Rational Drug Therapy Program  WVBMS Drug Therapy Guidelines  Growth Hormone Criteria

Criteria for Growth Hormones for Adults

Adult patients with growth hormone deficiency may be approved for replacement of endogenous growth hormone upon endocronologist documentation of medical necessity.  Requests for prior approval will receive review based on the following criteria:

 Childhood Onset

Patients who were growth hormone deficient during childhood and who have deficiency confirmed as an adult by a negative response to provocative testing.

Adult Onset:

Patients who have growth hormone deficiency, either alone or with multiple pituitary hormone deficiencies, such as hypopituitarism, as a result of pituitary disease, surgery, hypothalamic disease, radiation therapy, or trauma.

For the above patients:

• Biochemical diagnosis of growth hormone deficiency by means of a negative response to an appropriate stimulation test, ordered by an endocronologist.  The clonidine test is not acceptable for diagnosis in adults.

• No evidence of active malignancy or other contraindication.

• Other hormonal deficiencies with adequate replacement therapy.

• Initial dose @ 0.006 mg/kg daily.

• Maximum dose @ 0.025 mg/kg daily in patients under 35 years of age.

• Maximum dose @ 0.0125 mg/kg daily in patients over 35 years of age. 

Baseline and evaluation annually of the following to justify continued use:

• Insulin like growth factor 1 (IGF 1) at least once annually and following any change in dosage

• Fasting lipid profile

• BUN

• Fasting glucose

• Electrolyte levels

• Baseline bone density testing and then every three (3) years

• Evaluation of any new osteoarthritis and joint pain

Approval may be granted initially for a period of up to one year.  If an extension of benefits is needed, the physician must submit a progress report, including information regarding efficacy, adverse effects ,and compliance. This report must include the date that the patient was last seen.

Requests for prior approval should be sent to the Rational Drug Therapy Program, by fax at 1-800-531-7787 or telephone at 1-800-847-3859.

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Growth Hormone Deficiency in Children

1. Standard deviation of 2.0 or more below mean height for chronological age.
2. No expanding intracranial lesion or tumor diagnosed.
3. Growth rate below five centimeters per year.
4. Failure of any two stimuli test to raise the serum growth hormone level above 10 nanograms/milliliter.
5. Bone age 14-15 years or less in females and 15-16 years or less in males.
6. Epiphyses open.

1. Standard deviation of 2.0 or more below mean height for chronological age.
2. No expanding intracranial lesion or tumor diagnosed.
3. Growth rate below five centimeters per year.
4. Irreversible renal insufficiency with a creatinine clearance <75 ml/min per 1.73m2 but pre-renal transplant.
5. Bone age 14-15 years or less in females and 15-16 years or less in males.
6. Epiphyses open.

1. Chromosomal abnormality showing Turner's syndrome.
2. Standard deviation of 2.0 or more below mean height for chronological age.
3. No expanding intracranial lesion or tumor diagnosed.
4. Growth rate below five centimeters per year.
5. Bone age 14-15 year.
6. Epiphyses open.

1. Standard deviation of 2.0 or more below mean height for chronological age
2. No expanding intracranial lesion or tumor diagnosed.
3. Growth rate below five centimeters per year.
4. Bone age 14-15 years or less in females and 15-16 years or less in males.
5. Epiphyses open.
6. Mixed or normal response to any two stimuli test in raising serum growth hormone above 10 nanograms/milliliter.
7. IGF-1 levels less than 50th percentile for chronological age.

Rational Drug Therapy Program  West Virginia University School of Pharmacy  P.O. Box 9511  Morgantown, WV 26506-9511  Phone 800 847 3859  Fax 800 531 7787