PBAC's latest decision on Insulin glargine with lixisenatide: Recommended with restriction (2019). Considered for 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.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2018
Submissions
3
2018 → 2019
Eligible population
Adults 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.
Therapy area
Endocrinology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
HbA1c
Pivotal trial size
634 patients
Key trials
LIXILAN-L, GWCO, GetGoal-X
Comparator
insulin glargine once daily plus exenatide 5 to 10 mcg twice daily
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated by design.
Submission history
Mar 2018: Not recommended · Restricted
Mar 2018: Not recommended · Restricted
Mar 2019: Recommended with restriction · Authority Required