TirzepatideMounjaro
Treatment of adults with type 2 diabetes mellitus inadequately controlled with metformin, sulfonylurea, and/or insulin, who have failed or are intolerant/contraindicated to SGLT2 inhibitors.
Decisions on record
- Meeting Mar 2026 Recommended Type 2 diabetes mellitus (T2DM) no PSD
- Meeting Jul 2025 Deferred Type 2 diabetes mellitus inadequately controlled
- Meeting Nov 2024 Not recommended Diabetes mellitus type 2 with comorbid severe obesity or Aboriginal and Torres Strait Islander identity
- Meeting Jul 2023 Not recommended Type 2 Diabetes Mellitus (T2D)
Access path
- TGA registered · Mounjaro
TGA label narrower than the PBS population
- Jul 2023Not recommended
vs semaglutide, dulaglutide
- Nov 2024Not recommended
Comparator changed: semaglutide, dulaglutide → semaglutide
- Jul 2025Deferred
ICER dropped $35,000 → $30,000 (-14%)
- Mar 2026Recommended · restricted
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred making a recommendation for tirzepatide for the treatment of adult patients with inadequately controlled type 2 diabetes mellitus to allow further consultation with the sponsor regarding achieving a cost-effective listing. In deciding to defer making a recommendation, the PBAC considered that tirzepatide was not cost-effective at the prices proposed in the resubmission.PSD · Jul 2025
7.2 The PBAC noted the input from individuals, health care professionals and organisations which, consistent with both the July 2023 and November 2024 submission consumer comments, highlighted the benefits of treatment with tirzepatide including a significant reduction in glycated haemoglobin (HbA1c) and weight loss. The PBAC noted the input highlighted the high cost of tirzepatide in the private market as a barrier to access.PSD · Jul 2025
6.42 The resubmission presented a modelled economic evaluation of tirzepatide 10 mg and 15 mg once weekly compared to semaglutide 1 mg once weekly in patients using metformin background therapy based on clinical data from the SURPASS-2 trial with additional modelled data.PSD · Jul 2025
6.43 The resubmission also presented a scenario analysis comparing tirzepatide 5 mg once weekly with semaglutide 0.5 mg once weekly in patients using metformin background therapy based on an indirect comparison of the SURPASS-2 and SUSTAIN-7 trials with additional modelled data. The comparison of tirzepatide 5 mg once weekly with semaglutide 0.5 mg once weekly was considered as a supportive analysis and was not presented.PSD · Jul 2025
6.36 The resubmission described tirzepatide 5 mg once weekly as superior in terms of efficacy and non-inferior in terms of safety compared to semaglutide 0.5 mg once weekly in patients using metformin background therapy. The PBAC has previously considered that this claim was reasonable for efficacy but not safety (para 6.57 and 7.10, tirzepatide PSD, July 2023 PBAC meeting).PSD · Jul 2025
6.37 The resubmission did not make a clinical claim between tirzepatide 5 mg once weekly and semaglutide 1 mg once weekly in patients using metformin background therapy.PSD · Jul 2025
6.2 The PBAC noted and welcomed the input from individuals (115), health care professionals (7) and organisations (2) via the Consumer Comments facility on the PBS website. The PBAC noted that 77 of the 95 individuals who reported they have used this medicine for their own health condition did not indicate they had type 2 diabetes but instead provided input that focused on a PBS listing for weight loss.PSD · Jul 2025
6.3 The PBAC noted that the input received from health care professionals described the effectiveness of GLP-1 analogues in type 2 diabetes and the potential for additional benefits with the dual GLP-1/GIP actions of tirzepatide. The burden of type 2 diabetes in Aboriginal and Torres Strait Islander peoples was also highlighted.PSD · Jul 2025
Cost-effectiveness
The PBAC advised that an ICER in the order of $30,000 per QALY would be appropriate. The proposed effective price for tirzepatide was reduced to achieve an incremental cost per QALY of approximately $30,000 for tirzepatide 10 mg and 15 mg versus semaglutide 1 mg, but tirzepatide 5 mg versus semaglutide 1 mg remained substantially higher.
The PBAC reaffirmed its July 2023 advice that an ICER in the order of $30,000 per QALY would be appropriate. PBAC · 2026
Decision context
PopulationAdult patients with type 2 diabetes with BMI ≥35 kg/m² or who identify as Aboriginal and Torres Strait Islander peoples who are contraindicated, intolerant or inadequately controlled with SGLT2 inhibitors, on at least one of metformin, sulfonylurea, and/or insulin.
Risk sharingNew risk sharing arrangement consisting of a subsidisation cap with use beyond the nominated caps rebated to the government.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | semaglutide | $30k | RCT |
| Jul 2025 | Deferred | semaglutide | $30k | RCT · QoL |
| Nov 2024 | Not recommended | semaglutide | $35k–45k | RCT · HbA1c |
| Jul 2023 | Not recommended | semaglutide, dulaglutide | — | RCT · Glycaemic control and weight reduction |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| SURPASS-2 | Ph 3 | 1,879 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) | completed |
| SURPASS-4 | Ph 3 | 2,002 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) | completed |
| SURPASS-5 | Ph 3 | 475 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) | completed |
Consumer voice
Consumer input from 115 individuals, 7 healthcare professionals, and 2 organisations described benefits of tirzepatide for type 2 diabetes including improved blood glucose control, weight loss, and quality of life, while highlighting cost as a significant access barrier. Input also emphasized the substantial disease burden of type 2 diabetes, particularly in Aboriginal and Torres Strait Islander c
Input from individuals who reported they have used this medicine for type 2 diabetes described the benefits of tirzepatide use including improved daily blood glucose readings, improved HbA1c results and weight loss. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to later-line use (post-metformin/sulfonylurea/insulin failure) versus TGA's broader monotherapy or add-on indication.