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Zomacton — Blue Cross Blue Shield of Montana

Prader-Willi syndrome

Preferred products

  • Humatrope
  • Norditropin FlexPro
  • Nutropin AQ NuSpin
  • Genotropin
  • Genotropin MiniQuick
  • Skytrofa

Initial criteria

  • The patient is an adult (closed epiphysis) AND
  • The patient has ONE of the following diagnoses:
  • A. AIDS wasting/cachexia AND ALL of the following:
  • 1. The requested agent is a short-acting GH AND
  • 2. The patient is currently treated with antiretroviral therapy AND will continue ART in combination with the requested agent AND
  • 3. Meets one of the following weight loss/body composition criteria with documentation AND
  • 4. All other causes of weight loss have been ruled out
  • B. Short bowel syndrome AND BOTH of the following: requested agent is a short-acting GH AND patient is receiving specialized nutritional support
  • C. Growth hormone deficiency or growth failure due to inadequate secretion of endogenous GH AND ONE of the following: childhood-onset GHD with failed GH stimulation test as adult; low IGF-1 with pituitary lesion or ≥3 hormone deficiencies; causal genetic mutation or structural defect; failure of ≥2 GH stimulation tests as adult
  • D. Short-acting GH and diagnosis of Prader-Willi syndrome
  • E. Short-acting GH and diagnosis of 3rd degree burns
  • The request is for a long-acting GH agent AND if the patient has an FDA labeled indication, then ONE of the following: age within FDA labeling OR support for use at that age
  • The patient does NOT have any FDA labeled contraindications to requested agent
  • The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with one
  • The requested dose is within FDA labeling or supported compendia dosing
  • Short-acting GH step therapy: request is for preferred agent OR, if nonpreferred, one of the following: specific medical need (e.g., Serostim for AIDS wasting/cachexia or Zorbtive for SBS); currently stable; inadequate response or discontinuation of preferred; intolerance or contraindication to preferred; expected ineffectiveness or adverse outcomes; medical necessity; or evidence of greater efficacy
  • Long-acting GH step therapy: agent is FDA labeled for indication AND one of the following: preferred short-acting GH not FDA labeled; currently stable; ≥12 months on preferred short-acting GH; inadequate response or discontinuation of preferred; intolerance; expected ineffectiveness or adverse outcomes; medical necessity; or prior similar drug failure; and step conditions repeated for long-acting preferred vs nonpreferred comparison

Reauthorization criteria

  • The patient has been previously approved for GH therapy through the plan’s prior authorization process. Patients not previously approved require initial evaluation review.

Approval duration

SBS: 3 months; AIDS wasting/cachexia: 3 months; other indications: 12 months