Empagliflozin With LinagliptinGlyxambi
Type 2 diabetes mellitus in patients uncontrolled on dual oral therapy with either a DPP4 inhibitor or SGLT2 inhibitor in combination with metformin; also for dual therapy in treatment naïve patients with mild to moderate renal impairment uncontrolled on metformin or sulfonylurea monotherapy.
Decisions on record
- Meeting Nov 2017 Recommended Type 2 diabetes mellitus (T2DM)
- Meeting Mar 2017 Not recommended Type 2 diabetes
Access path
- TGA registered · Glyxambi
TGA label narrower than the PBS population
- Mar 2017Not recommended
inadequately defined clinical place in therapy, problematic implementation of restriction based on sulfonylurea…
- ↻ resubmittedNov 2017Recommended · restricted
Comparator changed: empagliflozin and linagliptin as individual components → Individual…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of empagliflozin with linagliptin for use in combination with metformin for the treatment of type 2 diabetes in patients uncontrolled on dual or triple therapy including metformin and a DPP4 or SGLT2 inhibitor.PSD · Nov 2017
7.2 The PBAC considered that the evidence presented in the submission supported a claim of non-inferior efficacy and safety for empagliflozin with linagliptin, compared to exenatide or insulin glargine, all in combination with metformin.PSD · Nov 2017
6.41 The resubmission did not present any economic analysis directly relating to the renal impairment population. The submission claimed that the price reduction was intended to account for the uncertainty regarding the cost-effectiveness of this listing. However, the benefit of this treatment was not adequately supported.PSD · Nov 2017
6.42 The pre-PBAC response proposed a discount of ''''''% on the previously requested approved ex-manufacturer price (AEMP) to account for uncertainty around the cost effectiveness of the FDC (the initial resubmission proposed a '''''% price reduction).PSD · Nov 2017
Empagliflozin with linagliptin FDC vs linagliptin or empagliflozin, in combination with metforminPSD · Nov 2017
6.35 The clinical claim was that empagliflozin with linagliptin FDC is superior in terms of efficacy and noninferior in terms of safety compared to either linagliptin or empagliflozin (in combination with metformin), and that empagliflozin with linagliptin FDC is bioequivalent to concomitant empagliflozin and linagliptin.PSD · Nov 2017
Cost-effectiveness
Cost-minimisation analyses presented; no ICER (incremental cost-effectiveness ratio) was calculated as comparisons were cost-minimisation only.
Decision context
PopulationAdults with type 2 diabetes mellitus uncontrolled on dual oral therapy including either a DPP4 inhibitor or SGLT2 inhibitor with metformin (HbA1c >7% or blood glucose >10 mmol/L); separately, treatment naïve patients with mild to moderate renal impairment (eGFR ≥45 <60 mL/min/1.73 m²) uncontrolled on metformin or sulfonylurea monotherapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended · restricted | Individual component products (empagliflozin and linagliptin); insulin glargine; exenatide; dapagliflozin with saxaglipt | — | RCT · HbA1c |
| Mar 2017 | Not recommended | empagliflozin and linagliptin as individual components | — | RCT · HbA1c |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Trial 1275.9 (NCT01734785) | Ph 3 | 607 | HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment | completed |
| Trial 1275.10 (NCT01778049) | Ph 3 | 708 | Change From Baseline of HbA1c After 24 Weeks of Treatment. | completed |
| EASIE (NCT00751114) | Ph 4 | 515 | HbA1c: Change From Baseline to Study Endpoint | completed |
| DURATION-2 (NCT00637273) | Ph 3 | 514 | Change in HbA1c From Baseline to Week 26 | completed |
| DURATION Neo 2 (NCT01652729) | Ph 3 | 365 | Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 | completed |
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 prior dual therapy or specific renal impairment criteria; TGA label permits use when both agents are appropriate without prior treatment failure requirement.