Romiplostim
Treatment of thrombocytopaenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who are non-splenectomised with inadequate response or intolerance to corticosteroids and immunoglobulins, or splenectomised with inadequate response to splenectomy.
Decisions on record
- Meeting Jul 2010 Recommended Idiopathic thrombocytopenia purpura (ITP)
- Meeting Mar 2010 Recommended Increases platelet production
- Meeting Jul 2009 Not recommended Thrombocytopenia
Access path
- Jul 2009Not recommended
uncertain long-term efficacy (24-week trial data only), unclear clinical place and population definition, surrogate…
- ↻ resubmittedMar 2010Recommended · restricted
- Mar 2010Recommended · restricted
- Jul 2010Recommended · restricted
- Jul 2010Recommended · restricted
- PBS listing · Authority Required
Cost-effectiveness
The PBAC accepted that the ICERs for splenectomised and non-splenectomised patients represented acceptable cost effectiveness, in the context of high clinical need. PBAC · 2010
Decision context
PopulationAdult patients with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who are splenectomised or non-splenectomised with inadequate response or intolerance to corticosteroids and immunoglobulins, with platelet counts ≤20 x 10^9/L or 20-30 x 10^9/L with significant bleeding.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2010 | Recommended · restricted | placebo | $45k–75k | RCT · QoL | other |
| Jul 2010 | Recommended · restricted | placebo | $45k–75k | RCT |
| Mar 2010 | Recommended · restricted | placebo | $45k–75k | RCT |
| Mar 2010 | Recommended · restricted | placebo | $45k–75k | RCT · Platelet response |
| Jul 2009 | Not recommended | placebo | $15k–75k | RCT · surrogate outcome: platelet count |
Similar precedents
Regulatory · TGA
Label broader than PBS population — PBAC recommends 'any' adult chronic ITP patients; TGA label restricts to those with prior treatment failure or intolerance.
Listed in law
PBS listings commencing 1 Jan 2023 were made by these 8 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 108 of 2022 | 14 Dec 2022 | Repealed | PDF ↗ |
| PB 108 of 2022 | 14 Dec 2022 | Repealed | PDF ↗ |
| PB 120 of 2022 | 22 Dec 2022 | Repealed | PDF ↗ |
| PB 120 of 2022 | 22 Dec 2022 | Repealed | PDF ↗ |
| PB 121 of 2022 | 22 Dec 2022 | Repealed | PDF ↗ |
| PB 122 of 2022 | 22 Dec 2022 | Repealed | PDF ↗ |
| PB 122 of 2022 | 22 Dec 2022 | Repealed | PDF ↗ |
| PB 126 of 2022 | 22 Dec 2022 | Repealed | PDF ↗ |