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Zorbtive — Blue Cross Blue Shield of Montana

growth failure due to inadequate secretion of endogenous growth hormone

Preferred products

  • Humatrope
  • Norditropin FlexPro
  • Nutropin AQ Nuspin
  • Saizen
  • Saizenprep
  • Omnitrope
  • Zomacton

Initial criteria

  • Patient is an adult (closed epiphysis).
  • If short-acting GH agent: request is for a preferred agent OR if non-preferred, one of the following:
  • - Request is for Serostim for AIDS wasting/cachexia or Zorbtive for SBS OR
  • - Patient is currently stable on requested agent (chart notes required) OR
  • - Patient tried and had inadequate response to a preferred agent (chart notes required) OR
  • - Preferred agent discontinued due to lack of efficacy/effectiveness/adverse event (chart notes required) OR
  • - Patient has intolerance, FDA labeled contraindication, or hypersensitivity to preferred agent not expected with requested non-preferred agent (chart notes required) OR
  • - Preferred agent expected to be ineffective or cause adherence barrier, worsen comorbidity, decrease function, or cause harm (chart notes required) OR
  • - Preferred agent not in best interest based on medical necessity OR prior trial of other drug in same class discontinued due to lack of efficacy/adverse event (chart notes required) OR
  • - Support for efficacy of requested nonpreferred agent over preferred (chart notes required).
  • If long-acting GH agent: requested agent is FDA labeled for indication AND one of the following conditions:
  • - Preferred short-acting GH agents not FDA labeled for indication OR
  • - Patient stable on requested agent (chart notes required) OR
  • - Patient completed ≥12 months therapy with preferred short-acting GH agent OR
  • - Patient tried and had inadequate response to preferred short-acting GH agent (chart notes required) OR
  • - Preferred short-acting GH agent discontinued due to lack of efficacy/adverse event (chart notes required) OR
  • - Patient has intolerance/hypersensitivity/contraindication to preferred short-acting GH (chart notes) OR
  • - Preferred short-acting GH agent expected to be ineffective or cause adherence barrier, worsen comorbidity, decrease function, or cause harm (chart notes) OR
  • - Preferred short-acting GH agent not in best interest (chart notes) OR
  • - Prior trial of other drug in same class discontinued due to lack of efficacy/adverse event (chart notes).
  • Also one of: requested agent is preferred OR preferred agents not FDA labeled for indication OR patient stable on requested agent (chart notes) OR patient completed ≥12 months therapy with preferred long-acting GH agent OR
  • Patient tried and had inadequate response to preferred long-acting GH agent (chart notes) OR preferred long-acting GH discontinued due to lack of efficacy/adverse event (chart notes) OR intolerance/contraindication to preferred long-acting (chart notes) OR expected to be ineffective/adherence barrier/harm (chart notes) OR not in best interest (chart notes) OR prior drug in same class discontinued due to lack of efficacy/adverse event (chart notes).
  • Diagnosis confirmation: one of the following:
  • - Short bowel syndrome and documented clinical benefit with requested agent OR
  • - AIDS wasting/cachexia: currently treated with antiretroviral therapy, continuing ART, and had clinical benefit (increase in weight or weight stabilization) OR
  • - Prader-Willi syndrome and had clinical benefit with requested agent OR
  • - Growth hormone deficiency/growth failure with evaluation of IGF-I level confirming dose appropriateness and documented clinical benefit (body composition, hip-to-waist ratio, cardiovascular health, bone mineral density, serum cholesterol, physical strength, or quality of life).
  • Patient has no FDA labeled contraindications to the requested agent.
  • Prescriber is a specialist (e.g., endocrinologist) or has consulted with one.
  • Requested dose is within FDA labeled or compendia-supported dosing.
  • Patient is being monitored for adverse effects of GH therapy.

Reauthorization criteria

  • Patient continues to derive clinical benefit and meets initial selection requirements for continued use.

Approval duration

SBS 3 months; AIDS wasting/cachexia 3 months; all other indications 12 months (BCBSMT/BCBSNM); otherwise SBS 4 weeks; AIDS wasting/cachexia 12 weeks; all other indications 12 months