SemaglutideOzempic
Treatment initiation and continuation in adults with established cardiovascular disease (myocardial infarction, stroke, or symptomatic peripheral arterial disease) and obesity, to reduce the risk of major adverse cardiovascular events.
Decisions on record
- Meeting Nov 2025 Recommended Established cardiovascular disease with obesity (BMI ≥35 kg/m² or ≥32.5 kg/m² for Asian, Aboriginal, Torres Strait Islander populations)
- Meeting Nov 2024 Recommended Diabetes mellitus type 2
- Meeting Nov 2023 Not recommended Severe obesity (post lifestyle-based weight management intervention)
- Meeting Mar 2022 Not recommended Obesity
- Meeting Mar 2021 Recommended Type 2 diabetes mellitus
- Meeting Mar 2020 Recommended Type 2 diabetes mellitus (T2DM)
- Meeting Nov 2019 Recommended Type 2 diabetes mellitus (T2DM)
Access path
- TGA registered · Ozempic
TGA label narrower than the PBS population
- Nov 2019Recommended
vs exenatide once weekly (main); dulaglutide once weekly…
- Mar 2020Recommended
Comparator changed: exenatide once weekly (main); dulaglutide once weekly (secondary) →…
- Mar 2021Recommended · restricted
- Mar 2022Not recommended
Population restriction narrower than clinical trial data and TGA indication without adequate justification; exclusion…
- ↻ resubmittedAug 2022Recommended · restricted
Evidence: RCT → Cost-minimisation
- Nov 2023Not recommended
Evidence: Cost-minimisation → RCT
- ↻ resubmittedNov 2024Recommended · restricted
Comparator changed: placebo → semaglutide 2 mg in 1.5 mL (1.34 mg/mL) pre-filled pen
- Nov 2025Recommended
Comparator changed: semaglutide 2 mg in 1.5 mL (1.34 mg/mL) pre-filled pen → placebo in…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended semaglutide for patients with established cardiovascular disease (eCVD) with obesity, in patients who have already experienced a cardiovascular event including myocardial infarction, stroke, or symptomatic peripheral arterial disease. The PBAC was satisfied that semaglutide provides, for some patients, a significant improvement in efficacy over standard of care.PSD · Nov 2025
7.2 The PBAC noted the input from individuals, health care professionals and organisations which highlighted the benefits of treatment with semaglutide for patients who have eCVD with obesity. The PBAC noted the input highlighted the high cost of semaglutide in the private market as a barrier to access.PSD · Nov 2025
6.52 The resubmission presented a stepped economic evaluation of semaglutide compared to placebo in patients with established cardiovascular disease who were overweight or obese. The resubmission presented the results for three alternative patient populations based on different BMI thresholds: ≥27 kg/m2 (consistent with the key trial population), ≥35 kg/m2 and ≥40 kg/m2. The economic evaluation was based on the SELECT trial with additional modelled data.PSD · Nov 2025
6.53 The economic evaluation was based on patient populations without pre-existing diabetes. No cost effectiveness estimates were provided for patients with pre-existing diabetes.PSD · Nov 2025
6.48 The resubmission described semaglutide as superior in terms of efficacy (in reducing major adverse cardiovascular events in patients with eCVD) and inferior in terms of safety compared to placebo. The ESC agreed with the evaluation that this claim was reasonable. 6.49 The following issues should be considered:PSD · Nov 2025
• The circumstances of use of semaglutide in the key trial may not be applicable to clinical practice. Real-world utilisation data suggest that patients undergo slower titration, remain on lower doses for maintenance and experience higher discontinuation rates compared to the trial. The evaluation considered these differences may lead to more modest treatment benefits than observed in the trial.PSD · Nov 2025
6.2 The PBAC noted and welcomed the input from individuals (5) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with semaglutide including reduced glycaemic variability, weight loss, and quality of life benefits including increased ability to work and provide care for family members.PSD · Nov 2024
Individuals noted mild gastrointestinal side effects and issues with accessing the medication due to shortages.PSD · Nov 2024
Cost-effectiveness
ICER values are redacted (shown as commercial-in-confidence in pricing table)
The PBAC considered that the listing of semaglutide 2 mg in 3 mL would not result in a net cost to the PBS. PBAC · 2024
Decision context
PopulationAdults aged ≥18 years with established cardiovascular disease (prior myocardial infarction, stroke, or symptomatic peripheral arterial disease) and BMI thresholds ranging from ≥27 kg/m² (or ≥25 kg/m² for Aboriginal/Torres Strait Islander/Asian persons) to ≥40 kg/m² (or ≥37.5 kg/m² for Aboriginal/Torres Strait Islander/Asian persons), depending on the selected option.
Risk sharingRisk sharing arrangement (RSA) noted as required by PBAC given extremely high estimated expenditure and criteria for defining patient population; special pricing arrangements proposed with lower effective DPMQs for lower dose strengths and higher effective DPMQ for 2.4 mg dose strength
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | placebo in combination with standard of care therapies | — | RCT · Cardiovascular event reduction |
| Nov 2024 | Recommended · restricted | semaglutide 2 mg in 1.5 mL (1.34 mg/mL) pre-filled pen | — | Single-arm · Bioequivalence |
| Nov 2023 | Not recommended | placebo | — | RCT · Weight loss and quality of life improvements |
| Aug 2022 | Recommended · restricted | — | — | Cost-minimisation |
| Mar 2022 | Not recommended | placebo | — | RCT · Weight loss |
| Mar 2021 | Recommended · restricted | dulaglutide 1.5 mg once weekly | — | RCT · HbA1c |
| Mar 2020 | Recommended | dulaglutide 1.5 mg once weekly | — | RCT · HbA1c and bodyweight |
| Nov 2019 | Recommended | exenatide once weekly (main); dulaglutide once weekly (secondary) | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Study 4649 (NCT04228354) | Ph 1 | 28 | Area under the semaglutide plasma concentration curve from 0 to tz | completed |
| Study 4387 (NCT03598621) | Ph 1 | 68 | AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 u… | completed |
| SUSTAIN 11 | Ph 3 | 2,274 | Change From Baseline in Glycated Haemoglobin (HbA1c) | completed |
Consumer voice
Five individuals provided consumer input describing benefits of semaglutide treatment including reduced glycaemic variability, weight loss, and quality of life improvements. Consumers also raised concerns about mild gastrointestinal side effects, medication access issues due to shortages, and requests for expanded PBS subsidisation.
The comments described a range of benefits of treatment with semaglutide including reduced glycaemic variability, weight loss, and quality of life benefits including increased ability to work and provide care for family members. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to established CVD with specific prior events (MI, stroke, PAD); excludes non-diabetic CVD patients without these criteria.