Etrasimod
Treatment of patients 16 years and older with moderate to severe ulcerative colitis (MSUC).
Decision on record
- Meeting Mar 2024 Recommended Moderate to severe ulcerative colitis (MSUC)
Access path
- Mar 2024Recommended · restricted
vs ozanimod (primary)
- PBS listing · Authority Required
From the public summary
The PBAC recommended the General Schedule, Authority Required (in writing) listing of etrasimod (ETR) for the treatment of moderate to severe ulcerative colitis (MSUC).PSD · Mar 2024
The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost effectiveness of ETR would be acceptable if it were cost minimised to the least costly alternative biologic or targeted synthetic biologic disease modifying anti-rheumatic drug (b/tsDMARD) therapy out of infliximab (IFX), tofacitinib (TOF), ozanimod (OZA), vedolizumab (VDZ), ustekinumab (UST) and golimumab (GOL).PSD · Mar 2024
The submission presented a cost-minimisation approach between ETR versus OZA, based on published AEMP of OZA because the effective AEMP was unknown to the sponsor. The submission stated that the calculations would need to be updated during the post-PBAC process using the effective AEMP of OZA following a positive recommendation for listing.PSD · Mar 2024
• OZA 0.23 mg orally daily for four days, then OZA 0.46 mg orally daily for three days, then OZA 0.92 mg orally daily thereafter.PSD · Mar 2024
Based on the results from the indirect treatment comparisons, the submission described ETR as having non-inferior effectiveness and non-inferior safety versus OZA and IFX, and superior effectiveness and non-inferior safety versus ADA.PSD · Mar 2024
Notwithstanding that potential transitivity issues may impact the reliability of the indirect treatment comparisons, the evaluation and ESC considered the results of the indirect treatment comparisons presented in the submission reasonably supported the clinical claim of non-inferior effectiveness versus OZA and IFX and non-inferior safety versus OZA, IFX and ADA.PSD · Mar 2024
The PBAC noted and welcomed the input from health care professionals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comments from the health professional described the efficacy of ETR in MSUC, the difference with OZA as it does not require a dose titration period, and that unlike some b/tsDMARDs ETR does not appear to lead to an increased risk of infections during treatment.PSD · Mar 2024
Cost-effectiveness
Cost-minimisation approach; no ICER calculated. Economic evaluation based on cost equivalence between ETR and OZA at equi-effective doses over 104 weeks.
Decision context
PopulationAdults and adolescents aged 16 years and older with moderate to severe ulcerative colitis (MSUC) who have failed standard therapies including 5-aminosalicylates, azathioprine or 6-mercaptopurine, or oral corticosteroids with thiopurine agents, with a Mayo clinic score ≥6 or partial Mayo score ≥6 (with rectal bleeding and stool frequency subscores both ≥2).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | ozanimod (primary) | — | RCT · Clinical remission and clinical response |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ELEVATE UC 12 | Ph 3 | 354 | Percentage of Participants Achieving Clinical Remission | completed |
Consumer voice
A health professional described etrolizumab's efficacy in moderate-to-severe ulcerative colitis, its advantage of not requiring dose titration unlike ozanimod, and a lower infection risk profile compared to other b/tsDMARDs. Crohn's and Colitis Australia supported the listing, emphasizing the value of additional oral treatment options and etrolizumab's simpler dose titration compared to other S1P
The comments from the health professional described the efficacy of ETR in MSUC, the difference with OZA as it does not require a dose titration period, and that unlike some b/tsDMARDs ETR does not appear to lead to an increased risk of infections during treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who failed prior therapies and meet specific Mayo clinic score thresholds; TGA label has no such requirements.