Sogroya — Blue Cross Blue Shield of Montana
short bowel syndrome (SBS)
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