Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Preferred Agent
Norditropin® FlexPro® (somatropin)
Nonpreferred Agents
Genotropin®, Genotropin® MiniQuick (somatropin)
Humatrope®, Humatropen® (somatropin)
Nutropin AQ® NuSpin® (somatropin)
Omnitrope® (somatropin)
Saizen®, saizenprep® (somatropin)
Serostim® (somatropin)
Zomacton® (somatropin)
Zorbtive® (somatropin)
Children – Initial Criteria
Human growth hormone may be considered medically necessary in the treatment of children when ALL of the following are met:
- The individual is a child (as defined by the prescriber); and
- The individual has ONE of the following diagnoses:
- The individual is a newborn (≤ 4 months of age) with hypoglycemia AND serum growth hormone (GH) concentration ≤ 5 mcg/L AND at least ONE of the following:
- Congenital pituitary abnormality (e.g., ectopic posterior pituitary and pituitary hypoplasia with abnormal stalk); or
- Deficiency of at least one additional pituitary hormone; or
- The individual is a newborn (≤ 4 months of age) with hypoglycemia AND growth hormone (GH) concentration < 20 mcg/L AND BOTH of the following:
- The individual does not have a known metabolic disorder; and
- The individual has a reduced IGFBP-3 level (e.g., < -2 SD); or
- The individual has a diagnosis of Turner syndrome; or
- The individual has a diagnosis of Noonan syndrome;or
- The individual has a diagnosis of Prader-Willi syndrome; or
- The individual has a diagnosis of SHOX gene deficiency; or
- The individual has a diagnosis of short bowel syndrome (SBS) AND is receiving specialized nutritional support; or
- The individual has a diagnosis of panhypopituitarism or has deficiencies in at least 3 or more pituitary axes AND serum IGF-I levels below the age- and sex-appropriate reference range when off GH therapy; or
- The individual has a diagnosis of chronic renal insufficiency and BOTH of the following:
- The individual’s height velocity (HV) for age is < -1.88 standard deviations (SD) OR HV for age is less than the third percentile; and
- Other etiologies for growth impairment have been addressed; or
- The individual has a diagnosis of small for gestational age (SGA) and ALL of the following:
- The individual is 2 years of age or older; and
- The individual has a documented birth weight and/or birth length that is 2 or more standard deviations (SD) below the mean for gestational age; and
- At 24 months of age, the individual failed to manifest catch-up growth evidenced by a height that remains 2 or more standard deviations (SD) below the mean for age and gender; or
- The individual has a diagnosis of growth hormone deficiency (GHD), short stature, or other AND ONE of the following:
- The individual has extreme short stature (e.g., height < -3 SD), normal nutrition, significantly reduced IGF-1 and IGFBP-3 (e.g., < -2 SD), and delayed bone age; or
- BOTH of the following:
- The individual has ONE of the following:
- Height more than 2 SD below the mean for age and sex; or
- Height more than 1.5 SD below the midparental height; or
- A decrease in height SD of more than 0.5 over one year in children > 2 years of age; or
- Height velocity (HV) more than 2 SD below the mean over one year or more than 1.5 SD sustained over two years; or
- Height-for-age curve that has deviated downward across two major height percentile curves (e.g., from above the 25th percentile to below the 10th percentile); or
- Age 2-4 years: HV less than 5.5 cm/year (< 2.2 inches/year); or
- Age 4-6 years: HV less than 5 cm/year (< 2 inches/year); or
- Age 6 years to puberty AND ONE of the following:
- The individual is a boy and HV is less than 4 cm/year (< 1.6 inches/year); or
- The individual is a girl and HV is less than 4.5 cm/year (< 1.8 inches/year); and
- One of the following:
- The individual has failed at least 2 GH stimulation tests (e.g., peak GH value of < 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab); or
- The individual has failed at least 1 GH stimulation test (e.g., peak GH value of < 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab) AND ONE of the following:
- Pathology of the central nervous system; or
- History of irradiation; or
- Other pituitary hormone defects (e.g., multiple pituitary hormone deficiency [MPHD]); or
- A genetic defect; or
- The individual has a pituitary abnormality and a known deficit of at least one other pituitary hormone; and
- The individual does NOT have any FDA labeled contraindications to the requested agent; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in the area of the individual’s diagnosis; and
- The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication; and
- ONE of the following:
- The request is for a preferred agent; or
- The request is for a nonpreferred agent and ONE of the following:
- The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to a preferred agent that is not expected to occur with the requested nonpreferred agent (medical record required); or
- The prescriber has provided information to support the efficacy of the requested nonpreferred agent over the preferred agent for the intended diagnosis (medical record required).
Length of Approval: 4 weeks for SBS
12 months for other indications
The use of human growth hormone for any other condition other than those listed above is considered not medically necessary and therefore, non-covered.
Procedure Codes