FDA-approved, for example:

• Growth hormone deficiency in children – Genotropin, Humatrope, Ngenla, Norditropin, Nutropin AQ, Omnitrope, Saizen, Skytrofa, Sogroya, 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, Sogroya
• HIV/AIDS-associated wasting or cachexia – Serostim
• Primary insulin-like growth factor (IGF)-1 deficiency – Increlex

non-FDA-approved, for example:

• Growth failure in children associated with chronic renal failure post-transplant (growth hormone agents)
• Short stature secondary to sickle cell disease (growth hormone agents)
• Silver-Russell Syndrome (growth hormone agents)

Note: The above lists may not include all FDA-approved and non-FDA-approved indications.

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.
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
• 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

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
    • growth velocity below the tenth percentile for age and gender as defined by one of the following:
      • age two to less than four years: < 5.5 cm/year; or
      • age four to less than six years: < 5 cm/year; or
      • age six years to puberty: < 4.5 cm/year (biologic females) or < 4 cm/year (biologic males); or
    • height dropping below initial percentile curve on standard pediatric growth chart when monitored over one year; and
  • prescriber is an endocrinologist or consult notes from an endocrinology office are provided; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa and Sogroya; and
  • one of the following:
    • results of two abnormal GH stimulation tests; or
    • results of one abnormal stimulation test and one abnormal IGF-1 or IGFBP-3 level; or
    • results of one abnormal test (IGF-1, IGFBP-3, or GH stimulation test); and
      • one of the following:
        • abnormal pituitary imaging; or
        • 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 or estrogen/progesterone, or desmopressin). 

• 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; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa and Sogroya.

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
    • growth velocity below the tenth percentile for age and gender as defined by one of the following:
      • age two to less than four years: < 5.5 cm/year; or
      • age four to less than six years: < 5 cm/year; or
      • age six years to puberty: < 4.5 cm/year (biologic females) or < 4 cm/year (biologic males); or
    • height dropping below initial percentile curve on standard pediatric growth chart when monitored over one year; and
  • one of the following:
    • rationale for why genetic testing cannot be provided as noted by one of the following:
      • member is new to prescriber and current prescriber has no means of obtaining labs used for diagnosis; or 
      • diagnosis made many years ago; or
    • genetic testing confirming diagnosis; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and 
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa and Sogroya. 

• 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
    • growth velocity below the tenth percentile for age and gender as defined by one of the following:
      • age two to less than four years: < 5.5 cm/year; or
      • age four to less than six years: < 5 cm/year; or
      • age six years to puberty: < 4.5 cm/year (biologic females) or < 4 cm/year (biologic males); 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; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa or Sogroya. 

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

Pediatric - Chronic renal failure post-transplant (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
    • growth velocity below the tenth percentile for age and gender as defined by one of the following:
      • age two to less than four years: < 5.5 cm/year; or
      • age four to less than six years: < 5 cm/year; or 
      • age six to puberty: < 4.5 cm/year (biologic females) or < 4 cm/year (biologic males); 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 the care of a renal specialist; and
  • growth has been monitored for at least one year post-transplant, without catch-up growth documented as height continually less than -2 standard deviations below mean or below third percentile from time of transplant to current request; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa and Sogroya. 

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

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
    • growth velocity below the tenth percentile for age and gender as defined by one of the following:
      • age two to less than four years: < 5.5 cm/year; or
      • age four to less than six years: < 5 cm/year; or
      • age six years to puberty: < 4.5 cm/year (biologic females) or < 4 cm/year (biologic males); 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 third percentile for gestational age); and
  • catch-up growth not achieved between the ages of two to four, as indicated by both of the following:
    • at least one height measurement less than -2 standard deviations below mean or below third percentile between age two to four years; and
    • member does not have evidence of consistent catch-up growth (defined as: from age two to current age [or age four, whichever is less], no consecutive years with height measurements greater than -2 standard deviations below mean or greater than third percentile); and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa and Sogroya. 

• 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 dosing; and
  • prescriber is a pediatric endocrinologist or other growth disorder specialist or consult notes are provided; 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
  • other 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.

Pediatric - Short stature secondary to sickle cell disease (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
  • growth velocity below the tenth percentile for age and gender as defined by one of the following:
    • age two to less than four years: < 5.5 cm/year; or
    • age four to less than six years: < 5 cm/year; or
    • age six years to puberty: < 4.5 cm/year (biologic females) or < 4 cm/year (biologic males); and
  • one abnormal test (GH stimulation, IGF-1, or IGFBP-3 test); and
  • prescriber is an endocrinologist or consult notes from an endocrinology office are provided; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa and Sogroya. 

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

Pediatric - Silver-Russell 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
    • growth velocity below the tenth percentile for age and gender as defined by one of the following:
      • age two to less than four years: < 5.5 cm/year; or
      • age four to less than six years: < 5 cm/year; or
      • age six years to puberty: < 4.5 cm/year (biologic females) or < 4 cm/year (biologic males); or
    • height dropping below initial percentile curve on standard pediatric growth chart when monitored over one year; and
  • one of the following:
    • rationale for why genetic testing cannot be provided as noted by one of the following:
      • member is new to prescriber and current prescriber has no means of obtaining labs used for diagnosis; or 
      • diagnosis made many years ago; or
    • genetic testing confirming diagnosis; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, clinical rationale for use of the requested agent instead of Skytrofa and Sogroya. 

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

Adult - GH deficiency or panhypopituitarism (growth hormone agents)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • prescriber is an endocrinologist or consult notes from an endocrinology office are provided; and
  • at least one symptom consistent with GH deficiency; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, the prescriber provides clinial rationale for use of the requested agent instead of Sogroya; and
  • one of the following:
    • results of two abnormal GH stimulation tests; or 
    • results of one abnormal stimulation test and one abnormal IGF-1 or IGFBP-3 level; or
    • results of one abnormal test (IGF-1, IGFBP-3, or GH stimulation test); and
      • one of the following:
        • abnormal pituitary imaging; or
        • 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 or estrogen/progesterone, or desmopressin).

• 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; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, the prescriber provides clinical rationale for use of the requested agent instead of Sogroya.

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; and
  • for all agents other than Genotropin, the prescriber provides clinical rationale for use of the requested agent instead of Genotropin; and
  • for Ngenla, the prescriber provides clinical rationale for use of the requested agent instead of Sogroya.