somatropin — Medica
Non-growth hormone deficient short stature (idiopathic short stature) in a child or adolescent
Initial criteria
- Age ≥5 years
- Baseline height ≤1.2 percentile or standard deviation score ≤ -2.25 for age and gender
- Growth velocity <4 cm/year OR <10th percentile for age and gender over ≥6 months
- Predicted adult height <160 cm (63 in) in males or <150 cm (59 in) in females
- Epiphyses are open
- Does not have constitutional delay of growth and puberty
- Medication prescribed by or in consultation with an endocrinologist
Reauthorization criteria
- If somatropin received ≥6 months and <10 months: age ≥5 years AND annualized growth rate has doubled compared with previous year; OR
- If somatropin received ≥10 months: age ≥5 and <12 years with height increase ≥2 cm/year; OR age ≥12 and <18 years with height increase ≥2 cm/year AND epiphyses open; OR age ≥18 years with height increase ≥2 cm/year AND epiphyses open AND mid-parental height not attained
Approval duration
6 months initial, 1 year continuation