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Drug Category: Endocrine and Metabolic Agents

Medication Class/Individual Agents: Pituitary Agents

I. Prior-Authorization Requirements

 Growth Hormone Secretagogue Receptor Agonist

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

macimorelin Macrilen ^ test  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

Contraindications:

  • active malignancy
  • growth promotion in children with fused epiphyses
  • acute critical illness due to complications following open–heart surgery or abdominal surgery

Warnings:

  • Dosage and schedule should be individualized.
  • Injection sites should be rotated to avoid lipoatrophy.

 

IGF-1 or IGFBP-3:

Values more than 2 standard deviations (SD) below the mean for IGF-1 (insulin-like growth factor-1, also known as somatomedin C) or IGFBP-3 (IGF binding protein-3) may suggest an abnormality in the growth hormone axis, but results of these tests can depend on transient issues such as poor nutrition or psychosocial deprivation. These tests, therefore, cannot be used as the sole determinant of a growth hormone deficiency diagnosis.

 

 Growth Hormones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

somatropin-Genotropin Genotropin PD PA  
somatropin-Humatrope Humatrope PA  
somatropin-Norditropin Norditropin PA  
somatropin-Nutropin AQ Nutropin AQ PA  
somatropin-Omnitrope Omnitrope PA  
somatropin-Saizen Saizen PA  
somatropin-Serostim Serostim PA  
somatropin-Zomacton Zomacton PA  
somatropin-Zorbtive Zorbtive PA  

 Recombinant Human Insulin-Like Growth Factor I

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

mecasermin Increlex PA  
Table Footnotes
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Growth hormone deficiency in children – Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton
  • Growth hormone gene deletion with the development of neutralizing antibodies to growth hormone – Increlex
  • Growth failure in children associated with chronic renal insufficiency before renal transplant – Nutropin AQ
  • Growth failure in children associated with Noonan Syndrome – Norditropin
  • Growth failure in children associated with Prader-Willi Syndrome – Genotropin, Omnitrope
  • Growth failure in children associated with Turner Syndrome – Genotropin, Humatrope, Norditropin, Nutropin AQ
  • Growth failure in children born small for gestational age – Genotropin, Humatrope, Norditropin, Omnitrope 
  • Growth hormone deficiency in adults – Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen
  • HIV/AIDS-associated wasting or cachexia – Serostim
  • Primary insulin-like growth factor (IGF)-1 deficiency – Increlex
  • Short-bowel syndrome in patients receiving specialized nutritional support – Zorbtive

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

 

Pediatric - Growth hormone (GH) deficiency or panhypopituitarism (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • short stature or growth failure, documented by one of the following:
      • pre-treatment height less than -2 standard deviations below mean or below third percentile on standard pediatric growth chart; or
      • height dropping below initial percentile curve on standard pediatric growth chart when monitored over one year; and
    • one of the following:
      • results of two abnormal tests, which can be either two abnormal GH stimulation tests or one abnormal stimulation test and one abnormal IGF-1 (insulin-like growth factor 1)/IGFBP-3 (insulin-like growth factor-binding protein-3) level; or
      • one abnormal test (IGF-1, IGFBP-3 or GH stimulation test), with either documentation of abnormal pituitary imaging or documented deficiency of at least three other pituitary hormones (TSH, ACTH, LH, FSH, or AVP/ADH) or appropriate current medication claims (levothyroxine, hydrocortisone or other glucocorticoid, testosterone [males] or estrogen/progesterone [females], or desmopressin)
    • one of the following:
      • member is under the care of an endocrinologist; or
      • other possible causes of short stature have been ruled out (i.e. hypothyroidism, malnutrition, chronic illness, skeletal disorders, pituitary tumor).

  

  • For recertification, documentation of measured growth velocity of at least 2.5 cm per year is required.

  

Pediatric - Hypoglycemia due to GH deficiency (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • test results indicating GH deficiency (at least one abnormal GH stimulation test is required); and
    • hypoglycemia-symptoms and low glucose level.

  

Pediatric - Noonan, Prader-Willi, or Turner Syndrome (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • short stature or growth failure, documented by one of the following:
      • pre-treatment height less than -2 standard deviations below mean or below third percentile on standard pediatric growth chart; or
      • height dropping below initial percentile curve on standard pediatric growth chart when monitored over one year; and
    • one of the following:
      • genetic testing confirming diagnosis; or
      • appropriate clinical rationale for why genetic testing cannot be provided.

  

  • For recertification, documentation of measured growth velocity of at least 2.5 cm per year is required.

  

Pediatric - Chronic renal failure up to time of renal transplantation (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • short stature or growth failure, documented by one of the following:
      • pre-treatment height less than -2 standard deviations below mean or below third percentile on standard pediatric growth chart; or
      • height dropping below initial percentile curve on standard pediatric growth chart when monitored over one year; and
    • one of the following:
      • other CRF-associated etiologies have been excluded; or
      • member is under care of a renal specialist.

  

Pediatric - Small for gestational age (SGA)/Intrauterine growth restriction (IUGR) with failed catch-up growth between age two - four (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ two years of age; and
    • short stature or growth failure, documented by one of the following:
      • pre-treatment height less than -2 standard deviations below mean or below third percentile on standard pediatric growth chart; or
      • height dropping below initial percentile curve on standard pediatric growth chart when monitored over one year; and
    • diagnosis of SGA/IUGR (birth weight or length less than -2 standard deviations below mean or below 3rd percentile for gestational age); and
    • catch-up growth not achieved between the ages of two - four (height continually less than -2 standard deviations below mean or below 3rd percentile from age two to current age).

  

  • For recertification, documentation of measured growth velocity of at least 2.5 cm per year is required.

  

Primary IGFD and Growth hormone gene deletion with the development of neutralizing antibodies to growth hormone (Increlex)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ two years of age; and
    • appropriate dose; and
    • member is under care of a pediatric endocrinologist or other growth disorder specialist; and
    • height standard deviation score ≤ -3; and
    • basal IGF-1 standard deviation score ≤ -3; and
    • normal or elevated growth hormone level; and
    • member has an open epiphysis; and
    • forms of secondary IGF-1 deficiency have been ruled out (i.e. growth hormone deficiency, malnutrition, hypothyroidism, use of chronic pharmacologic doses of anti-inflammatory steroids).

  

  • For recertification, documentation of the following is required:
    • response to therapy; and
    • open epiphyses.

 

  

Adult - GH deficiency or panhypopituitarism (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • results of two abnormal tests, which can be either two abnormal GH stimulation tests or one abnormal stimulation test and one abnormal IGF-1 (insulin-like growth factor 1)/IGFBP-3 (insulin-like growth factor-binding protein-3) level; or
      • one abnormal test (IGF-1, IGFBP-3 or GH stimulation test), with either documentation of abnormal pituitary imaging or documented deficiency of at least three other pituitary hormones (TSH, ACTH, LH, FSH, or AVP/ADH) or appropriate current medication claims suggesting deficiency of at least three other pituitary hormones (levothyroxine, hydrocortisone or other glucocorticoid, testosterone [males] or estrogen/progesterone [females], or desmopressin)
      • documentation of a GH complication; and
    • at least one complication of GH deficiency.

  

  • For recertification, documentation of the following is required:
    • IGF-1 or IGFBP-3 level within lab-specific reference range; and
    • for isolated or idiopathic adult GHD, positive response regarding documented GH complication.

  

Adult - HIV/AIDS-associated wasting or cachexia (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is receiving concurrent antiretroviral therapy; and
    • evidence of wasting, as indicated by one of the following (with or without chronic fever, weakness, or diarrhea):
      • an involuntary loss of at least 10% of body weight within one year; or
      • an involuntary loss of at least 7.5% of body weight within six months; or
      • a reduction in lean body mass (measured via bioelectrical impedance assay or BIA); or
      • BMI < 20 kg/m2; and
    • member has had a trial of an FDA-approved appetite stimulant (i.e., dronabinol or megestrol acetate) prior to initiation of GH therapy if the etiology of wasting or cachexia is decreased caloric intake; and
    • one of the following:
      • other causes of weight loss have been ruled out (i.e., gastrointestinal tract opportunistic infections, decrease in food intake due to oral, pharyngeal, esophageal lesions or candidiasis, gonadal dysfunction, adverse effects due to medications, or psychosocial factors); or
      • member is under the care of an Infectious Disease specialist.

  

Adult - Short-bowel syndrome (growth hormone agents)

  • Documentation of the following is required:
    • appropriate diagnosis (in members receiving specialized nutritional support); and
    • intended duration of therapy.


Original Effective Date: 09/2005

Last Revised Date: 08/2019


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Last updated 11/08/19