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Prior Authorization Protocol

GENOTROPINR, HUMATROPER, NUTROPINR, NORDITROPINR, OMNITROPER, SAIZENR, TEV-TROPINR, ZORBTIVETM (somatropin, human growth hormone)



HNMC

Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    Genotropin
    • Pediatric Patients: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature
    • Adult Patients: Treatment of adults with either adult onset or childhood onset GHD
    Humatrope
    • Pediatric Patients Treatment of children with short stature or growth failure associated with growth hormone (GH) deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, and failure to catch up in height after small for gestational age birth.
    • Adult Patients Treatment of adults with either childhood-onset or adult-onset GH deficiency
    Nutropin/ Nutropin AQ
    • Pediatric Patients: For the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.
    • For the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation.
    • For the long-term treatment of short stature associated with Turner syndrome.
    • For the long-term treatment of idiopathic short stature, also called non-growth hormone-deficient short stature, defined by height SDS < -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.
    • Adult Patients: For the replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: Adult Onset: Patients who have adult growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
    Norditropin
    • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), short stature associated with Noonan syndrome, short stature associated with Turner syndrome and short stature born SGA with no catch-up growth by age 2 to 4 years
    • Adult: Treatment of adults with either adult onset or childhood onset GHD
    Omnitrope
    • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature
    • Adult: Treatment of adults with either adult onset or childhood onset GHD
    Saizen
    • Pediatric: For the treatment of children with growth failure due to growth hormone deficiency (GHD).
    • Adults: Treatment of adults with either adult onset or childhood onset GHD

    Tev-Tropin

    • For the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
    Zorbtive
    • For the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support. ZorbtiveTM therapy should be used in conjunction with optimal management of Short Bowel Syndrome.
  2. Health Net Approved Indications and Usage Guidelines:
    CHILDREN
    • Failure or clinically significant adverse effects to Humatrope and Norditropin if requesting non-preferred products
    AND
    • Children and adolescents with growth hormone deficiency
    OR
    • Children and adolescents with Idiopathic Short Stature
    OR
    • SHOX (short stature homeobox-containing gene) deficiency in children
      • Shoxdna DxR genetic test that detects mutations and deletions in the SHOX gene

    OR

    • Chronic renal failure in pre-transplantation children
    OR
    • Prader-Willi syndrome, Turner syndrome, Noonan syndrome
    OR
    • Therapy of infantile hypoglycemia
    OR
    • Central nervous system tumor treated with radiation
    OR
    • Small for Gestational Age

    For continuation of use for the above indications, any of the following:

      • Increased growth rate by two cm over baseline in first year or one cm over baseline in 6 months for those patients undergoing a 6-month trial.
      • Continued growth rate exceeds 2.5 cm/year
      • For treatment of growth hormone deficiency, child's height remains below median adult height (5'10" for males, 5'5" for females) and mid-paternal height
      • For non-growth hormone deficiency treatment, the child's height continues to be > 2.25 standard deviations below the normal adult height for gender (5' 3" for a male and 4' 11" for a female).
    ADULTS
    • Failure or clinically significant adverse effects to Humatrope and Norditropin if requesting non-preferred products
    AND
    • Adult growth hormone deficiency
    o If a patient has multiple pituitary hormone deficiencies resulting from structural hypothalamic/pituitary disease, radiation, defined CNS pathology, cranial radiation, trauma, pituitary surgery, or genetic defect affecting the GH axis with low IGF-1 and low IGFBP-3, growth hormone can be approved.
    OR
    • Short-Bowel Syndrome


  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Preferred

    • Humatrope
    • Norditropin

    Non Preferred

    • Nutropin/AQ
    • Saizen
    • Genotropin
    • Tev-Tropin
    • Omnitrope
    • Zorbtive
    Children and Adolescents:
    • 0.15 to 0.3 mg/kg/wk SC for growth hormone deficiency
    • Up to 0.35 mg/kg/wk SC for Turner syndrome, Prader- Willi syndrome, Noonan syndrome, renal insufficiency
    • Up to 0.48 mg/kg/wk SC for idiopathic growth failure and SGA

    Adult:

    • 0.01 to 0.04 mg/kg/wk SC
    • Maximum dose up to 0.08 mg/kg/wk
    HNMC: 6 months

    Short Bowel
    • 4 weeks not renewable
  7. Product Availability:
    Genotropin: Cartridge 5, 12 mg; Syringe 0.2 to 2 mg in 0.2 mg increments
    Humatrope: Cartridge 6, 12, 24 mg; Vial 5mg
    Norditropin: Cartridge 5, 10, 15, 30 mg; Pen 5,10, 15 mg
    Nutropin: Vial 5,10 mg
    Nutropin AQ: Cartridge 10, 20 mg; Vial 10 mg; NuSpin 5, 10, 20 mg
    Omnitrope: Cartridge 5, 10 mg; Vial 5.8 mg
    Saizen: Vial 5, 8.8 mg; Cartridge 8.8 mg
    Tev-Tropin: Vial 5 mg
    Zorbtive: Vial 8.8 mg
  8. References:
    1. Attanasio AF, Bates PC, Ho KK, et al.The Hypopituitary Control and Complications Study International Advisory Board. Human growth hormone replacement in adult hypopituitary patients: long-term effects on body composition and lipid status--3-year results from the HypoCCS Database. J Clin Endocrinol & Metab. 87(4):1600-6,2002.
    2. Low-dose GH replacement improves the adverse lipid profile associated with the adult GH deficiency syndrome. Clin Endocrinol. 56(4):525-32, 2002
    3. Gillberg P, Bramnert M, Thoren M, et al. Commencing growth hormone replacement in adults with a fixed low-dose. Effects on serum lipoproteins, glucose metabolism, body composition, and cardiovascular function. Growth Hormone & Igf Research. 2001;11(5):273-81.
    4. Vahl N, Juul A, Jorgensen JO, et al. Continuation of growth hormone (GH) replacement in GH-deficient patients during transition from childhood to adulthood: a two-year placebo-controlled study. J Clin Endocrinol & Metab. 85(5):1874-81,2000.
    5. Lucidi P, Parlanti N, Piccioni F, et al. Short-term treatment with low doses of recombinant human GH stimulates lipolysis in visceral obese men. J Clin Endocrinol & Metab. 87(7):3105-9,2002.
    6. Smith JC, Evans LM, Wilkinson I, et al. Effects of GH replacement on endothelial function and large artery stiffness in GH-deficient adults: a randomized, double blind, placebo-controlled study. Clin Endocrinol. 56(4):493-501, 2002.
    7. Hana V. Prazny M. Marek J. Skrha J. Justova V. Reduced microvascular perfusion and reactivity in adult GH deficient patients is restored by GH replacement. Eur J Endocrinol.2002;147(3):333-337.
    8. Murray RD, Wieringa GE, Lissett CA, et al. Reduced capillary permeability and capillary density in the skin of GH-deficient adults: improvement after 12 months GH replacement. Clin Endocrinol. 2002; 56(4):519-24.
    9. Napoli R, Guardasole V, Matarazzo M, et al. Growth hormone corrects vascular dysfunction in patients with chronic heart failure. J Am Coll of Cardiology. 2002;39(1):90-95.
    10. Ezzat S, Fear S, Gaillard RC, et al. Gender-specific responses of lean body composition and non-gender-specific cardiac function improvement after GH replacement in GH-deficient adults. J Clin Endocrinol & Metab. 2002;87(6):2725-2733.
    11. Anker SD, Volterrani M, Pflaum CD, et al. Acquired growth hormone resistance in patients with chronic heart failure: implications for therapy with growth hormone. J Am Coll of Cardiology. 2001;38(2):443-52.
    12. Sneppen SB, Hoeck HC, Kollerup G, et al. Bone mineral content and bone metabolism during physiological GH treatment in GH-deficient adults--an 18-month randomized, placebo-controlled, double blinded trial. Eur J Endocrinol. 2002;146(2):187-95.
    13. Nilsson AG. Effects of growth hormone replacement therapy on bone markers and bone mineral density in growth hormone-deficient adults. Hormone Research. 2000;54 Suppl 1:52-57.
    14. Sugimoto T, Kaji H, Nakaoka D, et al. Effect of low-dose of recombinant human growth hormone on bone metabolism in elderly women with osteoporosis. Eur J Endocrinol. 2002;147(3):339-48.
    15. Biermasz NR. Hamdy NA. Janssen YJ. Roelfsema F. Additional beneficial effects of
    alendronate in growth hormone (GH)-deficient adults with osteoporosis receiving long-term
    recombinant human GH replacement therapy: a randomized controlled trial. J Clin Endocrinol & Metab. 2001;86(7):3079-3085.
    16. Sas TC, de Muinck Keizer-Schrama SM, Stijnen T, et al. Dutch Advisory Group on Growth Hormone. Bone mineral density assessed by phalangeal radiographic absorptiometry before and during long-term growth hormone treatment in girls with Turner's syndrome participating in a randomized dose-response study. Pediatric Research. 2001;50(3):417-22.
    17. Gilchrist FJ. Murray RD. Shalet SM. The effect of long-term untreated growth hormone deficiency (GHD) and 9 years of GH replacement on the quality of life (QOL) of GH-deficient adults. Clin Endocrinol. 2002;57(3):363-370.
    18. Drake WM, Howell SJ, Monson JP, et al. A prospective investigation of quality of life and psychological well-being after the discontinuation of GH treatment in adolescent patients who had GH deficiency during childhood. J Clin Endocrinol & Metab. 2001;86(8):3494-3498.
    19. Cominelli S, Raguso CA, Karsegard L, et al. Weight-losing HIV-infected patients on recombinant human growth hormone for 12 wk: a national study. Nutrition. 2002;18(7-8):583-586.
    20. Schwarz JM, Mulligan K, Lee J, et al. Effects of recombinant human growth hormone on hepatic lipid and carbohydrate metabolism in HIV-infected patients with fat accumulation. J Clin Endocrinol & Metab. 2002;87(2):942.
    21. Lo JC, Mulligan K, Noor MA, et al. The effects of recombinant human growth hormone on body composition and glucose metabolism in HIV-infected patients with fat accumulation. J Clin Endocrinol & Metab. 2001;86(8):3480-3487.
    22. Napolitano LA, Lo JC, Gotway MB, et al. Increased thymic mass and circulating naive CD4 T cells in HIV-1-infected adults treated with growth hormone. AIDS. 2002;16(8):1103-1111.
    23. Kotzmann H, Yilmaz N, Lercher P, et al. Differential effects of growth hormone therapy in malnourished hemodialysis patients. Kidney International. 2001;60(4):1578-1585.
    24. Mehls O. Haas S. Effects of recombinant human growth hormone in catabolic adults with chronic renal failure. Growth Hormone & Igf Research. 2000;10 Suppl B:S31-37.
    25. Losada F, Garcia-Luna PP, Gomez-Cia T, et al. Effects of human recombinant growth hormone on donor-site healing in burned adults. World J Surg. 2002;26:1:2-8.
    26. Slonim AE, Bulone L, Damore MB, et al. A preliminary study of growth hormone therapy for Crohn's disease. N Engl J Med. 2000;342(22):1633-1637.
    27. Wallace JD, Abbott-Johnson WJ, Crawford DH, et al. GH treatment in adults with chronic liver disease: a randomized, double blind, placebo-controlled, crossover study. J Clin Endocrinol & Metab. 2002;87(6):2751-2759.
    28. Sohmiya M. Kato Y. Effect of long-term treatment with recombinant human growth hormone on erythropoietin secretion in an anemic patient with panhypopituitarism. J Endocrinological Investigation. 2000;23(1):31-36.
    29. Henwood MJ. Grimberg A. Moshang T Jr. Expanded spectrum of recombinant human growth hormone therapy. Current Opinion in Pediatrics. 2002;14(4):437-442.
    30. Bercu BB, Murray FT, Frasier SD, et al. Long-term therapy with recombinant human growth hormone (Saizen) in children with idiopathic and organic growth hormone deficiency. Endocrine J. 2001;15(1):43-49.
    31. Johnston DI, Betts P, Dunger D, et al. A multicentre trial of recombinant growth hormone and low dose oestrogen in Turner syndrome: near final height analysis. Arch of Disease in Childhood. 2001; 84(1):76-81.
    32. Bramswig JH. Long-term results of growth hormone therapy in Turner syndrome. Endocrine J. 2001;15(1):5-13.
    33. Carrel AL. Myers SE. Whitman BY. Allen DB. Sustained benefits of growth hormone on body composition, fat utilization, physical strength and agility, and growth in Prader-Willi syndrome are dose-dependent. J Pediatric Endocrinol. 2001;14(8):1097-1105.
    34. l'Allemand D, Eiholzer U, Schlumpf M, et al. Cardiovascular risk factors improve during 3 years of growth hormone therapy in Prader-Willi syndrome. Eur J Pediatrics. 2000;159(11):835-842.
    35. Whitman BY. Myers S. Carrel A. Allen D. The behavioral impact of growth hormone treatment for children and adolescents with Prader-Willi syndrome: a 2-year, controlled study. Pediatrics. 2002;109(2):E35.
    36. Humatrope.[Prescribing information], Eli Lilly, Indianapolis, IN, August 2011.
    37. de Zegher F, Albertsson-Wikland K, Wollmann HA, et al. Growth hormone treatment of short children born small for gestational age: growth responses with continuous and discontinuous regimens over 6 years. J Clin Endocrinol & Metab. 2000;85(8):2816-21.
    38. de Zegher F, Ong K, van Helvoirt M, et al. High-dose growth hormone (GH) treatment in non-GH-deficient children born small for gestational age induces growth responses related to pretreatment GH secretion and associated with a reversible decrease in insulin sensitivity. J Clin Endocrinol & Metabol. 2002;87(1):148-151.
    39. Haffner D, Schaefer F, Nissel R, et al. Effect of growth hormone treatment on the adult height of children with chronic renal failure. German Study Group for Growth Hormone Treatment in Chronic Renal Failure. N Engl J Med. 2000;343(13):923-930.
    40. Czernichow P. Treatment with growth hormone in short children born with intrauterine growth retardation. Endocrine J. 2001;15(1):39-42.
    41. Zucchini S, Cacciari E, Balsamo A, et al. Final height of short subjects of low birth weight with and without growth hormone treatment. Arch of Disease in Childhood. 2001;84(4):340-343.
    42. Henwood MJ. Grimberg A. Moshang T Jr. Expanded spectrum of recombinant human growth hormone therapy. Curr Opin in Pediatrics. 2002;14(4):437-442.
    43. Kelnar CJ. Growth hormone therapy in Noonan syndrome. Hormone Research. 2000;53 Suppl 1:77-81.
    44. Aili Low JF, Barrow RE, Mittendorfer B, et al. The effect of short-term growth hormone treatment on growth and energy expenditure in burned children. Burns. 2001;27(5):447-452.
    45. Aili Low JF. Effect of growth hormone on growth delay in burned children: a 3-year follow-up study. Lancet. 1999.
    46. Henker J. Effect of growth hormone therapy in patients with Crohn's disease. J Pediatric Gastroenterol & Nutrition. 2002;34(4):424-425.
    47. Simon D, Lucidarme N, Prieur AM, et al. Linear growth in children suffering from juvenile idiopathic arthritis requiring steroid therapy: natural history and effects of growth hormone treatment on linear growth. J Pediatric Endocrinol. 2001;14 Suppl 6:1483-1486.
    48. Bechtold S, Ripperger P, Muhlbayer D, et al. GH therapy in juvenile chronic arthritis: results of a two-year controlled study on growth and bone. J Clin Endocrinol & Metab. 2001;86(12):5737-5744.
    49. Al-Mutair A. Bahabri S. Al-Mayouf S. Al-Ashwal A. Efficacy of recombinant human growth hormone in children with juvenile rheumatoid arthritis and growth failure. J Pediatric Endocrinol. 2000;13(7):899-905.
    50. Hutler M, Schnabel D, Staab D, et al. Effect of growth hormone on exercise tolerance in children with cystic fibrosis. Medicine & Science in Sports & Exercise. 2002;34(4):567-572.
    51. Hardin DS, Ellis KJ, Dyson M, et al. Growth hormone improves clinical status in prepubertal children with cystic fibrosis: results of a randomized controlled trial. J Pediatrics. 2001;139(5):636-642.
    52. Kanaka-Gantenbein C. Present status of the use of growth hormone in short children with bone diseases (diseases of the skeleton). J Pediatric Endocrinol. 2001;14(1):17-26.
    53. Rodeck B, Kardorff R, Melter M, Ehrich JH. Improvement of growth after growth hormone treatment in children who undergo liver transplantation. J Pediatric Gastroenterol & Nutrition. 2000;31(3):286-290.
    54. Frank GR. Smith RE. Effective growth hormone therapy in a growth hormone deficient patient with Duchenne muscular dystrophy without evidence of acceleration of the dystrophic process. J Pediatric Endocrinol. 2001;14(2):211-214.
    55. Clayton PE. Cowell CT. Safety issues in children and adolescents during growth hormone therapy--a review. Growth Hormone & Igf Research. 2000;10(6):306-317.
    56. Zorbtive.Prescribing information. Rockland, MA EMD Serono, January 2012
    57. Jensen SS. Effects of growth hormone administration in human obesity. Obesity Research. 2003;11:2:170-175.
    58. Svensson J, Stibrant Sunnerhagen K, Johannsson G. Five years of growth hormone replacement therapy in adults: age and gender related changes in isometric and isokinetic muscle strength. J Clin Endocrinol & Metab. 2003;88:5:2061-2069.
    59. Bjerregard SS, Steensgaard-Hansen F, Feldt-Rasmussen U. Cardiac effects of low-dose growth hormone replacement therapy in growth hormone-deficient adults: an 18-month randomized, placebo-controlled, double-blind study. Hormone Research. 2002;58:1:21-29.
    60. Acevedo M, Corbalan R, Chamorro G, et al. Adminstration of growth hormone to patients with advanced cardiac heart failure: effects upon left ventricular function, exercise capacity, and neurohormonal status. Int J Cardiol. 2003;87:2-3:185-191.
    61. Drake WM, Carroll PV, Maher KT, et al. The effect of cessation of growth hormone (GH) therapy on the bone mineral accretion in GH-deficient adolescents at the completion of linear growth. J Clin Endocrinol & Metab. 2003;88:4:1658-1663.
    62. Saadeh E, Ikizler TA, Shyr Y, et al. Recombinant human growth hormone in patients with acute renal failure. J Renal Nutrition. 2001;11:4:212-219.
    63. Weissberger AJ, Anastasiadis AD, Sturgess I, et al. Recombinant human growth hormone treatment in elderly patients undergoing elective total hip replacement. Clin Endocrinol. 2003;58:1:99-107.
    64. Brill KT, Weltman AL, Gentili, et al. Single and combined effects of growth hormone and testosterone administration on measures of body composition, physical performance, mood, sexual function, bone turnover, and muscle gene expression in healthy older men. J Clin Endocrinol & Metab. 2002;87:12:5649-5657.
    65. Van Pareren YK, de Munick Keizer-Schrama SM, Stijnen T, et al. Final height in girls with Turner Syndrome after long-term growth hormone treatment in three dosages and low dose estrogen. J Clin Endocrinol & Metab. 2002;88:3:1119-1125.
    66. Hertel NT, Holmberg C, Ronnholm KA, et al. Recombinant human growth hormone treatment, using two dose regimen in children with chronic renal failure-a report on linear growth and adverse effects. J Ped Endocrinol & Metab. 2002;15(5)577-88.
    67. Hagg AM, Stadler DD, Jackson RH, et al. Effects of growth hormone on pulmonary function, sleep quality, behavior, cognition, growth velocity, body composition, and resting energy expenditure in Prader-Willi syndrome. J Clin Endocrinol & Metab. 2003;88:5:2206-2212.
    68. Fine RN, Stablein D, Cohen AH, et al. Recombinant human growth hormone post-renal transplantation in children: a randomized, controlled study of the NAPRTCS. Kidney Int. 2002;62:2:688-696.
    69. Fine RN, Ho M, Tejani A, Blethen S. Adverse events with rh-GH treatment of patients with chromic renal insufficiency and end-stage renal disease. J Pediatrics. 2003;142:5:539-545.
    70. Cittadini A, Ines CL, Longobardi S, et al. A preliminary randomized study of growth hormone administration in Becker and Duchene muscular dystrophy. Eur Heart J. 2002;24:7:664-672.
    71. Nutropin. [Prescribing information] South San Francisco, CA Genentech, June 2014.
    72. Norditropin. [Prescribing information], Princeton, NJ, Novo Nordisk, May 2011.
    73. Saizen. [Prescribing information], Rockland, MA, Serono, June 2014.
    74. Genotropin. [Prescribing information], Ravensburg, Germany, Pharmacia Upjohn June 2014.
    75. Tev-Tropin. [Prescribing information], Sellersville, PA, Gate Pharmaceuticals, June 2014.
    76. Omnitrope. [Prescribing information], Princeton, NJ, Sandoz, June 2014.
    77. DrugDex Drug Database. Thompson Micromedex Web site. Available at: http://www.thomsonhc.com. Accessed June 17, 2014.
    78. Nilsson, AG, Svensson J, Johannsson G. Management of growth hormone deficiency in adults. Growth Hormone & Meatb Res. 2007;17:441-462.
    79. Bakker B. Oostdijk W. Geskus RB. Stokvis-Brantsma WH. Vossen JM. Wit JM. Growth hormone (GH) secretion and response to GH therapy after total body irradiation and Haematopoietic stem cell transplantation during childhood. Clin Endocrinol. 2007;67(4):589-97
    80. Seikaly MG. Salhab N. Warady BA. Stablein D. Use of rhGH in children with chronic kidney disease: lessons from NAPRTCS. Ped Nephrol. 2007;22(8):1195-204.
    81. Schnabel D. Grasemann C. Staab D. Wollmann H. Ratjen F. German Cystic Fibrosis Growth Hormone Study Group. A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the metabolic and respiratory effects of growth hormone in children with cystic fibrosis. Pediatrics. 2007;119(6):e1230-8.
    82. Radovick S. DiVall S. Approach to the growth hormone-efficient child during transition to adulthood. J of Clin Endocrin & Metab. 2007;92(4):1195-200.
    83. Gotherstrom G. Bengtsson BA. Bosaeus I. Johannsson G. Svensson J. A 10-year, prospective study of the metabolic effects of growth hormone replacement in adults. J Clin Endocrin & Metab. 2007;92(4):1442-5.
    84. van der Klaauw AA. Biermasz NR. Feskens EJ. et al. The prevalence of the metabolic syndrome is increased in patients with GH deficiency, irrespective of long-term substitution with recombinant human GH. Euro J Endocrinol. 2007;156(4):455-62.
    85. Lagrou K. Vanderfaeillie J. Froidecoeur C. et al. Belgian Study Group for Pediatric Endocrinology, Belgium. Effect of 2 years of high-dose growth hormone therapy on cognitive and psychosocial development in short children born small for gestational age. Euro J Endocrinol. 2007;156(2):195-201.
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