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Reason for request
Key points
Favourable opinion for reimbursement only in the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus.
Unfavourable opinion for reimbursement in the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with type 2 diabetes mellitus not treated by insulin.
What therapeutic improvement?
Therapeutic improvement compared to glucagon administered by injection in the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus.
Role in the care pathway?
Severe hypoglycaemia, which has potentially life-threatening consequences, requires emergency treatment. The international guidelines (ADA, AACE) and those specialising in paediatrics (ISPAD) recommend the administration of glucagon for the management of severe hypoglycaemia in diabetic patients having lost consciousness or incapable of taking glucose orally. Glucagon can be administered by the intramuscular (IM) or subcutaneous (SC) route by the diabetic patient’s family, providing that they have been trained.
According to the Committee’s opinion relative to GLUCAGEN (glucagon), glucagon injection is contraindicated in patients with type 2 diabetes treated with sulfonylureas.
Role of the medicinal product in the care pathway
BAQSIMI (intranasal glucagon) is a first-line treatment in severe hypoglycaemic episodes in type 1 diabetes or insulin-treated type 2 diabetes.
Given its conditions of use, with a single nasal dose in ready-to-use packaging and storage at room temperature, BAQSIMI (intranasal glucagon) offers advantages compared to the injectable formulation of glucagon; in fact, the latter requires preparation of the injection, training of the patient’s family in administering the injection and storage of the medicinal product in the refrigerator before use.
As with injectable glucagon, the Committee recommends not using BAQSIMI (intranasal glucagon) in severe hypoglycaemic episodes in type 2 diabetes treated with sulfonylureas. Glucagon is one of the most potent insulin secretion stimulants. However, sulfonylureas induce insulin secretion by short-circuiting the insulin regulation and secretion steps by glucose. Insulin secretion persists on sulfonylurea treatment, irrespective of glucose levels. Consequently, the administration of glucagon when the hypoglycaemia is caused by a sulfonylurea could exacerbate the situation by increasing insulin secretion.
BAQSIMI (intranasal glucagon) has no role in the care pathway for type 2 diabetes not treated by insulin.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of BAQSIMI (intranasal glucagon) is substantial only in the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. |
| Insufficient |
The Committee deems that the clinical benefit of BAQSIMI (intranasal glucagon) is insufficient to justify public funding cover in the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with type 2 diabetes mellitus not treated by insulin.
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Clinical Added Value
| minor |
Considering:
but taking into account:
the Committee considers that BAQSIMI (intranasal glucagon) provides a minor clinical added value (CAV IV) compared to injectable glucagon in the treatment of severe hypoglycaemia in patients aged 4 years and over with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus.
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