (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comments from individuals described the treatment burden associated with ocrelizumab IV administration, including lengthy treatment sessions, disrupted work and personal lives for both the individual and carer, and fatigue from the onerous nature of accessing treatment.PSD · Jul 2025
5.3 Health professional input described the comparable pharmacokinetics and clinical efficacy of ocrelizumab IV and ocrelizumab SC, and potential benefits of ocrelizumab SC, including greater convenience for patients, the potential to facilitate better access for individuals who currently face barriers to accessing ocrelizumab IV (i.e.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission presented cost-minimisation approach comparing ocrelizumab SC with ocrelizumab IV.
As a Category 4 submission, the economic analysis was not independently evaluated. PBAC · 2025
Decision context
PopulationAdults with clinically definite relapsing-remitting multiple sclerosis (diagnosed by MRI of brain and/or spinal cord), who have experienced at least 2 documented attacks of neurological dysfunction in the preceding 2 years, are ambulatory without assistance, and for whom ocrelizumab would be the sole PBS-subsidised disease-modifying therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | ocrelizumab IV (intravenous infusion 300 mg in 10 mL, 600 mg total dose) | — | RCT · Surrogate |
| Jul 2020 | Not recommended | best supportive care | — | RCT · PFS |
| Nov 2017 | Not recommended | best supportive care | — | RCT · PFS |
| Jul 2017 | Recommended · restricted | fingolimod, natalizumab, alemtuzumab (indirect comparisons via interferon beta-1a and other bridging comparators) | — | RCT · PFS |
Consumer voice
Consumers and health professionals reported that subcutaneous ocrelizumab administration would reduce treatment burden compared to IV infusion, improve quality of life through simpler administration and less travel, and increase accessibility for rural and remote patients and those with difficult venous access. Health professionals noted potential for improved treatment adherence and outcomes, whi
The comments from individuals described the treatment burden associated with ocrelizumab IV administration, including lengthy treatment sessions, disrupted work and personal lives for both the individual and carer, and fatigue from the onerous nature of accessing treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to RRMS only, excluding PPMS and non-relapsing forms covered by TGA label.