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    Growth Hormone

    August 2016

    Preferred Growth Hormones Nonpreferred Growth Hormones
    Norditropin Humatrope
    Nutropin/ Nutropin AQ Genotropin
    Saizen
    Serostim [only for AIDS wasting or cachexia]
    Omnitrope
    Tevtropin
    Zorbtive [only for patients with Short Bowel Syndrome (SBS)]
    Zomacton

    Each brand name includes all devices/dosage forms

    Note: As of May 1, 2012, patients on Genotropin will be required to meet renewal criteria and switch to a preferred product once their current PA for Genotropin expires.

    Coverage for pediatrics (under 18 years old)

    • Prescribing growth hormone (GH) is limited to pediatric endocrinologists or pediatric nephrologists
    • If there is no pediatric endocrinologist or pediatric nephrologist in the geographic location, the prescriber must have at least one annual consultation about the patient with the pediatric specialty
    • Patients new to GH therapy, must meet criteria below and be started on a preferred growth hormone
    • Patients continuing GH therapy and having met criteria listed below must be switched to a preferred growth hormone

    Criteria for growth hormone use in pediatrics

    Indications covered if the child is being treated by pediatric endocrinologist or pediatric nephrologists

    • Turner's Syndrome 
    • Prader-Willi Syndrome 
    • Noonan Syndrome 
    • Leri-Weill Dyschondrosteosis 
    • Renal Disease 
    • Hypoglycemia in newborns with a diagnosis of hypopituitarism or panhypopituitarism.  
    • Acquired Growth Hormone Deficiency (GHD), which can be due to, but is not limited to the following:
      • Pituitary surgery 
      • Pituitary insufficiency 
      • Radiation treatments 
      • Pituitary tumor 
      • Trauma 
      • Central nervous system tumors 
      • Cranial irradiation 
      • Panhypopituitarism

    Pediatric Growth Hormone Deficiency (GHD) Initiation of Therapy (6 month initial authorization) when the child is being treated by pediatric endocrinologist

    • Member must not have attained epiphyseal closure as determined by X-ray 
    • Member must have failed to respond to at least TWO standard GH stimulation tests (with insulin, levodopa, arginine, propranolol, clonidine, or glucagon), defined as a peak measured GH level of less than 10ng/ml after stimulation
    • Documented gender-specific delayed bone age
    • Height at initiation of therapy must be > 2 standard deviations below normal mean for age and sex and patient has demonstrated a growth velocity over the past year to be 1 SD below the mean for chronological age

    Initial authorization

    • Patients meeting these criteria will be approved for a 6-month trial
    • Patients with short stature but not meeting these criteria will not be covered for growth hormone therapy. Coverage may be reconsidered if the patient undergoes a 6 month trial of growth hormone supplied by a manufacturer and has demonstrated a restoration of normal growth and development as defined under “Treatment Continuation”

    Treatment continuation

    Approval is for a maximum of 1 year and must be reviewed annually except for children with pituitary damage (e.g., tumor, radiation, stroke or trauma).

    Therapy can be approved for an additional 6-12 months if:

    • Patient height is less than 5'6" for males or 5'1" for females AND
    • Epiphyses have not closed. Epiphyseal closure is defined as a bone age of 16 years in a male or 14 years in a female on wrist films AND
    • Patient demonstrates improved/normalized growth velocity. [Annual growth velocity in response to therapy is calculated to be > 4.5 cm/year in a pre-pubertal child or > 2.5 cm/year in a post-pubertal child] OR
    • Patient has hypopituitarism or panhypopituitarism

    Coverage for adults (18 years old and over)

    • Treatment must follow most current clinically accepted guidelines
    • Prescribing of growth hormone for adults is limited to endocrinologists specializing in the treatment of adult GHD
    • Patients new to GH therapy, must meet criteria below and be started on a preferred growth hormone 
    • Patients continuing GH therapy and having met criteria listed below must be switched to a preferred growth hormone

    Criteria for growth hormone use in adults

    GH therapy may be considered medically necessary and may be eligible for coverage for the following conditions:

    • Adult onset symptomatic GH deficiency associated with low GH levels (documented by failure of at least two GH stimulation tests following a GH wash out period of 1 to 3 months). (A failure is generally defined as a maximum peak of < 5 ng/mL measured by radioimmunoassay or <2.5 ng/mL measured by immunoradiometirc assay) [GH stimulation testing by insulin, levodopa, L-arginine, clonidine, or glucagon]
    • Childhood onset symptomatic GH deficiency, where persistent GH deficiency is documented by at least one failed GH stimulation test performed at least 3 months after the cessation of prior GH therapy
    • Adult onset symptomatic GH deficiency associated with multiple hormone deficiencies (i.e., panhypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma
    • The diagnosis of panhypopituitarism is established when either one of the two following criteria are met:
      • At least 2 additional hormone deficiencies (other than GH) requiring hormone replacement therapy are documented (e.g., thyroid-stimulating hormone, andrenocorticotropic hormone, prolactin, luteinizing hormone, follicle-stimulating hormone, antidiuretic hormone, oxytocin) as well as failure of at least 1 GH stimulation test OR
      • Three pituitary hormone deficiencies (other than GH) requiring hormone replacement therapy (where clinically appropriate) are documented AND a low IGF-1 level is documented in lieu of GH stimulation testing

    Growth hormone use in adults - renewal evaluation

    Growth hormone therapy is reviewed annually. IGF-1 levels are reviewed, and thyroid function tests, lipids, regular body weight, and waist/hip ratio measurements are also recommended.

    GH therapy has demonstrated benefits to the patient (from the start of therapy) in any of the following response parameters:

    • Body composition
    • Cardiovascular health
    • Bone mineral density
    • Serum cholesterol
    • Physical strength

    The physician has evaluated the patient’s serum insulin-like growth factor-1 (IGF-1) to confirm the appropriateness of the current dose.

    Serostim (growth hormone) PA criteria

    Serostim is a growth hormone that is indicated only for the treatment of AIDS wasting or cachexia.

    Serostim will be approved for use if:

    • Patient has been diagnosed with AIDS related wasting or cachexia AND
    • If patient is acidemic, attempts have been made to increase serum bicarbonate
    • Patient cannot tolerate or has insufficient weight gain on megesterol acetate (Megace) or dronabinol (Marinol) AND
    • A 12-week trial will be allowed on the first fill. After 12 weeks, additional authorization will be issued only if there is an improvement in lean body mass or weight measurements.

    Zorbtive (growth hormone) PA criteria

    Zorbtive is a growth hormone that is indicated only for the treatment of Short Bowel Syndrome (SBS) in patients receiving specialized nutritional support. Zorbtive will be approved for use if:

    • Patient has been diagnosed with indicated for the treatment of Short Bowel Syndrome (SBS) and is receiving specialized nutritional support

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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