somatropin — Medica
Child Born Small for Gestational Age or with Intrauterine Growth Restriction Including Silver-Russell Syndrome
Initial criteria
- Patient was born small for gestational age (birth weight and/or length > 2 SD below mean for gestational age and gender)
- Patient did not have sufficient catch-up growth before age 2 to 4 years
- Patient is ≥ 2 years of age
- Baseline height < 5th percentile for age and gender
- Medication prescribed by or in consultation with an endocrinologist
Reauthorization criteria
- Patient is continuing somatropin therapy (established on somatropin for ≥ 10 months)
- Patient < 12 years: height increased by ≥ 2 cm/year in most recent year OR patient ≥ 12 years: height increased by ≥ 2 cm/year in most recent year AND epiphyses are open
Approval duration
1 year