2. Is the request for Humatrope? Y N [If no, skip to question 6.]

Transcription

1 Pharmacy Prior Authorization AETA BETTER HEALTH FLORIDA Growth Hormone Agents This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign and date. Fax signed forms to Aetna Better Health Florida at When conditions are met, we will authorize the coverage of Growth Hormone Agents. Please note that all authorization requests will be reviewed as the AB rated generic (when available) unless states otherwise. Drug ame (please circle) Genotropin Humatrope orditropin utropin AQ Omnitrope Saizen Zorbtive Other, please specify Quantity Frequency Strength Route of Administration Expected Length of therapy Patient Information Patient ame: Patient ID: Patient Group o.: Patient DOB: Patient Phone: Prescribing Physician Physician ame: Specialty: PI umber: Physician Fax: Physician Phone: Physician Address: City, State, Zip: Diagnosis: ICD Code: Please circle the appropriate answer for each question. Question Circle es or 1. Is the request for a patient aged 16 years or less? [If no, skip to question 39.] 2. Is the request for Humatrope? [If no, skip to question 6.] 3. Is Humatrope requested for short stature in a child with SHOX (short stature homeobox-containing gene) deficiency? 4. Is the request for continuation of therapy? Reference umber: C7938 A / Effective Date: 03/01/2017 1

2 5. Does the patient meet ALL of the following criteria? Diagnosis: Confirmed diagnosis of SHOX Syndrome Circle es or 6. Is the request for orditropin? [If no, skip to question 10.] 7. Is orditropin requested for short stature in a child with oonan Syndrome? 8. Is the request for continuation of therapy? 9. Does the patient meet ALL of the following criteria? Diagnosis: Confirmed diagnosis of oonan Syndrome 10.Is the request for utropin AQ? [If no, skip to question 15.] 11.Is utropin requested for growth failure due to chronic renal insufficiency? 12.Is the request for continuation of therapy? 13.Prior to initiation of GH treatment, have existing metabolic derangements such as malnutrition, zinc deficiency, and secondary hyperparathyroidism been corrected? Reference umber: C7938 A / Effective Date: 03/01/2017 2

3 Circle es or 14. Does the patient meet ALL of the following criteria? Renal function: Documentation of chronic renal insufficiency (serum creatinine less than 30mg/dL), up to the time of renal transplant Diagnosis: Confirmed diagnosis of oonan Syndrome 15.Is the request for Genotropin or Omnitrope? [If yes, skip to question 17.] 16.Is the request for Saizen or Zomacton? [If yes, skip to question 30] 17.Is the request for a patient with Prader-Willi syndrome? [If no, skip to question 20.] 18.Is the request for continuation of therapy? 19. Does the patient meet ALL of the following criteria? Diagnosis: Confirmed diagnosis of Prader-Willi Syndrome (micro-deletion in the long arm of chromosome 15 or 2 maternal chromosome 15 and no paternal chromosome 15, or nonfunctional paternal chromosome 15) 20.Is the request for a patient who was born small for gestational age? [If no, skip to question 23.] 21.Is the request for continuation of therapy? Reference umber: C7938 A / Effective Date: 03/01/2017 3

4 Circle es or 22. Does the patient meet ALL of the following criteria? Age: Greater than 2 years old Birth weight/length: Greater than or equal to 2 standard deviations (SD) below the mean for gestational age Growth velocity: Failure to manifest catch-up growth by two years of age, defined as 2 standard deviations (SD) below the mean for bone age and gender 23.Is the request for a patient with Turner syndrome? [If no, skip to question 26.] 24.Is the request for continuation of therapy? 25. Does the patient meet ALL of the following criteria? Age: Greater than 2 years old Gender: Female Bone age: Less than 14 years Diagnosis: Confirmed diagnosis of Turner syndrome (peripheral blood karyotype showing a 45, XO genotype) 26.Is the request for a patient with idiopathic short stature? [If no, skip to question 30.] 27.Is the request for continuation of therapy? 28. Is the patient s diagnosis supported by ALL of the following? A mixed or normal response greater than 10 ng/ml to two Growth Hormone provocation tests (e.g., arginine, clonidine, glucagon, insulin, or levodopa) Growth velocity must be less than 5cm/year Other pituitary hormone deficiencies (e.g., hypothyroidism, chronic ischemic disease) have been ruled out. Submission of a MRI or supporting documentation confirming no expanding intracranial lesion or tumor Reference umber: C7938 A / Effective Date: 03/01/2017 4

5 Circle es or 29. Does the patient meet ALL of the following criteria? Growth velocity: Greater than or equal to 2.25 standard 30.Is the request for a patient with pediatric growth hormone deficiency? 31.Is the request for continuation of therapy? 32. Is the patient s diagnosis supported by ALL of the following? TWO subnormal responses to GH provocation tests (e.g., arginine, clonidine, glucagon, insulin and levodopa): Confirmation of stimulation test(s) with peak serum GH concentration less than 10 ng/ml OR OE abnormal GH test if the child has a defined CS pathology, multiple pituitary hormone deficiency, history of irradiation, or a genetic defect affecting the GH axis OR OE subnormal response to a GH provocation test with peak serum GH concentration less than 10ng/ml) and subnormal serum levels of insulin-like growth factor 1 (IGF- I) and insulin-like growth factor binding protein 3 (IGFBP3), greater than 2 standard deviations below the mean for age and gender, based on specific lab reference values Idiopathic Short Stature (ISS) has been ruled out (normal birth weight and GH sufficient) Other pituitary hormone deficiencies (e.g., hypothyroidism, chronic ischemic disease) have been ruled out. 33. Does the patient meet ALL of the following criteria? (or at less than the 10th percentile) Present height: Less than the 5th percentile for age and sex, or the mid-parental height Reference umber: C7938 A / Effective Date: 03/01/2017 5

6 Circle es or 34.Will the therapy be discontinued if any of the following occurs? Expected final adult height has been reached; or There is a poor response to treatment, generally defined as an increase in growth velocity of less than 50% from baseline, in the first year of therapy or Increase in Height Velocity is less than 2 cm total growth in 1 year of therapy; or There are persistent and uncorrectable problems with adherence to treatment 35.Is the growth hormone product prescribed by an endocrinologist, pediatric endocrinologist or pediatric nephrologist? [o further questions.] 36.Will the therapy be discontinued if any of the following occurs? Expected final adult height has been reached; or There is a poor response to treatment, generally defined as an increase in growth velocity of less than 50% from baseline, in the first year of therapy or Increase in Height Velocity is less than 2 cm total growth in 1 year of therapy; or There are persistent and uncorrectable problems with adherence to treatment 37. Does the patient meet all of the following criteria? Growth velocity is 2.5cm/year or greater AD Bone age is less than 16 years if male or 14 years if female (indicated in x-ray of fingers, hands, or wrists) AD Growth (epiphyseal) plates are open (evidenced by x-ray) - linear growth can no longer occur in patients with epiphyseal closure 38.Is the growth hormone product prescribed by an endocrinologist, pediatric endocrinologist or pediatric nephrologist? [o further questions.] 39.Is the request for an adult patient with growth hormone deficiency? [If no, skip to question 51.] 40.Is the requested product one of the following products: Genotropin, Saizen, Omnitrope, utropin, orditropin, or Humatrope? Reference umber: C7938 A / Effective Date: 03/01/2017 6

7 Circle es or 41.Has the patient received growth hormone treatment as a child? [If no, skip to question 45.] 42.Has the patient been retested for growth hormone deficiency after final height is achieved? 43.Was GH therapy discontinued for at least 3 months to ascertain the GH status? 44.Is the prescribed dose at the reduced dose level recommended for growth hormone deficient adults? [If yes, skip to question 50.] 45.Does the patient have a negative response to a standard growth hormone stimulation test? A negative response is defined as a maximum peak of less than 5 ng/ml, when measured by radioimmunoassay (RIA) (polyclonal antibody) or less than 2.5 ng/ml when measured by immunoradiometric assay (monoclonal antibody). [If no, skip to question 49.] 46.Does the patient receive the Insulin Tolerance Test (ITT)? [If yes, skip to question 48.] 47. Does the patient meet all of the following criteria? Patient has contraindication to ITT (e.g., coronary artery disease or seizures, abnormal EKG with history of ischemic heart disease or cardiovascular disease, and age greater than 60) AD Patient has undergone an alternative provocative test (i.e., glucagon or arginine test OL) AD If a single agent test (arginine) is used: Patient has subnormal IGF-1 with the presentation of a hypothalamic disorder(s) OR has normal IGF-1 with hypothalamic pituitary disorder(s) and has undergone a total of two tests. 48.Does the patient meet one of the following criteria? Patient has normal TSH levels OR Prior to completing a stimulation test, TSH deficiency was corrected [If yes, skip to question 50.] Reference umber: C7938 A / Effective Date: 03/01/2017 7

8 49.Does the patient have any of the following conditions? Documented deficiencies of 3-4 pituitary hormones, including FSH and/or LH (subnormal results in both FSH and LH, simultaneously, would count as one deficiency), TSH, ACTH, and arginine vasopressin (AVP) Documented deficiency of two pituitary hormones and IGF- 1 less than 84 ng/ml Circle es or 50.Is the growth hormone product prescribed by an endocrinologist? [o further questions.] 51. Is the request for an adult patient with short bowel syndrome? 52. Is the requested product Zorbtive? 53.Has the provider submitted documentation verifying the diagnosis of short bowel syndrome and the use of specialized nutrition support such as a high carbohydrate, low fat diet, enteral feedings, parenteral nutrition, fluid, and micronutrient supplements? Comments: I affirm that the information given on this form is true and accurate as of this date. Prescriber (Or Authorized) Signature Prescriber (Or Authorized) Signature Date Date Reference umber: C7938 A / Effective Date: 03/01/2017 8