nonpreferred short-acting GH agents — Blue Cross Blue Shield of New Mexico

Initial criteria

• The patient is an adult (closed epiphysis)
• IF the request is for a short-acting GH agent THEN ONE of the following: the request is for a preferred agent OR for a nonpreferred agent meeting ANY of A–H criteria (Serostim for AIDS wasting/cachexia or Zorbtive for SBS; currently treated and stable; inadequate response, discontinuation, intolerance, expected inefficacy, best-interest medical necessity, or evidence supporting efficacy advantage – all with required chart notes)
• IF the request is for a long-acting GH agent THEN ALL of: FDA-labeled for the indication AND meets ONE of A–I regarding preferred short-acting agent trial/failure criteria AND ONE of A–J regarding preferred long-acting agent trial/failure criteria
• Diagnosis criteria – ONE of: short bowel syndrome with clinical benefit; AIDS wasting/cachexia with ongoing antiretroviral therapy and documented benefit; Prader-Willi syndrome with clinical benefit; GH deficiency or growth failure with IGF-I evaluation and clinical benefit evidence
• The patient does NOT have any FDA-labeled contraindications to the requested agent
• The prescriber is a specialist (e.g., endocrinologist) or has consulted with a specialist
• Requested dose is within FDA labeling or compendia-supported dosing
• The patient is being monitored for adverse effects
• For Ohio Fully Insured or HIM Shop plans: no contraindications AND EITHER FDA-labeled indication OR compendia-supported indication OR two peer-reviewed journal articles showing safety/efficacy

Reauthorization criteria

• Clinical benefit with therapy documented (e.g., for SBS, AIDS wasting/cachexia, Prader-Willi syndrome, or GH deficiency as described)

Approval duration

SBS 3mo (BCBSMT/BCBSNM); AIDS wasting/cachexia 3mo (BCBSMT/BCBSNM); all other indications 12mo; SBS 4wk (other plans); AIDS wasting/cachexia 12wk (other plans); all other indications 12mo; Ohio plan exceptions 12mo