PBAC's latest decision on Eltrombopag olamine: Not recommended (2010). Considered for For initial treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of an adult patient with chronic immune (idiopathic) thrombocytopenia purpura (ITP) who is:
- Splenectomised and:
- who has an inadequate response to splenectomy, OR
- who requires additional chronic intervention to maintain a response post splenectomy where the intervention is associated with unacceptable toxicity; OR
- Non splenectomised and who has had an inadequate response to, or is intolerant to, both corticosteroids and immunoglobulins, and in whom splenectomy is contraindicated.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2010
Submissions
1
2010 → 2010
Eligible population
adult patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP)
Therapy area
Haematology
Line of therapy
Second-line | Later-line
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
RAISE, Kuter 2008S, Kuter 2008NS
Comparator
romiplostim
Economic model
Cost-minimisation
ICER note
Cost minimisation analysis presented; no ICER calculated as the submission claimed equi-effectiveness but PBAC rejected this claim due to uncertain clinical effectiveness
Why PBAC said no
Reasons cited in the latest PSD: Uncertain clinical effectiveness compared to romiplostim, considerable uncertainty in indirect comparison due to non-exchangeable trials with differences in patient populations and trial conduct, point estimates favoured romiplostim, non-inferiority margins not defined, insufficient evidence on comparative safety, incomplete cost-minimisation analysis ignoring resource utilisation differences including IVIg use uncertainty