OfatumumabKesimpta
Treatment of relapsing remitting multiple sclerosis (RRMS) in adult patients with relapsing forms of multiple sclerosis to delay progression of physical disability and reduce frequency of relapse.
Decisions on record
- Meeting Mar 2024 Not recommended Multiple sclerosis
- Meeting Mar 2021 Recommended Relapsing-remitting multiple sclerosis
- Meeting Nov 2014 Recommended 100 mg/5 mL injection, 5 mL vial 1 g/50 mL injection, 50 mL vial Arzerra® GlaxoSmithKline Australia Pty Ltd New Listing (Major submission) Chronic lymphocytic leukaemia Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing for the treatment of patients with chronic
Access path
- TGA registered · Kesimpta
TGA label narrower than the PBS population
- Nov 2014Recommended
vs chlorambucil monotherapy
- Mar 2021Recommended · restricted
Comparator changed: chlorambucil monotherapy → fingolimod
- Mar 2024Not recommended
Evidence: RCT → Meta-analysis
From the public summary
The PBAC did not recommend separating the current higher efficacy disease modifying therapies (DMT) tier into two distinct efficacy tiers on the basis that the clinical evidence presented did not adequately support the submission’s underlying claim that ofatumumab (proposed as a high-efficacy tier DMT) has superior comparative effectiveness versus fingolimod (as a proxy for the proposed mid-efficacy tier DMTs). 32PSD · Mar 2024
The PBAC considered the nominated comparator of fingolimod was reasonable, noting the submission used this as a proxy for the other DMTs proposed to make up the mid- efficacy tier (i.e. cladribine and ozanimod).PSD · Mar 2024
The current listing of ofatumumab was determined on a cost-minimisation basis with fingolimod but, by virtue of a price reduction for fingolimod in December 2022, ofatumumab currently has a price premium relative to fingolimod.PSD · Mar 2024
The submission presented a cost-utility analysis (CUA) to compare ofatumumab versus fingolimod. The submission stated that this comparison was intended to reflect the difference in cost-effectiveness between the proposed high-efficacy tier DMTs (natalizumab, alemtuzumab, ocrelizumab, ofatumumab) and the proposed mid- efficacy tier DMTs (fingolimod, cladribine, ozanimod).PSD · Mar 2024
The submission claimed that oofatumumab (as a high-efficacy tier treatment) is superior to fingolimod (as proxy for the mid-efficacy tier) in terms of clinical effectiveness with a different but non-inferior safety profile. The evaluation and the ESC considered the claim of superior effectiveness was not adequately supported by the evidence presented in the submission because:PSD · Mar 2024
• The claim relied on a two-step indirect comparison, a network meta-analysis and two unanchored, adjusted (IPTW and STC) comparisons. There were substantial transitivity and exchangeability issues between the trials that were included in the two-step indirect comparison in terms of baseline characteristics (e.g.PSD · Mar 2024
6.2 The PBAC noted and welcomed the input from individuals (4) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described the importance of having additional treatment options available for RRMS.PSD · Mar 2021
6.73 The submission stated that if the PBAC feels that the degree of uncertainty in these estimates warrants a Risk Sharing Arrangement, Novartis will discuss this with the Department of Health once other aspects of the submission have been agreed on. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2021
Cost-effectiveness
This was a cost-minimisation submission in March 2021; the March 2024 submission is a Category 2 request for tier restructuring with no new economic evaluation presented. No ICER is stated or calculated in this PSD.
Decision context
PopulationAdult patients with relapsing remitting multiple sclerosis (RRMS), including those with relapsing forms of MS who experience exacerbations followed by remission of symptoms.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Not recommended | fingolimod | — | Meta-analysis · ARR |
| Mar 2021 | Recommended · restricted | fingolimod | — | RCT · ARR |
| Nov 2014 | Recommended | chlorambucil monotherapy | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| COMPLEMENT-1 (OMB110911) | Ph 3 | 447 | Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC) | terminated |
Consumer voice
MS Australia emphasized the importance of providing access to a range of treatment options for multiple sclerosis patients, highlighting individual variability in treatment response, concomitant conditions, and circumstances including access to healthcare services for treatment, administration and monitoring.
MS Australia outlined the importance of enabling access to a range of treatment options for patients with MS given individual variability in treatment response, concomitant conditions and circumstances (including access to health services for treatment, administration and monitoring). Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to relapsing remitting MS (RRMS); TGA label covers all relapsing forms of MS broadly.