somatropin (Saizen)

following an abbreviated submission:

somatropin solution for injection (Saizen®) is accepted for use in NHS Scotland.

Indication under review:
Children and adolescents:
- Growth failure in children caused by decreased or absent secretion of endogenous growth hormone.
- Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.
- Growth failure in prepubertal children due to chronic renal failure (CRF).
- Growth disturbance (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later.

Adults:
- Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria:

- Childhood Onset:
Patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen is started.

- Adult Onset:
Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.

This new formulation has been shown to be bioequivalent to the previously available freeze-dried formulation and is available at an equivalent cost. It is in a ready to use cartridge and does not require reconstitution.