Icosapent EthylVAZKEPA
Treatment of patients with atherosclerotic cardiovascular disease (ASCVD) and elevated triglycerides (≥1.7 mmol/L and <5.6 mmol/L) who are receiving statin therapy to reduce the risk of cardiovascular events.
Decisions on record
- Meeting Mar 2024 Recommended Atherosclerotic cardiovascular disease with elevated triglycerides
- Meeting Nov 2023 Not recommended Atherosclerotic cardiovascular disease with elevated triglycerides
Access path
- TGA registered · VAZKEPA
TGA label narrower than the PBS population
- Nov 2023Not recommended
vs standard of care (dietary modification, lifestyle…
- ↻ resubmittedMar 2024Recommended · restricted
Comparator changed: standard of care (dietary modification, lifestyle interventions, and…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the listing of icosapent ethyl, on the basis that it should be available as a General Schedule Authority Required (STREAMLINED) listing for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD) and elevated triglycerides.PSD · Mar 2024
5.2 The PBAC recalled it had previously noted that based on results of the secondary prevention cohort from the REDUCE-IT trial, icosapent ethyl was associated with a statistically significant improvement in the two key outcomes, the 5-point major cardiac event (MACE) outcome (HR = 0.73; 95% CI: 0.65, 0.81) and the 3-point MACE outcome (HR = 0.72; 95% CI: 0.63, 0.82), and all the secondary outcomes, with the exception of total (all cause) mortality in the …PSD · Mar 2024
4.7 In November 2023, the PBAC considered that the base case ICER presented in the submission ($25,000 to < $35,000 per QALY) was significantly underestimated and included a number of parameters favourable to icosapent ethyl (paragraph 7.12, icosapent ethyl minutes, November 2023). The PBAC suggested three changes to the model which increased the ICER to $55,000 to < $75,000 per QALY:PSD · Mar 2024
• Increasing the 3% adjustment to the cardiovascular events in the placebo arm to 7% to better reflect the potential negative impact of the use of mineral oil;PSD · Mar 2024
events with an inferior but manageable safety profile. Source: Table 1.1.1, p25 of the submission. LDL = low-density lipoprotein; MI = myocardial infarction. For more detail on PBAC’s view, see section 5 PBAC outcome.PSD · Mar 2024
4.3 The November 2023 submission described icosapent ethyl as superior in terms of effectiveness with an inferior, but manageable, safety profile compared with placebo (as a proxy for standard of care).PSD · Mar 2024
6.3 The PBAC noted and welcomed the input from health care professionals (4) via the Consumer Comments facility on the PBS website. The comments described the benefits of treatment with icosapent ethyl, including the lowering of triglyceride levels and the risk of cardiovascular events in those with ASCVD, as well as reducing overall mortality rates.PSD · Nov 2023
4.21 In November 2023, the PBAC advised that an RSA would be required which consisted of expenditure caps based on the revised financial estimates, including a lower price, beyond which % rebates would apply (paragraph 7.15, icosapent ethyl minutes, November 2023).PSD · Mar 2024
Cost-effectiveness
Decision context
PopulationAdult patients with atherosclerotic cardiovascular disease (ASCVD) with triglyceride level ≥1.7 mmol/L and <5.6 mmol/L, and LDL cholesterol level >1.0 mmol/L and ≤2.6 mmol/L, receiving statin therapy.
Risk sharingTwo-tiered RSA with expenditure caps based on revised financial estimates and lower price, with rebates applying between tiers and above the second tier.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | standard of care | $45k–55k | RCT · Surrogate |
| Nov 2023 | Not recommended | standard of care (dietary modification, lifestyle interventions, and concomitant optimisation of LDL cholesterol lowerin | — | RCT · Cardiovascular events (nonfatal MI, nonfatal stroke, hospitalisation for unstable angina, coronary revascularisation, cardiovascular death, all-cause mortality) |
Consumer voice
hearts4heart welcomed the potential listing of a therapeutic treatment to manage triglyceride-associated residual cardiovascular risk as an additional option for managing ASCVD risk factors.
the listing of a therapeutic treatment to manage triglyceride associated residual cardiovascular risk would be a welcome addition to the options available which focus on other risk factors associated with ASCVD Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ASCVD only, excludes diabetes-without-ASCVD, and adds upper triglyceride and LDL cholesterol limits.