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Ngenla — Blue Cross Blue Shield of Texas

Prader-Willi syndrome

Preferred products

  • Humatrope
  • Norditropin FlexPro
  • Nutropin AQ NuSpin

Initial criteria

  • Patient is an adult (closed epiphysis)
  • If short-acting GH agent requested: must be a preferred agent OR meet one of the following:
  • - Request is for Serostim for AIDS wasting/cachexia or Zorbtive for SBS OR
  • - Patient is currently stable on requested agent OR
  • - Tried and had inadequate response to a preferred agent OR
  • - Preferred agent discontinued due to lack of efficacy or adverse event OR
  • - Intolerance, contraindication, or hypersensitivity to preferred agent OR
  • - Preferred agent expected to be ineffective, hinder adherence, worsen comorbidities, or cause harm OR
  • - Preferred agent not in patient's best interest based on medical necessity OR prior similar drug was discontinued due to ineffectiveness or intolerance OR
  • - Support for superior efficacy of requested nonpreferred agent over preferred agent
  • If long-acting GH agent requested: ALL of the following:
  • - Requested agent is FDA labeled for the indication AND one of the following:
  • -- Preferred short-acting GH agents not FDA labeled for requested indication OR
  • -- Patient stable on requested agent OR
  • -- ≥12 months of therapy with preferred short-acting GH agent OR
  • -- Inadequate response to preferred short-acting GH agent OR
  • -- Preferred short-acting GH agent discontinued due to lack of efficacy or adverse event OR
  • -- Intolerance, hypersensitivity, or contraindication to preferred short-acting GH agent OR
  • -- Preferred short-acting GH agent expected to be ineffective or harmful OR
  • -- Preferred short-acting GH agent not in patient's best interest OR prior similar drug discontinued due to ineffectiveness or intolerance
  • - AND one of the following for long-acting GH agent:
  • -- Requested agent is preferred OR
  • -- Preferred agents not FDA labeled for indication OR
  • -- Patient stable on requested agent OR
  • -- ≥12 months of therapy with preferred long-acting GH agent OR
  • -- Inadequate response to preferred long-acting GH agent OR
  • -- Preferred long-acting GH agent discontinued due to lack of efficacy or adverse event OR
  • -- Intolerance, hypersensitivity, or contraindication to preferred long-acting GH agent OR
  • -- Preferred long-acting GH agent expected to be ineffective or harmful OR
  • -- Preferred long-acting GH agent not in patient's best interest OR prior similar drug discontinued due to ineffectiveness or intolerance
  • Diagnosis-specific reauthorization indicators (must have clinical benefit):
  • - SBS with demonstrated clinical benefit OR
  • - AIDS wasting/cachexia with clinical benefit, on antiretroviral therapy OR
  • - Prader-Willi syndrome with clinical benefit OR
  • - GHD/growth failure with evaluated IGF-I and clinical benefit (improved composition, strength, bone mineral density, or quality of life)
  • Patient has no FDA labeled contraindications to the requested agent
  • Prescriber is an endocrinologist or has consulted with one
  • Requested dose is within FDA labeling or compendia-supported
  • Patient monitored for GH therapy adverse effects

Approval duration

SBS: 3 months (BCBSMT/NM) or 4 weeks (others); AIDS wasting/cachexia: 3 months (BCBSMT/NM) or 12 weeks (others); all other indications: 12 months