Recommendation made by the extraordinary PBAC meeting - May 2006

Recommendation made by the Pharmaceutical Benefits Advisory Committee (PBAC) at an extraordinary May 2006 Meeting relating to the listing of Insulin detemir on the Pharmaceutical Benefits Scheme (PBS)

May 2006 Extraordinary Meeting PBAC Outcomes - Positive Recommendation

Table containing positive recommendations for Insulin Glargine from May 2006 Extraordinary Meeting
Drug and Form Drug Use and Type Listing Requested by Sponsor PBAC Recommendation
Insulin detemir (rys) cartridge 3mL (Penfill®), prefilled device 3 mL (FlexPen®), 100 U/mL, Levemir®,

Novo Nordisk Pty Ltd

Major submission
Treatment for diabetes Restricted Benefit listing for treatment of type 1 or type 2 diabetes patients requiring intensive insulin therapy with 3 or more injections of insulin per day with one of the insulins being a short acting insulin.
Type 1 or Type 2 patients with a documented protamine allergy.
The PBAC recommended the listing of insulin detemir as a restricted benefit for Type 1 diabetes on a cost minimisation basis compared with insulin glargine.

The PBAC noted that the indirect comparison (which included five trials in Type 1 and one in Type 2 diabetes) showed that there was no statistically significant difference between insulin detemir and insulin glargine for Type 1 and 2 patients combined and Type 1 patients alone. The PBAC also noted that in the Type 2 diabetes trial, no significant differences were found between insulin detemir and NPH insulin in the clinical endpoints, including hypoglycaemic events. Thus the PBAC decided that use should be restricted to type 1 patients only on the PBS.