Reason for request
The actual benefit of the LEVEMIR proprietary medicinal products remains substantial in the indication of their Marketing Authorisation.
Improvement in actual benefit
Given, on the one hand :
- the glycaemic control obtained with LEVEMIR (insulin detemir) compared with that observed with NPH insulin and insulin glargine (LANTUS),
- the questionable clinical relevance of the difference in weight loss of around 1 kg observed on LEVEMIR compared with NPH insulin and insulin glargine,
- the absence of a difference among insulin detemir, insulin glargine and NPH insulin in terms of the occurrence of severe hypoglycaemic episodes and between insulin detemir and insulin glargine on total and nocturnal hypoglycaemia episodes,
- the absence of additional data from the post-marketing study with numerous limits, including the large number of patients who were lost to follow-up or who dropped out of the study (43 %),
- the opinion of experts, who do not recognise an advantage in their daily practice of LEVEMIR compared with another long-acting insulin analogue,
- existing doubts with regard to the occurrence of cancer related to taking long-acting insulin analogues,
- on the other hand, current recommendations which no longer favour treatment intensification for type 2 diabetes, which reduces the risk of hypoglycaemic episodes,
the Transparency Committee cannot confirm the previously recognised benefit of LEVEMIR in type 1 and type 2 diabetes.
Thus the Committee considers that LEVEMIR does not provide an improvement in actual benefit (IAB V, non-existent) in the management of adult or adolescent patients and children above age 2 with type 1 or type 2 diabetes.