Insulin DetemirLevemir
Recommended EndocrinologyUnrestrictedNot applicable line
Extension of listing to include people with type 2 diabetes who are not responsive to oral hypoglycaemic drugs. Previously listed for type 1 diabetes.
5
Submissions
3 resub
2005–07
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2007 Recommended Diabetes
Access path
- TGA registered · Levemir
TGA label narrower than the PBS population
- Jul 2005Recommended
vs insulin NPH
- Mar 2006Recommended · restricted
Comparator changed: insulin NPH → insulin glargine
- Mar 2006Recommended · restricted
Comparator changed: insulin NPH → insulin glargine
- Nov 2007Recommended · restricted
Evidence: Meta-analysis → RCT
- Nov 2007Recommended · restricted
Evidence: Meta-analysis → RCT
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
The submission presented a cost-minimisation analysis claiming that one unit of insulin detemir is equivalent to one unit of insulin glargine, based on the direct randomised controlled data. However, the PBAC had doubts regarding the equi-effective dose of detemir versus glargine. PBAC · 2007
ICER uncertainICER / price too highEconomic model disputed ×2No head-to-head trial
Decision context
PopulationPeople with type 2 diabetes who are not responsive to oral hypoglycaemic drugs
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2007 | Recommended · restricted | insulin glargine | — | RCT · Other |
| Nov 2007 | Recommended · restricted | insulin glargine | — | RCT · HbA1c |
| Mar 2006 | Recommended · restricted | insulin glargine | — | RCT, Meta-analysis · HbA1c, FPG, hypoglycaemic events |
| Mar 2006 | Recommended · restricted | insulin glargine | — | Meta-analysis · HbA1c |
| Jul 2005 | Recommended | insulin NPH | — | Meta-analysis · HbA1c |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC explicitly includes type 1 and type 2 diabetes patients; TGA discourages type 2 patients responding to oral agents.