Ngenla — Blue Cross Blue Shield of Texas

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