Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Growth Hormone With ISS 1741-A SGM P2024
Drug
GENOTROPIN (somatropin)
HUMATROPE (somatropin)
NORDITROPIN(somatropin)
NUTROPIN AQ (somatropin)
OMNITROPE(somatropin)
SAIZEN(somatropin)
ZOMACTON(somatropin)
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no contraindications or exclusions to the prescribed therapy.
A. FDA-Approved Indications 1. Pediatric patients with growth failure due to any of the following: a. Growth hormone (GH) deficiency b. Turner syndrome c. Noonan syndrome d. Small for gestational age (SGA) e. Prader-Willi syndrome f. Chronic kidney disease (CKD) g. Short stature homeobox-containing gene (SHOX) deficiency h. Idiopathic short stature (ISS)* 2. Adults with childhood-onset or adult-onset GH deficiency
* ISS may not be covered by some plans
B. Compendial Uses 1. Human immunodeficiency virus (HIV)-associated wasting/cachexia 2. Short bowel syndrome (SBS) 3. Growth failure associated with any of the following: a. Cerebral palsy b. Congenital adrenal hyperplasia c. Cystic fibrosis d. Russell-Silver syndrome
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review for both initial and continuation of therapy requests (where applicable): A. Medical records supporting the diagnosis of neonatal GH deficiency B. Pretreatment growth hormone provocative test result(s) (laboratory report or medical record documentation) C. Growth chart D. Pretreatment and/or current IGF-1 level (laboratory report or medical record documentation)* E. The following laboratory test reports must be provided: 1. Diagnostic karyotype results in Turner syndrome 2. Diagnostic genetic test results in Prader-Willi syndrome 3. Diagnostic molecular or genetic test results in SHOX deficiency F. The following information must be provided for all continuation of therapy requests: 1. Total duration of treatment (approximate duration is acceptable) 2. Date of last dose administered 3. Approving health plan/pharmacy benefit manager 4. Date of prior authorization/approval 5. Prior authorization approval letter
* IGF-1 levels vary based on the laboratory performing the analysis. Laboratory-specific values must be provided to determine whether the value is within the normal range.
III. CRITERIA FOR INITIAL APPROVAL
A. Pediatric Growth Hormone (GH) Deficiency Authorization of 12 months may be granted to members with pediatric growth hormone (GH) deficiency when EITHER criteria 1. or 2. below is met: 1. Member is a neonate or was diagnosed with GH deficiency as a neonate. Medical records must be available to support the diagnosis of neonatal GH deficiency (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or magnetic resonance imaging [MRI] results). 2. Member meets ALL of the following: i. Member has EITHER: a. Two pretreatment pharmacologic provocative GH tests with both results demonstrating a peak GH level < 10 ng/mL, OR b. A documented pituitary or CNS disorder (refer to Appendix A) and a pretreatment IGF-1 level > 2 standard deviations (SD) below the mean ii. For members < 2.5 years of age at initiation of treatment, the pretreatment height is > 2 SD below the mean and growth velocity is slow iii. For members ≥ 2.5 years of age at initiation of treatment: a. Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean, OR b. Pretreatment 1-year height velocity is > 2 SD below the mean iv. Epiphyses are open
B. Idiopathic Short Stature (ISS) (may not be covered by some plans) Authorization of 12 months may be granted to members with idiopathic short stature (ISS) when ALL of the following criteria are met: 1. Pretreatment height is > 2.25 SD below the mean 2. Predicted adult height is < 5’3” for boys and < 4’11” for girls 3. Pediatric GH deficiency has been ruled out with a provocative GH test (peak GH level ≥ 10 ng/mL) 4. Epiphyses are open
C. Small for Gestational Age (SGA) Authorization of 12 months may be granted to members born small gestational age (SGA) when ALL of the following criteria are met: 1. Member meets one of the following: i. Birth weight < 2500 g at gestational age > 37 weeks ii. Birth weight or length less than 3rd percentile for gestational age iii. Birth weight or length ≥ 2 SD below the mean for gestational age 2. Pretreatment age is ≥ 2 years 3. Member failed to manifest catch-up growth by age 2 (i.e., pretreatment height > 2 SD below the mean) 4. Epiphyses are open
D. Turner Syndrome Authorization of 12 months may be granted to members with Turner syndrome when ALL of the following criteria are met: 1. Diagnosis was confirmed by karyotyping 2. Pretreatment height is less than the 5th percentile for age 3. Epiphyses are open
E. Growth Failure Associated with Chronic Kidney Disease (CKD), Cerebral Palsy, Congenital Adrenal Hyperplasia, Cystic Fibrosis, or Russell-Silver Syndrome Authorization of 12 months may be granted to members with chronic kidney disease (CKD), cerebral palsy, congenital adrenal hyperplasia, cystic fibrosis, or Russell-Silver syndrome when ALL of the following criteria are met: 1. For members < 2.5 years of age at initiation of treatment, the pretreatment height is > 2 SD below the mean and growth velocity is slow 2. For members ≥ 2.5 years of age at initiation of treatment: i. Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean, OR ii. Pretreatment 1-year height velocity is > 2 SD below the mean 3. Epiphyses are open
F.Prader-Willi Syndrome Authorization of 12 months may be granted to members with Prader-Willi syndrome when the diagnosis was confirmed by genetic testing demonstrating ANY of the following: 1. Deletion in the chromosomal 2-q13 region 2. Maternal uniparental disomy in chromosome 15 3. Imprinting defects, translocations, or inversions involving chromosome 15
G. Noonan Syndrome Authorization of 12 months may be granted to members with Noonan syndrome when both of the following criteria are met: 1. Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the meanOR pretreatment 1-year height velocity is > 2 SD below the mean 2. Epiphyses are open3
H. Short Stature Homeobox-Containing Gene (SHOX) Deficiency Authorization of 12 months may be granted to members with short stature homeobox- containing gene (SHOX) deficiency when ALL of the following criteria are met: 1. The diagnosis of SHOX deficiency was confirmed by molecular or genetic analyses 2. Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean OR pretreatment 1-year height velocity is > 2 SD below the mean 3. Epiphyses are open
I. Adult Growth Hormone (GH) Deficiency Authorization of 12 months may be granted to members with adult growth hormone (GH) deficiency when ANY of the following criteria is met: 1. Member meets both of the following: i. Member has had 2 pretreatment pharmacologic provocative GH tests and both results demonstrated deficient GH responses defined as the following: a. Insulin tolerance test (ITT) with a peak GH level ≤ 5 ng/mL b. Macrilen with a peak GH level of less than 2.8 ng/mL c. Glucagon stimulation test with a peak GH level ≤ 3.0 ng/mL in patients with a body mass index (BMI) ≤ 30 kg/m2 and a high pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI < 25 kg/m2 d. Glucagon stimulation test with a peak GH level ≤ 1.0 ng/mL in patients with a BMI of ≥ 25 kg/m2 and a low pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI > 30 kg/m2 ii. Member has a low pretreatment IGF-1 (between 0 to 2 SD below the mean for age and gender) 2. Member meets both of the following: i. Member has had 1 pretreatment pharmacologic provocative GH test that demonstrated deficient GH responses defined as one of the following: a. Insulin tolerance test (ITT) with a peak GH level ≤ 5 ng/mL b. Macrilen with a peak GH level of less than 2.8 ng/mL c. Glucagon stimulation test with a peak GH level ≤ 3.0 ng/mL in patients with a body mass index (BMI) ≤ 30 kg/m2 and a high pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI < 25 kg/m2 d. Glucagon stimulation test with a peak GH level ≤ 1.0 ng/mL in patients with a BMI of ≥ 25 kg/m2 and a low pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI > 30 kg/m2 ii. Member has a pretreatment IGF-1 level that is more than 2 SD below the mean for age and gender 3. Member has organic hypothalamic-pituitary disease (e.g., suprasellar mass with previous surgery and cranial irradiation) with ≥ 3 documented pituitary hormone deficiencies (refer to Appendix B) and a low pretreatment IGF-1 more than 2 standard deviations below the mean for age and gender 4. Member has genetic or structural hypothalamic-pituitary defects (refer to Appendix C) 5. Member has childhood-onset GH deficiency and a congenital abnormality of the CNS, hypothalamus or pituitary (refer to Appendix C)
J. HIV-Associated Wasting/Cachexia Authorization of 12 weeks may be granted to members with HIV-associated wasting/cachexia when ALL of the following criteria are met: 1. Member trialed and experienced a suboptimal response to alternative therapies (e.g., cyproheptadine, dronabinol, megestrol acetate or testosterone if hypogonadal) or contraindication or intolerance to alternative therapies 2. Member is currently on antiretroviral therapy 3. BMI was less than 18.5 kg/m2 prior to initiating therapy with growth hormone (see Appendix D)
K. Short Bowel Syndrome Authorization of a lifetime total of 8 weeks may be granted to members with short bowel syndrome who depend on intravenous parenteral nutrition for nutritional support when GH will be used in conjunction with optimal management of SBS.
IV. CONTINUATION OF THERAPY
A. Pediatric GH Deficiency, Turner Syndrome, Noonan Syndrome, Chronic Kidney Disease (CKD), Small Gestational Age (SGA), Idiopathic Short Stature (ISS), Short Stature Homeobox-Containing Gene (SHOX) deficiency, Congenital Adrenal Hyperplasia, Cerebral Palsy, Cystic Fibrosis, or Russell-Silver Syndrome Authorization of 12 months may be granted for continuation of therapy for pediatric growth hormone (GH) deficiency, Turner syndrome, Noonan syndrome, chronic kidney disease (CKD), small gestational age (SGA), idiopathic short stature (ISS), short stature homeobox- containing gene (SHOX) deficiency, congenital adrenal hyperplasia, cerebral palsy, cystic fibrosis, or Russell-Silver syndrome when ALL of the following criteria are met: 1. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for pediatric GH deficiency, Turner syndrome, Noonan syndrome, CKD, SGA, ISS, SHOX deficiency, congenital adrenal hyperplasia, cerebral palsy, cystic fibrosis, or Russell-Silver syndrome 2. Epiphyses are open (confirmed by X-ray or X-ray is not available) 3. Member’s growth rate is > 2 cm/year unless there is a documented clinical reason for lack of efficacy (e.g., on treatment less than 1 year, nearing final adult height/late stages of puberty)
B. Prader-Willi Syndrome Authorization of 12 months may be granted for continuation of therapy for Prader-Willi syndrome when both of the following criteria are met: 1. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for Prader-Willi syndrome 2. Member’s body composition and psychomotor function have improved or stabilized in response to GH therapy
C. Adult Growth Hormone (GH) Deficiency Authorization of 12 months may be granted for continuation of therapy for adult growth hormone (GH) deficiency when ANY of the following criteria is met: 1. Member meets ALL of the following: i. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for adult GH deficiency ii. Member has had 2 pretreatment pharmacologic provocative GH tests and both results demonstrated deficient GH responses defined as the following: a. Insulin tolerance test (ITT) or another provocative GH test with a peak GH level ≤ 5 ng/mL b. Macrilen with a peak GH level of less than 2.8 ng/mL c. Glucagon stimulation test with a peak GH level ≤ 3.0 ng/mL in patients with a body mass index (BMI) ≤ 30 kg/m2 and a high pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI < 25 kg/m2 d. Glucagon stimulation test with a peak GH level ≤ 1.0 ng/mL in patients with a BMI of ≥ 25 kg/m2 and a low pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI > 30 kg/m2 iii. Member has a low pretreatment IGF-1 (between 0 to 2 SD below the mean for age and gender) iv. Current IGF-1 level is not elevated for age and gender 2. Member meets ALL of the following: i. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for adult GH deficiency ii. Member has had 1 pretreatment pharmacologic provocative GH test that demonstrated deficient GH responses defined as one of the following: a. Insulin tolerance test (ITT) or another provocative GH test with a peak GH level ≤ 5 ng/mL b. Macrilen with a peak GH level of less than 2.8 ng/mL c. Glucagon stimulation test with a peak GH level ≤ 3.0 ng/mL in patients with a body mass index (BMI) ≤ 30 kg/m2 and a high pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI < 25 kg/m2 d. Glucagon stimulation test with a peak GH level ≤ 1.0 ng/mL in patients with a BMI of ≥ 25 kg/m2 and a low pretest probability of GHD (e.g., acquired structural abnormalities) OR a BMI > 30 kg/m2 iii. Member has a pretreatment IGF-1 level that is more than 2 SD below the mean for age and gender iv. Current IGF-1 level is not elevated for age and gender 3. Member meets ALL of the following: i. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for adult GH deficiency ii. Member has organic hypothalamic-pituitary disease (e.g., suprasellar mass with previous surgery and cranial irradiation) with ≥ 3 documented pituitary hormone deficiencies (refer to Appendix B) and a low pretreatment IGF-1 more than 2 standard deviations below the mean for age and gender iii. Current IGF-1 level is not elevated for age and gender 4. Member meets both of the following: i. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for adult GH deficiency ii. Member has genetic or structural hypothalamic-pituitary defects (refer to Appendix C) and current IGF-1 level is not elevated for age and gender 5. Member meets both of the following: i. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for adult GH deficiency ii. Member has childhood-onset GH deficiency and a congenital abnormality of the CNS, hypothalamus or pituitary (refer to Appendix C) and current IGF-1 level is not elevated for age and gender
D. HIV-Associated Wasting/Cachexia Authorization of 12 weeks may be granted for continuation of therapy for HIV-associated wasting/cachexia when ALL of the following criteria are met: 1. Member is currently receiving the requested medication or another growth hormone product (e.g., Norditropin) indicated for HIV-associated wasting/cachexia 2. Member is diagnosed with HIV-associated wasting/cachexia 3. Member is currently on antiretroviral therapy 4. Member is currently receiving treatment with growth hormone excluding obtainment as samples or via manufacturer’s patient assistance programs 5. Current BMI is less than 27 kg/m2 (see Appendix D)
V. APPENDICES
A. Appendix A: Examples of Hypothalamic/Pituitary/CNS Disorders 1. Congenital genetic abnormalities a. Transcription factor defects (PIT-1, PROP-1, LHX3/4, HESX-1, PITX-2) b. Growth hormone releasing hormone (GHRH) receptor gene defects c. GH secretagogue receptor gene defects d. GH gene defects 2. Congenital structural abnormalities a. Optic nerve hypoplasia/septo-optic dysplasia b. Agenesis of corpus callosum c. Empty sella syndrome d. Ectopic posterior pituitary e. Pituitary aplasia/hypoplasia f. Pituitary stalk defect g. Holoprosencephaly h. Encephalocele i. Hydrocephalus j. Anencephaly or prosencephaly k. Arachnoid cyst l. Other mid-line facial defects (e.g., single central incisor, cleft lip/palate) m. Vascular malformations 3. Acquired structural abnormalities (or causes of hypothalamic/pituitary damage) a. CNS tumors/neoplasms (e.g., craniopharyngioma, glioma/astrocytoma, pituitary adenoma, germinoma) b. Cysts (Rathke cleft cyst or arachnoid cleft cyst) c. Surgery d. Radiation e. Chemotherapy f. CNS infections g. CNS infarction h. Inflammatory processes (e.g., autoimmune hypophysitis) i. Infiltrative processes (e.g., sarcoidosis, histiocytosis, hemochromatosis) j. Head trauma/traumatic brain injury k. Aneurysmal subarachnoid hemorrhage l. Perinatal or postnatal trauma m. Surgery of the pituitary or hypothalamus
C. Appendix C: Requirements for GH-Stimulation Testing in Adults 1. Testing for adult GHD is not required a. Three or more pituitary hormone deficiencies and low IGF-1 b. Congenital structural abnormalities i. Transcription factor defects (PIT-1, PROP-1, LHX3/4, HESX-1, PITX-2) ii. GHRH receptor-gene defects iii. GH-gene defects associated with brain structural defects iv. Single central incisor v. Cleft lip/palate c. Acquired causes (i.e., perinatal insults) 2. Testing for adult GHD is required a. Acquired i. Skull-base lesions ii. Pituitary adenoma iii. Craniopharyngioma iv. Rathke’s cleft cyst v. Meningioma vi. Glioma/astrocytoma vii. Neoplastic sellar and parasellar lesions viii. Chordoma ix. Hamartoma x. Lymphoma xi. Metastases xii. Other brain injury xiii. Traumatic brain injury xiv. Sports-related head trauma xv. Blast injury xvi. Infiltrative/granulomatous disease xvii. Langerhans cell histiocytosis xviii. Autoimmune hypophysitis (primary or secondary) xix. Sarcoidosis xx. Tuberculosis xxi. Amyloidosis b. Surgery to the sella, suprasellar, and parasellar region c. Cranial irradiation d. Central nervous system infections (bacteria, viruses, fungi, parasites) e. Infarction/hemorrhage (e.g., apoplexy, subarachnoid hemorrhage, ischemic stroke, snake bite) f. Empty sella g. Hydrocephalus h. Idiopathic
D. Appendix D: Calculation of BMI
Weight (pounds) x 703 Weight (kg)
BMI = ------------------------------- OR -----------------
[Height (inches)]2 [Height (m)]2
BMI classification: Underweight < 18.5 kg/m2
Normal weight 18.5 – 24.9 kg/m2
Overweight 25 – 29.9 kg/m2
Obesity (class 1) 30 – 34.9 kg/m2
Obesity (class 2) 35 – 39.9 kg/m2
Extreme obesity (class 3) ≥ 40 kg/m2
Place of Service:
Outpatient
The above policy is based on the following references:
Genotropin [package insert]. New York, NY: Pfizer Inc.; April 2019.
Humatrope [package insert]. Indianapolis, IN: Eli Lilly and Company; December 2023.
Norditropin [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; March 2020.
Nutropin AQ [package insert]. South San Francisco, CA: Genentech, Inc.; December 2016.
Omnitrope [package insert]. Princeton, NJ: Sandoz Inc.; June 2019.
Saizen [package insert]. Rockland, MA: EMD Serono Inc.; February 2020.
Zomacton [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; July 2018.
Wakeling EL, Brioude F, Lokulo-Sodipe O, et al. Diagnosis and management of Silver-Russell syndrome: first international consensus statement. Nat Rev Endocrinol. 2017;13(2):105-124.
Nemechek PM, Polsky B, Gottlieb MS. Treatment Guidelines for HIV-Associated Wasting. Mayo Clin Proc. 2000;75:386-394.
Grinspoon S, Mulligan K for the Department of Health and Human Services Working Group on the Prevention and Treatment of Wasting and Weight Loss. Weight loss and wasting in patients infected with human immunodeficiency virus. Clin Infect Dis. 2003;36(Suppl 2):S69-78.
Polsky B, Kotler D, Steinhart C. HIV-associated wasting in the HAART era: guidelines for assessment, diagnosis, and treatment. AIDS Patient Care STDS. 2001;15(8):411-23.
Parekh NR, Steiger E. Criteria for the use of recombinant human growth hormone in short bowel syndrome. Nutrition Clin Prac. 2005;20:503-508.
Congilio SJ, Stevenson RD, Rogol AD. Apparent growth hormone deficiency in children with cerebral palsy. Dev Med Child Neurol. 1996;38(9):797-804.
Shim ML, Moshang T, Oppenheim WL, et al. Is treatment with growth hormone effective in children with cerebral palsy? Dev Med Child Neurol. 2004;46(8):569-71.
Gallagher MP, Levine LS, Oberfield SE. A review of the effects of therapy on growth and bone mineralization in children with congenital adrenal hyperplasia. Growth Horm IGF Res. 2005;15 Suppl A:S26-30.
Lin-Su K, Vogiatzi MG, Marshall I, et al. Treatment with growth hormone and luteinizing hormone releasing hormone analog improves final adult height in children with congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2005;90:3318-3325.
Quintos JB, Vogiatzi MG, Harbison MD, et al. Growth hormone therapy alone or in combination with gonadotropin-releasing hormone analog therapy to improve the height deficit in children with congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2001;86(4):1511-1517.
Hardin DS, Adams-Huet B, Brown D, et al. Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial. J Clin Endocrinol Metab. 2006; 91(12):4925-9.
Hardin DS, Ellis KJ, Dyson M, et al. Growth hormone improves clinical status in prepubertal children with cystic fibrosis: Results of a randomized controlled clinical trial. J Pediatr. 2001;139:636-42.
Hardin DS, Rice J, Ahn C, et al. Growth hormone treatment enhances nutrition and growth in children with cystic fibrosis receiving enteral nutrition. J Pediatr. 2005;146:324-8.
Ranke MB, Lindberg A. Growth hormone treatment of short children born small for gestational age or with Silver-Russell syndrome: Results from KIGS (Kabi International Growth Study), including the first report on final hei Acta Paediatr Suppl. 1996;417:18-26.
Gharib H, Cook DM, Saenger PH, et al. American Association of Clinical Endocrinologists Growth Hormone Task Force. Medical guidelines for clinical practice for growth hormone use in adults and children 2003 Update. Endocr Pract. 2003;9(1):64-76.
National Institute for Clinical Excellence: Guidance on the use of human growth hormone (somatropin) for the treatment of growth failure in children. May 2010. http://www.nice.org.uk/guidance/ta88. Accessed January 13, 2024.
Wilson TA, Rose SR, Cohen P, et al. Update of Guidelines for the Use of Growth Hormone in Children: The Lawson Wilkins Pediatric Endocrinology Society Drug and Therapeutics Committee. J Pediatr. 2003;143:415-421.
Franklin SL, Geffner ME. Growth hormone: the expansion of available products and indications. Pediatr Clin North Am. 2011;58:1141-1165.
Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-I treatment in children and adolescents: growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency. Horm Res Paediatr. 2016;86:361-397.
Allen NG, Bangalore Krishna K, Lee PA. Use of gonadotropin-releasing hormone analogs in children. Curr Opin Pediatr. 2021;33(4):442-448.
Deal CL, Tony M, Hoybye C, et al. Growth Hormone Research Society workshop summary: consensus guidelines for recombinant human growth hormone therapy in Prader-Willi syndrome. J Clin Endocrinol Metab. 2013;98:E1072-E1087.
Blum WF, Crowe BJ, Quigley CA, et al. Growth hormone is effective in treatment of short stature associated with short stature homeobox-containing gene deficiency: two-year results of a randomized, controlled, multicenter trial. J Clin Endocrinol Metab. 2007;92:219-228.
Blum WF, Ross JL, Zimmermann AG, et al. GH treatment to final height produces similar height gains in patients with SHOX deficiency and Turner syndrome: results of a multicenter trial. J Clin Endocrinol Metab. 2013;98(8):E1383-92.
Cook DM, Yuen KCJ, Biller BMK, Kemp SF, Lee Vance M. 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(2):1-28.
Molitch ME, Clemmons DR, Malozowski S, et al. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96:1587-1609.
National Institute for Clinical Excellence: Human growth hormone (somatropin) in adults with growth hormone deficiency. August 2003.
Deal C, Hasselmann C, Pfaffle RW, et al. Associations between pituitary imaging abnormalities and clinical and biochemical phenotypes in children with congenital growth hormone deficiency: data from an international observational study. Horm Res Paediatr. 2013;79:283-292.
National Heart, Lung, and Blood Institute. Obesity Education Initiative: The practical guide: identification, evaluation, and treatment of overweight and obesity in adults. Bethesda, MD: US Dept of Health and Human Services, National Heart, Lung, and Blood Institute; 2000. NIH Publication No. 00-4084.
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: 1191-1232.
Butler MG, Miller JL, Forster JL. Prader-Willi syndrome – clinical genetics, diagnosis and treatment approaches: An update. Curr Pediatr Rev. 2019;15(4):207-244.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
