Description
Exogenous human growth hormone is a recombinant polypeptide hormone. Human growth hormone plays a role in stimulating skeletal, connective tissue, muscle, and organ growth in children and adolescents, as well as metabolism in adults.
Recombinant growth hormone products are considered clinically identical, with no evidence that one commercial product is different or more advantageous than another, apart from differences in how the Growth Hormone product is stored, dosed, and administered by device. Therefore, one commercial Growth Hormone product is not recommended over another because there are no prospective head-to-head trials comparing the clinical efficacy of one commercial product with another.
Human growth hormone is a self-administered medication and is covered under the pharmacy benefit.
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
Genotropin®, Genotropin® MiniQuick (somatropin)
Norditropin® FlexPro® (somatropin)
Nonpreferred Agents
Humatrope®, Humatropen® (somatropin)
Nutropin AQ® NuSpin® (somatropin)
Omnitrope® (somatropin)
Saizen®, saizenprep® (somatropin)
Serostim® (somatropin)
Zomacton® (somatropin)
Zorbtive® (somatropin)
Long-Acting Growth Hormone
Skytrofa® (lonapegsomatropin-tcgd)
Human Growth Hormone should be billed through a member's pharmacy benefit but may be considered medically necessary to bill through a member's medical benefit if the following criteria is met:
- ONE of the following:
- The individual is receiving the human growth hormone for training and education purposes; or
- The individual's primary insurance requires medical claim processing; or
- A medical reason is provided as to why an individual cannot self-administer (i.e., physical disability, anxiety/panic attack, previous severe reaction to the human growth hormone; or
- The individual is hospitalized; and
- The individual must also meet the below specific criteria for the requested product for a child or adult (as defined by the prescriber).
The use of human growth hormone for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
SHORT-ACTING GROWTH HORMONE
Children - Initial Criteria
Short-acting 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 (less than or equal to four (4) months of age) with hypoglycemia AND serum growth hormone (GH) concentration less than or equal to 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 (less than or equal to four (4) months of age) with hypoglycemia AND growth hormone (GH) concentration less than 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., less than -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 AND ONE of the following:
- The individual's age is within FDA labeling for the requested indication for the requested agent; or
- The prescriber has provided information in support of using the requested agent for the individual's age for the requested indication; or
- The individual has a diagnosis of panhypopituitarism or has deficiencies in at least three (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 less than -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 two (2) years of age or older; and
- The individual has a documented birth weight and/or birth length that is two (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 two (2) or more standard deviations (SD) below the mean for age and sex; or
- The individual has a diagnosis of idiopathic short stature (ISS) AND ALL of the following:
- The individual has a height less than or equal to -2.25 SD below the corresponding mean height for age and sex; and
- The individual has open epiphyses; and
- ONE of the following:
- The individual has a predicted adult height that is below the normal range AND ONE of the following:
- The individual's sex is male and predicted adult height is less than 63 inches; or
- The individual's sex is female and predicted adult height is less than 59 inches; or
- The individual is more than two (2) SD below their mid-parental target height; and
- BOTH of the following:
- The individual has been evaluated for constitutional delay of growth and puberty (CDGP); and
- The individual does NOT have a diagnosis of CDGP; or
- The individual has a diagnosis of growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous growth hormone AND ONE of the following:
- The individual has extreme short stature (e.g., height less than or equal to -3 SD), normal nutrition, significantly reduced IGF-1 and IGFBP-3 (e.g., less than -2 SD), and delayed bone age; or
- BOTH of the following:
- The individual has ONE of the following:
- Height more than two (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 greater than two (2) years of age; or
- Height velocity (HV) more than two (2) SD below the mean over one year or more than 1.5 SD sustained over two (2) years; or
- Height-for-age curve that has deviated downward across two major height percentile curves (e.g., from above the 25 th percentile to below the 10 th percentile); or
- BOTH of the following:
- The individual's age is 2-4 years; and
- The individual has a HV less than 5.5 cm/year (less than 2.2 inches/year); or
- BOTH of the following:
- The individual's age is 4-6 years; and
- The individual has a HV less than 5 cm/year (less than 2 inches/year); or
- The individual's age is six (6) years to puberty AND ONE of the following:
- The individual's sex is male and HV is less than 4 cm/year (less than 1.6 inches/year); or
- The individual's sex is female and HV is less than 4.5 cm/year (less than 1.8 inches/year); and
- ONE of the following:
- The individual has failed at least two (2) GH stimulation tests (e.g., peak GH value of less than 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab); or
- The individual has failed at least one (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
- 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).
The use of short- acting human growth hormone for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
