PrasugrelPrasugrel Lupin
Treatment of acute coronary syndrome (myocardial infarction or unstable angina) managed by percutaneous coronary intervention (PCI), in combination with aspirin.
Decisions on record
- Meeting Jul 2024 Recommended Acute coronary syndrome managed by percutaneous coronary intervention
- Meeting Mar 2024 Not recommended Acute coronary syndrome (ACS)
- Meeting Jul 2009 Recommended Antiplatelet drug
Access path
- TGA registered · Prasugrel Lupin
TGA label narrower than the PBS population
- Jul 2009Recommended · restricted
vs clopidogrel
- Mar 2024Not recommended
Comparator changed: clopidogrel → ticagrelor
- ↻ resubmittedJul 2024Recommended
Comparator changed: ticagrelor → ticagrelor and clopidogrel
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended prasugrel, in combination with aspirin, for the treatment of acute coronary syndrome (ACS) i.e., myocardial infarction (MI) or unstable angina, managed by percutaneous coronary intervention (PCI). The PBAC noted that the early re-entry resubmission had satisfactorily addressed the outstanding issues and considered that the cost minimisation approach (CMA) presented, which was based 9PSD · Jul 2024
5.2 The PBAC noted that the proposed restriction appropriately included a criterion stating that treatment should be ceased if a PCI is not performed. Further, the PBAC noted that that criterion that patients must have previously had a PCI planned should be removed and that the prescriber note recommending that patients aged over 75 years or weighing less than 60 kg should use a 5 mg/day dose should be amended to “Patient must be treated with the …PSD · Jul 2024
4.10 At the March 2024 PBAC meeting, the PBAC, noted that there were numerous errors and issues with the modelled evaluation and overall, considered that the model was uninformative as the claim of superior efficacy was not accepted. The PBAC considered that an early re-entry submission should present: i. a CMA between prasugrel and clopidogrel incorporating drug costs only.PSD · Jul 2024
4.11 The resubmission presented a weighted CMA versus ticagrelor and clopidogrel; however, based on Australian treatment guidelines and prescribing data from the PBS, the resubmission considered that a weighting of 60% ticagrelor and 40% clopidogrel was more accurate.PSD · Jul 2024
4.3 The resubmission acknowledged that there were inherent uncertainties in the clinical claim based on the evidence provided and accepted the PBAC’s assessment in March 2024 that prasugrel (in combination with aspirin) was non-inferior compared to ticagrelor (in combination with aspirin) in terms of efficacy. The claim that prasugrel was non-inferior compared to ticagrelor in terms of safety was unchanged.PSD · Jul 2024
4.4 In the March 2024 submission, prasugrel (in combination with aspirin) was described as superior in terms of effectiveness and non-inferior in terms of safety compared with ticagrelor (in combination with aspirin).PSD · Jul 2024
Cost-effectiveness
Cost-minimisation analysis (CMA) only; no ICER calculated as prasugrel was assessed as non-inferior to comparators on efficacy and safety grounds.
The PBAC considered that a weighted CMA based on the expected replacement of clopidogrel and ticagrelor would be reasonable. PBAC · 2024
Decision context
PopulationAdults aged ≥18 years with acute coronary syndrome (myocardial infarction or unstable angina) managed by percutaneous coronary intervention (PCI), treated in combination with aspirin, excluding those with a known history of stroke or transient ischaemic attack.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended | ticagrelor and clopidogrel | — | Cost-minimisation · Cost-minimisation |
| Mar 2024 | Not recommended | ticagrelor | — | RCT · Composite of death, MI or stroke; mortality (all cause), stroke, MI, stent thrombosis, bleeding |
| Jul 2009 | Recommended · restricted | clopidogrel | $15k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ISAR-REACT 5 | Ph 4 | 4,018 | Composite of death, myocardial infarction or stroke | completed |
Consumer voice
No consumer comments were received for this item. One comment from NACHHO in March 2024 noted that a small number of patients were accessing prasugrel privately.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC excludes patients with prior stroke or TIA history, whereas TGA label includes all moderate-to-high-risk ACS patients regardless of stroke history.