somatropin (Omnitrope)

Following a full submission

somatropin (Omnitrope®) is accepted for use within NHS Scotland for:

Infants, children and adolescents

- Growth disturbance due to insufficient secretion of growth hormone (GH) - Growth disturbance associated with Turner syndrome

- Growth disturbance associated with chronic renal insufficiency

- Growth disturbance (current height standard deviation score (SDS) <–2.5 and parental adjusted SDS <–1) in short children/adolescents born small for gestational age, with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity SDS <0 during the last year) by four years of age or later

- Prader-Willi syndrome (PWS) disturbance due to insufficient secretion of growth hormone, for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.

Adults

- Replacement therapy in adults with pronounced GH deficiency. Patients with severe GH deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GH deficiency. In patients with childhood onset isolated GH deficiency (no evidence of hypothalamic

- pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those who have low insulinlike growth factor 1 (IGF-1) concentrations (SDS <-2), who may be considered for one test. The cut-off point of the dynamic test should be strict. Somatropin (Omnitrope) is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference recombinant human growth hormone (somatropin (Genotropin).

The British National Formulary advises that it is good practice to use the brand name when prescribing biological medicinal products.