PBAC's latest decision on Insulin degludec: Recommended with restriction (2025). Considered for Treatment of type 1 diabetes mellitus in patients aged 1 year or older requiring basal insulin therapy.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2013
Submissions
2
2013 → 2025
Eligible population
Adults and children aged 1 year or older with type 1 diabetes mellitus requiring basal-bolus insulin therapy, excluding patients with type 2 diabetes.
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Glycaemic control; hypoglycaemia episodes
Key trials
Study 3583, Study 3770, Study 1835, Study 3995 (SWITCH 1), HypoDeg
Comparator
insulin glargine 100 IU/mL
Economic model
Cost-minimisation
ICER note
Cost consequences analysis was performed instead of cost-effectiveness analysis; no ICER was calculated.
Submission history
Mar 2013: Not recommended
Jul 2025: Recommended with restriction · Restricted