script.reportAU
Rheumatology

Sarilumab

Brand: Kevzara

PBAC's latest decision on Sarilumab: Not recommended (2018). Considered for Severe active rheumatoid arthritis in adult patients who have had an inadequate response to conventional disease-modifying anti-rheumatic drugs (cDMARDs).

PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2018
Submissions
1
2018 → 2018

Eligible population

Adults with severe active rheumatoid arthritis and inadequate response to conventional disease-modifying anti-rheumatic drugs (cDMARDs), with no prior PBS-subsidised biologic DMARD treatment in the previous 12 months.

Therapy area
Rheumatology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ACR response (20%, 50%, 70%) at Week 12 and 24
Key trials
MOBILITY-B, TARGET, MONARCH, OPTION, MEASURE, LITHE, TOWARD, ROSE, BREVACTA, RADIATE, ADACTA, SUMMACTA, EXTEND
Comparator
tocilizumab subcutaneous formulation
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; ICER not applicable by design.

Why PBAC said no

Reasons cited in the latest PSD: Pricing concerns regarding the 150mg formulation resulting in price advantage (double the cost) compared to tocilizumab at reduced dosages for adverse event management; streamlined authority listing deemed inappropriate; wording of restrictions required clarification regarding total treatment durations.

Similar precedents

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