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Gastroenterology

Etrasimod

Brand: Velsipity

PBAC's latest decision on Etrasimod: Recommended with restriction (2024). Considered for Treatment of patients 16 years and older with moderate to severe ulcerative colitis (MSUC).

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2024
Submissions
1
2024 → 2024

Eligible population

Adults 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).

Therapy area
Gastroenterology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Clinical remission and clinical response
Key trials
ELEVATE UC 12, ELEVATE UC 52, True North, Touchstone, ACT 1, ACT 2, Jiang 2015, Kobayashi 2016, Remicade, ULTRA 1, ULTRA 2, Suzuki 2014
Comparator
ozanimod (primary)
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach; no ICER calculated. Economic evaluation based on cost equivalence between ETR and OZA at equi-effective doses over 104 weeks.

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