Ozanimod

PBAC's latest decision on Ozanimod: Recommended with restriction (2022). Considered for Treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response, lost response, or were intolerant to standard treatment.

Eligible population

Adult patients with moderate to severe ulcerative colitis (Mayo score ≥6) who have had an inadequate response, lost response, or intolerance to standard medical management.

Therapy area

Gastroenterology

Line of therapy

Later-line

Evidence base

RCT

Primary endpoint

Clinical remission, clinical response, endoscopic improvement

Pivotal trial size

1,012 patients

Key trials

True North, Touchstone, ULTRA-1, ULTRA-2, Suzuki 2014

Comparator

infliximab (primary); adalimumab, vedolizumab, golimumab, tofacitinib (secondary)

Economic model

Cost-minimisation

ICER note

Cost minimisation approach; no ICER calculated. PBAC recommended listing on basis of cost minimisation with the least costly alternative therapy.

Submission history

• Mar 2020: Recommended with restriction · Authority Required
• Mar 2022: Recommended with restriction · Authority Required
• Nov 2022: Recommended with restriction · Authority Required

Similar precedents

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