DulaglutideTrulicity
Treatment of type 2 diabetes. The submission concerns temporary supply of an overseas-sourced version to address shortage caused by increased demand due to semaglutide shortage.
Decisions on record
- Meeting Jul 2024 Noted Type 2 diabetes mellitus no PSD
- Meeting May 2022 Recommended Type 2 diabetes mellitus (T2DM) in combination with metformin no PSD
- Meeting Mar 2022 Deferred Type 2 diabetes mellitus
- Meeting Jul 2020 Recommended Type 2 Diabetes Mellitus (T2DM)
- Meeting Nov 2019 Deferred Type 2 diabetes mellitus (T2DM)
- Meeting Nov 2017 Recommended Type 2 diabetes mellitus (T2DM)
Access path
- TGA registered · Trulicity
TGA label equal than the PBS population
- Nov 2017Recommended
vs exenatide once weekly (main) and exenatide twice daily…
- Nov 2019Deferred
Comparator changed: exenatide once weekly (main) and exenatide twice daily…
- Jul 2020Recommended
Comparator changed: exenatide 10 mcg twice daily → exenatide 10 mcg BID
- May 2022Recommended
Comparator changed: exenatide 10 mcg BID → dulaglutide 1.5 mg
- Oct 2022Recommended · restricted
Evidence: RCT → Cost-minimisation
- PBS listing · Restricted
From the public summary
The PBAC deferred making its decision on whether to recommend the listing of dulaglutide 3.0 mg and 4.5 mg for the treatment of Type II Diabetes Mellitus (T2DM) in combination with metformin as a TGA Delegate’s Overview was not available at the time of PBAC consideration. The PBAC was of a mind to recommend dulaglutidePSD · Mar 2022
3.0 mg and 4.5 mg on a cost-minimisation basis compared to dulaglutide 1.5 mg pending receipt of a positive TGA Delegate’s Overview.PSD · Mar 2022
Although the clinical data from the AWARD-11 trial indicated a dose response relationship to efficacy (based on reduction in HbA1c) for dulaglutide 1.5 mg vs dulaglutide 3.0 mg vs dulaglutide 4.5 mg, the submission proposed that for pricingPSD · Mar 2022
The submission described dulaglutide 3.0 mg and 4.5 mg as non-inferior in terms of effectiveness compared to dulaglutide 1.5 mg. The PBAC considered this claim was adequately supported. 7PSD · Mar 2022
The PBAC noted and welcomed the input from individuals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comment from the individual described their experience using Ozempic® (semaglutide) for weight loss and was therefore not directly relevant to the submission.PSD · Mar 2022
Diabetes Australia supported listing dulaglutide 3 mg and 4.5 mg on the PBS. Diabetes Australia highlighted the importance of ensuring access to medicines for T2DM noting that the number of people developing the condition is likely to continue increasing.PSD · Mar 2022
No risk sharing arrangement was proposed. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2022
Cost-effectiveness
This is a minor submission for temporary listing of an alternative source product in response to supply shortage; no economic evaluation required.
The PBAC did not support listing at the requested price as it considered that the s19A listing should not come at an increased cost. PBAC · 2022
Decision context
PopulationPatients with type 2 diabetes requiring dulaglutide treatment during supply shortage period.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Oct 2022 | Recommended · restricted | — | — | Cost-minimisation |
| May 2022 | Recommended | dulaglutide 1.5 mg | — | RCT · Surrogate |
| Jul 2020 | Recommended | exenatide 10 mcg BID | — | Cost-minimisation · Cost-minimisation |
| Nov 2019 | Deferred | exenatide 10 mcg twice daily | — | RCT · HbA1c |
| Nov 2017 | Recommended | exenatide once weekly (main) and exenatide twice daily (supplementary) | — | RCT · HbA1c reduction |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| AWARD-11 | Ph 3 | 1,842 | Change in Hemoglobin A1c (HbA1c) From Baseline | completed |
| SUSTAIN 7 | Ph 3 | 1,201 | Change in HbA1c | completed |
| AWARD-1 | Ph 3 | 978 | Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) | completed |
| AWARD-2 | Ph 3 | 810 | Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) | completed |
| AWARD-9 | Ph 3 | 300 | Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) | completed |
Consumer voice
Diabetes Australia supported listing dulaglutide 3 mg and 4.5 mg on the PBS, highlighting the importance of ensuring access to medicines for type 2 diabetes and noting that the AWARD-11 trial results support including these doses to provide treatment options for managing T2DM.
Diabetes Australia supported listing dulaglutide 3 mg and 4.5 mg on the PBS. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both indicate treatment of type 2 diabetes; PBAC's temporary supply context does not narrow the therapeutic indication itself.