Zomacton — Blue Cross Blue Shield of New Mexico

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