FIASP

New indication.

Favourable opinion for reimbursement in the treatment of diabetes mellitus in adolescents and children aged 1 year and above.

What therapeutic improvement?

No clinical added value compared to NOVORAPID (insulin aspart) in the treatment of diabetes mellitus in adolescents and children aged 1 year and above.

Role in the care pathway?

Type 1 diabetes

Children and adolescents with type 1 diabetes require insulin therapy and nutritional management.

There are a number of possible insulin therapy regimens:

• treatment with 2 injections/d: injection of a mixture of fast-acting insulin (or fast-acting analogue) and intermediate-acting insulin,
• treatment with 3, 4 or 5 injections/d: a mixture of fast-acting insulin (or fast-acting analogue) and intermediate-acting insulin is combined with a fast-acting insulin (or fast-acting analogue),
• “basal-bolus” treatment with 3, 4 or 5 injections/d: an intermediate-acting “basal insulin” (twice/d) or a long-acting insulin analogue (once to twice/d) is combined with a fast-acting “prandial insulin” (or fast-acting analogue) injected as a bolus before each of the main meals (3 times/d),
• treatment using a subcutaneous portable pump (continuous infusion with a fixed or variable basic flow rate depending on the time of day or night and bolus at mealtimes). Pump administration requires the use of fast-acting insulin (or fast-acting analogue).

The choice of insulin therapy regimen is dependent on the glycaemic targets for each child and adolescent, their preferences and lifestyle, and those of their family.

Type 2 diabetes

The initial treatment of type 2 diabetes in children and adolescents focuses on lifestyle changes, since type 2 diabetes in children and adolescents is mainly related to being overweight. If these lifestyle changes are not effective, medicinal treatment with metformin (MA in children from 10 years of age and adolescents), and sometimes insulin, may be initiated. In some cases, it may be necessary to temporarily initiate insulin at the start of treatment in the event of severe hyperglycaemia symptoms at the time of diagnosis.

Role of the medicinal product in the care pathway

In the treatment of type 1 diabetes in adolescents and children aged 1 year and above, FIASP (insulin aspart) is a first-line treatment in the context of a basal-bolus regimen. 

As a fast-acting insulin, the role of FIASP (insulin aspart) in the care pathway for the treatment of type 2 diabetes in adolescents and children aged 1 year and above is as follows:

• following the failure of lifestyle changes, medicinal treatment with metformin (MA in children from 10 years of age and adolescents,) and sometimes insulin, may be initiated.
• in some cases, it may be necessary to temporarily initiate insulin at the start of treatment in the event of severe hyperglycaemia symptoms at the time of diagnosis.

In the study available, the higher incidence of severe or confirmed nocturnal hypoglycaemia in the FIASP group, particularly with postmeal administration, compared to the NOVORAPID group, with both containing the same active substance (insulin aspart), raises the question of the benefit of its use compared to NOVORAPID (insulin aspart) in a paediatric population.