Pharmacy Prior Authorization Criteria

Growth Hormones - PA, NF

Indications for Prior Authorization

Genotropin, Humatrope, Norditropin Flexpro, Nutropin AQ NuSpin, Omnitrope, Saizen, and Zomacton

For diagnosis of Pediatric Growth Hormone Deficiency
Indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.

Skytrofa (lonapegsomatropin-tcgd)

For diagnosis of Pediatric Growth Hormone Deficiency
Indicated for the 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).

Ngenla (somatrogon-ghla)

For diagnosis of Pediatric Growth Hormone Deficiency
Indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.

Genotropin and Omnitrope

For diagnosis of Prader-Willi Syndrome (PWS)
Indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing.
For diagnosis of Small for Gestational Age (SGA)
Indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2.

Norditropin Flexpro, Humatrope, and Zomacton

For diagnosis of Small for Gestational Age (SGA)
Indicated for the treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.

Genotropin, Humatrope, Norditropin Flexpro, Nutropin AQ NuSpin, Omnitrope, and Zomacton

For diagnosis of Turner Syndrome
Indicated for the treatment of pediatric patients with short stature associated with Turner syndrome.

Humatrope and Zomacton

For diagnosis of SHOX Deficiency
Indicated for the treatment of pediatric patients with short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency.

Nutropin AQ NuSpin

For diagnosis of Growth Failure Secondary to Chronic Kidney Disease (CKD)
Indicated for the treatment of growth failure associated with CKD up to the time of renal transplantation. Nutropin AQ therapy should be used in conjunction with optimal management of CKD.

Norditropin Flexpro

For diagnosis of Noonan Syndrome
Indicated for the treatment of pediatric patients with short stature associated with Noonan Syndrome.
For diagnosis of Prader-Willi Syndrome
Indicated for the treatment of pediatric patients with growth failure due to Prader-Willi syndrome (PWS).

Genotropin, Nutropin AQ NuSpin, and Omnitrope

For diagnosis of [Non-Approvable Use] Idiopathic Short Stature (ISS) [E]
Indicated for the treatment of idiopathic short stature, also called non-growth hormone-deficient short stature, 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.
**Please Note: The request for growth hormone (GH) injections to treat idiopathic short stature (ISS) is not authorized. There is no consensus in current peer-reviewed medical literature regarding the indications, efficacy, safety, or long-term consequences of GH therapy in children with ISS who are otherwise healthy.

Norditropin Flexpro and Humatrope

For diagnosis of [Non-Approvable Use] Idiopathic Short Stature (ISS) [E]
Indicated for the treatment of pediatric patients with 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.
**Please Note: The request for growth hormone (GH) injections to treat idiopathic short stature (ISS) is not authorized. There is no consensus in current peer-reviewed medical literature regarding the indications, efficacy, safety, or long-term consequences of GH therapy in children with ISS who are otherwise healthy.

Genotropin, Nutropin AQ NuSpin, Omnitrope, and Saizen

For diagnosis of Adult Growth Hormone Deficiency
Indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult-Onset: 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; or
Childhood-Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

Norditropin Flexpro, Humatrope, and Zomacton

For diagnosis of Adult Growth Hormone Deficiency
Indicated for the replacement of endogenous GH in adults with GH deficiency.

Serostim

For diagnosis of AIDS Wasting or Cachexia
Indicated for the 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.

Zorbtive

For diagnosis of Short Bowel Syndrome
Indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support.

Zomacton

For diagnosis of [Non-Approvable Use] Idiopathic Short Stature (ISS) [E]
Indicated for the treatment of pediatric patients with Idiopathic Short Stature (ISS), 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.
**Please Note: The request for growth hormone (GH) injections to treat idiopathic short stature (ISS) is not authorized. There is no consensus in current peer-reviewed medical literature regarding the indications, efficacy, safety, or long-term consequences of GH therapy in children with ISS who are otherwise healthy.

Sogroya (somapacitan-beco)

For diagnosis of Pediatric Growth Hormone Deficiency
Indicated for the treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
For diagnosis of Adult Growth Hormone Deficiency
Indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD).

Criteria

Norditropin Flexpro, Omnitrope

Includes children who have undergone brain radiation. If patient is a Transition Phase Adolescent or Adult who had childhood onset GH deficiency, utilize criteria for Transition Phase Adolescent or Adult GH Deficiency. NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal. *Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

One of the following:

One of the following: [12]

Both of the following: [24-26]

Infant is less than 4 months of age
Infant has suspected GH deficiency based on clinical presentation (e.g., persistent neonatal hypoglycemia, persistent or prolonged neonatal jaundice/elevated bilirubin, male infant with microgenitalia, midline anatomical defects, failure to thrive, etc.)

History of neonatal hypoglycemia associated with pituitary disease

Diagnosis of panhypopituitarism

All of the following:

Diagnosis of pediatric GH deficiency as confirmed by one of the following: [10, 11, 12]

Height is documented by one of the following (utilizing age and gender growth charts related to height): [11]

Height is greater than 2.0 standard deviations [SD] below midparental height
Height is greater than 2.25 SD below population mean (below the 1.2 percentile for age and gender)

Growth velocity is greater than 2 SD below mean for age and gender

Delayed skeletal maturation of greater than 2 SD below mean for age and gender (e.g., delayed greater than 2 years compared with chronological age)

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

One of the following:

Both of the following: [10, 11, 12]

Patient has undergone two of the following provocative GH stimulation tests:

Arginine
Clonidine
Glucagon
Insulin
Levodopa

AND

Both GH response values are less than 10 mcg/L

Both of the following: [11]

Patient is less than 1 year of age

AND

One of the following is below the age and gender adjusted normal range as provided by the physician's lab: [A, 13, 14]

Insulin-like Growth Factor 1 (IGF-1/Somatomedin-C)
Insulin Growth Factor Binding Protein-3 (IGFBP-3)

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22, 23]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

One of the following:

One of the following: [12]

Both of the following: [24-26]

Infant is less than 4 months of age
Suspected GHD based on clinical presentation (e.g., persistent neonatal hypoglycemia that is not responsive to treatment, persistent or prolonged neonatal jaundice/elevated bilirubin, male infant with microgenitalia, midline anatomical defects, etc.)

History of neonatal hypoglycemia associated with pituitary disease

Diagnosis of panhypopituitarism

All of the following:

Diagnosis of pediatric GH deficiency as confirmed by one of the following: [10, 11, 12]

Height is documented by one of the following (utilizing age and gender growth charts related to height): [11]

Height is greater than 2.0 standard deviations [SD] below midparental height
Height is greater than 2.25 SD below population mean (below the 1.2 percentile for age and gender)

Growth velocity is greater than 2 SD below mean for age and gender

Delayed skeletal maturation of greater than 2 SD below mean for age and gender (e.g., delayed greater than 2 years compared with chronological age)

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

One of the following:

Both of the following: [10, 11, 12]

Patient has undergone two of the following provocative GH stimulation tests:

Arginine
Clonidine
Glucagon
Insulin
Levodopa

AND

Both GH response values are less than 10 mcg/L

Both of the following: [11]

Patient is less than 1 year of age

AND

One of the following is below the age and gender adjusted normal range as provided by the physician's lab: [A, 13, 14]

Insulin-like Growth Factor 1 (IGF-1/Somatomedin-C)
Insulin Growth Factor Binding Protein-3 (IGFBP-3)

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22, 23]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

One of the following:

One of the following: [12]

Both of the following: [24-26]

Infant is less than 4 months of age
Suspected GHD based on clinical presentation (e.g., persistent neonatal hypoglycemia that is not responsive to treatment, persistent or prolonged neonatal jaundice/elevated bilirubin, male infant with microgenitalia, midline anatomical defects, etc.)

History of neonatal hypoglycemia associated with pituitary disease

Diagnosis of panhypopituitarism

Submission of medical records (e.g., chart notes) documenting all of the following:

Diagnosis of pediatric GH deficiency as confirmed by one of the following: [10, 11, 12]

Height is documented by one of the following (utilizing age and gender growth charts related to height): [11]

Height is greater than 2.0 standard deviations [SD] below midparental height
Height is greater than 2.25 SD below population mean (below the 1.2 percentile for age and gender)

Growth velocity is greater than 2 SD below mean for age and gender

Delayed skeletal maturation of greater than 2 SD below mean for age and gender (e.g., delayed greater than 2 years compared with chronological age)

AND

One of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

One of the following:

Both of the following: [10, 11, 12]

Patient has undergone two of the following provocative GH stimulation tests:

Arginine
Clonidine
Glucagon
Insulin
Levodopa

AND

Both GH response values are less than 10 mcg/L

Both of the following: [11]

Patient is less than 1 year of age

AND

One of the following is below the age and gender adjusted normal range as provided by the physician's lab: [A, 13, 14]

Insulin-like Growth Factor 1 (IGF-1/Somatomedin-C)
Insulin Growth Factor Binding Protein-3 (IGFBP-3)

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

Submission of medical records (e.g., chart notes) documenting height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22, 23]

Previous height and date obtained
Current height and date obtained

AND

Submission of medical records (e.g., chart notes) documenting both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Skytrofa

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

One of the following:

One of the following: [12]

History of neonatal hypoglycemia associated with pituitary disease

Diagnosis of panhypopituitarism

All of the following:

Diagnosis of pediatric GH deficiency as confirmed by one of the following: [10, 11, 12]

Height is documented by one of the following (utilizing age and gender growth charts related to height): [11]

Height is greater than 2.0 standard deviations [SD] below midparental height
Height is greater than 2.25 SD below population mean (below the 1.2 percentile for age and gender)

Growth velocity is greater than 2 SD below mean for age and gender

Delayed skeletal maturation of greater than 2 SD below mean for age and gender (e.g., delayed greater than 2 years compared with chronological age)

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Both of the following: [10, 11, 12]

Patient has undergone two of the following provocative GH stimulation tests:

Arginine
Clonidine
Glucagon
Insulin
Levodopa

AND

Both GH response values are less than 10 mcg/L

AND

Patient is 1 year of age or older

AND

Patient weight is 11.5 kg or greater

AND

Prescribed by or in consultation with an endocrinologist

Skytrofa

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22, 23]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

Sogroya

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

One of the following:

One of the following: [12]

History of neonatal hypoglycemia associated with pituitary disease

Diagnosis of panhypopituitarism

All of the following:

Diagnosis of pediatric GH deficiency as confirmed by one of the following: [10, 11, 12]

Height is documented by one of the following (utilizing age and gender growth charts related to height): [11]

Height is greater than 2.0 standard deviations [SD] below midparental height
Height is greater than 2.25 SD below population mean (below the 1.2 percentile for age and gender)

Growth velocity is greater than 2 SD below mean for age and gender

Delayed skeletal maturation of greater than 2 SD below mean for age and gender (e.g., delayed greater than 2 years compared with chronological age)

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Both of the following: [10, 11, 12]

Patient has undergone two of the following provocative GH stimulation tests:

Arginine
Clonidine
Glucagon
Insulin
Levodopa

AND

Both GH response values are less than 10 mcg/L

AND

Patient is 2.5 years of age or older

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

AND

Trial and failure, contraindication or intolerance to both of the following:

Skytrofa
Ngenla

Sogroya

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22, 23]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

AND

Trial and failure, contraindication or intolerance to both of the following:

Skytrofa
Ngenla

Sogroya

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

One of the following:

One of the following: [12]

History of neonatal hypoglycemia associated with pituitary disease

Diagnosis of panhypopituitarism

Submission of medical records (e.g., chart notes) documenting all of the following:

Diagnosis of pediatric GH deficiency as confirmed by one of the following: [10, 11, 12]

Height is documented by one of the following (utilizing age and gender growth charts related to height): [11]

Height is greater than 2.0 standard deviations [SD] below midparental height
Height is greater than 2.25 SD below population mean (below the 1.2 percentile for age and gender)

Growth velocity is greater than 2 SD below mean for age and gender

Delayed skeletal maturation of greater than 2 SD below mean for age and gender (e.g., delayed greater than 2 years compared with chronological age)

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Both of the following: [10, 11, 12]

Patient has undergone two of the following provocative GH stimulation tests:

Arginine
Clonidine
Glucagon
Insulin
Levodopa

AND

Both GH response values are less than 10 mcg/L

AND

Patient is 2.5 years of age or older

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication or intolerance to both of the following:

Skytrofa
Ngenla

Sogroya

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

Submission of medical records (e.g., chart notes) documenting height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22, 23]

Previous height and date obtained
Current height and date obtained

AND

Submission of medical records (e.g., chart notes) documenting both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication or intolerance to both of the following:

Skytrofa
Ngenla

Ngenla

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

One of the following:

One of the following: [12]

History of neonatal hypoglycemia associated with pituitary disease

Diagnosis of panhypopituitarism

All of the following:

Diagnosis of pediatric GH deficiency as confirmed by one of the following: [10, 11, 12]

Height is documented by one of the following (utilizing age and gender growth charts related to height): [11]

Height is greater than 2.0 standard deviations [SD] below midparental height
Height is greater than 2.25 SD below population mean (below the 1.2 percentile for age and gender)

Growth velocity is greater than 2 SD below mean for age and gender

Delayed skeletal maturation of greater than 2 SD below mean for age and gender (e.g., delayed greater than 2 years compared with chronological age)

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Both of the following: [10, 11, 12]

Patient has undergone two of the following provocative GH stimulation tests:

Arginine
Clonidine
Glucagon
Insulin
Levodopa

AND

Both GH response values are less than 10 mcg/L

AND

Patient is 3 years of age or older

AND

Prescribed by or in consultation with an endocrinologist

Ngenla

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric Growth Hormone Deficiency (GHD)

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22, 23]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope [B, 11]

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Prader-Willi Syndrome

Diagnosis of Prader-Willi Syndrome [10, 11]

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope [B, 11]

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Prader-Willi Syndrome

One of the following:

Evidence of positive response to therapy (e.g., increase in total lean body mass, decrease in fat mass)

Both of the following:

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label],Saizen [off-label], Zomacton [off-label] [B, 11]

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Prader-Willi Syndrome

Diagnosis of Prader-Willi Syndrome [10, 11]

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label], Saizen [off-label], Zomacton [off-label] [B, 11]

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Prader-Willi Syndrome

One of the following:

Evidence of positive response to therapy (e.g., increase in total lean body mass, decrease in fat mass)

Both of the following:

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label], Saizen [off-label], Zomacton [off-label] [B, 11]

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Prader-Willi Syndrome

Diagnosis of Prader-Willi Syndrome [10, 11]

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label], Saizen [off-label], Zomacton [off-label] [B, 11]

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Prader-Willi Syndrome

One of the following:

Evidence of positive response to therapy (e.g., increase in total lean body mass, decrease in fat mass)

Submission of medical records (e.g., chart notes) documenting both of the following:

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Norditropin Flexpro, Omnitrope

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal. *Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure in Children Small for Gestational Age (SGA)

Diagnosis of SGA based on demonstration of catch up growth failure in the first 24 months of life using a 0-36 month growth chart as confirmed by the following criterion: [10]

One of the following is below the 3rd percentile for gestational age (more than 2 SD below population mean):

Birth weight
Birth length

AND

Height remains less than or equal to 3rd percentile (more than 2 SD below population mean) [10]

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure in Children Small for Gestational Age (SGA)

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure in Children Small for Gestational Age (SGA)

Diagnosis of SGA based on demonstration of catch up growth failure in the first 24 months of life using a 0-36 month growth chart as confirmed by the following criterion: [10]

One of the following is below the 3rd percentile for gestational age (more than 2 SD below the population mean):

Birth weight
Birth length

AND

Height remains less than or equal to 3rd percentile (more than 2 SD below population mean) [10]

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure in Children Small for Gestational Age (SGA)

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [28]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure in Children Small for Gestational Age (SGA)

Diagnosis of SGA based on demonstration of catch up growth failure in the first 24 months of life using a 0-36 month growth chart as confirmed by the following criterion: [10]

Submission of medical records (e.g., chart notes) documenting one of the following is below the 3rd percentile for gestational age (more than 2 SD below the population mean):

Birth weight
Birth length

AND

Submission of medical records (e.g., chart notes) documenting height remains less than or equal to 3rd percentile (more than 2 SD below population mean) [10]

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure in Children Small for Gestational Age (SGA)

Submission of medical records (e.g., chart notes) documenting height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [28]

Previous height and date obtained
Current height and date obtained

AND

Submission of medical records (e.g., chart notes) documenting both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Norditropin Flexpro, Omnitrope

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal. *Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Turner Syndrome or Noonan Syndrome

Diagnosis of pediatric growth failure associated with one of the following: [10, 22]

Both of the following:

Turner Syndrome (Gonadal Dysgenesis)

AND

Documentation of both of the following:

Patient is female
Bone age less than 14 years

Both of the following:

Noonan Syndrome

AND

Documentation of one of the following:

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Height is below the 5th percentile on growth charts for age and gender [10]

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Turner Syndrome or Noonan Syndrome

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Turner Syndrome [off-label for Saizen] or Noonan Syndrome [off-label] [B, 11]

Diagnosis of pediatric growth failure associated with one of the following: [10, 22]

Both of the following:

Turner Syndrome (Gonadal Dysgenesis)

AND

Documentation of both of the following:

Patient is female
Bone age less than 14 years

Both of the following:

Noonan Syndrome

AND

Documentation of one of the following:

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Height is below the 5th percentile on growth charts for age and gender [10]

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Turner Syndrome [off-label for Saizen] or Noonan Syndrome [off-label] [B, 11]

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Turner Syndrome [off-label for Saizen] or Noonan Syndrome [off-label] [B, 11]

Diagnosis of pediatric growth failure associated with one of the following: [10, 22]

Both of the following:

Turner Syndrome (Gonadal Dysgenesis)

AND

Submission of medical records (e.g., chart notes) documenting both of the following:

Patient is female
Bone age less than 14 years

Both of the following:

Noonan Syndrome

AND

Submission of medical records (e.g., chart notes) documenting one of the following:

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Submission of medical records (e.g., chart notes) documenting height below the 5th percentile on growth charts for age and gender [10]

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Turner Syndrome [off-label for Saizen] or Noonan Syndrome [off-label] [B, 11]

Submission of medical records (e.g., chart notes) documenting height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Submission of medical records (e.g., chart notes) documenting both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claim or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Norditropin Flexpro, Omnitrope

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Short-Stature Homeobox (SHOX) Gene Deficiency [off-label] [B, 11]

Diagnosis of pediatric growth failure with short stature homeobox (SHOX) gene deficiency as confirmed by genetic testing [2]

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Short-Stature Homeobox (SHOX) Gene Deficiency [off-label] [B, 11]

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Short-Stature Homeobox (SHOX) Gene Deficiency

Diagnosis of pediatric growth failure with short stature homeobox (SHOX) gene deficiency as confirmed by genetic testing [2]

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Short-Stature Homeobox (SHOX) Gene Deficiency

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Short-Stature Homeobox (SHOX) Gene Deficiency

Diagnosis of pediatric growth failure with short stature homeobox (SHOX) gene deficiency as confirmed by genetic testing [2]

AND

Submission of medical records (e.g., chart notes) documenting one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Short-Stature Homeobox (SHOX) Gene Deficiency

Submission of medical records (e.g., chart notes) documenting height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Submission of medical records (e.g., chart notes) documenting both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Norditropin Flexpro* [off-label] [B, 11], Omnitrope* [off-label] [B, 11]

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure associated with Chronic Renal Insufficiency

Diagnosis of pediatric growth failure associated with chronic renal insufficiency [10]

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Prescribed by or in consultation with one of the following:

Endocrinologist
Nephrologist

Norditropin Flexpro* [off-label] [B, 11], Omnitrope* [off-label][B, 11]

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure associated with Chronic Renal Insufficiency

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with one of the following:

Endocrinologist
Nephrologist

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

NOTE: Documentation of previous height, current height and goal expected adult height will be required for renewal.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure associated with Chronic Renal Insufficiency [off-label] [B, 11]

Diagnosis of pediatric growth failure associated with chronic renal insufficiency [10]

AND

Documentation of one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Prescribed by or in consultation with one of the following:

Endocrinologist
Nephrologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure associated with Chronic Renal Insufficiency [off-label] [B, 11]

Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with one of the following:

Endocrinologist
Nephrologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure associated with Chronic Renal Insufficiency [off-label] [B, 11]

Diagnosis of pediatric growth failure associated with chronic renal insufficiency [10]

AND

Submission of medical records (e.g., chart notes) documenting one of the following: [22]

Both of the following:

Patient is male
Bone age less than 16 years

Both of the following:

Patient is female
Bone age less than 14 years

AND

Prescribed by or in consultation with one of the following:

Endocrinologist
Nephrologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Growth Failure associated with Chronic Renal Insufficiency [off-label] [B, 11]

Submission of medical records (e.g., chart notes) documenting height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: [22]

Previous height and date obtained
Current height and date obtained

AND

Submission of medical records (e.g., chart notes) documenting both of the following:

Expected adult height not attained
Documentation of expected adult height goal

AND

Prescribed by or in consultation with one of the following:

Endocrinologist
Nephrologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Norditropin Flexpro, Omnitrope

Use the following criteria for child- and adult-onset with pituitary disease; use Isolated GHD in Adult criteria for patients without pituitary disease. *Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Adult Growth Hormone Deficiency

Diagnosis of adult GH deficiency as a result of one of the following: [10, 12, 21]

Clinical records supporting a diagnosis of childhood-onset GHD

Both of the following:

Adult-onset GHD

AND

Clinical records documenting that hormone deficiency is a result of hypothalamic-pituitary disease from organic or known causes (e.g., damage from surgery, cranial irradiation, head trauma, or subarachnoid hemorrhage)

AND

One of the following: [10, 12, 20-21]

Both of the following:

Patient has undergone one of the following GH stimulation tests to confirm adult GH deficiency:

Insulin tolerance test (ITT)
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

Both of the following:

Documented deficiency of three of the following anterior pituitary hormones:

Prolactin
Adrenocorticotropic hormone (ACTH)
Thyroid stimulating hormone (TSH)
Follicle-stimulating hormone/luteinizing hormone (FSH/LH)

AND

IGF-1/Somatomedin-C level is below the age and gender adjusted normal range as provided by the physician's lab

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope

Use the following criteria for child- and adult-onset with pituitary disease; use Isolated GHD in Adult criteria for patients without pituitary disease.*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Adult Growth Hormone Deficiency

Evidence of ongoing monitoring as demonstrated by documentation within the past 12 months of an IGF-1/Somatomedin C level [10, 12, 21]

AND

Prescribed by or in consultation with an endocrinologist

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Use the following criteria for child- and adult-onset with pituitary disease; use Isolated GHD in Adult criteria for patients without pituitary disease.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Adult Growth Hormone Deficiency

Diagnosis of adult GH deficiency as a result of one of the following: [10, 12, 21]

Clinical records supporting a diagnosis of childhood-onset GHD

Both of the following:

Adult-onset GHD

AND

Clinical records documenting that hormone deficiency is a result of hypothalamic-pituitary disease from organic or known causes (e.g., damage from surgery, cranial irradiation, head trauma, or subarachnoid hemorrhage)

AND

One of the following: [10, 12, 21]

Both of the following:

Patient has undergone one of the following GH stimulation tests to confirm adult GH deficiency:

Insulin tolerance test (ITT)
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

Both of the following:

Documented deficiency of three of the following anterior pituitary hormones:

Prolactin
ACTH
TSH
FSH/LH

AND

IGF-1/Somatomedin-C level is below the age and gender adjusted normal range as provided by the physician's lab

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Use the following criteria for child- and adult-onset with pituitary disease; use Isolated GHD in Adult criteria for patients without pituitary disease.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Adult Growth Hormone Deficiency

Evidence of ongoing monitoring as demonstrated by documentation within the past 12 months of an IGF-1/Somatomedin C level [10, 12, 21]

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Use the following criteria for child- and adult-onset with pituitary disease; use Isolated GHD in Adult criteria for patients without pituitary disease.

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Adult Growth Hormone Deficiency

Diagnosis of adult GH deficiency as a result of one of the following: [10, 12, 21]

Submission of medical records (e.g., chart notes) supporting a diagnosis of childhood-onset GHD

Both of the following:

Adult-onset GHD

AND

Submission of medical records (e.g., chart notes) documenting that hormone deficiency is a result of hypothalamic-pituitary disease from organic or known causes (e.g., damage from surgery, cranial irradiation, head trauma, or subarachnoid hemorrhage)

AND

One of the following: [10, 12, 21]

Both of the following:

Patient has undergone one of the following GH stimulation tests to confirm adult GH deficiency:

Insulin tolerance test (ITT)
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

Both of the following:

Submission of medical records (e.g., chart notes) documenting deficiency of three of the following anterior pituitary hormones:

Prolactin
ACTH
TSH
FSH/LH

AND

IGF-1/Somatomedin-C level is below the age and gender adjusted normal range as provided by the physician's lab

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Use the following criteria for child- and adult-onset with pituitary disease; use Isolated GHD in Adult criteria for patients without pituitary disease.

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Adult Growth Hormone Deficiency

Submission of medical records (e.g., chart notes) documenting evidence of ongoing monitoring within the past 12 months of an IGF-1/Somatomedin C level [10, 12, 21]

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Norditropin Flexpro, Omnitrope [off-label]

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Transition Phase Adolescent Patients

One of the following: [21]

Attained expected adult height
Closed epiphyses on bone radiograph

AND

One of the following: [20, 21]

Both of the following:

Documentation of high risk of GH deficiency due to GH deficiency in childhood from one of the following:

Embryopathic/congenital defects

Genetic mutations

Irreversible structural hypothalamic-pituitary disease

Panhypopituitarism

Deficiency of three of the following anterior pituitary hormones:

ACTH
TSH
Prolactin
FSH/LH

AND

One of the following:

IGF-1/Somatomedin-C level is below the age and gender adjusted normal range as provided by the physician's lab

All of the following:

Patient does not have a low IGF-1/Somatomedin C level

AND

Discontinued GH therapy for at least 1 month

AND

Patient has undergone one of the following GH stimulation tests after discontinuation of therapy for at least 1 month:

ITT
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

All of the following:

At low risk of severe GH deficiency (e.g., due to isolated and/or idiopathic GH deficiency)

AND

Discontinued GH therapy for at least 1 month

AND

Patient has undergone one of the following GH stimulation tests after discontinuation of therapy for at least 1 month:

ITT
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope [off-label]

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Transition Phase Adolescent Patients

Evidence of positive response to therapy (e.g., increase in total lean body mass, exercise capacity or IGF-1 and IGFBP-3 levels)

AND

Prescribed by or in consultation with an endocrinologist

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Transition Phase Adolescent Patients [off-label] [B]

One of the following: [21]

Attained expected adult height
Closed epiphyses on bone radiograph

AND

One of the following: [20, 21]

Both of the following:

Documentation of high risk of GH deficiency due to GH deficiency in childhood from one of the following:

Embryopathic/congenital defects

Genetic mutations

Irreversible structural hypothalamic-pituitary disease

Panhypopituitarism

Deficiency of three of the following anterior pituitary hormones:

ACTH
TSH
Prolactin
FSH/LH

AND

One of the following:

IGF-1/Somatomedin-C level is below the age and gender adjusted normal range as provided by the physician's lab

All of the following:

Patient does not have a low IGF-1/Somatomedin C level

AND

Discontinued GH therapy for at least 1 month

AND

Patient has undergone one of the following GH stimulation tests after discontinuation of therapy for at least 1 month:

ITT
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

All of the following:

At low risk of severe GH deficiency (e.g., due to isolated and/or idiopathic GH deficiency)

AND

Discontinued GH therapy for at least 1 month

AND

Patient has undergone one of the following GH stimulation tests after discontinuation of therapy for at least 1 month:

ITT
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Transition Phase Adolescent Patients [off-label] [B]

Evidence of positive response to therapy (e.g., increase in total lean body mass, exercise capacity or IGF-1 and IGFBP-3 levels)

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Transition Phase Adolescent Patients [off-label] [B]

Submission of medical records (e.g., chart notes) documenting one of the following: [21]

Attained expected adult height
Closed epiphyses on bone radiograph

AND

Submission of medical records (e.g., chart notes) documenting one of the following: [20, 21]

Both of the following:

Documentation of high risk of GH deficiency due to GH deficiency in childhood from one of the following:

Embryopathic/congenital defects

Genetic mutations

Irreversible structural hypothalamic-pituitary disease

Panhypopituitarism

Deficiency of three of the following anterior pituitary hormones:

ACTH
TSH
Prolactin
FSH/LH

AND

One of the following:

IGF-1/Somatomedin-C level is below the age and gender adjusted normal range as provided by the physician's lab

All of the following:

Patient does not have a low IGF-1/Somatomedin C level

AND

Discontinued GH therapy for at least 1 month

AND

Patient has undergone one of the following GH stimulation tests after discontinuation of therapy for at least 1 month:

ITT
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

All of the following:

At low risk of severe GH deficiency (e.g., due to isolated and/or idiopathic GH deficiency)

AND

Discontinued GH therapy for at least 1 month

AND

Patient has undergone one of the following GH stimulation tests after discontinuation of therapy for at least 1 month:

ITT
Glucagon
Macimorelin

AND

Patient has one of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Transition Phase Adolescent Patients [off-label] [B]

Evidence of positive response to therapy (e.g., increase in total lean body mass, exercise capacity or IGF-1 and IGFBP-3 levels)

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Norditropin Flexpro, Omnitrope

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Isolated Growth Hormone Deficiency in Adults

Documented deficiency of GH as demonstrated by both of the following: [20-21]

Patient has undergone two of the following GH stimulation tests:

ITT
Glucagon
Macimorelin

AND

Patient has two of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

AND

Prescribed by or in consultation with an endocrinologist

Norditropin Flexpro, Omnitrope

*Approve at NDC list "SOMATROPPA”.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Isolated Growth Hormone Deficiency in Adults

Evidence of ongoing monitoring as demonstrated by documentation within the past 12 months of an IGF-1/Somatomedin C level [10, 12, 21]

AND

Prescribed by or in consultation with an endocrinologist

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [off-label] [B, 21]

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Isolated Growth Hormone Deficiency in Adults

Documented deficiency of GH as demonstrated by both of the following: [20-21]

Patient has undergone two of the following GH stimulation tests:

ITT
Glucagon
Macimorelin

AND

Patient has two of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [off-label] [B, 21]

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Isolated Growth Hormone Deficiency in Adults

Evidence of ongoing monitoring as demonstrated by documentation within the past 12 months of an IGF-1/Somatomedin C level [10, 12, 21]

AND

Prescribed by or in consultation with an endocrinologist

AND

Trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [off-label] [B, 21]

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Isolated Growth Hormone Deficiency in Adults

Submission of medical records (e.g., chart notes) documenting deficiency of GH as demonstrated by both of the following: [20-21]

Patient has undergone two of the following GH stimulation tests:

ITT
Glucagon
Macimorelin

AND

Patient has two of the following corresponding peak GH values:

ITT less than or equal to 5 mcg/L
Glucagon less than or equal to 3 mcg/L
Macimorelin less than 2.8 ng/mL 30, 45, 60 and 90 minutes following macimorelin administration

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [off-label] [B, 21]

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Isolated Growth Hormone Deficiency in Adults

Submission of medical records (e.g., chart notes) documenting evidence of ongoing monitoring within the past 12 months of an IGF-1/Somatomedin C level [10, 12, 21]

AND

Prescribed by or in consultation with an endocrinologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following: [B]

Norditropin (somatropin)
Omnitrope (somatropin)

Serostim

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Human Immunodeficiency Virus (HIV)-Associated Cachexia

Diagnosis of HIV-associated wasting syndrome or cachexia [7, 15, 18, 19]

AND

One of the following: [7, 15, 18, 19, C]

Unintentional weight loss of greater than 10% over the last 12 months

Unintentional weight loss of greater than 7.5% over the last 6 months

Loss of 5% body cell mass (BCM) within 6 months

Body mass index (BMI) less than 20 kg/m^2

All of the following

Patient is male
BCM less than 35% of total body weight
BMI less than 27 kg/m^2

All of the following

Patient is female
BCM less than 23% of total body weight
BMI less than 27 kg/m^2

AND

Nutritional evaluation since onset of wasting first occurred [7, 15, 18, 19]

AND

Patient has not had weight loss as a result of other underlying treatable conditions (e.g., depression, mycobacterium avium complex, chronic infectious diarrhea, or malignancy with the exception of Kaposi's sarcoma limited to skin or mucous membranes) [7, 15, 18, 19]

AND

Anti-retroviral therapy has been optimized to decrease the viral load [7, 15, 18, 19]

Serostim

Prior Authorization (Reauthorization)

Length of Approval: 6 months [D]
For diagnosis of Human Immunodeficiency Virus (HIV)-Associated Cachexia

Evidence of positive response to therapy (i.e., greater than or equal to 2% increase in body weight and/or BCM) [17, 18]

AND

One of the following targets or goals has not been achieved: [17, 18]

Weight
BCM
BMI

Zorbtive

NOTE: Treatment with Zorbtive will not be authorized beyond 4 weeks. Administration for more than 4 weeks has not been adequately studied.

Prior Authorization

Length of Approval: 4 Week(s)
For diagnosis of Short Bowel Syndrome

Diagnosis of Short Bowel Syndrome [9, 16]

AND

Patient is currently receiving specialized nutritional support (e.g., intravenous parenteral nutrition, fluid, and micronutrient supplements) [9, 16]

AND

Patient has not previously received 4 weeks of treatment with Zorbtive [9, 16]

All Products

Approval Length: N/A - Requests for non-approvable diagnoses should not be approved

Prior Authorization, Non Formulary

Requests for coverage of growth hormone for the diagnosis of Idiopathic Short Stature (ISS) are not authorized and will not be approved. There is no consensus in current peer-reviewed medical literature regarding the indications, efficacy, safety, or long-term consequences of GH therapy in children with ISS who are otherwise healthy. [E]

Guideline ID
GL-158337
Formulary
Premium
Effective date
Jan 1, 2025
P&T approval date
Mar 17, 2000

P & T Revisions

2024-11-01, 2024-09-19, 2024-02-28, 2023-11-20, 2023-10-27, 2023-09-21, 2023-08-31, 2023-08-23, 2023-08-07, 2023-07-20, 2022-12-21, 2022-08-22, 2022-06-16, 2022-04-28, 2021-12-06, 2021-07-28, 2021-05-19, 2020-10-31, 2020-08-21, 2020-04-27, 2019-08-19

References

Genotropin Prescribing Information. Pharmacia & Upjohn Co, a Division of Pfizer Inc. New York, NY. April 2019.
Humatrope Prescribing Information. Eli Lilly and Company. Indianapolis, IN. December 2023.
Norditropin Flexpro Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. March 2020.
Nutropin AQ NuSpin Prescribing Information. Genentech, Inc. South San Francisco, CA. December 2016.
Omnitrope Prescribing Information. Sandoz Inc. Princeton, NJ. March 2024.
Saizen Prescribing Information. EMD Serono, Inc. Rockland, MA. February 2020.
Serostim Prescribing Information. EMD Serono, Inc. Rockland, MA. June 2019.
Zomacton Prescribing Information. Ferring Pharmaceuticals Inc. Parsippany, NJ. April 2024.
Zorbtive Prescribing Information. EMD Serono, Inc. Rockland, MA. September 2019.
Gharib H, Cook DM, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for GH use in adults and children-2003 update. Endocr Pract. 2003;9(1):64-76.
Wilson TA, Rose SA, Cohen P, et al. Update on guidelines for the use of GH in children: The Lawson Wilkins pediatric endocrinology society drug and therapeutics committee. J Pediatrics 2003 (Oct): 415-21
GH Research society. Consensus guidelines for the diagnosis and treatment of GH deficiency in childhood and adolescence: Summary statement. J Clin Endocinol Metab. 2000; 85: 3990-93.
Badaru A, Wilson DM. Alternatives to growth hormone stimulation testing in children. Trends Endocrinol Metab 2004;15(6):252-8.
Gandrud LM, Wilson DM. Is growth hormone stimulation testing in children still appropriate? Growth Horm IGF Res 2004;14(3):185-94.
Corcoran C, Grinspoon S. Treatment for wasting in patients with the acquired immunodeficiency syndrome. N Engl J Med 1999; 340 (22):1740-50.
Byrne TA, Wilmore DW, Iyer K et al. Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome. Ann Surg 2005;242:655-61.
Polsky B, Kotler D, Steinhart C. HIV-associated wasting in the HAART era: guidelines for assessment, diagnosis, and treatment. AIDS Patient Care STDS. 2001;15:411-23.
Polsky B, Kotler D, Steinhart C. Treatment guidelines for HIV-associated wasting. HIV Clin Trials. 2004;5:50-61.
Nemechek P, Polsky B, Gottlieb M. Treatment guidelines for HIV-associated wasting. Mayo Clin Proc. 2000;75:386-394.
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. Endocr Pract. 2019;25(No. 11):1191-1232. Available at: https://www.sciencedirect.com/science/article/pii/S1530891X20351454. Accessed July 12, 2021.
Cook DM, Yuen KC, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in growth hormone-deficient adults and transition patients -2009 update. Endocr Pract. 2009;15(suppl 2):1-29. Available at: https://www.researchgate.net/publication/38037397. Accessed July 12, 2021.
Mauras N, Attie KM, Reiter EO, Saenger P, Baptista J. High dose recombinant human growth hormone (GH) treatment of GH-deficient patients in puberty increases near-final height: a randomized, multicenter trial. Genentech, Inc., Cooperative Study Group. J Clin Endocrinol Metab. 2000;85(10):3653-60.
Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-treatment in children and adolescents: growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency. Horm Res Paediatr. 2016;86:361-397. Available at: https://www.karger.com/Article/Pdf/452150. Accessed June 21, 2019.
Wit JM, van Unen H. Growth of infants with neonatal growth hormone deficiency. Arch Dis Child. 1992; 67: 920-924.
Herber SM, Milner RD. Growth hormone deficiency presenting under age 2 years. Arch Dis Child. 1984 Jun; 59(6): 557–560.
Per clinical consult with pediatric endocrinologist, July 23, 2018.
Skytrofa Prescribing Information. Ascendis Pharma Endocrinology, Inc. Princeton, NJ. May 2024.
Sogroya Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. April 2023.
UpToDate. Diagnosis of growth hormone deficiency in children, Available at: https://www.uptodate.com/contents/diagnosis-of-growth-hormone-deficiency-in-children?search=pediatric%20gorwth%20hormone%20deficinecy&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#. Accessed August 6, 2024.
Thomas, H., and Kumar, B. The usefulness of serum IGF-1 and serum IGFBP-3 for the diagnosis of growth hormone deficiency in comparison to clonidine stimulation test: a prospective cohort study. Available at: file:///C:/Users/kdekhtaw/Downloads/medip,+IJCP-3963+O.pdf. Accessed June 22, 2023.
Ngenla Prescribing Information. Pfizer Laboratories Division of Pfizer Inc. New York, NY. June 2023.

End Notes

Several recent review articles in the literature have suggested that GH stimulation tests should no longer be used to diagnose GHD. [13,14] The authors argue that GH stimulation test may have side effects, lack precision, accuracy, and do not predict response to GH therapy. It has been suggested that newer diagnostic procedures such as serum IGF-1, IGFBP-3 concentrations, genetic testing and neuroimaging could provide an alternative approach to the diagnosis of GHD in childhood.
Overall, there are no observable differences in the results obtained among the different preparations as long as the regimen follows currently approved daily injections. Many of the products are available in a variety of injection devices that are meant to make administration more appealing and easier. Currently, there is no evidence that clinical outcome differs among the various injection systems, although there may be patient and parent preferences for some of these devices. [11, 21]
Even a 5% weight loss in persons with HIV infection indicates a poor prognosis. [2]
Patients with HIV-associated wasting may begin an initial 12-week course of therapy with Serostim, 6 mg/day s.c. The clinician should monitor treatment responses by obtaining serial body weights and BCM measurements by BIA. A positive response to therapy probably should be considered as a 2% increase in body weight and/or BCM. Maintenance therapy may continue on a monthly basis as long as wasting is still evident. Once BCM has normalized, therapy can be stopped, with the patient being observed for an 8-week period. Over these 8 weeks, body weight, BCM, and any appearance of wasting symptoms can be monitored. If wasting reappears, therapy can be restarted. [17]
Guidelines for idiopathic short stature recommend against the routine use of GH in every child with height standard deviation score ≤ - 2.25. [23]
When GHD is congenital and near complete, the diagnosis is relatively easy to confirm because affected children present with severe growth failure, delayed bone age, and very low serum concentrations of GH, IGF-1, and IGFBP-3 [8]. For patients with all of these clinical characteristics, it is reasonable to make the diagnosis of GHD without performing GH stimulation testing. [29]
Measurements of IGF-1 and IGFBP-3 have shown comparable diagnostic performance with growth hormone stimulation tests and are valuable for patient`s convenience and ease of performance and can be useful in the workup of growth hormone deficiency. [30]

Revision History

2024-11-01: Removed Nutropin as a preferred alternative.
2024-09-19: 2024 annual review: no criteria changes. Background updates.
2024-02-28: GPI clean up - add Ngenla to "All Products" criteria box.
2023-11-20: Updated Sogroya Non-Formulary criteria.
2023-10-27: Program update to remove trial requirement for Skytrofa and Ngenla. Sogroya will require additional trial of both Skytrofa and Ngenla.
2023-09-21: Added Ngenla to guideline with criteria for PGHD. Added NF reauth criteria for "Transition Phase Adolescent Patients" indication. Added Sogroya as a non-preferred target drug to "Transition Phase Adolescent Patients" indication. Background updates.
2023-08-31: Added operational note. No changes to criteria.
2023-08-23: update guideline
2023-08-07: Updated guideline due to Nutropin shortage.
2023-07-20: update guideline
2022-12-21: Due to Norditropin shortage, formulary strategy for non-preferred agents that previously required a trial of Norditropin and Nutropin will be updated to require a trial of one agent.
2022-08-22: Annual review: no criteria changes.
2022-06-16: Addition of initial and reauth NF criteria
2022-04-28: GPI Reclassification
2021-12-06: Added Non-Formulary criteria and criteria for Skytrofa to the guideline.
2021-07-28: Criteria updates for PGHD, AGHD, Transition Phase, and IGHD in Adults. Indication, background, and reference updates.
2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
2020-10-31: GPI replication update for Omnitrope, Nutropin AQ, Norditropin.
2020-08-21: 2020 Annual Review: Removed discontinued/obsolete products;updated t/f language
2020-04-27: Revised preferred products in guideline.
2019-08-19: 2019 annual review; added macimorelin as a diagnostic option in adult GHD (2.1.2).

Growth Hormones - PA, NF

Indications for Prior Authorization

Genotropin, Humatrope, Norditropin Flexpro, Nutropin AQ NuSpin, Omnitrope, Saizen, and Zomacton

Skytrofa (lonapegsomatropin-tcgd)

Ngenla (somatrogon-ghla)

Genotropin and Omnitrope

Norditropin Flexpro, Humatrope, and Zomacton

Genotropin, Humatrope, Norditropin Flexpro, Nutropin AQ NuSpin, Omnitrope, and Zomacton

Humatrope and Zomacton

Nutropin AQ NuSpin

Norditropin Flexpro

Genotropin, Nutropin AQ NuSpin, and Omnitrope

Norditropin Flexpro and Humatrope

Genotropin, Nutropin AQ NuSpin, Omnitrope, and Saizen

Norditropin Flexpro, Humatrope, and Zomacton

Serostim

Zorbtive

Zomacton

Sogroya (somapacitan-beco)

Criteria

Norditropin Flexpro*, Omnitrope*

Norditropin Flexpro*, Omnitrope*

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Skytrofa

Skytrofa

Sogroya

Sogroya

Sogroya

Sogroya

Ngenla

Ngenla

Norditropin Flexpro*, Omnitrope* [B, 11]

Norditropin Flexpro*, Omnitrope* [B, 11]

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label],Saizen [off-label], Zomacton [off-label] [B, 11]

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label], Saizen [off-label], Zomacton [off-label] [B, 11]

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label], Saizen [off-label], Zomacton [off-label] [B, 11]

Genotropin, Humatrope [off-label], Nutropin AQ NuSpin [off-label], Saizen [off-label], Zomacton [off-label] [B, 11]

Norditropin Flexpro*, Omnitrope*

Norditropin Flexpro*, Omnitrope*

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin [off-label] [B, 11], Saizen [off-label] [B, 11], Zomacton

Norditropin Flexpro*, Omnitrope*

Norditropin Flexpro*, Omnitrope*

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Norditropin Flexpro*, Omnitrope*

Norditropin Flexpro*, Omnitrope*

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

Genotropin [off-label], Humatrope, Nutropin AQ NuSpin [off-label], Saizen [off-label] [B, 11], Zomacton

Norditropin Flexpro* [off-label] [B, 11], Omnitrope* [off-label] [B, 11]

Norditropin Flexpro* [off-label] [B, 11], Omnitrope* [off-label][B, 11]

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Zomacton

Norditropin Flexpro*, Omnitrope*

Norditropin Flexpro*, Omnitrope*

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [B, 21]

Norditropin Flexpro*, Omnitrope* [off-label]

Norditropin Flexpro*, Omnitrope* [off-label]

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton

Norditropin Flexpro*, Omnitrope*

Norditropin Flexpro*, Omnitrope*

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [off-label] [B, 21]

Genotropin, Humatrope, Nutropin AQ NuSpin, Saizen, Sogroya, Zomacton [off-label] [B, 21]

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope [B, 11]

Norditropin Flexpro, Omnitrope [B, 11]

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope [off-label]

Norditropin Flexpro, Omnitrope [off-label]

Norditropin Flexpro, Omnitrope

Norditropin Flexpro, Omnitrope