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BYDUREON (exenatide), antidiabetic

DIABETOLOGY - New indication
Opinions on drugs - Posted on Dec 18 2018

Reason for request

Extension of indication

Insufficient clinical benefit to justify reimbursement for type 2 diabetes in combination with basal insulin with or without metformin

 

  • BYDUREON now has MA in combination with a basal insulin for type 2 diabetes patients having failed to achieve adequate glycaemic control.

  • Its efficacy on HbA1c variation has only been compared versus placebo, in combination with insulin glargine ± metformin, eventhough a comparison versus a clinically relevant comparator was feasible and all other GLP1 analogues have been compared to an active comparator.

  • The effect size of BYDUREON versus placebo appears to be modest.

  • There is no evidence of a reduction in insulin use with the addition of BYDUREON.

 


Clinical Benefit

Insufficient

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Clinical Added Value

Not applicable

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Therapeutic use

-