Prior Authorization Criteria Form This form applies to Paramount Commercial Members Only. Non-Preferred Growth Hormone Products

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1 Prior Authorization Criteria Form This form applies to Paramount Commercial Members Only Criteria: P0078 Approved: 3/2017 Reviewed: Non-Preferred Growth Hormone Products Complete/review information, sign and date. Please fax signed forms to Paramount at You may contact Paramount by phone at with questions regarding the Prior Authorization process. When conditions are met, we will authorize the coverage of Non Preferred Growth Hormone Products. Drug Name (select from list of drugs shown) Genotropin (somatostatin) Humatrope (somatropin) Nutropin (somatostatin) Omnitrope (somatostatin) Saizen (somatostatin) Quantity Frequency Strength Route of Administration Patient Information Patient Name: Patient ID: Patient Group No.: Patient DOB: Patient Phone: Prescribing Physician Physician Name: Physician Phone: Physician Fax: Physician Address: City, State, Zip: Expected Length of Therapy Nutropin AQ (somatostatin) Zomacton (somatostatin) Diagnosis: ICD Code: Comments: Please circle the appropriate answer for each question. 1. Has the patient had an inadequate treatment response to a previous trial of Norditropin AND Humatrope? 2. Does the patient meet one of the following criteria: A) The patient has a documented contraindication to to Norditropin or any of its components OR B) the patient is intolerant to or had a confirmed adverse event to Norditropin? 3. Does the patient meet one of the following criteria: A) The patient has a documented contraindication to Humatrope or any of its components OR B) the patient is intolerant to or had a confirmed adverse event to Humatrope? 4. Is growth hormone being prescribed for a patient experiencing growth failure associated with chronic kidney disease? [If no, skip to question 7.] 1/5

2 5. Is the prescribed growth hormone product Nutropin/Nutropin AQ? 6. Is the patient currently receiving growth hormone therapy? [If no, skip to question 20.] 7. Is growth hormone being prescribed for a patient with Prader Willi syndrome? [If no, skip to question 10.] 8. Is the prescribed growth hormone product Genotropin or Omnitrope? 9. Is the patient currently receiving growth hormone therapy? [If no, skip to question 32.] 10. Is the patient currently receiving growth hormone therapy for any of the following pediatric conditions: A) Pediatric growth hormone deficiency, B) Turner Syndrome, C) Noonan Syndrome, D) Growth failure associated with chronic kidney disease, E) Small for gestational age, F) SHOX (short stature homeobox containing gene) deficiency, or G) Prader Willi Syndrome? 11. Is the patient currently receiving growth hormone therapy for adult growth hormone deficiency? 12. Is the patient currently receiving growth hormone therapy for human immunodeficiency virus (HIV) associated wasting or cachexia? [If yes, skip to question 42.] 13. Does the patient have a diagnosis of pediatric growth hormone deficiency? [If no, skip to question 15.] 14. Does the patient meet ANY of the following conditions: A) Patient failed 2 pretreatment growth hormone stimulation tests (peak level below 10 ng/ml), B) Patient has pituitary or central nervous system disorder (e.g., genetic defect, central nervous system tumor, congenital structural abnormality) AND pretreatment insulin like growth factor 1 (IGF 1) level more than 2 standard deviations below the mean, C) Patient is a neonate, D) Patient was diagnosed with growth hormone deficiency as a neonate? 15. Does the patient have a diagnosis of Turner syndrome? [If no, skip to question 17.] 16. Was the diagnosis confirmed by karyotyping? 17. Does the patient have a diagnosis of Noonan syndrome? [If no, skip to question 19.] 18. Is the patient at least 3 years of age? 19. Does the patient have a diagnosis of growth failure associated with chronic kidney disease? [If no, skip to question 21.] 20. Is the patient post kidney transplant? [If yes, no further questions.] 2/5

3 [If no, skip to question 29.] 21. Does the patient have a diagnosis of born small for gestational age (SGA)? [If no, skip to question 23.] 22. Does the patient meet ALL of the following conditions: A) Patient is at least 2 years of age, B) Birth weight less than 2500 g at gestational age more than 37 weeks OR a birth weight or length below 3rd percentile or at least 2 standard deviations below the mean for gestational age, C) Did not manifest catch up growth by age 2? 23. Does the patient have a diagnosis of idiopathic short stature? [If no, skip to question 27.] 24. Is the prescribed growth hormone product one of the following: Genotropin, Nutropin/Nutropin AQ, Omnitrope? 25. Is the patient currently receiving growth hormone therapy? 26. Does the patient meet ALL of the following conditions: A) Pretreatment height more than 2.25 standard deviations below the mean, B) Adult height prediction below 63 inches (5'3") for boys and below 59 inches (4'11") for girls, C) Pediatric growth hormone deficiency has been ruled out by appropriate provocative growth hormone test result of more than 10 ng/ml? 27. Does the patient have a diagnosis of SHOX deficiency? [If no, skip to question 31.] 28. Does the patient meet ALL of the following conditions: A) Diagnosis confirmed by molecular or genetic testing, B) Patient is at least 3 years of age? 29. Does the patient meet ONE of the following conditions: A) If younger than 2.5 years of age, pretreatment height more than 2 standard deviations below the mean and slow growth velocity, B) If 2.5 years of age or older, pretreatment 1 year height velocity more than 2 standard deviations below the mean OR pretreatment height more than 2 standard deviations below the mean plus a 1 year height velocity more than 1 standard deviation below the mean? 30. Does the patient have open epiphyses? 31. Does the patient have a diagnosis of Prader Willi syndrome? [If no, skip to question 33.] 32. Has the diagnosis been confirmed by one of the following: A) Deletion in the chromosomal 15q11.2 q13 region, B) Maternal uniparental disomy in chromosome 15, C) Imprinting defects or translocations involving chromosome 15? 33. Does the patient have a diagnosis of adult growth hormone deficiency? [If no, skip to question 35.] 34. Does the patient meet ANY of the following conditions: A) Failed 3/5

4 2 pretreatment growth hormone stimulation tests (peak level below 5 ng/ml), B) Structural abnormality of the hypothalamus or pituitary AND 3 or more pituitary hormone deficiencies, C) Childhood onset growth hormone deficiency with congenital (genetic or structural) abnormality of the hypothalamus/pituitary, D) Failed 1 pretreatment growth hormone stimulation test (peak level below 5 ng/ml) AND low pretreatment insulin like growth factor 1 (IGF 1) level? 35. Does the patient have a diagnosis of HIV associated wasting or cachexia? [If no, skip to question 37.] 36. Does the patient meet ALL of the following conditions: A) Receiving antiretroviral therapy, B) Suboptimal response to at least 1 other therapy for wasting or cachexia (e.g., megestrol, dronabinol, cyproheptadine, or testosterone therapy if hypogonadal) OR has a contraindication or intolerance to alternative therapies, C) Pretreatment body mass index is less than 18.5 kg/m2, D) Unintentional weight loss of greater than 5 percent of body weight in the previous 6 months? 37. Does the patient have a diagnosis of short bowel syndrome? 38. Will growth hormone be used in conjunction with optimal management of short bowel syndrome? 39. Does the patient meet the following conditions for continuation of GH therapy: A) For Prader Willi syndrome in patients with open epiphyses only: Patient is experiencing improvement AND body composition and psychomotor function have improved or stabilized, B) For Prader Willi syndrome in patients with closed epiphyses only: Current insulin like growth factor 1 (IGF 1) level is not elevated for age and gender AND body composition and psychomotor function have improved or stabilized, C) For all other diagnoses: patient is experiencing improvement AND has open epiphyses? 40. Does the patient have any of the following: A) Structural abnormality of the hypothalamus/pituitary and 3 or more pituitary hormone deficiencies, B) Childhood onset growth hormone deficiency with congenital (genetic or structural) abnormality of the hypothalamus/pituitary? 41. Does the patient have a current insulin like growth factor 1 (IGF 1) level that is normal for age and gender? 42. Has the patient demonstrated response to growth hormone therapy (i.e., body mass index has improved or stabilized)? 43. Does the patient have an active malignancy? [If yes, no further questions.] 44. Is growth hormone therapy being prescribed by or in consultation with any of the following specialists: A) Endocrinologist, B) 4/5

5 Geneticist, C) Pediatric nephrologist, D) Infectious disease specialist, E) Gastroenterologist, F) Nutritional support specialist? I affirm that the information given on this form is true and accurate as of this date. Prescriber (Or Authorized) Signature and Date 5/5

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