Lixisenatide
Treatment of type 2 diabetes in combination with insulin, in patients with inadequate glycaemic control despite treatment with insulin and oral antidiabetic agents.
Decision on record
- Meeting Jul 2014 Not recommended lixisenatide 20 micrograms/0.2 mL injection, 28 unit doses, Lyxumia® Sanofi-Aventis Australia Pty Ltd New listing (Major submission) Type 2 diabetes Authority required (Streamlined) listing for treatment of diabetes mellitus type 2 as triple combination therapy with basal insulin and either metformi
Access path
- Jul 2014Not recommended
Comparator changed: exenatide (twice daily) → rapid-acting/short-acting components of…
- Jul 2014Not recommended
Comparator changed: exenatide (twice daily) → rapid-acting/short-acting components of…
From the public summary
7.1 The PBAC rejected the submission on the basis that lixisenatide’s non-inferiority to exenatide (twice daily) had not been adequately established. Therefore the PBAC did not accept the basis of the submission’s cost-minimisation analysis against exenatide.PSD · Jul 2014
7.2 The PBAC noted that the requested listing did not permit use of lixisenatide in combination with a sulfonylurea due to the absence of TGA registration in this setting and that it would not be possible to apply the current listing for exenatide to a proposed listing for lixisenatide.PSD · Jul 2014
6.26 The submission noted that exenatide is listed on the PBS subject to a special pricing arrangement and requested a similar special pricing arrangement for lixisenatide.PSD · Jul 2014
The submission’s cost-minimisation analysis was based on an estimated effective ex- manufacturer price of exenatide twice daily, but because the sponsor did not know the exact price of exenatide, it reserved the right to review the requested price for lixisenatide. The Pre-Sub-Committee Response (p.3-4) further indicated an intention by the sponsor to accept a cost-minimisation price to the effective price of exenatide.PSD · Jul 2014
6.21 The submission described lixisenatide as clinically equivalent in terms of comparative effectiveness and as having a similar safety and tolerability profile compared with exenatide, on a background of metformin, alone or in combination a sulfonylurea.PSD · Jul 2014
6.22 The submission also claimed that in the head-to-head trial, fewer patients treated with lixisenatide experienced nausea, hypoglycaemia and symptomatic hypoglycaemic events than patients treated with exenatide. These claims are not statistically supported and therefore the ESC did not accept the overall claim of non- inferiority based on the evidence presented in the submission.PSD · Jul 2014
6.2 The PBAC noted and welcomed the input from health care professionals (2) via the Consumer Comments facility on the PBS website. The comments described a benefit of treatment with lixisenatide as allowing a smaller insulin dose to be administered which in turn leads to the potential for less hypoglycaemia and less weight gain to be experienced by a patient.PSD · Jul 2014
6.2 The PBAC noted that no consumer comments were received for this item under agenda item 5.8. However, the PBAC noted and welcomed the input from health care professionals (2) via the Consumer Comments facility on the PBS website but received under agenda item 5.9.PSD · Jul 2014
Cost-effectiveness
Cost minimisation analysis was performed (not a cost-utility or cost-effectiveness analysis). No ICER in AUD per QALY or LY was stated.
The submission sought listing on a cost minimisation with rapid-acting/short-acting components of basal-bolus insulin regimens and premixed insulin. PSD · 2014
Decision context
PopulationAdults with type 2 diabetes insufficiently controlled with basal insulin, with or without oral antidiabetic agents (metformin, sulphonylurea), requiring intensification of insulin therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Not recommended | exenatide (twice daily) | — | RCT · HbA1c |
| Jul 2014 | Not recommended | rapid-acting/short-acting components of basal-bolus insulin regimens and premixed insulin | — | RCT · HbA1c |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| GetGoal-X | Ph 3 | 639 | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | completed |
| GetGoal-S | Ph 3 | 859 | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | completed |
| GetGoal-L-Asia | Ph 3 | 311 | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | completed |
Consumer voice
Two healthcare professionals submitted comments describing benefits of lixisenatide treatment, including reduced insulin doses, lower hypoglycaemia risk, less weight gain, and effectiveness as a next step after oral agent failure.
the ability to use smaller insulin doses, which in turn means less chance of experiencing hypoglycaemia and less weight gain Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to basal insulin combinations with inadequate control, excluding the TGA-permitted metformin-alone and sulphonylurea-alone combinations.