Glatiramer AcetateCopaxone
Treatment of multiple sclerosis. The submission requested listing a new form of 40 mg glatiramer acetate pre-filled pen under the same circumstances as the PBS-listed 40 mg glatiramer pre-filled syringe.
Decisions on record
- Meeting Mar 2022 Recommended Multiple sclerosis
- Meeting Mar 2021 Recommended Multiple sclerosis
- Meeting Jul 2017 Not recommended Clinically isolated syndrome (CIS)
- Meeting Mar 2015 Recommended Multiple sclerosis
Access path
- TGA registered · Copaxone
TGA label equal than the PBS population
- Mar 2015Recommended
vs glatiramer acetate 20 mg/mL daily
- Jul 2017Not recommended
Uncertain whether the population defined in the restriction was representative of patients at high risk of developing…
- ↻ resubmittedMar 2021Recommended
Comparator changed: Placebo → Copaxone (glatiramer acetate)
- Mar 2022Recommended
Comparator changed: Copaxone (glatiramer acetate) → glatiramer acetate 40 mg pre-filled…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of a new form of 40 mg glatiramer acetate pre- filled pen (GA PFP) under the same circumstances as the PBS-listed 40 mg glatiramer pre-filled syringe (GA PFS) for the treatment of multiple sclerosis.PSD · Mar 2022
6.2 The PBAC recommended listing GA PFP on a cost-minimisation basis to the PBS-listed GA PFS. The PBAC noted the listing of GA PFP is expected to have no net cost to the PBS.PSD · Mar 2022
5.9 As a minor submission, the economic analysis has not been independently evaluated.PSD · Mar 2021
5.10 The minor submission presented a cost-minimisation analysis of Glatira compared with Copaxone. The minor submission estimated the equi-effective doses to be: 20 mg Glatira = 20 mg Copaxone 40 mg Glatira = 40 mg CopaxonePSD · Mar 2021
5.3 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of the GA PFP compared with the GA PFS.PSD · Mar 2022
5.4 The Therapeutic Goods Administration (TGA) confirmed that GA PFP and GA PFS are the same, noting that GA PFS is integrated into a GA PFP.PSD · Mar 2022
5.2 The PBAC noted and welcomed input from an individual (1) and an organisation (1) via the Consumer Comments facility on the PBS website. The PBAC noted that both the individual and MS Australia’s comments described a range of benefits of treatment with GA PFP, including easier administration, reduced adverse effects, improved adherence, and an option for patients with reduced dexterity.PSD · Mar 2022
6.81 The sponsor did not propose a risk share arrangement, stating that it would be difficult in practice to effectively separate clinically isolated syndrome from multiple sclerosis prescribing, which would possibly result in pre-defined annual risk share caps being inadvertently exceeded. No special pricing arrangement was sought by the sponsor.PSD · Jul 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as submission assumed no differences in utilisation of healthcare resources between formulations.
The PBAC recommended listing GA PFP on a cost-minimisation basis to the PBS-listed GA PFS. PBAC · 2022
Decision context
PopulationPatients with multiple sclerosis treated with glatiramer acetate 40 mg
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended | glatiramer acetate 40 mg pre-filled syringe (GA PFS) | — | Cost-minimisation · Cost-minimisation |
| Mar 2021 | Recommended | Copaxone (glatiramer acetate) | — | RCT · MRI (gadolinium-enhancing lesions) |
| Jul 2017 | Not recommended | Placebo | — | RCT · Time to conversion to clinically definite multiple sclerosis |
| Mar 2015 | Recommended | glatiramer acetate 20 mg/mL daily | — | Meta-analysis · ARR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| PreCISe | Ph 3 | 481 | Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion | completed |
| GTR001 (GATE Study) | Ph 3 | 794 | The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 | completed |
| GALA | Ph 3 | 1,404 | Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Est… | completed |
Consumer voice
An individual and MS Australia provided consumer input describing benefits of glatiramer acetate pre-filled pen (GA PFP) treatment, including easier administration, reduced adverse effects, improved adherence, and suitability for patients with reduced dexterity.
both the individual and MS Australia's comments described a range of benefits of treatment with GA PFP, including easier administration, reduced adverse effects, improved adherence, and an option for patients with reduced dexterity Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation cover treatment of multiple sclerosis with glatiramer acetate 40 mg; no population restriction applied.