NORDITROPINE FLEXPRO (somatropine)

Key points

Approval of reimbursement for:

• Growth delay (current height < -3 SD and adjusted parental height < -1 SD) in children born small for gestational age with a birth weight and/or length < -2 SD, whose growth has not caught up (growth rate < 0 SD over the last year) by 4 years of age or over.

The actual clinical benefit is now moderate; it was previously low.

Therapeutic improvement?

No therapeutic improvement.

Role in therapeutic strategy?

Somatropin may only be used strictly in accordance the marketing authorisation indications. The decision to treat must be based on the therapeutic benefit guide criteria for each indication, and the dosages must always be observed. However, the somatropin dose may be adapted according to growth, clinical tolerance, and IGF-1 concentrations.

The treatment benefit must be reassessed regularly.

Role of the medicinal product

The organic causes or treatments capable of explaining a growth delay must be investigated and ruled out prior to commencing rhGH treatment. Growth may only be stimulated in children before epiphyseal closure occurs. Limited follow-up is available in respect of treatment initiation right before puberty in children born small for gestational age. Hence, it is not recommended to commence treatment right before puberty. The criteria for initiating rhGH treatment that must all be met are:

• height justifying treatment initiation ≤ – 3 SD for chronological age;
• birth length less than – 2 SD for gestational age;
• children whose growth has not caught up (growth rate < 0 SD over the last year) by 4 years of age or over;
• height < – 1 SD with respect to expected height based on parental height.

Children treated with rhGH will undergo medical follow-up every 3 months, including once a year with their specialist, to assess the efficacy of this treatment, and the benefit of continuing it. The criteria for discontinuing treatment are:

• onset or progression of a tumoral process;
• after the first year of treatment, growth rate < + 1 SD;
• growth rate < 2 cm/year;
• epiphyseal closure on X-rays.

In children, the treatment must be discontinued after 1 year in non-responders (growth rate < 2 cm/year). In any case, somatropin treatment must be reassessed after 1 to 2 years of treatment, when sufficient follow-up on growth progression is available.