Effective Date

Date of Origin   

01-01-2026           

Genotropin®

(somatropin)

Multi-dose pen for subcutaneous injection

Miniquick single-dose delivery device for subcutaneous injection

Treatment of pediatric patients with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GHD)
• Growth failure due to Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing
• Growth failure in pediatric patients born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years
• Growth failure associated with Turner syndrome
• Idiopathic short stature (ISS) defined by height standard deviation score (SDS) less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means

Replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: 

• Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma
• Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes

4

Humatrope®

(somatropin)

Subcutaneous injection 

Treatment of pediatric patients with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GH)
• Short stature associated with Turner syndrome
• Idiopathic short stature (ISS) defined by height standard deviation score (SDS) less than -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
• Short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency
• Short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age

Replacement of endogenous GH in adults with growth hormone deficiency

5

Ngenla™

(somatrogon-ghla)

Subcutaneous prefilled pen injection 

Treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone

14

Norditropin® FlexPro®

(somatropin)

Subcutaneous injection

Treatment of pediatric patients with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GH)
• Short stature associated with Noonan syndrome
• Short stature associated with Turner syndrome
• Short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age
• Idiopathic Short Stature (ISS) height standard deviation score (SDS) less than -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
• Growth failure due to Prader-Willi syndrome (PWS)

Replacement of endogenous GH in adults with growth hormone deficiency (GHD)

6

Nutropin® AQ

(somatropin)

Pen cartridge for subcutaneous injection

Nuspin for subcutaneous injection

Treatment of pediatric patients with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GH)
• Growth failure associated with chronic kidney disease (CKD) up to the time of renal transplantation
• Idiopathic Short Stature (ISS) defined by height SDS less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means
• Short stature associated with Turner Syndrome

Replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

• Adult Onset: Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma
• Childhood Onset: Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes

8

Omnitrope®

(somatropin)

Prefilled cartridge for subcutaneous injection

Vial for subcutaneous injection

Treatment of children with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GH)
• Growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing.
• Growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years
• Growth failure associated with Turner Syndrome
• Idiopathic short stature (ISS) defined by height standard deviation score (SDS) less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means

Replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

• Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma 
• Childhood Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes

7

Saizen®

(somatropin)

Vial for subcutaneous injection

Treatment of children with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GH)

Replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

• Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma 
• Childhood Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes

1

Serostim®

(somatropin)

Subcutaneous injection

Treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight and improve physical endurance. Concomitant antiretroviral therapy is necessary.

2

Skytrofa®

(lonapegsomatropin-tcgd)

Subcutaneous injection

Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)

Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD)

22

Sogroya®

(somapacitan-beco)

Subcutaneous injection 

Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) 

Replacement of endogenous GH in adults with growth hormone deficiency (GHD)

15

Zomacton®

(somatropin)

Subcutaneous injection

Treatment of pediatric patients with:

• Growth failure due to inadequate secretion of endogenous growth hormone (GH)
• Short stature associated with Turner syndrome
• Idiopathic short stature (ISS), height standard deviation score (HSDS) less than or equal to -2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range
• Short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency
• Short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years

Replacement of endogenous GH in adults with GH deficiency

9

Zorbtive®

(somatropin)

Subcutaneous injection

Treatment of short bowel syndrome in adult patients receiving specialized nutritional support

3

Growth Hormone Deficiency in Children and Adults

Growth hormone deficiency (GHD) can be divided into congenital and acquired forms. The single most important clinical manifestation of GHD is growth failure. Careful documentation of height velocity (HV) is critical to making the correct diagnosis.(10) Patients with congenital GHD have only slightly reduced birth length and may not immediately show growth failure. Neonatal morbidity may include hypoglycemia. Children with acquired GHD present with severe growth failure, delayed bone age, and increased weight: height ratios. Causes of acquired GHD include intracranial tumors involving the hypothalamic-pituitary region, cranial irradiation, and head trauma.(10)

Clinical presentation, diagnosis, and treatment of GHD in children and adolescents, as described by the 2016 Pediatric Endocrine Society Guidelines for Growth Hormone (GH) and Insulin-Like Growth Factor-1 (IGF-1) Treatment in Children and Adolescents(11), the 2019 GH Research Society (GRS) Guidelines for the Diagnosis, Genetics, and Therapy of Short Stature Children(12), and the 2000 GRS Consensus Guidelines for the Diagnosis and Treatment of GH Deficiency in Childhood and Adolescence(13) is stated as follows:

• A more comprehensive evaluation is warranted in children with one or more of the following:
  • Height-for-age curve that has deviated downward across two major height percentile curves (e.g., from above the 25th percentile to below the 10th percentile)(10)
  • Age 2-4 years: HV less than 5.5 cm/year (less than 2.2 inches/year)(10)
  • Age 4-6 years: HV less than 5 cm/year (less than 2 inches/year)(10)
  • Age 6 years to puberty:(10)
    • HV less than 4 cm/year for boys (less than 1.6 inches/year)
    • HV less than 4.5 cm/year for girls (less than 1.8 inches/year)
  • Decrease in height standard deviation (SD) of more than 0.5 over one year in children over 2 years of age(13)
  • HV more than 2 SD below the mean over one year, or more than 1.5 SD sustained over 2 years(13)
  • Height more than 1.5 SD below the mid-parental height(12,13)
  • Height greater than 2 SD below the mean for age and sex(12)
  • Severe short stature (e.g., height less than or equal to -2.5 standard deviations [SD], i.e., 0.6th percentile), or less severe short stature combined with growth failure(12,13)
  • Features that raise concerns for hypothalamic-pituitary dysfunction, either congenital or acquired, with decelerating growth, even if the child’s height is within the normal range(10,12)
  • Evidence for deficits in other hypothalamic-pituitary hormones, either congenital or acquired(12)
• Once the decision to evaluate a short child has been made, a variety of different tests can be performed. Assessment of pituitary GH production is difficult because GH secretion is pulsatile. Between normal pulses of GH secretion, serum GH levels are often low, below the limits of sensitivity of most conventional assays. Because of these issues, the diagnosis of GHD is made with a combination of clinical assessment and auxology, levels of IGF-1 and insulin-like growth factor binding protein 3 (IGFBP-3), and GH stimulation (provocation) tests.(10,12,13)  
• The IGF-1, IGFBP-3, and bone age testing results may be interpreted as follows:
  • Moderately or severely reduced: IGF-1 and IGFBP-3 less than -2 SD with delayed bone age; possibility of GHD should be explored by provocative testing in most cases(13)
  • Somewhat low: IGF-1 and IGFBP-3 between 0 and -2 SD; decision about whether to perform provocative testing depends on other factors(13)
  • Clearly normal: IGF-1 and IGFBP-3 SD greater than or equal to 0; no further testing required(13)
  • If the IGF-1 and IGFBP-3 are discordant, IGF-1 takes precedence except for infants and young children, in whom IGFBP-3 should guide the decision about further testing.(12,13)
• Provocative (stimulation) GH testing is indicated for most patients to confirm GHD. However, because this testing has limitations, it is strongly recommended not to be the sole diagnostic criterion of GHD.(11,13) In general, two different tests (e.g., insulin tolerance test [ITT], glucagon, arginine, clonidine, L-dopa, GH-releasing peptide-2 [GHRP2]) should be used for provocative GH testing.(11,12) For those with known pathology of the central nervous system, history of irradiation, other pituitary hormone defects (e.g., multiple pituitary hormone deficiency [MPHD]), or a genetic defect, one test is sufficient.(12,13)
• The use of GH provocative testing is not required for diagnosis of GHD in the following conditions:
  • In patients possessing all three conditions: auxological criteria, hypothalamic-pituitary defect (such as major congenital malformation [ectopic posterior pituitary and pituitary hypoplasia with abnormal stalk], tumor or irradiation), and deficiency of at least one additional pituitary hormone(10,11,12)
  • In a newborn with hypoglycemia who does not attain a serum GH concentration above 5 mcg/L and has deficiency of at least one additional pituitary hormone and/or congenital pituitary abnormality (ectopic posterior pituitary and pituitary hypoplasia with abnormal stalk)(10,11,12)
  • Infant or young child with extreme short stature (e.g., height less than -3 SD), normal nutrition, significantly reduced IGF-1 and IGFBP-3 (e.g., less than -2 SD), and delayed bone age(12)
  • In newborns who present with hypoglycemia in the absence of a metabolic disorder, a serum GH level of less than 20 mcg/L suggests GHD. An IGFBP-3 measurement (e.g., less than -2 SD) is of value for the diagnosis of GHD in infancy.(13)
  • When an alternative diagnosis for short stature is evident, such as Turner syndrome, Noonan syndrome, Prader-Willi syndrome (PWS), SHOX deficiency, chronic renal insufficiency, or in children born small for gestational age (SGA) with unexplained persistent short stature(12)
• Some guidelines acknowledge that a threshold test result distinguishing “normal” from GHD has not been well established.(11,12) Most pediatric endocrinologists define a “normal” response by a serum GH concentration of greater than 10 mcg/L, but a cutoff of 7.5 mcg/L is often used for modern assays.(12,13)
• Treatment of children with GHD is the following:
  • Weight-based or body-surface-area dosing should be used(11,12,13)
  • Measure serum IGF-1 levels to monitor adherence and for dose changes(11,12,13)
  • Serum levels of IGF-1 should be measured approximately 4 weeks after beginning GH treatment and/or making a dose adjustment(13)
  • Routine follow-up (once IGF-1 levels are in target range) of pediatric patients should be conducted on a 3- to 6-month basis(13)
  • Treatment is appropriate for children with GHD whose epiphyses are open(13)
• Treatment is generally continued at least until linear growth decreases to less than 2.0 to 2.5 cm/year.(11)

Guidelines for patients transitioning from pediatric to adult care, as described by the 2016 Pediatric Endocrine Society Guidelines for GH and IGF-1 Treatment in Children and Adolescents(11), the 2000 GRS Consensus Guidelines for the Diagnosis and Treatment of GH Deficiency in Childhood and Adolescence(13), the 2019 American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology Guidelines for Management of GHD Deficiency in Adults and Patients Transitioning from Pediatric to Adult Care(24), and the 2011 Endocrine Society Clinical Practice Guidelines for Evaluation and Treatment of Adult GHD(25) is stated as follows:

• Only a minority of children with childhood-onset GHD will remain deficient as adults and require ongoing GH therapy. The transition period is loosely defined as occurring from late puberty in mid-to-late teens until 6-7 years after reaching established adult muscle, bone composition, and near-adult height.(11,27)
• For patients transitioning from pediatric to adult care:
  • Because the majority of isolated childhood-onset GHD patients will have normal results when tested as adults, it is important to repeat GH stimulation testing to determine if ongoing therapy is required.(11,24,27)
  • Measurement of the serum IGF-1 concentration should be the initial test of the somatotropic axis if re-evaluation of the somatotropic axis is clinically indicated.(11)
  • GH provocative testing should be performed to evaluate the function of the somatotropic axis in the transition period if indicated by a low IGF-1 level.(11,24,25)
  • Patients with MPHD (greater than or equal to 3 PHD) regardless of etiology, GHD with an established causal genetic mutation, or GHD with a specific pituitary/hypothalamic structural defect (except ectopic posterior pituitary), should be diagnosed with persistent GHD.(11,13,24,27) GH treatment should be offered to individuals with persistent GHD in the transition period.(11,24,25,27)

Clinical presentation, diagnosis, and treatment of GHD in adults, as described by the 2019 AACE and American College of Endocrinology Guidelines for Management of GHD in Adults and Patients Transitioning from Pediatric to Adult Care(24), and the 2011 Endocrine Society Clinical Practice Guidelines for Evaluation and Treatment of Adult GHD(25) is stated as follows:

• The diagnosis of adult GHD should be based on the combination of documented pituitary or hypothalamic disease, panhypopituitarism, and a subnormal serum IGF-1 concentration (lower than the gender- and age-specific lower limit of normal). GH levels decline with aging, whereas serum IGF-1 levels can be lowered by factors such as malnutrition and various comorbidities (e.g., diabetes, renal and/or hepatic disease). Stimulation (provocative) tests should only be performed based on the clinical context of each patient with a history suggestive of reasonable clinical suspicion of GHD, and with the intent to initiate GH therapy if the diagnosis is confirmed.(24)
• Diagnosis of adult GHD, without the need for stimulation/provocation tests, can be made in the following patient subtypes:(24,25)
  • Organic hypothalamic-pituitary disease (e.g., suprasellar mass with previous surgery and cranial irradiation) and presence MPHD (greater than or equal to 3 PHD) together with subnormal serum IGF-1 levels (less than -2 SD)
  • Genetic defects affecting the hypothalamic-pituitary axes
  • Hypothalamic-pituitary structural brain defects
• Diagnosis of adult GHD, with the need of at least one GH stimulation tests should be performed to confirm the diagnosis in patients with less than or equal to 2 PHD and low IGF-1 levels (less than -2 SD) as these alone are not sufficient to make a diagnosis of adult GHD. In transition patients who have completed longitudinal growth:(24)
  • Patients with idiopathic isolated GHD with low-normal (0 to -2 SD) or low (less than -2 SD) serum IGF-1 levels should be retested for GHD with GH-stimulation tests after at least 1 month following discontinuation of GH therapy.(24,25)
  • Patients with isolated GHD (IGHD) with organic hypothalamic-pituitary disease (e.g., craniopharyngioma, pituitary hypoplasia, ectopic posterior pituitary, or previous cranial irradiation) and clinical suspicion for GHD is high, at least one GH stimulation test should be performed. If suspicion is low, two GH stimulation tests should be performed.(24)
• The ITT is considered the gold-standard test to confirm a diagnosis of GHD in adults with a cut-point of less than or equal to 5 mcg/L. However, experts increasingly report the disuse of this test due to safety concerns, laboriousness, potential to cause serious hypoglycemia in some patients, and contraindication in certain patients. If the ITT is contraindicated or not appropriate for the patient, the glucagon-stimulation test (GST) (cut-point of 3 mcg/L) and the macimorelin test (cut-point of less than or equal to 2.8 mcg/L), should be utilized as alternatives. Arginine and levodopa testing are not recommended due to low sensitivity and specificity in adult and transition patients.(24)

Idiopathic Short Stature

Idiopathic short stature (ISS) refers to extreme short stature that does not have a diagnostic explanation. "Short stature" has been defined by the AACE as height more than 2 SD below the mean for age and sex, without evidence of systemic, endocrine, nutritional, or chromosomal abnormalities.(17,20) A consensus conference of the International Societies of Pediatric Endocrinology and the GRS proposed that children with ISS whose heights are less than -2 SD and who are more than 2 SD below their mid-parental target height or had a predicted height less than -2 SD warrant consideration for treatment.(17,20) A successful growth response in the first year while on GH therapy includes a change in height SD of more than 0.3-0.5, HV increment of greater than 3 cm/year, or HV SD of more than +1. Treatment is appropriate until linear growth decreases to less than 2 cm/year and/or a bone age of greater than 14 years in girls and 16 years in boys.(17)

GH therapy was approved in the United States for children with ISS with a height less than or equal to -2.25 SD (less than or equal to 1.2 percentile) below the mean for age and sex, associated with growth rates unlikely to permit attainment of adult height (AH) in the normal range (this corresponds to an AH less than 63 inches for males and less than 59 inches for females), in whom diagnostic work up excluded other causes for short stature that should be observed or treated by other means, and in pediatric patients whose epiphyses are not closed.(11) The evaluation should attempt to identify children with growth patterns consistent with constitutional delay of growth and puberty (CDGP) because they are likely to have catch-up growth without GH treatment. Clinical evidence supporting CDGP includes delayed bone age and/or history of delayed growth and puberty in a parent. Moreover, adolescent boys with CDGP and moderate short stature (taller than -2.5 SD) are more appropriately treated with testosterone replacement rather than GH.(17) On average, with 5 years of GH treatment there will be approximately a 5 cm (2 inch) increase in AH. Highly variable responses are possible, including no measurable increases in some patients. Therefore, improvement should be assessed after 12 months of therapy and discontinuation of therapy should be considered if adequate height gain is not achieved.(11)

Growth Failure in Chronic Kidney Disease

The goal of GH therapy in children with chronic kidney disease (CKD) is normalization of final height. KDOQI guidelines recommend that GH therapy should be initiated when the following criteria have been met:(18-19)

• All other treatable risk factors for growth impairment have been addressed and the child has growth potential
• There is evidence of growth impairment, defined as short stature (height SD less than -1.88 or height-for-age less than third percentile) and growth failure (height velocity-for-age SD less than -1.88 or height velocity-for-age less than 3rd percentile), that persists beyond 3 months despite treatment of nutritional deficiencies and metabolic abnormalities

Short Bowel Syndrome

Short bowel syndrome (SBS) is a disabling malabsorption disorder with significant morbidity and mortality, reduced quality of life, and health care costs. SBS is defined as the inability to maintain nutritional, fluid, and/or electrolyte homeostasis while consuming a normal, healthy diet after a bowel resection.(31) SBS is considered when the total small bowel in continuity (even with the total small bowel length including that bypassed may be normal) of less than 200 cm.(32) Complications from abdominal surgery, malignancy, mesenteric ischemic events, Crohn's disease, trauma, or other causes can necessitate a bowel resection. The use of PN, often required in the management of SBS, carries its own complications, high cost, and impairment in quality of life. Dependency on PN at 1, 2, and 5 years in patients with SBS was reported in 74%, 64%, and 48% of patients, respectively.(32) Patients are relatively unlikely (less than 10%) to completely wean off PN after 2-3 years post most recent intestinal resection.(31)

A phase 3, prospective, randomized, placebo-controlled trial enrolled 41 PN-dependent SBS patients who were studied in an inpatient-like setting for 6 weeks, with 2 weeks of diet and medication optimization and PN stabilization followed by a 4-week treatment period. Patients were randomized into 3 groups: recombinant human growth hormone (rhGH) plus glutamine, GH without glutamine, and placebo plus glutamine. A significant reduction was seen in PN requirements in both groups treated with GH at the end of the 4-week treatment period. PN reduction remained significantly reduced during a 12-week observation period only in the group treated with GH plus glutamine. Zorbtive for the short term (4 weeks) treatment to aid in the PN weaning in adult SBS patients, was approved based on these results.(32)

The long-term benefits of GH for this use comes with a considerable amount of skepticism over side effects, replicating results of the trial in ambulatory settings, and cost, causing limited acceptance into clinical practice.(32) European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines recommend treatment with somatotropin be used under the guidance of a physician experience in the management of SBS. Recommendations, although categorized as weak with moderate support, suggest candidates for growth factor treatment use teduglutide, a GLP-2 analog, as first-line.(31)

Growth Failure in Children Born Small for Gestational Age

Low birth weight remains a major cause of morbidity and mortality in early infancy and childhood. The International Societies of Pediatric Endocrinology and the GRS 2007 Consensus Statement on the Management of the Child Born Small for Gestational Age (SGA) recommend that SGA should be defined as a birth weight and/or birth length less than -2 SD below the population average. Approximately 90% of term SGA infants display sufficient catch-up growth to attain a height above -2 SD by the age of 2 years, whereas 10% remain short throughout childhood and adolescence.(21) A child who reaches 24 months of age and fails to manifest catch-up growth (i.e., height remains less than 2 SD below the mean for age and gender) meets the indication to receive GH therapy.(23) Discontinuation of GH treatment in adolescence is recommended when growth rate decreases to less than 2 cm/year.(21)

HIV Patients with Wasting or Cachexia

HIV/AIDS wasting syndrome is defined by the Centers for Disease Control and Prevention (CDC) as an involuntary weight loss of greater than 10% of body weight.(28) The incidence of wasting has declined since the introduction of anti-retroviral therapy (ART), but many patients still meet the criteria for serious weight loss and wasting. Tissue wasting responds rapidly to ART, and the primary therapy for HIV wasting is ART.(28,30) The diagnosis of HIV wasting requires one of the following:(29)

• 10% unintentional weight loss over 12 months
• 7.5% unintentional weight loss over 6 months
• Greater than 5% unintentional weight loss over 4 months
• 5% body cell mass (BCM) loss within 6 months
• Body mass index (BMI) less than 20 kg/m^2
• In men: BCM less than 35% of total body weight and BMI less than 27 kg/m^2
• In women: BCM less than 23% of total body weight and BMI less than 27 kg/m^2

Growth Hormone Statute

U.S. Code Title 21 - Food and Drugs, Chapter 9 - Federal Food, Drug, and Cosmetic Act, Subchapter III - Prohibited Acts and Penalties §333(e) states: Prohibited distribution of human growth hormone

(1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human GH for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services (HHS) under section 355 of this title and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.
(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].
(4) As used in this subsection the term ‘‘human growth hormone’’ means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.(26)

Efficacy

Recombinant growth hormone products are considered clinically identical, with no evidence that one commercial product is different or more advantageous than another, apart from differences in how the GH product is stored, dosed, and administered by device. Therefore, one commercial GH product is not recommended over another because there are no prospective head-to-head trials comparing the clinical efficacy of one commercial product with another.(18,24)

Safety

Somatropin (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Zomacton and Zorbtive) has the following contraindications:(1-9)

• Acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or acute respiratory failure
• Active malignancy
• Active proliferative or severe non-proliferative diabetic retinopathy
• Known hypersensitivity to somatropin or any of its excipients

Somatropin (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, and Zomacton) have the following additional contraindications:(1,4-9)

• Children with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment
• Pediatric patients with closed epiphyses

Somatrogon-ghla (Ngenla) has the following contraindications:(14)

• Acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or acute respiratory failure
• Hypersensitivity to somatrogon-ghla or any of the excipients in Ngenla
• Closed epiphyses
• Active malignancy
• Active proliferative or severe non-proliferative diabetic retinopathy
• Prader-Willi syndrome patients who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment

Lonapegsomatropin-tcgd (Skytrofa) has the following contraindications:(22)

• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
• Hypersensitivity to somatropin or any of the excipients in Skytrofa
• Children with closed epiphyses
• Active malignancy
• Active proliferative or severe non-proliferative diabetic retinopathy
• Children with Prader-Willi syndrome who are severely obese, upper airway obstruction or sleep apnea, or have severe respiratory impairment

Somapacitan-beco (Sogroya) has the following contraindications:(15)

• Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
• Active malignancy
• Hypersensitivity to somapacitan-beco or any of its excipients
• Active proliferative or severe non-proliferative diabetic retinopathy
• Pediatric patients with closed epiphyses
• Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment

1

Saizen prescribing information. EMD Serono, Inc. February 2020.

2

Serostim prescribing information. EMD Serono, Inc. June 2019.

3

Zorbtive prescribing information. EMD Serono, Inc. September 2019.

4

Genotropin prescribing information. Pfizer Laboratories Div Pfizer Inc. July 2025.

5

Humatrope prescribing information. Eli Lilly and Company. July 2025.

6

Norditropin prescribing information. Novo Nordisk. July 2025.

7

Omnitrope prescribing information. Sandoz Inc. July 2025.

8

Nutropin AQ NuSpin prescribing information. Genentech Inc. July 2025.

9

Zomacton prescribing information. Ferring Pharmaceuticals Inc. July 2025 

10

Kelly A, Winer KK, Kalkwarf H, et al. Age-based reference ranges for annual height velocity in US children. J Clin Endocrinol Metab. 2014;99(6):2104-2112. doi:10.1210/jc.2013-4455

11

Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-I treatment in children and adolescents: Growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency. Horm Res Paediatr. 2016;86(6):361-397. doi:10.1159/000452150

12

Collett-Solberg PF, Ambler G, Backeljauw PF, et al. Diagnosis, genetics, and therapy of short stature in children: A Growth Hormone Research Society international perspective. Horm Res Paediatr. 2019;92(1):1-14. doi:10.1159/000502231

13

Growth Hormone Research Society. Consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research Society. GH Research Society. J Clin Endocrinol Metab. 2000;85(11):3990-3993. doi:10.1210/jcem.85.11.6984

14

Ngenla prescribing information. Pfizer Laboratories Div Pfizer Inc. July 2025.

15

Sogroya prescribing information. Novo Nordisk Inc. July 2025.

16

Reference no longer used.

17

Cohen P, Rogol AD, Deal CL, et al. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008;93(11):4210-4217. doi:10.1210/jc.2008-0509

18

Kizler TA, Burrowes JD, Byham-Gray LD. KDOQI Nutrition in CKD Guideline Work Group. KDOQI clinical practice guideline for nutrition in CKD: 2020 update. Am J Kidney Dis. 2020;76(3):S1-S107.

19

Drube J, Wan M, Bonthuis M, et al. Clinical practice recommendations for growth hormone treatment in children with chronic kidney disease. Nat Rev Nephrol. 2019;15(9):577-589. doi:10.1038/s41581-019-0161-4

20

Deodati A, Cianfarani S. The rationale for growth hormone therapy in children with short stature. J Clin Res Pediatr Endocrinol. 2017;9(Suppl 2):23-32. doi:10.4274/jcrpe.2017.S003

21

Clayton PE, Cianfarani S, Czernichow P, Johannsson G, Rapaport R, Rogol A. Management of the child born small for gestational age through to adulthood: a consensus statement of the International Societies of Pediatric Endocrinology and the Growth Hormone Research Society. J Clin Endocrinol Metab. 2007;92(3):804-810. doi:10.1210/jc.2006-2017

22

Skytrofa prescribing information. Ascendis Pharma Endocrinology, Inc. July 2025.

23

Lee PA, Chernausek SD, Hokken-Koelega ACS, Czernichow P, International Small for Gestational Age Advisory Board. International Small for Gestational Age Advisory Board consensus development conference statement: management of short children born small for gestational age, April 24-October 1, 2001. Pediatrics. 2003;111(6 Pt 1):1253-1261. doi:10.1542/peds.111.6.1253

24

Yuen KCJ, Biller BMK, Radovick S, et al. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of growth hormone deficiency in adults and patients transitioning from pediatric to adult care: 2019 AACE growth hormone task force. Endocr Pract. 2019;25(11):1191-1232. doi:10.4158/GL-2019-0405

25

Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Vance ML, Endocrine Society. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(6):1587-1609. doi:10.1210/jc.2011-0179

26

21 USC 333 - Penalties. GovInfo. Available at: https://uscode.house.gov

27

Rapaport R, Cook DM. Transition of childhood-onset growth hormone-deficient patients to adult healthcare. Pediatr Endocrinol Rev. 2006;4 Suppl 1:82-90.

28

Nemechek PM, Polsky B, Gottlieb MS. Treatment guidelines for HIV-associated wasting. Mayo Clin Proc. 2000;75(4):386-394. doi:10.4065/75.4.386

29

Polsky B, Kotler D, Steinhart C. HIV-associated wasting in the HAART era: guidelines for assessment, diagnosis, and treatment. AIDS Patient Care STDS. 2001;15(8):411-423. doi:10.1089/108729101316914412

30

Mangili A, Murman DH, Zampini AM, Wanke CA. Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition for healthy living cohort. Clin Infect Dis. 2006;42(6):836-842. doi:10.1086/500398

31

Pironi L, Arends J, Bozzetti F, et al. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016;35(2):247-307. doi:10.1016/j.clnu.2016.01.020

32

Parrish CR, DiBaise JK. Managing the adult patient with short bowel syndrome. Gastroenterol Hepatol (N Y). 2017;13(10):600-608.

M ; N ; O ; Y

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cart

13.3 MG

M ; N ; O ; Y

N

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

0.7 MG

M ; N ; O ; Y

N

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

1.4 MG

M ; N ; O ; Y

N

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

1.8 MG

M ; N ; O ; Y

N

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

2.1 MG

M ; N ; O ; Y

N

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

2.5 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

3 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

3.6 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

4.3 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

5.2 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

6.3 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

7.6 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

9.1 MG

M ; N ; O ; Y

N

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

11 MG

M ; N ; O ; Y

N

Sogroya

somapacitan-beco solution pen-injector

10 MG/1.5ML ; 15 MG/1.5ML ; 5 MG/1.5ML

M ; N ; O ; Y

N

Ngenla

somatrogon-ghla solution pen-injector

24 MG/1.2ML ; 60 MG/1.2ML

M ; N ; O ; Y

N

Saizen

Somatropin (Non-Refrigerated) For Inj 5 MG

5 MG

M ; N ; O ; Y

N

Saizen

Somatropin (Non-Refrigerated) For Inj 8.8 MG

8.8 MG

M ; N ; O ; Y

N

Serostim

Somatropin (Non-Refrigerated) For Subcutaneous Inj 4 MG

4 MG

M ; N ; O ; Y

N

Serostim

Somatropin (Non-Refrigerated) For Subcutaneous Inj 5 MG

5 MG

M ; N ; O ; Y

N

Serostim

Somatropin (Non-Refrigerated) For Subcutaneous Inj 6 MG

6 MG

M ; N ; O ; Y

N

Zorbtive

Somatropin (Non-Refrigerated) For Subcutaneous Inj 8.8 MG

8.8 MG

M ; N ; O ; Y

N

Zomacton

Somatropin For Inj 10 MG

10 MG

M ; N ; O ; Y

N

Omnitrope

Somatropin For Inj 5.8 MG

5.8 MG

M ; N ; O ; Y

N

Humatrope

Somatropin For Inj Cartridge

6 MG

M ; N ; O ; Y

N

Humatrope

Somatropin For Inj Cartridge

12 MG

M ; N ; O ; Y

N

Humatrope

Somatropin For Inj Cartridge

24 MG

M ; N ; O ; Y

N

Zomacton

Somatropin For Subcutaneous Inj 5 MG

5 MG

M ; N ; O ; Y

N

Genotropin

Somatropin For Subcutaneous Inj Cartridge

5 MG

M ; N ; O ; Y

N

Genotropin

Somatropin For Subcutaneous Inj Cartridge

12 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.2 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.4 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.6 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.8 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.2 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.4 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.6 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.8 MG

M ; N ; O ; Y

N

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

2 MG

M ; N ; O ; Y

N

Omnitrope

Somatropin Solution Cartridge

5 MG/1.5ML

M ; N ; O ; Y

N

Omnitrope

Somatropin Solution Cartridge

10 MG/1.5ML

M ; N ; O ; Y

N

Nutropin aq nuspin 5

Somatropin Solution Pen-Injector

5 MG/2ML

M ; N ; O ; Y

N

Norditropin flexpro

Somatropin Solution Pen-Injector

5 MG/1.5ML

M ; N ; O ; Y

N

Nutropin aq nuspin 10

Somatropin Solution Pen-Injector

10 MG/2ML

M ; N ; O ; Y

N

Norditropin flexpro

Somatropin Solution Pen-Injector

10 MG/1.5ML

M ; N ; O ; Y

N

Norditropin flexpro

Somatropin Solution Pen-Injector

15 MG/1.5ML

M ; N ; O ; Y

N

Nutropin aq nuspin 20

Somatropin Solution Pen-Injector

20 MG/2ML

M ; N ; O ; Y

N

Norditropin flexpro

Somatropin Solution Pen-Injector

30 MG/3ML

M ; N ; O ; Y

N

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin

Somatropin For Subcutaneous Inj Cartridge

12 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin

Somatropin For Subcutaneous Inj Cartridge

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.2 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

2 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

1.8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Genotropin miniquick

Somatropin For Subcutaneous Inj Prefilled Syr

0.2 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Humatrope

Somatropin For Inj Cartridge

24 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Humatrope

Somatropin For Inj Cartridge

6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Humatrope

Somatropin For Inj Cartridge

12 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Ngenla

somatrogon-ghla solution pen-injector

24 MG/1.2ML ; 60 MG/1.2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Norditropin flexpro

Somatropin Solution Pen-Injector

15 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Norditropin flexpro

Somatropin Solution Pen-Injector

5 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Norditropin flexpro

Somatropin Solution Pen-Injector

10 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Norditropin flexpro

Somatropin Solution Pen-Injector

30 MG/3ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Nutropin aq nuspin 10

Somatropin Solution Pen-Injector

10 MG/2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Nutropin aq nuspin 20

Somatropin Solution Pen-Injector

20 MG/2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Nutropin aq nuspin 5

Somatropin Solution Pen-Injector

5 MG/2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Omnitrope

Somatropin For Inj 5.8 MG

5.8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Omnitrope

Somatropin Solution Cartridge

5 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Omnitrope

Somatropin Solution Cartridge

10 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Saizen

Somatropin (Non-Refrigerated) For Inj 5 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Saizen

Somatropin (Non-Refrigerated) For Inj 8.8 MG

8.8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Serostim

Somatropin (Non-Refrigerated) For Subcutaneous Inj 4 MG

4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Serostim

Somatropin (Non-Refrigerated) For Subcutaneous Inj 5 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Serostim

Somatropin (Non-Refrigerated) For Subcutaneous Inj 6 MG

6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cart

13.3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

2.1 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

1.8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

1.4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

lonapegsomatropin-tcgd for subcutaneous inj cartridge

0.7 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

6.3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

9.1 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

5.2 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

4.3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

11 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

3.6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Skytrofa

Lonapegsomatropin-tcgd For Subcutaneous Inj Cartridge

7.6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Sogroya

somapacitan-beco solution pen-injector

10 MG/1.5ML ; 15 MG/1.5ML ; 5 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Zomacton

Somatropin For Inj 10 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Zomacton

Somatropin For Subcutaneous Inj 5 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Zorbtive

Somatropin (Non-Refrigerated) For Subcutaneous Inj 8.8 MG

8.8 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Adults: Long and Short Acting Growth Hormone

Adults – Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met: 

1. The patient is an adult (as defined by the prescriber) AND
2. ONE of the following:
   1. The patient has a diagnosis of AIDS wasting/cachexia AND ALL of the following:
      1. The requested agent is a short-acting growth hormone (GH) AND
      2. The patient is currently treated with antiretroviral therapy AND
      3. The patient will continue antiretroviral therapy in combination with the requested agent AND
      4. BOTH of the following:
         1. ONE of the following:
            1. The patient has had ONE of the following:
               1. Unintentional weight loss greater than or equal to 10% over 12 months OR
               2. Unintentional weight loss greater than or equal to 7.5% over 6 months OR
            2. The patient has a body cell mass (BCM) loss greater than or equal to 5% within 6 months OR
            3. The patient’s sex is male and has a BCM less than 35% of total body weight and body mass index (BMI) less than 27 kg/m^2 OR
            4. The patient’s sex is female and has a BCM less than 23% of total body weight and BMI less than 27 kg/m^2 OR
            5. There is support that the patient's BCM is less than 35% or less than 23% (based on sex) and BMI less than 27 kg/m^2 are medically appropriate for diagnosing AIDS wasting/cachexia OR
            6. The patient’s BMI is less than 20 kg/m^2 AND
         2. All other causes of weight loss have been ruled out OR
   2. The patient has a diagnosis of short bowel syndrome (SBS) AND BOTH of the following:
      1. The requested agent is a short-acting growth hormone (GH) AND
      2. The patient is receiving specialized nutritional support OR
   3. The patient has a diagnosis of growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous growth hormone (GH) AND the patient has ONE of the following:
      1. Had a diagnosis of childhood-onset GHD AND has failed at least ONE GH stimulation test as an adult OR
      2. Low insulin-like growth factor-1 (IGF-1) level AND ONE of the following:
         1. Organic hypothalamic-pituitary disease OR
         2. Pituitary structural lesion or trauma OR
         3. Panhypopituitarism or multiple (greater than or equal to 3) pituitary hormone deficiency (MPHD) OR
      3. An established causal genetic mutation OR hypothalamic-pituitary structural defect other than ectopic posterior pituitary OR
      4. Failed at least TWO GH stimulation tests as an adult OR
      5. Failed at least ONE GH stimulation test as an adult AND the patient has an organic pituitary disease OR
   4. ​​​The patient has another FDA labeled indication for the requested agent and route of administration OR 
   5. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
3. The request is for a long-acting growth hormone (GH) agent AND if the patient has an FDA labeled indication, then ONE of the following: 
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. There is support for using the requested agent for the patient’s age for the requested indication AND
4. ONE of the following:
   1. The request is for a short-acting GH agent, then ONE of the following:
      1. The request is for a preferred short-acting agent OR
      2. The request is for a non-preferred short-acting agent AND ONE of the following: (medical records required)
         1. The patient has an intolerance or hypersensitivity to ONE preferred short-acting agent that is NOT expected to occur with the requested agent OR
         2. The patient has an FDA labeled contraindication to ALL preferred short-acting agent(s) that is NOT expected to occur with the requested agent OR
         3. There is support for the efficacy of the requested agent over ALL preferred short-acting agent(s) for the requested indication OR
   2. The request is for a long-acting GH agent, then ALL of the following:
      1. The requested agent is FDA labeled for the requested indication AND
      2. The patient has ONE of the following:
         1. Received at least 12 months of therapy with a preferred short-acting agent OR
         2. An intolerance or hypersensitivity to ONE preferred short-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
         3. An FDA labeled contraindication to ALL preferred short-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
      3. ONE of the following:
         1. The requested agent is a preferred long-acting agent OR
         2. The requested agent is a non-preferred long-acting agent AND the preferred long-acting agent(s) are NOT FDA labeled for the requested indication OR
         3. The patient has ONE of the following:
            1. Received at least 12 months of therapy with a preferred long-acting agent OR
            2. An intolerance or hypersensitivity to ONE preferred long-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
            3. An FDA labeled contraindication to ALL preferred long-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
5. The patient does NOT have any FDA labeled contraindications to the requested agent AND
6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
7. The requested quantity (dose) is within FDA labeling or supported in compendia for the requested indication

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of Approval: SBS - 4 weeks; AIDS wasting/cachexia - 12 weeks; All other indications - 12 months

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Adults – Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met: 

1. The patient has been previously approved for therapy with growth hormone (GH) through the plan’s Prior Authorization process (Note: patients not previously approved for therapy with GH will require initial evaluation review) AND
2. The patient is an adult (as defined by the prescriber) AND
3. ONE of the following:
   1. The patient has a diagnosis of short bowel syndrome (SBS) AND has had clinical benefit with the requested agent OR
   2. The patient has a diagnosis of AIDS wasting/cachexia AND ALL of the following:
      1. The patient is currently treated with antiretroviral therapy AND
      2. The patient will continue antiretroviral therapy in combination with the requested agent AND
      3. The patient has had clinical benefit with the requested agent (i.e., an increase in weight or weight stabilization) OR
   3. The patient has a diagnosis of growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous GH AND BOTH of the following:
      1. The patient's insulin-like growth factor-1 (IGF-1) level has been evaluated to confirm the appropriateness of the current dose AND
      2. The patient has had clinical benefit with the requested agent (i.e., body composition, hip-to-waist ratio, cardiovascular health, bone mineral density, serum cholesterol, physical strength, or quality of life) OR 
   4. The patient has a diagnosis other than SBS, AIDS wasting/cachexia, GHD, or growth failure due to inadequate secretion of endogenous GH AND has had clinical benefit with the requested agent AND
4. ONE of the following:
   1. The request is for a short-acting GH agent, then ONE of the following:
      1. The request is for a preferred short-acting agent OR
      2. The request is for a non-preferred short-acting agent AND ONE of the following: (medical records required)
         1. The patient has an intolerance or hypersensitivity to ONE preferred short-acting agent that is NOT expected to occur with the requested agent OR
         2. The patient has an FDA labeled contraindication to ALL preferred short-acting agent(s) that is NOT expected to occur with the requested agent OR
         3. There is support for the efficacy of the requested agent over ALL preferred short-acting agent(s) for the requested indication OR
   2. The request is for a long-acting GH agent, then ALL of the following:
      1. The requested agent is FDA labeled for the requested indication AND
      2. The patient has ONE of the following:
         1. Received at least 12 months of therapy with a preferred short-acting agent OR
         2. An intolerance or hypersensitivity to ONE preferred short-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
         3. An FDA labeled contraindication to ALL preferred short-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
      3. ONE of the following:
         1. The requested agent is a preferred long-acting agent OR
         2. The requested agent is a non-preferred long-acting agent AND the preferred long-acting agent(s) are NOT FDA labeled for the requested indication OR
         3. The patient has ONE of the following:
            1. Received at least 12 months of therapy with a preferred long-acting agent OR
            2. An intolerance or hypersensitivity to ONE preferred long-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
            3. An FDA labeled contraindication to ALL preferred long-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
5. The patient is being monitored for adverse effects of GH AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent AND
7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
8. The requested quantity (dose) is within FDA labeling or supported in compendia for the requested indication 

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of Approval: SBS - 4 weeks; AIDS wasting/cachexia - 12 weeks; All other indications - 12 months

Children: Long-Acting Growth Hormone

Children – Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient is a child (as defined by the prescriber) AND
2. ONE of the following:
   1. The patient has a diagnosis of growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous growth hormone (GH) AND the patient has ONE of the following:
      1. Extreme short stature (e.g., height less than or equal to -3 SD), normal nutrition, significantly reduced insulin-like growth factor-1 (IGF-1) and IGFBP-3 (e.g., less than -2 SD), and delayed bone age OR
      2. BOTH of the following:
         1. The patient has ONE of the following:
            1. Height greater than 2 SD below the mean for age and sex OR
            2. Height greater than 1.5 SD below the mid-parental height OR
            3. Decrease in height SD of greater than 0.5 SD over one year in children greater than 2 years of age OR
            4. Height velocity (HV) greater than 2 SD below the mean over one year or greater than 1.5 SD sustained over two years OR
            5. Height-for-age curve that has deviated downward across two major height percentile curves (e.g., from above the 25th percentile to below the 10th percentile) OR
            6. BOTH of the following:
               1. The patient’s age is 2-4 years AND
               2. The patient has a HV less than 5.5 cm/year (less than 2.2 inches/year) OR
            7. BOTH of the following:
               1. The patient’s age is 4-6 years AND
               2. The patient has a HV less than 5 cm/year (less than 2 inches/year) OR
            8. The patient’s age is 6 years to puberty AND ONE of the following:
               1. The patient’s sex is male and HV is less than 4 cm/year (less than 1.6 inches/year) OR
               2. The patient’s sex is female and HV is less than 4.5 cm/year (less than 1.8 inches/year) AND
         2. The patient has ONE of the following:
            1. Failed at least TWO GH stimulation tests (e.g., peak GH value of less than 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab) OR
            2. Failed at least ONE GH stimulation test (e.g., peak GH value of less than 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab) AND ONE of the following:
               1. Pathology of the central nervous system OR
               2. History of irradiation OR
               3. Other pituitary hormone defects (e.g., multiple pituitary hormone deficiency [MPHD]) OR
               4. A genetic defect OR
            3. A pituitary abnormality and a known deficit of at least ONE other pituitary hormone OR
   2. The patient has another FDA labeled indication for the requested agent and route of administration OR 
   3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
3. If the patient has an FDA labeled indication, then ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. There is support for using the requested agent for the patient’s age for the requested indication AND
4. ALL of the following:
   1. The requested agent is FDA labeled for the requested indication AND
   2. The patient has ONE of the following:
      1. Received at least 12 months of therapy with a preferred short-acting GH agent OR
      2. An intolerance or hypersensitivity to ONE preferred short-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
      3. An FDA labeled contraindication to ALL preferred short-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
   3. ONE of the following:
      1. The requested agent is a preferred long-acting GH agent OR
      2. The requested agent is a non-preferred long-acting agent AND the patient has ONE of the following:
         1. Received at least 12 months of therapy with a preferred long-acting agent OR
         2. An intolerance or hypersensitivity to ONE preferred long-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
         3. An FDA labeled contraindication to ALL preferred long-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent AND
7. The requested quantity (dose) is within FDA labeling or supported in compendia for the requested indication 

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of Approval: 12 months

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Children – Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met: 

1. The patient has been previously approved for therapy with growth hormone (GH) through the plan’s Prior Authorization process (Note: patients not previously approved for therapy with GH will require initial evaluation review) AND
2. The patient is a child (as defined by the prescriber) AND
3. ONE of the following:
   1. The patient has a diagnosis of growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous GH AND BOTH of the following:
      1. The patient does NOT have closed epiphyses AND
      2. The patient’s height has increased greater than or equal to 2 cm over the previous year with GH therapy OR
   2. The patient has a diagnosis other than GHD or growth failure due to inadequate secretion of endogenous GH AND has had clinical benefit with the requested agent AND
4. ALL of the following:
   1. The requested agent is FDA labeled for the requested indication AND
   2. The patient has ONE of the following:
      1. Received at least 12 months of therapy with a preferred short-acting GH agent OR
      2. An intolerance or hypersensitivity to ONE preferred short-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
      3. An FDA labeled contraindication to ALL preferred short-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
   3. ONE of the following:
      1. The requested agent is a preferred long-acting GH agent OR
      2. The requested agent is a non-preferred long-acting agent AND the patient has ONE of the following:
         1. Received at least 12 months of therapy with a preferred long-acting agent OR
         2. An intolerance or hypersensitivity to ONE preferred long-acting agent that is NOT expected to occur with the requested agent (medical record required) OR
         3. An FDA labeled contraindication to ALL preferred long-acting agent(s) that is NOT expected to occur with the requested agent (medical record required) AND
5. The patient is being monitored for adverse effects of GH AND
6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
7. The patient does NOT have any FDA labeled contraindications to the requested agent AND
8. The requested quantity (dose) is within FDA labeling or supported in compendia for the requested indication

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of Approval: 12 months

Children: Short-Acting Growth Hormone

Children – Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient is a child (as defined by the prescriber) AND
2. ONE of the following:
   1. ALL of the following:
      1. The patient is a newborn (less than or equal to 4 months of age) with hypoglycemia AND
      2. The patient has a serum growth hormone (GH) concentration less than or equal to 5 mcg/L AND
      3. ONE of the following:
         1. Congenital pituitary abnormality (e.g., ectopic posterior pituitary and pituitary hypoplasia with abnormal stalk) OR
         2. Deficiency of at least ONE additional pituitary hormone OR
   2. ALL of the following:
      1. The patient is a newborn (less than or equal to 4 months of age) with hypoglycemia AND
      2. The patient has a growth hormone (GH) concentration of less than 20 mcg/L AND
      3. The patient does NOT have a known metabolic disorder AND
      4. The patient has a reduced insulin-like growth factor binding protein 3 (IGFBP-3) level (e.g., less than -2 SD) OR
   3. The patient has ONE of the following diagnoses:
      1. Turner syndrome OR
      2. Noonan syndrome OR
      3. Prader-Willi syndrome OR
      4. SHOX gene deficiency OR
      5. Short bowel syndrome (SBS) AND BOTH of the following:
         1. The patient is receiving specialized nutritional support AND
         2. ONE of the following: 
            1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
            2. There is support for using the requested agent for the patient’s age for the requested indication OR
      6. Panhypopituitarism or has deficiencies in at least THREE or more pituitary axes AND serum insulin-like growth factor-1 (IGF-1) levels below the age- and sex-appropriate reference range when off GH therapy OR
      7. Chronic renal insufficiency AND BOTH of the following:
         1. The patient’s height velocity (HV) for age is less than -1.88 SD OR HV for age is less than the 3rd percentile AND
         2. Other etiologies for growth impairment have been addressed OR
      8. Small for gestational age (SGA) AND ALL of the following:
         1. The patient is 2 years of age or older AND
         2. The patient has a documented birth weight and/or birth length that is greater than or equal to 2 SD below the mean for gestational age AND
         3. At 24 months of age, the patient failed to manifest catch-up growth evidenced by a height that remains greater than or equal to 2 SD below the mean for age and sex OR
      9. Idiopathic short stature (ISS) AND ALL of the following:
         1. The patient has a height less than or equal to -2.25 SD below the corresponding mean height for age and sex AND
         2. The patient has open epiphyses AND
         3. ONE of the following:
            1. The patient has a predicted adult height that is below the normal range AND ONE of the following:
               1. The patient’s sex is male and predicted adult height is less than 63 inches OR
               2. The patient’s sex is female and predicted adult height is less than 59 inches OR
            2. The patient is greater than 2 SD below their mid-parental target height AND
         4. BOTH of the following:
            1. The patient has been evaluated for constitutional delay of growth and puberty (CDGP) AND
            2. The patient does NOT have a diagnosis of CDGP OR
      10. Growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous growth hormone (GH) AND ONE of the following:
          1. The patient has extreme short stature (e.g., height less than or equal to -3 SD), normal nutrition, significantly reduced insulin-like growth factor-1 (IGF-1) and IGFBP-3 (e.g., less than -2 SD), and delayed bone age OR
          2. BOTH of the following:
             1. The patient has ONE of the following:
                1. Height greater than 2 SD below the mean for age and sex OR
                2. Height greater than 1.5 SD below the mid-parental height OR
                3. A decrease in height SD of greater than 0.5 SD over one year in children greater than 2 years of age OR
                4. Height velocity (HV) greater than 2 SD below the mean over one year or greater than 1.5 SD sustained over two years OR
                5. Height-for-age curve that has deviated downward across two major height percentile curves (e.g., from above the 25th percentile to below the 10th percentile) OR
                6. BOTH of the following:
                   1. The patient’s age is 2-4 years AND
                   2. The patient has a HV less than 5.5 cm/year (less than 2.2 inches/year) OR
                7. BOTH of the following:
                   1. The patient’s age is 4-6 years AND
                   2. The patient has a HV less than 5 cm/year (less than 2 inches/year) OR
                8. The patient’s age is 6 years to puberty AND ONE of the following:
                   1. The patient's sex is male and HV is less than 4 cm/year (less than 1.6 inches/year) OR
                   2. The patient's sex is female and HV is less than 4.5 cm/year (less than 1.8 inches/year) AND
             2. The patient has ONE of the following:
                1. Failed at least TWO GH stimulation tests (e.g., peak GH value of less than 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab) OR
                2. Failed at least ONE GH stimulation test (e.g., peak GH value of less than 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab) AND ONE of the following:
                   1. Pathology of the central nervous system OR
                   2. History of irradiation OR
                   3. Other pituitary hormone defects (e.g., multiple pituitary hormone deficiency [MPHD]) OR
                   4. A genetic defect OR
                3. A pituitary abnormality and a known deficit of at least ONE other pituitary hormone OR
   4. ​​​The patient has another FDA labeled indication for the requested agent and route of administration OR 
   5. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
3. ONE of the following:
   1. The request is for a preferred agent OR
   2. The request is for a non-preferred agent AND ONE of the following: (medical records required)
      1. The patient has an intolerance or hypersensitivity to ONE preferred agent that is NOT expected to occur with the requested agent OR
      2. The patient has an FDA labeled contraindication to ALL preferred agent(s) that is NOT expected to occur with the requested agent OR
      3. There is support for the efficacy of the requested agent over ALL preferred agent(s) for the requested indication AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent AND
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
6. The requested quantity (dose) is within FDA labeling or supported in compendia for the requested indication

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of Approval: 4 weeks - SBS; 12 months - all other indications

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Children – Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met: 

1. The patient has been previously approved for therapy with growth hormone (GH) through the plan’s Prior Authorization process (Note: patients not previously approved for therapy with GH will require initial evaluation review) AND
2. The patient is a child (as defined by the prescriber) AND
3. ONE of the following:
   1. The patient has a diagnosis of short bowel syndrome (SBS) AND BOTH of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. ONE of the following: 
         1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
         2. There is support for using the requested agent for the patient’s age for the requested indication OR
   2. The patient has a diagnosis of idiopathic short stature (ISS) AND ALL of the following:
      1. The patient's height has increased greater than or equal to 2 cm over the previous year with GH therapy AND
      2. ONE of the following:
         1. The patient's sex is male and bone age is less than 16 years OR 
         2. The patient's sex is female and bone age is less than 15 years AND
      3. The patient has open epiphyses OR
   3. BOTH of the following:
      1. The patient has ONE of the following diagnoses:
         1. Growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous GH OR
         2. Noonan's syndrome OR
         3. SHOX deficiency OR
         4. Turner syndrome OR
         5. Small for gestational age (SGA) OR
         6. Renal function impairment with growth failure AND
      2. BOTH of the following:
         1. The patient does NOT have closed epiphyses AND
         2. The patient’s height has increased greater than or equal to 2 cm over the previous year with GH therapy OR
   4. The patient has a diagnosis of Prader-Willi syndrome AND has had clinical benefit with the requested agent OR
   5. The patient has a diagnosis other than SBS, ISS, GHD, growth failure due to inadequate secretion of endogenous GH, Noonan's syndrome, SHOX deficiency, Turner syndrome, SGA, renal function impairment with growth failure, and Prader-Willi syndrome AND has had clinical benefit with the requested agent AND
4. ONE of the following:
   1. The request is for a preferred agent OR
   2. The request is for a non-preferred agent AND ONE of the following: (medical records required)
      1. The patient has an intolerance or hypersensitivity to ONE preferred agent that is NOT expected to occur with the requested agent OR
      2. The patient has an FDA labeled contraindication to ALL preferred agent(s) that is NOT expected to occur with the requested agent OR
      3. There is support for the efficacy of the requested agent over ALL preferred agent(s) for the requested indication AND
5. The patient is being monitored for adverse effects of GH AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent AND
7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
8. The requested quantity (dose) is within FDA labeling or supported in compendia for the requested indication

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of Approval: 4 weeks - SBS; 12 months - all other indications