Prior authorization criteria for:

Genotropin®,

Humatrope®,

Norditropin®,

Norditropin® Nordiflex,

Nutropin®,

Nutropin® AQ,

Saizen®,

Serostim®,

Tev-Tropin®,

Zorbtive®


(somatropin)



Protropin®


(somatrem)

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COVERED USES:

All FDA-approved indications not otherwise excluded from Part D are covered.

GH has FDA approval for the following conditions:

Zorbtive is also approved for the treatment of short bowel syndrome.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

For GHD in adults must be prescribed by or on the recommendation of an endocrinologist.

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication is necessary.

CRITERIA:

Pediatrics

  1. Growth Hormone Deficiency (GHD)
    1. Evidence of short stature/growth failure by:
      1. Height standard deviation score (SDS) of more than 3 SD below the mean for chronological age/sex, or
      2. Height for age/sex is below the 3rd percentile (or greater than 2 SD below the mean) and untreated growth velocity (GV) is below the 25th percentile (must have at least 1 year of growth data), or
      3. Severe growth rate deceleration (GV measured over one year of more than 2 SD below the mean for age/sex)
    2. Other causes of growth failure have been ruled out (hypothyroidism, chronic systemic disease, skeletal disorders, and psychosocial deprivation), and
    3. Documented biochemical GHD by:
      1. Two GH stimulation tests (using a provocative agent such as arginine, clonidine, glucagon, insulin or levodopa) showing peak GH concentrations of less than 10ng/ml, or
      2. One GH stim test below 10ng/ml in children with defined CNS pathology, history of irradiation, or genetic conditions associated with GHD, or
      3. One GH stim test level less than 15ng/ml and IGF-1 and IGFBP-3 levels below normal for bone age/sex, or
      4. Evidence of multiple pituitary hormone deficiencies (at least one other deficient hormone including LH, FSH, TSH, and ACTH).
  2. Prader-Willi Syndrome (PWS)
    1. Must meet GHD criteria above (1-3), and
    2. Documented muscle hypotonia (weakness) by exam
  3. Turner's Syndrome (TS)
    1. Diagnosis confirmed by genetic testing, and
    2. Evidence of short stature/growth failure meeting one of the criteria above (1i-iii), and
  4. Noonan Syndrome
    1. Diagnosis confirmed by genetic testing or made by pediatric endocrinologist based on clinical features (i.e. classic facies, congential heart disease, abnormal skeletal features, factor XI deficiency, hearing loss, developmental delays), and
    2. Height greater than 2 SDS below the mean for chronological age and sex, and
    3. GV measured over one year prior to initiation of therapy of greater than 1 SDS below the mean for age/sex
  5. Chronic Renal Insufficiency
    1. Other causes of growth failure have been ruled out and nutritional status has been optimized, and
    2. Evidence of short stature/growth failure meeting one of the criteria above (1i-iii), and
    3. Authorization will be withdrawn after transplantation.
  6. Small for Gestational Age (SGA)
    1. Birth weight and/or length at least three SDs below the mean for gestational age, and
    2. Failure to reach catch-up growth by two years of age, defined as height at least two SDs below the mean for age/sex
    Authorization for A-E above will be given for up to 12 months.

    Reauthorization will require:
    • After first year of therapy: A doubling of pretreatment GV or an increase in growth rate of at least 2 cm/yr
    • Ongoing: Evidence of GV of greater than 2.5 cm/year and evidence of open epiphyses

EXCLUSION CRITERIA:

GH will not be covered for treatment of idiopathic short stature. In addition, GH will not be covered unless it meets the following criteria for the specified indications below:

Adults

  1. GHD in Adults Due to Destructive Lesions of the Pituitary
    1. GHD is due to either the result of destructive hypothalamic or pituitary disease, radiation therapy, surgery, or trauma, and
    2. At least 2 other pituitary hormone deficiencies (i.e. TSH, ACTH, Gonadotropins, and ADH), and
    3. Confirmation of GHD by provocative stim. testing (using insulin, levodopa, arginine, clonidine, or glucagon) with results showing peak GH concentrations less than 5ng/ml
  2. GHD in Adults who had GHD as a child
    1. After linear growth has stopped (GV less than 2.5cm/yr), GH should be stopped for at least 3 months and provocative stim. testing should be repeated, and
    2. Have peak GH levels less than 5ng/ml after provocative stim. testing on at least 2 standard GH stim. tests (using insulin, levodopa, arginine, clonidine, or glucagon)
      1. For adults with low IGF-I levels, only one stim. test is required (IGF-1 level of less than 80ng/ml or greater than 2 SDs below mean)
      Reauth. will require evidence of improved quality of life and good tolerability and annual documentation of IGF-I levels with appropriate dosage adjustments as GH requirements in adults often decrease with age.
  3. AIDS Wasting
    1. Involuntary loss of at least 10% of body weight, and
    2. Absence of other related illnesses contributing to weight loss, and
    3. Documented failure, intolerance, or contraindication to appetite stimulants and/or other anabolic agents.
    Auth. will be given for a max. of 12 months.
  4. Short Bowel Syndrome (Zorbtive® Only)
    1. Ability to ingest solid food, and
    2. Must be receiving specialized nutrition support (i.e. high carbohydrate, low-fat diet, enteral feedings, parenteral nutrition)
      3. Auth. will be given for a max. of 4 weeks. Efficacy beyond 4 weeks has not been established. Reauth. beyond 4 weeks will not be granted.

COVERAGE DURATION:

Initial authorization and reauthorization will be approved for up to 1 year except short bowel syndrome. (max. of 4 weeks).

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