Daclizumab
Treatment of relapsing-remitting multiple sclerosis (RRMS). The submission sought a General Schedule Authority Required listing, with treatment restricted to patients with clinically definite RRMS diagnosed by MRI, at least 2 documented attacks in the preceding 2 years, ambulatory status, and monotherapy.
Decisions on record
- Meeting Nov 2016 Recommended Relapsing-remitting multiple sclerosis
- Meeting Jul 2016 Deferred Relapsing-remitting multiple sclerosis
Access path
- Jul 2016Deferred
vs fingolimod
- Nov 2016Recommended
Comparator changed: fingolimod → fingolimod (primary); dimethyl fumarate and ABCR…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of daclizumab on the basis that the presented direct comparison of IM IFN β-1a and indirect comparisons of daclizumab and fingolimod supported a conclusion that daclizumab is likely to be superior to IFN β-1a and may be non-inferior to fingolimod, with regards to comparative efficacy, but may be inferior to IFN β-1a with regards to comparative safety.PSD · Nov 2016
7.2 The PBAC considered there was substantial uncertainty about the indirect comparisons with fingolimod using placebo and IM IFN β-1a as common comparators (paragraphs 6.10, 6.14, 6.17 and 6.23 refer). The PBAC also again considered it was unable to draw meaningful conclusions with regards to comparative safety from the indirect comparisons with fingolimod, and further considered that daclizumab may have a worse safety profile than IFN β-1a.PSD · Nov 2016
6.25 The July 2016 submission presented a cost-minimisation analysis versus fingolimod.PSD · Nov 2016
6.26 The PBAC considered that daclizumab 150 mg is likely to be administered at 28 day intervals, rather than monthly intervals for any pricing considerations.PSD · Nov 2016
6.22 The submission described daclizumab as non-inferior in terms of comparative efficacy and safety compared to fingolimod. It also described daclizumab as superior in terms of efficacy and similar in terms of safety compared to IM IFN β-1a.PSD · Nov 2016
6.23 The PBAC considered there was substantial uncertainty with the indirect comparisons with fingolimod using either placebo or IM IFN β-1a as the common comparator. Given the wide confidence intervals and exchangeability issues with the indirect comparison, the PBAC did not consider the claim of non-inferior efficacy with fingolimod to be adequately supported.PSD · Nov 2016
6.2 The PBAC noted and welcomed the input from health care professionals (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described the value of an additional treatment option, and noted that in clinical trials, daclizumab had demonstrated efficacy, tolerability and safety against an active comparator and that the monthly administration would be advantageous for some patients on more frequently dosed treatments.PSD · Jul 2016
6.39 The submission noted that fingolimod is subject to a special pricing arrangement.PSD · Jul 2016
Cost-effectiveness
No ICER stated; this was a minor submission with no new economic evaluation presented.
Decision context
PopulationAdults with clinically definite relapsing-remitting multiple sclerosis (RRMS) diagnosed by MRI of the 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, and receiving daclizumab as monotherapy. Treatment must be initiated and managed by a neurologist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended | fingolimod (primary); dimethyl fumarate and ABCR therapies (interferon beta-1a, interferon beta-1b, glatiramer acetate) | — | RCT · PFS |
| Jul 2016 | Deferred | fingolimod | — | RCT · Relapse rate, disability progression |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| SELECT | Ph 2 | 621 | Adjusted Annualized Relapse Rate Between Baseline and Week 52 | completed |
Consumer voice
Health care professionals and organisations provided input describing the value of an additional treatment option. The comments were noted and welcomed by the PBAC.
The PBAC noted and welcomed the input from health care professionals (1) and organisations (2) via the Consumer Comments facility on the PBS website. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to RRMS with ≥2 attacks in 2 years, MRI-diagnosed, ambulatory, monotherapy; TGA label covers all relapsing forms.