PBAC's latest decision on Insulin glargine: Recommended (2018). Considered for Treatment of type 1 and type 2 diabetes mellitus. A biosimilar brand of insulin glargine for patients requiring basal insulin therapy.
PBAC outcome
Recommended
Unrestricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
6
first 2005
Submissions
6
2005 → 2018
Eligible population
Adults with type 1 and type 2 diabetes mellitus requiring basal insulin therapy, as demonstrated in the INSTRIDE 1 and INSTRIDE 2 trials comparing Semglee to Lantus.
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Efficacy and safety non-inferiority
Key trials
INSTRIDE 1, INSTRIDE 2
Comparator
Lantus (reference brand of insulin glargine)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis. This was a minor submission; no cost-effectiveness analysis with ICER was conducted. The submission was based on demonstrated biosimilarity to the reference product and price reduction.
Submission history
Jul 2005: Not recommended · Not applicable
Mar 2006: Recommended
Mar 2015: Recommended · Unrestricted
Jul 2015: Recommended with restriction · Restricted
Nov 2015: Recommended with restriction · Unrestricted