Romiplostim And Eltrombopag
Treatment of immune thrombocytopenia (ITP) in adults and children. The submission reviews extensions to current PBS restrictions including sequential use between the two TPO-RAs, use as an alternative to splenectomy, paediatric use, and platelet count criteria for treatment initiation and continuation.
Decisions on record
- Meeting May 2022 Recommended Primary immune thrombocytopenia (ITP)
- Meeting Nov 2021 Recommended Idiopathic thrombocytopenic purpura (ITP) no PSD
Access path
- May 2022Recommended
vs not applicable — this is a restriction review, not a new…
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended the proposed extension to the restrictions of romiplostim and eltrombopag. The PBAC noted that since the listing of TPO-RAs on the PBS a decade ago, the safety and efficacy of these medicines is now better understood, with TPO-RAs now being the standard of care for refractory ITP as per International and Australian Guidelines.PSD · May 2022
• switching between eltrombopag and romiplostim be allowed at any time and wording in the restriction about switching within 24 weeks be removed to mitigate any confusion among prescribersPSD · May 2022
Cost-effectiveness
This is a restriction review of existing PBS listings (2009–2014). No new economic evaluation or ICER is presented; the submission addresses clinical practice updates and safety/efficacy reassessment.
The PBAC noted that since the listing of TPO-RAs on the PBS a decade ago, the safety and efficacy of these medicines is now better understood, with TPO-RAs now being the standard of care for refractory ITP as per International and Australian Guidelines. PBAC · 2022
Decision context
PopulationAdults and children with chronic immune thrombocytopenia (ITP) who have failed or are intolerant to corticosteroids and immunoglobulins; includes both splenectomised and non-splenectomised patients.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2022 | Recommended | not applicable — this is a restriction review, not a new drug submission with economic comparison | — | Registry |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use after corticosteroid/immunoglobulin failure; TGA label permits first-line use in treatment-naïve patients.