HUMAN GROWTH HORMONE GENOTROPIN

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1 Drug Prior Authorization Guideline HUMAN GROWTH HORMONE GENOTROPIN (somatropin) PA9728 Covered Service: Yes when meets criteria below Prior Authorization Required: Yes Additional Information: Medicare Policy: BadgerCare Plus Policy: GENOTROPIN is the preferred human growth hormone (somatropin). Prescribed by (or in consultation with) endocrinology, gastroenterology, nephrology, trauma/burn, or infectious disease specialists with prior authorization through Navitus. Prior authorization is dependent on the member s Medicare coverage. Prior authorization is not required for Medicare Cost products (Dean Care Gold) and Medicare Supplement (Select) when this drug is provided by participating providers. Prior authorization is required if a member has Medicare primary and Dean Health Plan secondary coverage. This policy is not applicable to our Medicare Replacement product (Dean Advantage). Dean Health Plan covers this benefit when BadgerCare Plus also covers the benefit. Please refer to Forward Health: Dean Health Plan Approved Criteria: 1.0 ADULT - Growth Hormone Deficiency (GHD): 1.1 Presence of pituitary disease or condition affecting pituitary function, such as pituitary tumor, surgical damage, hypothalamic disease, irradiation or trauma, OR 1.2 Continuing treatment of childhood onset GHD AND 1.3 Two growth hormone (GH) stimulation tests <5 ng/ml (mcg/l), OR 1.4 Two pituitary hormone deficiencies (other than growth hormone) requiring hormone replacement, such as TSH, ACTH, Gonadotropins and ADH AND one growth hormone stimulation test less than 5 ng/ml, OR 1 of 5

2 1.5 Three pituitary hormone deficiencies (other than growth hormone) requiring hormone replacement AND IGF-1 level below 80 ng/ml 2.0 ADULT - Short Bowel Syndrome (Maximum 4 week coverage, not eligible for renewal) 2.1 Patient is > 18 years of age, AND 2.2 Inability to ingest solid food, AND 2.3 Dependent on parenteral nutrition at least five days per week to provide at least 3,000 calories per week 3.0 ADULT - AIDS-related Wasting 3.1 Involuntary weight loss of greater than 10% of pre-illness baseline body weight or body mass index (BMI) less than 20 kg/m 2, AND 3.2 Absence of concurrent illness or medical condition other than HIV infection that would explain weight loss, AND 3.3 Failure or intolerance of appetite-stimulating steroids (e.g. MEGACE) 4.0 PEDIATRIC - Growth Hormone Deficiency (GHD) 4.1 Two growth hormone (GH) stimulation tests < 10ng/mL (mcg/l), OR 4.2 One GH stimulation test < 15ng/mL AND IGF-I and IGF-BP3 levels below normal (<2.5 th percentile) as determined by the laboratory reference range for age, OR 4.3 One GH stimulation test < 10ng/mL for child with defined CNS pathology, history of irradiation or genetic conditions associated with GHD, OR 4.4 Multiple pituitary hormone deficiencies exist (at least two other in addition to the GHD) AND 4.5 Open growth plates; when prescribed to promote growth and increase height, AND 4.6 Height is less than 3rd percentile (-1.88 SD) OR one-year growth velocity is less than 3 rd percentile (-1.88 SD) as specified for age and sex 5.0 PEDIATRIC - Turner s, Noonan s or SHOX Syndrome 5.1 Open growth plates, AND 5.2 Height is less than the 5th percentile (-1.65 SD) OR projected height is less than 3rd percentile as specified for age and sex 6.0 PEDIATRIC - Chronic Renal Insufficiency (CRI) before transplantation 6.1 Open growth plates, AND 6.2 Height is less than the 3rd percentile (-1.88 SD) OR one-year growth velocity is less than 3 rd percentile (-1.88 SD) as specified for age and sex 7.0 PEDIATRIC - Prader-Willi Syndrome (PWS) 2 of 5

3 7.1 Diagnosis of PWS confirmed through genetic testing, AND 7.2 Open growth plates 8.0 PEDIATRIC - Small for gestational age 8.1 Birth weight and/or length were more than 2 standard deviations (SD) below the mean for gestational age, and failed to show catch-up growth by age 2, AND 8.2 Height is less than the 3rd percentile (>1.88 SD) specified for age and sex 9.0 PEDIATRIC Burn Patients 9.1 Maximum 1 year coverage, not eligible for renewal 9.2 Third-degree burns and/or burn cover more than 40% of body surface area Comment(s): 1.0 For adults, restricted to (or in consultation with) Endocrinologists, Gastroenterologists, or Infectious Disease with prior authorization through Navitus. 2.0 For pediatrics, restricted to (or in consultation with) Pediatric Endocrinologists or Nephrologists or Pediatric Trauma / Burn specialists with prior authorization through Navitus. 3.0 Specialty pharmacy required 4.0 This drug is limited to thirty (30) day supply 5.0 CONTINUATION COVERAGE for ADULT Growth Hormone (GH) Therapy 5.1 Original documentation confirmed a diagnosis of GH deficiency, AND 5.2 Medication adherence is adequate 6.0 CONTINUATION COVERAGE for PEDIACTRIC Growth Hormone (GH) Therapy 6.1 Annual growth velocity is >4.5 cm/yr in a pre-pubertal child or >2.5 cm/yr in a postpubertal child, AND 6.2 Expected final adult height has not been achieved, AND 6.3 Epiphyses have not closed. Epiphyseal closure defined as bone age of 16 years in male or 14 years in females, AND 6.4 Medication adherence is adequate, AND 6.5 For the first year of therapy only; increase in growth velocity is > 50 percent, AND 6.6 For patients with Prader-Willi Syndrome only; if prescribed GH to improve body composition: body composition (lean body mass) has significantly improved 7.0 NOTE: The use of physician samples or manufacturer discounts does not guarantee later coverage under the provisions of the medical certificate and/or 3 of 5

4 pharmacy benefit. All criteria must be met in order to obtain coverage of the listed drug product. Pharmacy & Therapeutics Committee Date(s) Initial Approval: Prior to 1991 Revised: March 17, 2000 March 16, 2001 November 15, 2002 March 21, 2003 July 25, 2003 March 19, 2004 Reviewed: November 8, 1996 March 14, 1997 March 20, 1998 March 19, 1999 September 17, 1999 March 15, 2002 Revised: Committee/Source Utilization Management Committee/Medical Affairs/ Navitus P&T Medical Director Committee/Medical Affairs Medical Director Committee/Quality and Care Management Division/Pharmacist Date(s) February 9, 2005 May 16, 2012 December 16, 2015 September 20, 2017 Reviewed: Utilization Management Committee/Medical Affairs/ Dean Endocrinology Utilization Management Committee/Medical Affairs/ PBM Utilization Management Committee/Medical Affairs Utilization Management Committee/Medical Affairs/Pharmacy Practice Leader December 14, 2005 February 8, 2006 December 10, 2008 December 28, of 5

5 Committee/Source Date(s) Reviewed: Medical Director Committee/Medical Affairs Medical Director Committee/Medical Affairs/Pharmacist Medical Director Committee/Medical Affairs/ Pharmacist Medical Director Committee/Quality and Care Management Division/Pharmacist May 16, 2012 December 18, 2013 November 19, 2014 December 16, 2015 September 20, 2017 Effective: 10/01/2017 Published: 10/01/ of 5

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