Growth Hormone, Growth Stimulating Agents Managed Medicaid

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Growth Hormone, Growth Stimulating Agents Managed Medicaid

Transcript Of Growth Hormone, Growth Stimulating Agents Managed Medicaid

Clinical Pharmacy Program Guidelines for Growth Hormone, Growth Stimulating Agents – Managed Medicaid

Program Medication

Prior Authorization Human Growth Hormone:

Preferred Agents:

Somatropin (Zomacton®)

Nonpreferred Agents:

Somatropin (Genotropin®, Humatrope®, Norditropin®, NordiFlex®, Nutropin®, Nutropin AQ®, Nutropin AQ® NuSpin™, Omnitrope®, Saizen®, Zorbtive®, and Serostim®)

Markets in Scope
Issue Date Pharmacy and Therapeutics Approval Date Effective Date

Growth Stimulating Products : Mecasermin (Increlex®) CA, Colorado, Hawaii, Maryland, Nevada, New Jersey, New York- Medicaid, New York EPP, Rhode Island, South Carolina 6/2009 11/2020
12/2020

1. Background:

Somatropin is indicated for the treatment of growth hormone deficiency, short stature associated with Turner syndrome or Noonan syndrome, short-stature homeobox (SHOX) gene deficiency, growth failure due to Prader-Willi syndrome, short stature in children born small for gestational age, growth failure in children with chronic renal insufficiency up to the time of transplant, short bowel syndrome in patients receiving specialized nutritional support, and HIV-associated wasting. Somatropin is also indicated for replacement of endogenous growth hormone in adults with confirmed growth hormone deficiency.

**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.

Mecasermin is indicated for the treatment of growth failure in children with severe primary insulin-like growth factor-1 (IGF-1) deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone.

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2. Coverage Criteria:
A. Pediatric Growth Hormone Deficiency (GHD)
Note: 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.
1. Initial Therapy
a. Somatropin will be approved based on one of the following criteria:
(1) Both of the following:
1. One of the following:
(a) All of the following:
i. Infant is < 4 months of age ii. Infant has growth deficiency iii. Prescribed by an endocrinologist
-OR-
(b) Both of the following:
i. History of neonatal hypoglycemia associated with pituitary disease
ii. Prescribed by an endocrinologist
-OR-
(c) Both of the following:
i. Diagnosis of panhypopituitarism ii. Prescribed by an endocrinologist
-AND-
2. If the request is for a non-preferred medication, there must be a reason or special circumstance that the patient must be treated with a non-preferred medication
-OR-
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(2) All of the following:
(a) Diagnosis of pediatric GH deficiency as confirmed by one of the following:
i. Projected height (as determined by extrapolating pretreatment growth trajectory along current channel to 18-20 year mark) is > 2.0 standard deviations [SD] below midparental height utilizing age and gender growth charts related to height:
-OR-
ii. Height is > 2.25 SD below population mean (below the 1.2 percentile for age and gender) utilizing age and gender growth charts related to height
-OR-
iii. Growth velocity is > 2 SD below mean for age and gender
-OR-
iv. Delayed skeletal maturation of > 2 SD below mean for age and gender (e.g., delayed > 2 years compared with chronological age)
-AND-
(b) One of the following:
i. Patient is male and one of the following:
▪ Tanner stage less than 4 ▪ Bone age < 16 years measured in the past 12 months
-OR-
ii. Patient is female and one of the following:
▪ Tanner stage less than 4 ▪ Bone age < 14 years measured in the past 12 months
-AND-
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(c) Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following:
i. Both of the following:
▪ Patient has undergone two of the following provocative GH stimulation tests:
- Arginine - Clonidine - Glucagon - Insulin - Levodopa - Growth hormone releasing hormone
-AND-
▪ Both GH response values are < 10 mcg/L
-OR-
ii. Both of the following:
▪ Patient is < 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:
- Insulin-like Growth Factor 1 (IGF1/Somatomedin-C)
- Insulin Growth Factor Binding Protein-3 (IGFBP3)
-AND-
(d) One of the following:
i. Request does not exceed a maximum supply limit of 0.3 mg/kg/week
-OR-
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ii. Both of the following:
 Tanner Stage 3 or greater  Request does not exceed a maximum supply
limit of 0.7 mg/kg/week
-AND-
(e) Prescribed by an endocrinologist
-AND-
(f) If the request is for a non-preferred medication, there must be a reason or special circumstance that the patient must be treated with a non-preferred medication
Authorization will be issued for 12 months.
Note: Documentation of previous height, current height and goal expected adult height will be required for renewal.
2. Reauthorization
a. Somatropin will be approved based on all of the following criteria:
(1) Height increase of at least 2 cm/year over the previous year documented by both of the following:
(a) Previous height and date obtained (b) Current height and date obtained
-AND-
(2) Both of the following:
(a) Expected adult height not attained (b) Documentation of expected adult height goal (e.g. genetic
potential)
-AND-
(3) Calculated height (growth) velocity over the past 12 months
-ANDConfidential and Proprietary, © 2021 UnitedHealthcare Services Inc.
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(4) One of the following: (a) Patient is male and one of the following: i. Tanner stage less than 4 ii. Bone age < 16 years measured in the past 12 months -OR(b) Patient is female and one of the following: i. Tanner stage less than 4 ii. Bone age < 14 years measured in the past 12 months -AND-
(5) One of the following: (a) Request does not exceed a maximum supply limit 0.3 mg/kg/week -OR(b) Both of the following: i. Tanner Stage 3 or greater ii. Request does not exceed a maximum supply limit of 0.7 mg/kg/week -AND-
(6) Prescribed by an endocrinologist Authorization will be issued for 12 months. B. Prader-Willi Syndrome
1. Initial Therapy a. Somatropin will be approved based on all of the following criterion: (1) Diagnosis of Prader-Willi Syndrome
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-AND(2) Prescribed by an endocrinologist
-AND(3) If the request is for a non-preferred medication, there must be a
reason or special circumstance that the patient must be treated with a non-preferred medication Authorization will be issued for 12 months. 2. Reauthorization a. Somatropin will be approved based on one of the following criteria: (1) Both of the following: (a) Evidence of positive response to therapy (e.g., increase in total lean body mass, decrease in fat mass)
-AND(b) Prescribed by an endocrinologist
-OR(2) All of the following:
(a) Height increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: i. Previous height and date obtained ii. Current height and date obtained -AND-
(b) Both of the following: i. Expected adult height not attained ii. Documentation of expected adult height goal -AND-
(c) Prescribed by an endocrinologist Confidential and Proprietary, © 2021 UnitedHealthcare Services Inc.
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Authorization will be issued for 12 months.
C. Growth Failure in Children Small for Gestational Age (SGA)
1. Initial Therapy
a. Somatropin will be approved based on all of the following criteria:
(1) Diagnosis of SGA based on demonstration of catch up growth failure in the first 24 months of life using a birth to 36 month growth chart as confirmed by the following criterion:
(a) Documentation that one of the following is below the 3rd percentile for gestational age (greater than or equal to 2 SD below population mean):
i. Birth weight ii. Birth length
-AND-
(b) Patient has demonstrated failure of catch up growth in the first 24 months of life
-AND-
(2) Documentation that height remains ≤ 3rd percentile (greater than or equal to 2 SD below population mean)
-AND-
(3) Prescribed by an endocrinologist
-AND-
(4) If the request is for a non-preferred medication, there must be a reason or special circumstance that the patient must be treated with a non-preferred medication
Authorization will be issued for 12 months.
Note: Documentation of previous height, current height and goal expected adult height will be required for renewal.
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2. Reauthorization a. Somatropin will be approved based on all of the following criteria: (1) Height increase of at least 2 cm/year over the previous year documented by both of the following: (a) Previous height and date obtained (b) Current height and date obtained -AND(2) Documentation of both of the following: (a) Expected adult height not attained (b) Expected adult height goal -AND(3) Prescribed by an endocrinologist
Authorization will be issued for 12 months. D. Turner Syndrome or Noonan Syndrome
1. Initial Therapy a. Somatropin will be approved based on all of the following criteria: (1) Diagnosis of pediatric growth failure associated with one of the following: (a) Both of the following: i. Turner Syndrome (Gonadal Dysgenesis) -ANDii. Both of the following: ▪ Patient is female ▪ One of the following:
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• Bone age < 14 years measured in the past 12 months
• Tanner stage less than 4
-OR-
(b) Both of the following:
i. Noonan Syndrome
-AND-
ii. One of the following:
▪ Patient is male and one of the following:
- Tanner stage less than 4 - Bone age < 16 years measured in the past 12
months
-OR-
▪ Patient is female and one of the following:
- Tanner stage less than4 - Bone age < 14 years measured in the past 12
months
-AND(2) Height is below the 5th percentile on growth charts for age and
gender
-AND-
(3) Prescribed by an endocrinologist
-AND-
(4) If the request is for a non-preferred medication, there must be a reason or special circumstance that the patient must be treated with a non-preferred medication
Authorization will be issued for 12 months.
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HeightAgeSomatropinPatientRequest