Eltrombopag OlamineELTROMBOPAG-RZ
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.
Decision on record
- Meeting Jul 2013 Not recommended Decreased platelet count
Access path
- TGA registered · ELTROMBOPAG-RZ
TGA label narrower than the PBS population
- Nov 2010Recommended
vs romiplostim
- PBS listing · Authority Required
Cost-effectiveness
Cost minimisation analysis presented; no ICER calculated as the submission claimed equi-effectiveness but PBAC rejected this claim due to uncertain clinical effectiveness
The PBAC considered that there was insufficient evidence to draw any reliable conclusions regarding the comparative safety of eltrombopag and romiplostim in patients with chronic ITP. In particular, there were no comparative safety data on the long-term use of these treatments. PBAC · 2010
Decision context
Populationadult patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP)
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2010 | Recommended | romiplostim | — | RCT · Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to splenectomised patients or non-splenectomised with failed corticosteroids/immunoglobulins and contraindicated splenectomy; TGA label broader.