Diroximel FumarateVumerity
Treatment of relapsing-remitting multiple sclerosis (RRMS) in patients diagnosed as clinically definite RRMS by MRI with at least two documented relapses within the preceding two years.
Decision on record
- Meeting Mar 2022 Recommended Multiple sclerosis
Access path
- TGA registered · Vumerity
TGA label narrower than the PBS population
- Mar 2022Recommended · restricted
vs dimethyl fumarate (DMF)
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (STREAMLINED) listing of diroximel fumarate (DRF) for the treatment of relapsing-remitting multiple sclerosis (RRMS). The PBAC considered the claim of non-inferior effectiveness and safety to dimethyl fumarate (DMF) was reasonable.PSD · Mar 2022
The PBAC considered it was reasonable to align the restriction wording of DRF with that of DMF, however considered as there is only one dose form and pack size for DRF (including for temporary dose reductions due to adverse events), that it was reasonable to have one listing for DRF, with 5 repeats that would facilitate both initial and continuing treatment.PSD · Mar 2022
The submission presented a cost-minimisation analysis of DRF compared to DMF, based on the continuing treatment doses. The initial phase (7 days for both drugs, half of the maintenance dose) was not considered in the calculation.PSD · Mar 2022
The equi-effective dose for continuing treatment was estimated as:PSD · Mar 2022
The submission described DRF as non-inferior in terms of efficacy compared to DMF.PSD · Mar 2022
This claim was adequately supported given the bioavailability of the active metabolite (MMF) presented in the comparative pharmacokinetic (PK) trials.PSD · Mar 2022
The PBAC noted and welcomed the input from individuals (6) and MS Australia via the Consumer Comments facility on the PBS website. The comments described the benefits to patients of an alternative to DMF which offered the same level of effectiveness with fewer gastrointestinal side effects, a known issue associated with DMF treatment which impacts quality of life for patients.PSD · Mar 2022
The submission requested a special pricing arrangement for DRF. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
Decision context
PopulationAdults with relapsing-remitting multiple sclerosis diagnosed as clinically definite by MRI of brain and/or spinal cord with at least 2 documented attacks of neurological dysfunction in the preceding 2 years; ambulatory without assistance or support; receiving DRF as sole PBS-subsidised disease modifying therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | dimethyl fumarate (DMF) | — | RCT · Gastrointestinal tolerability |
Consumer voice
Six individuals and MS Australia noted that an alternative to DMF with similar effectiveness but fewer gastrointestinal side effects would benefit patients, as GI side effects from DMF significantly impact quality of life.
The comments described the benefits to patients of an alternative to DMF which offered the same level of effectiveness with fewer gastrointestinal side effects Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with ≥2 relapses in 2 years and ambulatory without assistance; TGA label does not specify these criteria.