Prior Authorization Form

Transcription

1 Prior Authorization Form Growth Hormone This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign and date. Fax signed forms to CVS/Caremark at When conditions are met, we will authorize the coverage of Growth Hormone. Drug Name (specify drug) 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: Diagnosis: Please circle the appropriate answer for each question. ICD Code: 1. Does the patient have any of the following contraindications or exclusions to the use of GH therapy: An active malignancy or history of malignancy in the past 12 months Active proliferative or severe non-proliferative diabetic retinopathy An acute critical illness (not including neonatal hypoglycemia) Concurrent use with Increlex [If yes, then no further questions.] 2. Does the patient have HIV-associated wasting syndrome AND meet all of the following conditions: On antiretroviral therapy Tried and had a suboptimal response to alternative therapies (e.g., dronabinol, megestrol, cyproheptadine, testosterone therapy) Ruled out alternative causes of wasting (e.g., inadequate caloric intake, testosterone deficiency, peripheral GH resistance) [If no, then skip to question 6.] 3. Is the patient currently on somatropin through a CVS Caremark administered benefit?

2 [If yes, then skip to question 5.] 4. Has the patient received previous rounds of GH therapy? [If no, then skip to question 46.] 5. Did the patient s body mass index (BMI) improve or stabilize in response to somatropin therapy? 6. Does the patient have a diagnosis of short bowel syndrome (SBS) and meet the following criteria for approval: Patient is receiving specialized nutritional support AND Patient has received less than 8 weeks of GH therapy (lifetime) for SBS 7. Is the patient using GH therapy for one of the following reasons: Cerebral palsy Congenital adrenal hyperplasia Cystic fibrosis [If yes, then no further questions.] 8. Is the patient using GH therapy for one of the following reasons: In combination with leuprolide for children with growth failure and advancing puberty Russell Silver syndrome 9. Is GH therapy prescribed for a pediatric patient? [If no, then skip to question 39.] 10. Is the patient currently undergoing treatment with GH therapy through the CVS Caremark benefit? [If yes, then skip to question 37.] 11. Does the patient have neonatal hypoglycemia AND meet all of the following conditions: Other causes of hypoglycemia have been ruled out or other treatments have been ineffective The patient has a pretreatment randomly assessed GH level less than 20 ng/ml 12. Does the patient meet the following conditions: The patient has open epiphyses The patient has been evaluated for other causes of growth failure [e.g., hypothyroidism, malignancy, chronic systemic disease, skeletal disorders, malnutrition, celiac disease] 13. Does the patient have pediatric GHD?

3 [If no, then skip to question 20.] 14. Did the patient have a delayed bone age for chronological age prior to initiation of GH therapy? 15. Is the patient less than 2.5 years of age AND meet the following criteria: Has a pretreatment height of greater than 2 SD below the mean AND [If yes, then skip to question 17.] 16. Does the patient meet the following conditions for use of GH therapy in pediatric patients: 17. Prior to initiation of GH therapy, has the patient failed 2 pharmacologic provocative tests (peak level below 10 ng/ml)? 18. Does the patient have a pituitary or CNS disorder (e.g., pituitary resection, blunt trauma to pituitary gland, CNS tumors, CNS malformation, CNS irradiation, multiple pituitary hormone deficiencies, or panhypopituitarism)? 19. Does the patient have a pretreatment IGF-1/IGFBP3 level greater than 2 SD below the mean? 20. Does the patient have the diagnosis of Turner syndrome confirmed by karyotyping AND is the patient 2 years of age or older? [If no, then skip to question 23.] 21. Is the patient between the ages of 2 and less than 2.5 years old AND meet the following criteria? Has a pretreatment height of greater than 2 SD below the mean AND 22. Does the patient meet the following criteria:

4 23. Does the patient have a diagnosis of Noonan syndrome? [If no, then skip to question 25.] 24. Does the patient meet all of the following conditions: Is 3 years of age or older 25. Does the patient have a diagnosis of chronic renal insufficiency? [If no, then skip to question 29.] 26. Does the patient meet all of the following conditions: Metabolic, endocrine, and nutritional abnormalities have been treated or stabilized Patient has not had a kidney transplant 27. Is the patient less than 2.5 years of age and meet the following criteria: Has a pretreatment height of greater than 2 SD below the mean AND 28. Does the patient meet all of the following conditions: 29. Does the patient have a diagnosis of small for gestational age (SGA)? [If no, then skip to question 31.] 30. Does the patient meet all of the following conditions: Is 2 years of age or older Has a birth weight less than 2500 g at gestational age of greater than 37 weeks OR a birth weight or length less than 3rd percentile for gestational age Has failed to manifest catch-up growth by age Does the patient have the diagnosis of Prader-Willi Syndrome? [If no, then skip to question 35.] 32. Does the patient meet all of the following conditions:

5 Ruled out upper airway obstruction via appropriate testing or examination GH therapy will be discontinued if patient develops severe respiratory impairment while on therapy 33. Is the patient less than 2.5 years of age and meet the following criteria: Has a pretreatment height of less than 2 SD below the mean AND 34. Does the patient meet all of the following conditions: Has a pretreatment 1-year height velocity less than 2 SD below the mean OR a 35. Does the patient have a diagnosis of SHOX (short stature homeobox-containing gene) deficiency confirmed by molecular or genetic testing analyses? 36. Does the patient meet all of the following conditions: Is 3 years of age or older 37. Does the patient have neonatal hypoglycemia AND meet the following criteria for continuation of therapy: Patient is euglycemic or the patient s therapy will be adjusted to optimize therapy [If yes, skip to question 46.] 38. Does the patient meet all of the following conditions for continuation of GH therapy: The patient is growing greater than 2 cm/year The patient has open epiphyses For Prader-Willi syndrome only: body composition has improved 39. Does the patient have a diagnosis of adult GHD? 40. Is the patient currently undergoing treatment with GH therapy through the CVS Caremark benefit? [If yes, then skip to question 45.]

6 41. Has the patient been assessed for other causes of GHDlike symptoms (e.g., hypothyroidism, malignancy, chronic systemic disease)? 42. Prior to initiation of therapy, has the patient failed at least two pharmacologic provocative tests with peak level less than 5 µg/l? 43. Does the patient have one of the following: Greater than or equal to 3 pituitary hormone deficiencies (includes panhypopituitarism) OR Patient had childhood-onset GHD with known mutations, embryopathic lesions, or irreversible structural lesions/damage 44. Does the patient meet all of the following conditions for use of GH therapy in an adult: Has a documented low pretreatment IGF-1 level Has failed 1 pharmacologic provocative test prior to initiation of GH therapy with peak levels less than 5 µg/l? 45. Will the patient s serum insulin-like growth factor 1 (IGF-1) be evaluated to confirm the appropriateness of continued therapy? 46. Is the GH therapy being prescribed by or in consultation with one of the following specialists: endocrinologist gastroenterologist/nutritional support specialist (SBS) pediatric nephrologist (CRI) infectious disease specialist (HIV wasting) Comments: I affirm that the information given on this form is true and accurate as of this date. Prescriber (Or Authorized) Signature and Date