Ticagrelor00
Treatment of acute coronary syndrome (ACS) in combination with aspirin for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in adult patients.
Decisions on record
- Meeting Mar 2023 Not recommended Acute coronary syndrome (ACS)
- Meeting Jul 2011 Recommended Acute coronary syndrome
Access path
- TGA registered · 00
TGA label narrower than the PBS population
- Jul 2011Recommended
vs clopidogrel
- Mar 2023Not recommended
Unreasonable assumption of nil financial impact; disparity in price between clopidogrel and ticagrelor would result in…
From the public summary
5.1 The PBAC did not recommend a change to the restriction level of ticagrelor (Brilinta®) for the treatment of acute coronary syndrome (ACS) from Authority Required (STREAMLINED) to Unrestricted Benefit (as per submission’s initial request) or 4PSD · Mar 2023
5.2 The PBAC considered that the submission’s assumption of no increase in the uptake of ticagrelor and no financial impact was unreasonable. The PBAC noted prescribers’ familiarity with prescribing ticagrelor and its established place in therapy in practice, however, considered that this did not preclude potential substitution for clopidogrel.PSD · Mar 2023
Cost-effectiveness
This is a Category 3 submission (change to restriction level) with no new economic evaluation; no ICER calculated or presented.
The PBAC suggested any resubmission requesting a restricted benefit for ticagrelor should be presented on a cost-minimisation basis to clopidogrel. PBAC · 2023
Decision context
PopulationAdult patients with acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction) treated in combination with aspirin.
Risk sharingTicagrelor was previously subject to a Deed of Agreement with a Risk Sharing Arrangement encompassing subsidisation caps; the Deed was terminated in 2017 following the end of the nominal Deed Term.
Why it was knocked back
- Unreasonable assumption of nil financial impact; disparity in price between clopidogrel and ticagrelor would result in costs to the Commonwealth if uptake increased; no additional clinical benefits from unrestricting; prescriber confusion claim disagreed with by PBAC; inappropriate comparator nominated.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Not recommended | clopidogrel | — | Not applicable |
| Jul 2011 | Recommended | clopidogrel | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| PLATO | Ph 3 | 18,624 | Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial I… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC omits TGA's explicit coverage of patients managed with percutaneous coronary intervention or CABG.