Ngenla (somatrogon-ghla) — Blue Cross Blue Shield of Alabama
Children with growth hormone deficiency (GHD) or growth failure due to inadequate secretion of endogenous growth hormone or other FDA-labeled/compendia-supported pediatric GH indications
Preferred products
- Skytrofa (lonapegsomatropin-tcgd)
Initial criteria
- Patient is a child (as defined by prescriber)
- ONE of the following: diagnosis of GHD or growth failure due to inadequate secretion of GH meeting growth, IGF-1/IGFBP-3, bone age, and growth velocity criteria as specified; OR patient has another FDA-labeled or compendia-supported indication for GH therapy
- If the client has preferred agent(s), BOTH of the following:
- • Requested agent is FDA-labeled for requested indication
- • ONE of the following: preferred short-acting GH agents are NOT FDA-labeled for indication OR patient has ≥12 months of therapy with a preferred short-acting GH agent OR intolerance/hypersensitivity/contraindication to preferred short-acting GH agent
- If the client has preferred long-acting GH agent(s), ONE of the following: requested agent is preferred OR preferred agent is NOT FDA-labeled for indication OR patient has ≥12 months of therapy with preferred long-acting GH agent OR intolerance/hypersensitivity/contraindication to preferred long-acting GH agent
- Prescriber is a specialist (e.g., endocrinologist) or has consulted one
- Patient has no FDA-labeled contraindications
- Requested dose within FDA labeling or supported in compendia (AHFS or DrugDex 1 or 2a)
Reauthorization criteria
- Patient previously approved for GH therapy
- Patient is a child (per prescriber)
- If client has preferred agent(s): requested agent FDA-labeled for requested indication AND step-therapy conditions as above regarding short-acting and long-acting preferred GH agents
- ONE of the following: diagnosis of GHD or growth failure with open epiphyses AND height increase ≥2 cm over previous year; OR diagnosis other than GHD with documented clinical benefit
- Patient monitored for adverse effects of GH therapy
- Prescriber is a specialist or has consulted one
- Patient has no FDA-labeled contraindications
- Requested dose within FDA labeling or compendia support
Approval duration
12 months