Aetna Better Health 2000 Market Street, Suite 850 Philadelphia, PA 19103 AETNA BETTER HEALTH Non-Formulary Prior Authorization guideline for Growth Hormone and related agents Revised April 2014 Growth Hormone and related agents Formulary: Norditropin, Nutropin, Non-Formulary - Genotropin, Humatrope, Omnitrope,Saizen, Serostim, Tev-Tropin, Valtropin, Zorbtive (somatropin), Increlex,(mecasermin), Authorization guidelines For patients who have the following: 1. Not used for idiopathic short stature (considered cosmetic use and not medically necessary) 2. No evidence of diabetic retinopathy (proliferative and non proliferative) per medical records 3. No evidence of active malignant conditions per medical records 4. No evidence of acute critical illness per medical records 5. No hypersensitivity to any of the product components. 6. Not used for growth promotion in pediatric patients with epiphyseal closure (linear growth can no longer occur. i.e., bone age>14 yrs old) The potential for achieving additional growth after Tanner 4-5 (full maturity) is small as this correlates with epiphyeseal closure. Growth Hormone Deficiency (GHD) - Neonates/Infants: 1. Random GH level <20ng/ml (by RIA test). 2. Abnormal IGFBP-3 (in infants) 3. Other causes have been ruled out or treated (hypothyroidism, metabolic disorders)
Diagnosis GHD If GHD is attributed to an intracranial tumor, absence of tumor growth or recurrence should be documented for 6-12 months before initiation of GH. Note In 2009, FDA has restricted use of Iplex to current patients receiving therapy. Iplex is unavailable for new patients. Turner Syndrome (TS), Prader-Willi Syndrome, SHOX deficiency, or Noonan Syndrome Chronic Renal Insufficiency (CRI) Small for Gestational Age (SGA) with failure to catchup by 2-4 years of age IGF-1 Deficiency (Increlex only) Required documentation Recent (within the last 3 months) height and weight and pretreatment growth velocity (Note: most patients will have short stature: height <5 th percentile for age and sex) Other factors contributing to growth failure have been ruled out, or are being treated (e.g., hypothyroidism normal TSH, T4) For members Tanner Stage 3 or, 14 years old - Recent bone age to support open epiphyses so linear growth can occur (i.e., bone age <14 years of age Fasting Growth Hormone Stimulation test with arginine, clonidine, glucagon, insulin or levodopa: Peak <10 ng/ml (by RIA), or Peak <5 ng/ml (by IRMA) 1 agent with peak level required if cause is known: o Structural or developmental abnormalities: anencephaly, pituitary aplasia o Genetic disorders: e.g., PROP1 and PIT1 mutations, septo-optic dysplasia o Acquired causes: e.g., craniopharyngeomas*, cranial irradiation, brain surgery, head trauma, CNS infections 2 agents with peak levels required if cause is unknown (idiopathic). Documentation to support the diagnosis (e.g., Turner Syndrome confirmed by karyotype studies) Recent (within the last 3 months) height <5th percentile of the normal growth curve for age and sex, weight, and pretreatment growth velocity For members Tanner Stage 3 or, 14 years old. Recent bone age to support open epiphyses so linear growth can occur (i.e., bone age <14 years of age) Documentation to support the diagnosis of CRI prior to renal transplant Documentation to support correction of existing metabolic abnormalities For members Tanner Stage 3 or, 14 years old, recent bone age to support open epiphyses so linear growth can occur (i.e., bone age <14 years of age) Recent height and weight (within the last 3 months) and pretreatment growth velocity (Note: patients may not have short stature) At least 2 years of age Documented Birth weight or length <3rd percentile for gestational age, or Birth weight <2500 grams at a gestational age of more than 37 weeks Recent (within the last 3 months) height <5th percentile of the normal growth curve for age, weight, and pretreatment growth velocity Recent bone age to support open epiphyses so linear growth can occur (i.e., bone age <14 years of age) 2 years of age (Increlex), No evidence of epiphyseal closure No hypersensitivity to mecasermin or benzyl alcohol (Increlex only) No evidence of neoplastic disease Documentation supports a diagnosis of severe primary IGF-1 deficiency (other causes of low IGF-1 have been ruled out) height standard deviation score less than or equal to 3 basal IGF-1 standard deviation score less than or equal to 3 2
Pediatric patients: HIVassociated failure to thrive (Serostim): (off label) normal or elevated growth hormone levels OR Documentation supports diagnosis of GH gene deletion and development of neutralizing antibodies to GH Height, weight, IBW, usual weight Progressive weight loss below IBW (or usual body weight if usual weight <IBW) over the last year Dietary consult and dietary modifications over the past 3 months with documented adequate caloric intake Metabolic panel to r/o volume depletion- look for a BUN/creatinine ratio of < 20:1 Authorization and Limitations Initial Approval: Pediatric Growth Failure Indications: 6 months (document baseline information) Pediatric HIV-associated failure to thrive (Serostim): 3 months (document baseline height, weight, IBW, usual weight) IGF-1 Deficiency: 6 months Adult GHD: 6 months (document baseline IGF-I, GH test results, dose) Adults with wasting due to HIV or AIDS (Serostim): 3 months (document height, weight, IBW, usual weight) Extended Approval: Pediatric Growth Failure Indications - Continue 6 month renewals if: Final height has not been achieved Epiphyses are open, so linear growth is possible Growth velocity is >5cm/year on current dose, or growth velocity is <5cm/year but dose has been increased. Note: Growth velocity will typically decrease as final height is approached (growth velocity <2 cm/year). Review of the pharmacy claims history supports compliance Pediatric HIV-associated failure to thrive (Serostim) - Reauthorize for 12 weeks (maximum 48 weeks total) if: Documentation supports clinical response and weight gain IGF-1 Deficiency: 6 months if at least doubling of pretreatment growth velocity 1 year if growth velocity 2.5 cm/yr and epiphyses are open Adults with GHD - Reauthorize for 1 year if: Dose has been adjusted to target serum IGF-1 at the middle for the age-and sexappropriate reference range quoted by the laboratory used Reauthorize for 6 months if: IGF-I is low but dose is being increased Adults with wasting due to HIV or AIDS (Serostim) - Reauthorize for 12 weeks (maximum 48 weeks total) if: Documentation supports clinical response and weight gain 3
PROCUREMENT Specialty pharmacy source: CVS Specialty Pharmacy Contact: CVS Specialty Pharmacy toll free number: 1-866-638-1232 CVS Specialty Pharmacy fax number: 1-866-207-7231 Additional Information: Growth Hormone and related agents are NOT covered for members with the following criteria: Use not approved by the FDA; AND The use is unapproved and not supported by the literature or evidence as an accepted off-label use. 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. 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. National Institute for Health and Clinical Excellence (NICE). Human growth hormone (somatropin) for the treatment of growth failure in children. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. 49 p. (Technology appraisal guidance; no. 188). 2. Clinical Pharmacology online: http://www.clinicalpharmacology-ip.com 3. Facts and Comparisons online: http://online.factsandcomparisons.com 4
4. American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in adults and children--2003 update. Endocr Pract. 2003;9:65-76. 5. American Association of Clinical Endocrinologists. 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):1-27. Accessed at http://alt.aace.com/pub/pdf/guidelines/growthhormoneguidelines.pdf on 4/18/11 6. Hintz RL. 2000 Consensus guidelines for the diagnosis and treatment of growth hormone deficiency in childhood and adolescence: summary statement of the Growth Hormone Research Society on child and adolescent growth hormone deficiency. J Clin Endocrinol Metab 2000;85:3990-3993. Copyright Aetna Inc. All rights reserved. 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.cpt only copyright 2008 American Medical Association. All Rights Reserved. 5