Peginterferon Beta-1a
Recommended NeurologyAuthority RequiredFirst-line line 💬 consumer voice
First-line treatment of patients with remitting-relapsing multiple sclerosis who have experienced at least 2 documented attacks of neurological dysfunction in the preceding 2 years and are ambulatory without assistance.
1
Submissions
2014–14
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2014 Recommended 63 microgram/0.5 mL injection, 0.5 mL syringe + 94 microgram/0.5 mL injection, 0.5 mL syringe 63 microgram/0.5 mL injection, 0.5 mL injection device + 94 microgram/0.5 mL injection, 0.5 mL injection device 125 microgram/0.5 mL injection, 2 x 0.5 mL syringes 125 microgram/0.5 mL injection, 2 x 0.5 mL
Access path
- Nov 2014Recommended · restricted
vs interferon beta-1a
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended peginterferon beta-1a as an Authority Required listing for the treatment of multiple sclerosis on a cost-minimisation basis compared with interferon beta-1a.PSD · Nov 2014
7.2 The PBAC agreed that the equi-effective doses from the trials were peginterferon beta-1a 125 µg fortnightly to interferon beta-1a IM 30 µg once a week or interferon beta-1a SC 44 µg three times per week.PSD · Nov 2014
Economic analysis
6.13 The equi-effective doses were estimated as peg(INF) 125 µg once every two weeks vs. INFB-1a IM 30 µg (once per week) or INFB-1a SC 44 µg (3 times per week). The estimates are based on the trials. This dose is consistent with the clinical claim of non-inferiority. The TGA delegate’s overview notes that the proposed Q2W dose of peg(INF) is benchmarked against the current weekly dose of INFb-1a.PSD · Nov 2014
Clinical claim
6.11 The clinical claim was one of non-inferior efficacy and non-inferior safety. This claim was supported in terms of the primary efficacy outcome and all but one of the safety outcomes. Superiority was suggested in one secondary outcome and one safety outcome across the trials. However there are limitations to the indirect comparison due to the BRAVO trial being unblinded and due to different trial durations.PSD · Nov 2014
6.12 The ESC considered that the claim of non-inferior efficacy and non-inferior safety compared to interferon beta-1a was reasonably well supported by the indirect comparison.PSD · Nov 2014
Consumer comments
6.2 The PBAC noted and welcomed the input from organisations (2) via the Consumer Comments facility on the PBS website. The comments described the perceived benefit to patients of having another treatment option for MS.PSD · Nov 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as drug cost per patient per year equals comparator cost.
The PBAC considered the claim that listing of peginterferon beta-1a on the PBS will be cost neutral to the Commonwealth to be reasonable. PBAC · 2014
Cost-effectiveness accepted
Decision context
PopulationAdults with clinically definite relapsing-remitting multiple sclerosis diagnosed by MRI of brain and/or spinal cord, with at least 2 documented attacks of neurological dysfunction in the preceding 2 years, who are ambulatory without assistance or support.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Recommended · restricted | interferon beta-1a | — | Meta-analysis · ARR |
Consumer voice
Two consumer organisations provided input describing the perceived benefit to patients of having another treatment option for MS.
The comments described the perceived benefit to patients of having another treatment option for MS. Consumer comments · PSD
unmet needtreatment options