AETNA BETTER HEALTH Prior Authorization guideline for Growth Hormone Agents

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1 AETNA BETTER HEALTH Prior Authorization guideline for Growth Hormone Agents Growth Hormone and related agents Formulary: Omnitrope vials Non-Formulary: Genotropin, Humatrope, Saizen, Serostim, Tev-Tropin, Valtropin, Zorbtive (somatropin), Norditropin, Nutropin, Increlex (mecasermin) Authorization guidelines Omnitrope vial formulation is the preferred Growth Hormone (GH) product; consideration for an alternative product will be provided upon one of the following: A. Documentation to support trial and failure or contraindication to preferred product B. An inability or disability to use vial formation (i.e., visual impairment) C. Treatment is for an indication not supported by the preferred GH product Omnitrope is covered for members that meet the following indication specific criteria: Growth Hormone Deficiency in Children and Adolescents: Note: Provider must submit chart notes that include the following documentation: weight, height, growth velocity, and lab values (GH levels, IGF-1 / IGFBP-3), stim test results, bone age Growth Hormone will be approved for member who meets ALL of the following criteria at initiation of treatment: Endocrinologist B. Infant is less than 4 months of age and has growth hormone deficiency; C. History of neonatal hypoglycemia associated with pituitary disease; D. Diagnosis of pan hypopituitarism; E. History of irradiation, surgery or trauma to hypothalamic-pituitary area; F. A defined CNS pathology confirmed by MRI or CT; a. Note: MRI/CT should be done to exclude a brain tumor (e.g., craniopharyngioma). Patients with GHD have an abnormality of the pituitary gland (e.g., ectopic bright spot, empty or small sella) G. For diagnosis of Pediatric GH deficiency, documentation of the following: a. Member meets ONE of the following: i. Height: 1. Height is greater than 2 standard deviations (SD) below mid parental height (projected height) 2. Height is greater than 2.25 standard deviations (SD) below population 1

2 mean for age and gender ii. Growth Velocity (GV): GV is greater than 2 standard deviations (SD) below population mean for age and gender iii. Delayed skeletal maturation(delayed bone age confirmed by X-ray): 1. Bone age(ba) compared to chronological age(ca) is equal to or greater than 2 SD below mean for age and gender (e.g., delayed more than or equal to 2 years compared with chronological age) b. Member must meet ONE of following laboratory results: i. Member has undergone TWO provocative GH stimulation test (e.g., Arginine, Clonidine, Glucagon, Insulin, Levodopa, GhRh) GH response values are less than 10 mcg/l; ii. One abnormal GH test is sufficient for children with defined CNS pathology, multiple pituitary hormone deficiency (MPHD), history of irradiation, or a genetic defect affecting the GH axis; iii. Member is less than 1 year of age IGF-1 (insulin-like Growth factor) or IGFBP-3 (Insulin Growth Factor Binding Protein-3) is below the age and gender adjusted normal range as provided by the physician s lab c. Epiphyses are open (confirmation of open growth plates in patients over 12 years of age) d. Other pituitary hormone deficiencies (e.g., hypothyroidism, chronic ischemic disease) have been ruled out Prader-Willi Syndrome (PWS): Endocrinologist; B. Diagnosis of Prader-Willi Syndrome (deletion in chromosomal 15q11.2-q13 region, maternal uniparental disomy in chromosome 15, imprinting defects or translocations involving chromosome 15); C. Growth velocity: GV is greater than 2 standard deviations (SD) below population mean for age and gender; D. Epiphyses are open (confirmation of open growth plates in patients over 12 years of age) 2

3 Turner Syndrome (TS, gonadal Dysgenesis): Endocrinologist B. Diagnosis of Turner Syndrome (karyotype showing a 45, XO genotype) C. Member is Female (greater than 2 years of age) and Bone age is less than 14 years D. Growth velocity: GV is greater than 2 standard deviations (SD) below population mean for age and gender E. Epiphyses are open (confirmation of open growth plates in patients over 12 years of age) Noonan Syndrome (NS): Endocrinologist B. Diagnosis of Noon Syndrome C. Epiphyses are open (confirmation of open growth plates in patients over 12 years of age) D. Bone age(ba) compared to chronological age(ca) is equal to or greater than 2 SD below mean for age and gender (e.g., delayed more than or equal to 2 years compared with chronological age); E. Growth velocity: GV is greater than 2 standard deviation (SD) below population mean for age and gender Short stature with SHOX (short stature homeobox-containing gene) deficiency (SHOXD): Endocrinologist B. Diagnosis of pediatric growth failure with short-stature homeobox (SHOX) gene deficiency as confirmed by genetic testing C. Epiphyses are open (confirmation of open growth plates in patients over 12 years of age) D. Bone age(ba) compared to chronological age(ca) is equal to or greater than 2 SD below mean for age and gender (e.g., delayed more than or equal to 2 years compared with chronological age); E. Growth velocity: GV is greater than 2 standard deviations (SD) below population mean for age and gender Growth failure associated with Chronic Renal Insufficiency (CRI) or Chronic Kidney disease (CKD) (up to the time of renal transplantation): 3

4 Endocrinologist B. Diagnosis of pediatric growth failure due to chronic renal insufficiency (e.g., serum creatinine is less than 30 mg/dl, up to the time of renal transplant) C. Bone age(ba) compared to chronological age(ca) is equal to or greater than 2 SD below mean for age and gender (e.g., delayed more than or equal to 2 years compared with chronological age); D. Growth velocity: GV is greater than2 standard deviations (SD) below population mean for age and gender Note: Prior to initiation of GH treatment, existing metabolic derangements such as malnutrition, zinc deficiency, and secondary hyperparathyroidism should be corrected. Growth failure in Children Small for Gestational Age (SGA): Note: Provider must submit chart notes with that include the following documentation: GA, birth weight, height, and growth chart A. Member is greater than 2 years of age B. Diagnosis of SGA (fetal growth retardation), child who failed to catch up growth in first 24 months of life (by 2 years of age) or with no catch up growth using a 0-36 month growth chart and showing: a. Member is below the 3 rd percentile for gestational age (more than 2 standard deviations (SD) below population mean) for birth weight and length; b. Member s height remains below the 3 rd percentile (more than 2 standard deviations (SD) below population age and gender) Initial Approval duration: 12 months Renewal criteria for GH therapy in Children: Note: Provider must submit documentation for renewal: previous height, current height and expected adult height goal. Member must meet the following for renewal approval: A. Documentation supporting positive response to therapy: a. Height increase of at least 2.5cm/year (post-pubertal growth rate) or 4.5cm/year (prepubertal growth rate) b. Expected final height is not achieved B. Bone age is less than 16 years for males; less than 14 years for female; C. Growth (epiphyseal) plates are still open D. For children with PWS: Documentation supporting positive response to therapy (e.g., increase in total lean body mass, decrease in fat mass); above renewal requirements are met. 4

5 Renewal Approval duration: 12 months Discontinuation criteria for GH therapy in Children: A. Expected final adult height has been reached; B. Member had poor response to treatment, generally defined as an increase in growth velocity (GV) of less than 50% from baseline in the 1 st year of therapy; C. Increase in height velocity is less than 2 cm total growth in 1 year of therapy; D. Epiphyseal fusion has occurred; E. There are persistent and uncorrectable problems with adherence to treatment Transition Phase Adolescent patients A. a. Member has attained expected adult height b. Closed epiphyses on bone radiograph c. Member is at high risk of GH deficiency due to childhood-onset GHD (COGHD) from one of following: i. Hypothalamic-pituitary structural defect or tumor; ii. At least 3 deficiency of anterior pituitary hormones (e.g., FSH/LH, TSH, ACTH, Prolactin), pan hypopituitarism; iii. Genetic cause of GH B. IGF-1 (insulin-like Growth factor) is below the age and gender adjusted normal range as provided by the physician s lab C. Member has stopped growth hormone (GH) therapy for at least one month diagnosis of growth hormone deficiency (GHD) has been reconfirmed by ONE of the following: a. One low insulin-like growth factor-1 (IGF-1)/ insulin-like growth factor-binding 3 (IGFBP-3) and one growth hormone (GH) stim test with growth hormone (GH) peak value o fless than 10 mcg/ml; b. Two growth hormone (GH) stim tests with GH peak value of less than 10 mcg/ml Note: Transition Phase: Defined as period of life starting in late puberty and ending with full adult maturation ( from mid to late teenage years until 6-7 years after achievement of final height) Adolescent: is a person between ages of 10 and 19 as defined by WHO (world health organization) There is no proven benefit to continuing GH treatment in adulthood for childhood GH treatment of conditions other than GHD (e.g., Turner s syndrome) 5

6 Initial Approval duration: 12 months Renewal criteria for Transition Phase Adolescent patients: Note: Provider must submit documentation for renewal: chart notes, IGF-1 levels A. Member must meet the following for renewal approval: Documentation supporting positive response to therapy (e.g., increased in total lean body mass, increased exercise capacity or increased IGF-1 levels) Renewal Approval duration: 12 months Adult Growth Hormone Deficiency: Note: Provider must submit documentation supporting diagnosis, stim test results, IGF-1 levels. A. a. Diagnosis of childhood-onset GHD (COGHD); b. Diagnosis of adult-onset GHD (AOGHD); B. Documentation supporting hormone deficiency is due to hypothalamic-pituitary disease from organic or known causes (e.g., damage from surgery, cranial irradiation, head trauma, or subarachnoid hemorrhage); C. Member has undergone ONE provocative growth hormone (GH) stimulation tests (e.g., insulin tolerance test (ITT), Arginine+ growth hormone-releasing hormone (GHRH), glucagon, Arginine) confirming adult GH deficiency one of following peak values: a. Insulin tolerance test (ITT) is less than or equal to 5 ng/ml b. Arginine+growth hormone-releasing hormone (GHRH): less than or equal to 11 ng/ml if BMI less than 25 kg/m2; less than or equal to 8 ng/ml if BMI greater than or equal to 25 and less than 30 kg/m2; less than or equal to 4 ng/ml if BMI greater than or equal to 30 kg/m2 c. Glucagon: less than or equal to 3 ng/ml d. Arginine: less than or equal to 0.4 ng/ml Note: ITT is gold standard stimulation test agent. ITT is contraindicated with coronary artery disease, seizures, abnormal EKG with history of Ischemic heart disease or cardiovascular disease, and not appropriate for those > age 60. Others should be used when ITT is contraindicated. Glucagon has more diagnostic accuracy. Arginine alone is rarely used. If arginine is used alone, a second stimulation test may be required depending on IGF-1 levels. If the IGF-1 is subnormal with presentation of a hypothalamic disorder then one stim test is required. If the IGF-1 is normal with hypothalamic disorder then TWO stim tests are required. 6

7 D. Member has at least 3 deficiency of anterior pituitary hormones (e.g., FSH/LH, TSH, ACTH, Prolactin), pan hypopituitarism; E. IGF-1 (insulin-like Growth factor) is below the age and gender adjusted normal range as provided by the physician s lab Initial Approval duration: 12 months Renewal criteria for Adult Growth Hormone deficiency: Note: Provider must submit documentation for renewal: chart notes, IGF-1 levels Member must meet the following criteria for renewal approval: Documentation supporting positive response to therapy (e.g., increased in total lean body mass, increased exercise capacity or increased IGF-1 levels) Renewal Approval duration: 12 months HIV-associated Cachexia or Wasting: (Serostim only) Note: Provider must submit documentation of BMI, weight, and ideal body weight (IBW) (prior to initiation and after initiation of Serostim for renewals) A. Prescribed by or in consultation with an infectious Disease or HIV Specialist; B. Currently on antiretroviral therapy; C. Inadequate response, intolerable side effects or contraindication to megestrol acetate or dronabinol; D. Member has not had weight loss due to other causes (e.g., depression, mycobacterium avium complex (MAC), chronic infectious diarrhea, or malignancy with exception of Kaposi s sarcoma limited to skin or mucous membranes); E. Body mass index (BMI) less than 20 kg/m2 prior to initiating therapy with Serostim; F. Unintentional weight loss of more than 10% (>10%) over last 12 months or more than 5% (>5%) over the last 6 months; G. Member weights less than 90% of the lower limit of ideal body weight (IBW) Initial approval duration: 3 months Renewal criteria Member must meet the following for renewal approval: A. Documentation supporting positive response to therapy (BMI has improved or stabilized) B. Currently on antiretroviral therapy Renewal Approval duration: 9 months (Maximum total: 48 weeks) Short Bowel Syndrome: (Zorbtive only) Member must meet the following for approval: 7

8 A. Diagnosis of Short Bowel syndrome; B. Member is 18 years or older C. Patient is currently receiving specialized nutrition support (e.g., IV parenteral nutrition, fluid, and micronutrient supplements) ; D. Member has not previously received 4 weeks of treatment with Zorbtive Initial Approval: 4 weeks. Note that treatment with Zorbtive will not be approved beyond 4 weeks as administration for more than 4 weeks has not been adequately studied. Additional Information: Growth Hormone is NOT covered for members with the following criteria: A. Amyotrophic lateral sclerosis B. Anabolic therapy to enhance body mass or strength for professional, recreational or social reasons C. Anti-aging D. Burn injuries E. Chronic catabolic states, including inflammatory bowel disease, pharmacologic glucocorticoid administration, and respiratory failure F. Constitutional delay of growth and development G. Idiopathic Short Stature (ISS)* H. Insulin-like growth factor-i (IGF-1) deficiency (also known as neurosecretory defect)russell-silver syndrome (that does not result in small for gestational age) I. Stem Cell mobilization J. Traumatic brain injury K. Wound healing Medically Necessary A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Determination of Medical Necessity for covered care and services, whether made on a Prior Authorization, Concurrent Review, Retrospective Review, or exception basis, must be documented in writing. 8

9 The determination is based on medical information provided by the Member, the Member s family/caretaker and the Primary Care Practitioner, as well as any other Providers, programs, agencies that have evaluated the Member. All such determinations must be made by qualified and trained Health Care Providers. A Health Care Provider who makes such determinations of Medical Necessity is not considered to be providing a health care service under this Agreement. References: 1. Cook D, Yuen K, Biller B et al. American Association of Clinical Endocrinologist Medical Guidelines for Clinical Practice for Growth Hormone use in Growth Hormone Deficient Adults and Transition Patients 2009 Update. Endocrine Practice, 2009; 15(Suppl 2): Accessed online Aug Gharib H, Cook DM, et.al. American association of clinical endocrinologists medical guidelines for clinical practice for growth hormone use in adults and children update. Endocrine Practice, 2003; 9(1): Richmond EJ, Rogol AD. Diagnosis of growth hormone deficiency in children. UpToDate www. uptodate.com. Accessed on 08/ Snyder, P. Growth hormone deficiency in adults. UpToDate. Accessed on 08/ Mandy, G. Small for gestational age infant. UpToDate. Accessed on 08/ Gold Standard, Inc. Norditropin. Clinical pharmacology [database online] Available at Accessed April Norditropin [Prescribing Information]. Bagsvaerd, Denmar: Novo Nordisk; Feb Accesses April 8, Nutropin [Prescribing Information]. San Francisco, CA: Genentech; Dec Accessed April 8, Saizen [Prescribing Information]. Rockland, MA: EMD Serono Inc.; Dec Accessed April 8, Serostim [Prescribing Information]. Rockland, MA: EMD Serono Inc.;Dec Accessed April 8, Zorbtive[Prescribing Information]. Rockland, MA: EMD Serono Inc.; May Accessed April 8, Omnitrope [Prescribing Information]. Princeton, NJ: Sandoz, Inc.; Dec Accessed April 8, Humatrope [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC;Dec Accessed April 8, Genotropin [Prescribing Information]. Belgium N.V., Puurs, Belgium: Pfizer Manufacturing; Dec Accessed April 8, Zomacton [Prescribing Information]. Parsippany, NJ: Ferring Pharmaceuticals; Jan Accessed April 8, Molitch M, Clemmons DR, Malozowski S et al.; The Endocrine Society s Guideline. Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline. Clin Endocrinol Metab. 2006; 91(5): Wilson T, Rose S, Cohenp et al.; Update of Guidelines for the use of Growth Hormone in Children: The Lawson Wilkins Pediatric Endocrinology Society Drug and Therapeutics Committee. Journal of Pediatrics, Accessed online Aug Gold Standard, Inc. Zomacton. Clinical pharmacology [database online] Available at Accessed Sep, Rose SR, Cook DM, Fine MJ. Growth Hohmone therapy guidelines: Clinical and managed care perspectives. Am J Pharm Benefits. 2014;6(5):e134-e146. Accessed online April Talge NM, Mudd LM, Sikorskii A, Basso O. United States birtb weight reference corrected for implausible gestational age estimates. Pediatrics 2014; 133; 844 9

10 853. DOI: /peds Barstow C, Rerucha C. Evaluation of short and tall stature in children. Am Fam Physician Jul 1;92(1):