Empagliflozin, Empagliflozin With Metformin, Linagliptin, Linagliptin With Metformin
Type 2 Diabetes Mellitus in patients uncontrolled on dual oral therapy, for use in triple oral therapy (DPP4 inhibitor + SGLT2 inhibitor + metformin).
Access path
- Nov 2017Recommended · restricted
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the Authority Required (STREAMLINED) listing of empagliflozin, empagliflozin with metformin fixed dose combinations (FDC), linagliptin, and linagliptin with metformin FDCs, for use in triple oral therapy (DPP4 + SGLT2 + metformin) in patients with type 2 Diabetes Mellitus (T2DM) on the basis of acceptable cost-effectiveness demonstrated by the concurrent major submission for the empagliflozin and linagliptin FDC. 3PSD · Nov 2017
5.2 The PBAC recalled that at the November 2017 meeting, it recommended the listing of empagliflozin with linagliptin FDC for use in combination with metformin in patients with T2DM. The PBAC also recalled that it has previously accepted bioequivalence between empagliflozin with linagliptin FDC and the concomitant use of empagliflozin and linagliptin individual components (empagliflozin with linagliptin PSD, March 2017 para 7.6), as well as the …PSD · Nov 2017
4.5 This submission relied on the empagliflozin with linagliptin FDC major submission to the November 2017 PBAC meeting to establish the cost-effectiveness of thePSD · Nov 2017
Cost-effectiveness
This is a minor submission relying on evidence from a concurrent major submission (empagliflozin with linagliptin FDC). No separate economic analysis performed; cost-effectiveness established via reference to the concurrent major submission.
This submission relied on the empagliflozin with linagliptin FDC major submission to the November 2017 PBAC meeting to establish the cost-effectiveness of the requested listing. PSD · 2017
Decision context
PopulationPatients with type 2 Diabetes Mellitus who are uncontrolled on dual oral therapy and require triple oral therapy with a DPP4 inhibitor, SGLT2 inhibitor, and metformin.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended · restricted | — | — | Other |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients uncontrolled on dual oral therapy requiring triple therapy; TGA label permits use from monotherapy onward.