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Zomacton — Blue Cross Blue Shield of New Mexico

growth failure due to inadequate secretion of endogenous growth hormone

Preferred products

  • Humatrope (somatropin)
  • Norditropin FlexPro (somatropin)
  • Nutropin AQ Nuspin (somatropin)

Initial criteria

  • The patient has a pituitary abnormality and a known deficit of at least one other pituitary hormone OR the patient has another FDA labeled indication OR the patient has another compendia-supported indication for the requested agent and route of administration
  • The patient is a child (open epiphysis)
  • If the patient has an FDA labeled indication, then patient age is within labeling OR there is support for the patient’s age for that indication
  • ALL of the following:
  • • The requested agent is FDA labeled for the requested indication
  • • ONE of the following short‑acting growth hormone conditions:
  •  1. The preferred short-acting GH agent(s) are NOT FDA labeled for the requested indication OR
  •  2. The patient is currently being treated and stable on the requested agent [chart notes required] OR
  •  3. The patient has received ≥12 months of therapy with a preferred short-acting GH agent OR
  •  4. The patient has tried and had inadequate response to a preferred short-acting GH agent [chart notes required] OR
  •  5. A preferred short-acting GH agent was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  •  6. The patient has intolerance, hypersensitivity, or FDA labeled contraindication to a preferred short-acting GH agent not expected with the requested agent [medical record required] OR
  •  7. A preferred short-acting GH agent is expected to be ineffective or cause adherence barrier, worsen comorbidity, reduce function, or cause harm [chart notes required] OR
  •  8. A preferred short-acting GH agent is not in the best interest of the patient based on medical necessity [chart notes required] OR
  •  9. The patient has tried another drug in the same class as a preferred short‑acting GH agent with discontinuation due to lack of efficacy or adverse event [chart notes required]
  • • ONE of the following long‑acting growth hormone conditions:
  •  1. The requested agent is a preferred agent OR
  •  2. The preferred long‑acting GH agents are NOT FDA labeled for this indication OR
  •  3. The patient is currently treated and stable on the requested agent [chart notes required] OR
  •  4. The patient has received ≥12 months therapy with a preferred long‑acting GH agent OR
  •  5. The patient has tried and had inadequate response to a preferred long‑acting GH agent [chart notes required] OR
  •  6. A preferred long‑acting GH agent was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  •  7. The patient has intolerance, hypersensitivity, or FDA labeled contraindication to a preferred long‑acting GH agent not expected with the requested nonpreferred agent [medical record required] OR
  •  8. A preferred long‑acting GH agent is expected ineffective, interferes with adherence, worsens comorbidities, reduces functioning, or causes harm [chart notes required] OR
  •  9. A preferred long‑acting GH agent is not in the best interest of the patient [chart notes required] OR
  •  10. The patient has tried another drug in same class or mechanism as a preferred long‑acting GH agent with discontinuation due to lack of efficacy or adverse event [chart notes required]
  • Imaging indicates patient does not have closed epiphyses if female ≥12 years or male ≥14 years [medical records required]
  • The prescriber is a specialist in the area (e.g., endocrinologist) or has consulted with one
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • Requested quantity (dose) is within FDA labeled dosing or supported in compendia

Reauthorization criteria

  • The patient has been previously approved for GH therapy through plan prior authorization
  • The patient is a child (open epiphysis)
  • ALL of the following criteria repeated from initial (short‑ and long‑acting step requirements)
  • ONE of the following:
  • • The patient has a diagnosis of growth hormone deficiency or growth failure due to inadequate secretion of endogenous GH AND imaging shows open epiphyses (female >12 or male >14) AND height or height velocity has improved since initiation or last GH approval OR
  • • The patient has a diagnosis other than GH deficiency or growth failure due to inadequate endogenous GH AND has had clinical benefit with the requested agent
  • The patient is being monitored for adverse effects of GH therapy
  • The prescriber is a specialist or has consulted with one
  • The patient has no FDA labeled contraindications
  • Dose is within FDA labeling or supported compendia

Approval duration

12 months