Reason for request
The actual benefit of TRESIBA is substantial in the treatment of type 1 and type 2 diabetes in adults.
Improvement in actual benefit
In view of :
- the glycaemic control achieved with TRESIBA (insulin degludec) which is comparable to that observed with insulin glargine (LANTUS) in type 1 and type 2 diabetes and insulin detemir (LEVEMIR) in type 1 diabetes,
- the difficulty in assessing the clinical relevance of any advantage in terms of a reduction in the occurrence of hypoglycaemic episodes, particularly at night in view of the very small differences observed by comparison with other long-acting analogues, despite the use of rigorous assessment methods,
- the non-demonstration of any impact in terms of morbidity and mortality, particularly cardiovascular,
- the absence of any robust data that allow the preferential recommendation of one long-acting insulin analogue,
the Committee considers that TRESIBA does not provide any improvement in actual benefit (level V, nonexistent) in the management, with long-acting insulin analogues (LANTUS and LEVEMIR), of adult patients with type 1 or type 2 diabetes.