BaricitinibOlumiant
Initial and continuing treatment of adults with severe atopic dermatitis who have failed to achieve an adequate response to topical corticosteroids and/or topical calcineurin inhibitors.
Decisions on record
- Meeting Jul 2021 Not recommended Severe atopic dermatitis
- Meeting Mar 2018 Recommended Severe active rheumatoid arthritis (RA)
- Meeting Nov 2017 Deferred Severe active rheumatoid arthritis
- Meeting Jul 2017 Deferred Severe active rheumatoid arthritis
Access path
- TGA registered · Olumiant
TGA label narrower than the PBS population
- Jul 2017Deferred
vs adalimumab
- Nov 2017Deferred
Comparator changed: adalimumab → tofacitinib
- Mar 2018Recommended
Comparator changed: tofacitinib → tofacitinib (cost-minimisation basis); least costly…
- Jul 2021Not recommended
Comparator changed: tofacitinib (cost-minimisation basis); least costly biological DMARD…
From the public summary
The PBAC did not recommend the listing of baricitinib (BARI) for the treatment of adults with severe atopic dermatitis (AD). Whilst the PBAC accepted that the claim of inferior efficacy of BARI compared to dupilumab (DUPI) was reasonable, the magnitude of difference in response was uncertain. The PBAC also considered that the safety profile for BARI is inferior to DUPI and noted concerns remain regarding the long-term safety of BARI.PSD · Jul 2021
The PBAC noted that BARI is a novel medicine, as no other Janus Kinase (JAK) inhibitors are available on the PBS for AD. The PBAC acknowledged the clinical need for additional alternative systemic treatments for severe atopic dermatitis, but considered that there was limited additional need, given the availability of DUPI for patients with severe AD.PSD · Jul 2021
The submission presented a comparison of BARI to DUPI, using the doses recommended for AD (BARI 2 mg/4 mg once daily and DUPI 600 mg as an initial dose, then 300 mg every two weeks, thereafter). The analysis was based on an equivalent cost over a 2-year period to capture differences in dosing regimens and medicine- specific monitoring (additional routine monitoring costs are required with BARI treatment), less a ''''''''''% discount on the total costs to …PSD · Jul 2021
Given the clinical conclusion was inferior effectiveness versus DUPI, a more appropriate approach would have been a cost effectiveness analysis (see PBAC Guidelines v5 p60). The submission’s cost comparison is unlikely to capture the full cost and consequences of BARI listing on the PBS.PSD · Jul 2021
with severe AD for whom an adequate response has not been achieved with TCS. Source: Table 1.1-1, p34 of the submission.PSD · Jul 2021
Abbreviations: AD=atopic dermatitis; TCS=topical corticosteroids; IGA=investigator’s global assessment of the patient’s overall severity of their AD; EASI=Eczema Area and Severity Index; SCORAD=Scoring Atopic Dermatitis; DLQI=Dermatology Life Quality Index; POEM=Patient Oriented Eczema Measure; NRS=Numerical Rating Scale; EASI50/75=50/75% improvement in EASI score. 1PSD · Jul 2021
The PBAC noted the advice received from AD support groups: Eczema Support Australia and Allergy & Anaphylaxis Australia (A&AA). The organisations noted that patients with AD vary in response to treatments as well as contraindications and side effects from treatments and, therefore, access to alternatives to DUPI are highly valued by patients and clinicians.PSD · Jul 2021
Eczema Support Australia noted that disease management is complex, and currently 8PSD · Jul 2021
Cost-effectiveness
ICER value is redacted (commercially sensitive); the submission proposed a relative price discount for BARI compared to DUPI but specific ICER figures are not published in this PSD.
The PBAC accepted that a cost-minimisation against the least costly comparator might be a reasonable approach. PBAC · 2018
Decision context
PopulationAdults with severe atopic dermatitis (PGA score of 4 and EASI score ≥20, or severe AD of the face or palm of hand) who have failed to achieve an adequate response to topical therapies.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Not recommended | dupilumab | — | RCT |
| Mar 2018 | Recommended | tofacitinib (cost-minimisation basis); least costly biological DMARD | — | RCT · ACR20 |
| Nov 2017 | Deferred | tofacitinib | — | Meta-analysis · ACR20 |
| Jul 2017 | Deferred | adalimumab | — | RCT · ACR20 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| JADV (RA-BEAM) | Ph 3 | 1,307 | Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR… | completed |
| JADW (RA-BEACON) | Ph 3 | 527 | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response… | completed |
| JADX (RA-BUILD) | Ph 3 | 684 | Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR… | completed |
| JADZ (RA-BEGIN) | Ph 3 | 588 | Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR… | completed |
| JADY (RA-BEYOND) | Ph 3 | 2,877 | Number of Participants Who Experienced Adverse Events (AEs) or Serious AE | completed |
Consumer voice
Consumers and AD support organisations emphasised the variability of treatment response and side effects among patients with atopic dermatitis, and highlighted the value of treatment alternatives to dupilumab. They noted that disease management is complex and that access to multiple treatment options is important for patients and clinicians.
patients with AD vary in response to treatments as well as contraindications and side effects from treatments and, therefore, access to alternatives to DUPI are highly valued by patients and clinicians Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe AD with documented failure of topical therapies; TGA label includes moderate-to-severe without prior treatment requirement.