Insulin Glargine With Lixisenatide
Treatment of adults with Type 2 diabetes mellitus who have inadequate glycaemic control with basal insulin, in combination with metformin or where metformin is contraindicated.
Decision on record
- Meeting Mar 2018 Not recommended Type 2 diabetes mellitus (T2DM)
Access path
- Mar 2018Not recommended
uncertain comparative effectiveness despite non-inferiority claim, complex and potentially unsafe PBS restriction with…
- Mar 2018Not recommended
uncertain comparative effectiveness, use outside restriction likely, concerns regarding compliance with proposed PBS…
- Mar 2019Not recommended
Comparator changed: insulin glargine plus exenatide (twice daily) → insulin glargine once…
From the public summary
7.1 The PBAC did not recommend the listing of insulin glargine with lixisenatide fixed ratio combination (FRC) for treatment of adults with type 2 diabetes mellitus who have inadequate glycaemic control with basal insulin on the basis that the proposed price was unacceptably high given the residual uncertainty around the claim of non- inferiority and the appropriate equi-effective doses.PSD · Mar 2019
7.2 The PBAC acknowledged there may be practical benefits for some patients in reducing the number of daily injections from three to one, however also considered there may be disadvantages to some patients due to reduced flexibility of insulin glargine dosing and the potential inferiority of lixisenatide compared to exenatide.PSD · Mar 2019
6.25 Based on the claim of non-inferior efficacy and safety, a cost-minimisation analysis of insulin glargine with lixisenatide FRC versus insulin glargine plus exenatide twice daily was presented. The evaluation noted that this was only reasonable if the PBAC accepted the claim of non-inferior effectiveness and safety.PSD · Mar 2019
6.26 As the PBAC previously noted, some of the alternative therapies identified would be likely to be less costly than insulin glargine plus exenatide twice daily. The evaluation considered that a cost-minimisation against insulin glargine plus exenatide twice daily only did not represent a true cost-minimisation, and comparison against the least costly alternative therapies may have been more appropriate. 14PSD · Mar 2019
6.2 The PBAC noted and welcomed the input from individuals (1) via the Consumer Comments facility on the PBS website. The comment received described insulin glargine with lixisenatide as a promising alternative treatment for diabetic patients with reduced response to basal insulin alone.PSD · Mar 2019
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated by design.
The PBAC considered that insulin glargine with lixisenatide FRC was non-inferior in comparative safety to the comparator. PBAC · 2018
Decision context
PopulationAdults aged ≥18 years with Type 2 diabetes mellitus who have inadequate glycaemic control (HbA1c >7% or blood glucose >10 mmol/L in >20% of tests) despite treatment with basal insulin and oral antidiabetic agents, or basal insulin alone where metformin is contraindicated, and requiring treatment with a GLP-1 agonist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Not recommended | insulin glargine once daily plus exenatide 5 to 10 mcg twice daily | — | RCT · HbA1c |
| Mar 2018 | Not recommended | insulin glargine plus exenatide twice daily | — | RCT · HbA1c |
| Mar 2018 | Not recommended | insulin glargine plus exenatide (twice daily) | — | RCT · HbA1c |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| LIXILAN-L | Ph 3 | 736 | Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30 | completed |
Consumer voice
One individual submitted a consumer comment describing insulin glargine with lixisenatide as a promising alternative treatment for diabetic patients with reduced response to basal insulin alone.
insulin glargine with lixisenatide as a promising alternative treatment for diabetic patients with reduced response to basal insulin alone Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to basal insulin failure with specific HbA1c thresholds; TGA label includes broader prior therapy failures.