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Prior Authorization Form

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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 1-888-836-0730. 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: ICD Code:

Please circle the appropriate answer for each question.

1. Does the patient have any of the following

contraindications or exclusions to the use of GH therapy:

Y N · 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:

Y N · 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?

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[If yes, then skip to question 5.]

4. Has the patient received previous rounds of GH therapy? Y N [If no, then skip to question 46.]

5. Did the patient’s body mass index (BMI) improve or stabilize in response to somatropin therapy?

Y N [If yes, then skip to question 46.]

[If no, then no further questions.]

6. Does the patient have a diagnosis of short bowel syndrome (SBS) and meet the following criteria for approval:

Y N · Patient is receiving specialized nutritional support AND

· Patient has received less than 8 weeks of GH therapy (lifetime) for SBS [If yes, then skip to question 46.]

7. Is the patient using GH therapy for one of the following reasons:

Y N · 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:

Y N

· In combination with leuprolide for children with growth failure and advancing puberty · Russell Silver syndrome

[If yes, then skip to question 46.]

9. Is GH therapy prescribed for a pediatric patient? Y N [If no, then skip to question 39.]

10. Is the patient currently undergoing treatment with GH therapy through the CVS Caremark benefit?

Y N [If yes, then skip to question 37.]

11. Does the patient have neonatal hypoglycemia AND meet all of the following conditions:

Y N

· 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 [If yes, then skip to question 46.]

12. Does the patient meet the following conditions: Y N · 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]

[If no, then no further questions.]

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[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?

Y N [If no, then no further questions.]

15. Is the patient less than 2.5 years of age AND meet the following criteria:

Y N · Has a pretreatment height of greater than 2 SD below the mean AND · A slow growth velocity

[If yes, then skip to question 17.]

16. Does the patient meet the following conditions for use of GH therapy in pediatric patients:

Y N

· Has a pretreatment 1-year height velocity greater than 2 SD below the mean OR a pretreatment height of greater than 2 SD below the mean plus a 1-year height velocity greater than 1 SD below the mean

[If no, then no further questions.]

17. Prior to initiation of GH therapy, has the patient failed 2 pharmacologic provocative tests (peak level below 10 ng/mL)?

Y N

[If yes, then skip to question 46.]

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)?

Y N

[If no, then no further questions.]

19. Does the patient have a pretreatment IGF-1/IGFBP3 level greater than 2 SD below the mean?

Y N [If yes, then skip to question 46.]

[If no, then no further questions.]

20. Does the patient have the diagnosis of Turner syndrome confirmed by karyotyping AND is the patient 2 years of age or older?

Y N

[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?

Y N · Has a pretreatment height of greater than 2 SD below the mean AND · A slow growth velocity

[If yes, then skip to question 46.]

22. Does the patient meet the following criteria: Y N

· Has a pretreatment 1-year height velocity greater than 2 SD below the mean OR a pretreatment height of greater than 2 SD below the mean plus a 1-year height velocity greater than 1 SD below the mean

[If yes, then skip to question 46.] [If no, then no further questions.]

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23. Does the patient have a diagnosis of Noonan syndrome? Y N [If no, then skip to question 25.]

24. Does the patient meet all of the following conditions: Y N · Is 3 years of age or older

· Has a pretreatment 1-year height velocity greater than 2 SD below the mean OR a pretreatment height of greater than 2 SD below the mean plus a 1-year height velocity greater than 1 SD below the mean

[If yes, then skip to question 46.] [If no, then no further questions.]

25. Does the patient have a diagnosis of chronic renal insufficiency?

Y N [If no, then skip to question 29.]

26. Does the patient meet all of the following conditions: Y N

· Metabolic, endocrine, and nutritional abnormalities have been treated or stabilized · Patient has not had a kidney transplant

[If no, then no further questions.]

27. Is the patient less than 2.5 years of age and meet the following criteria:

Y N · Has a pretreatment height of greater than 2 SD below the mean AND · A slow growth velocity

[If yes, then skip to question 46.]

28. Does the patient meet all of the following conditions: Y N

· Has a pretreatment 1-year height velocity greater than 2 SD below the mean OR a pretreatment height of greater than 2 SD below the mean plus a 1-year height velocity greater than 1 SD below the mean

[If yes, then skip to question 46.] [If no, then no further questions.]

29. Does the patient have a diagnosis of small for gestational age (SGA)?

Y N [If no, then skip to question 31.]

30. Does the patient meet all of the following conditions: Y N · 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 2 [If yes, then skip to question 46.]

[If no, then no further questions.]

31. Does the patient have the diagnosis of Prader-Willi Syndrome?

Y N [If no, then skip to question 35.]

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· Ruled out upper airway obstruction via appropriate testing or examination

· GH therapy will be discontinued if patient develops severe respiratory impairment while on therapy

[If no, then no further questions.]

33. Is the patient less than 2.5 years of age and meet the following criteria:

Y N · Has a pretreatment height of less than 2 SD below the mean AND · A slow growth velocity

[If yes, then skip to question 46.]

34. Does the patient meet all of the following conditions: Y N

· Has a pretreatment 1-year height velocity less than 2 SD below the mean OR a pretreatment height of greater than 2 SD below the mean plus a 1-year height velocity greater than 1 SD below the mean

[If yes, then skip to question 46.] [If no, then no further questions.]

35. Does the patient have a diagnosis of SHOX (short stature homeobox-containing gene) deficiency confirmed by molecular or genetic testing analyses?

Y N

[If no, then no further questions.]

36. Does the patient meet all of the following conditions: Y N · Is 3 years of age or older

· Has a pretreatment 1-year height velocity greater than 2 SD below the mean OR a pretreatment height of greater than 2 SD below the mean plus a 1-year height velocity greater than 1 SD below the mean

[If yes, then skip to question 46.] [If no, then no further questions.]

37. Does the patient have neonatal hypoglycemia AND meet the following criteria for continuation of therapy:

Y N

· 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:

Y N · The patient is growing greater than 2 cm/year

· The patient has open epiphyses

· For Prader-Willi syndrome only: body composition has improved [If yes, then skip to question 46.]

[If no, then no further questions.]

39. Does the patient have a diagnosis of adult GHD? Y N [If no, then no further questions.]

40. Is the patient currently undergoing treatment with GH therapy through the CVS Caremark benefit?

Y N [If yes, then skip to question 45.]

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41. Has the patient been assessed for other causes of GHD-like symptoms (e.g., hypothyroidism, malignancy, chronic systemic disease)?

Y N

[If no, then no further questions.]

42. Prior to initiation of therapy, has the patient failed at least two pharmacologic provocative tests with peak level less than 5 µg/L?

Y N

[If yes, then skip to question 46.]

43. Does the patient have one of the following: Y N

· 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

[If yes, then skip to question 46.]

44. Does the patient meet all of the following conditions for use of GH therapy in an adult:

Y N · 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?

[If yes, then skip to question 46.] [If no, then no further questions.]

45. Will the patient’s serum insulin-like growth factor 1 (IGF-1) be evaluated to confirm the appropriateness of continued therapy?

Y N

[If no, then no further questions.]

46. Is the GH therapy being prescribed by or in consultation with one of the following specialists:

Y N · 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.

References

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