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somatropin — Cigna

Prader-Willi Syndrome

Initial criteria

  • Growth Hormone Deficiency in a Child or Adolescent: Patient has a growth hormone stimulation test result < 10 ng/mL.
  • Growth Hormone Deficiency in an Adult or Transition Adolescent: Patient has or had three or more pituitary hormone deficiencies prior to hormone replacement therapy if required AND the age- and gender-adjusted serum insulin-like growth factor-1 is or was below the lower limit of the normal reference range prior to growth hormone therapy AND patient has known perinatal insults OR congenital or genetic defects.
  • Chronic Kidney Disease in a Child or Adolescent: Patient has or had chronic kidney disease defined by a glomerular filtration rate < 60 milliliters/minute AND persistent growth failure defined by baseline height < 5th percentile for age and gender AND baseline height velocity below the 25th percentile over 3 months (infants ≤ 1 year) or 6 months (children/adolescents).
  • Noonan Syndrome in a Child or Adolescent: Diagnosis confirmed by a heterozygous pathogenic variant in BRAF, KRAS, MAP2K1, MRAS, NRAS, PTPN11, RAF1, RASA2, RIT1, RRAS2, SOS1, or SOS2, OR by either a heterozygous variant or biallelic pathogenic variants in LZTR1, OR prescriber has made a clinical diagnosis.
  • Prader-Willi Syndrome: Diagnosis established by identification of abnormal DNA methylation of chromosome 15q11.2-q13.
  • Short Stature Homeobox-Containing Gene Deficiency in a Child or Adolescent: Patient’s baseline height < 5th percentile for age and gender AND has short stature homeobox-containing gene deficiency demonstrated by chromosome analysis.
  • Child Born Small for Gestational Age or with Intrauterine Growth Restriction Including Silver-Russell Syndrome: Patient was born small for gestational age (birth weight and/or length > 2 SD below mean) AND did not have sufficient catch-up growth before age 2–4 years.
  • Turner Syndrome: Diagnosis confirmed by karyotype (chromosome) analysis AND patient’s baseline height < 5th percentile for age and gender.
  • Short Bowel Syndrome in an Adult: Patient is dependent on intravenous parenteral nutrition OR has already been started on somatropin therapy for this condition or has responded to somatropin therapy in the past.
  • Human Immunodeficiency Virus Infection with Wasting or Cachexia in an Adult (Serostim only): Patient has tried one appetite stimulant or other anabolic agent OR appetite stimulants or other anabolic agents are contraindicated.
  • Non-Growth Hormone Deficient Short Stature (Idiopathic Short Stature) in a Child or Adolescent: Medication prescribed by or in consultation with an endocrinologist.

Reauthorization criteria

  • Chronic Kidney Disease in a Child or Adolescent: Patient continues to meet chronic kidney disease definition (GFR < 60 mL/minute) AND continues to show growth response.
  • Noonan Syndrome in a Child or Adolescent: Diagnosis confirmed as above.
  • Prader-Willi Syndrome: Diagnosis confirmed as above.
  • Short Stature Homeobox-Containing Gene Deficiency in a Child or Adolescent: Patient continues to have confirmed genetic deficiency.
  • Child Born Small for Gestational Age or with Intrauterine Growth Restriction Including Silver-Russell Syndrome: Patient continues to meet definition of born small for gestational age and lacks sufficient catch-up growth before age 2–4 years.
  • Turner Syndrome: Diagnosis confirmed by karyotype analysis.