Growth Hormone (somatropin and related products) — Coverage Criteria
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Criteria and prior authorization requirements for coverage of growth hormone (somatropin and related products) for pediatric and adult indications under Wellmark (Blue Cross Blue Shield - Iowa). Applies to prescribers and prior authorization reviewers determining medical necessity.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Therapy - Pediatric GHD
Covered when ONE of the following is met for pediatric GHD:
Initial Therapy - Turner Syndrome
Covered when ALL of the following are met:
Approval: 12 months
Initial Therapy - Noonan Syndrome
Covered when ALL of the following are met:
Approval: 12 months
Initial Therapy - Chronic Kidney Disease
Covered when ALL of the following are met:
Nutropin/Nutropin AQ may be requested without prior use of preferred agents for CKD per exception; Approval: 12 months
Initial Therapy - SGA
Covered when ALL of the following are met:
Approval: 12 months
Initial Therapy - Prader-Willi Syndrome
Covered when the following is met:
Approval: 12 months
Initial Therapy - SHOX deficiency
Covered when ALL of the following are met:
Approval: 12 months
Initial Therapy - Adult GHD
Covered when ANY of the following groups are met:
Approval: 12 months
Approval: 12 months
Refer to Appendices A and B; Approval: 12 months
Initial Therapy - HIV-associated wasting/cachexia
Covered when ALL of the following are met:
Approval duration: 12 weeks
Initial Therapy - Short Bowel Syndrome
Covered when ALL of the following are met:
Approval duration: 12 weeks
Continuation Therapy - Pediatric GHD and related indications
Continuation covered when ALL of the following are met:
Approval: 12 months
Continuation Therapy - Prader-Willi
Continuation covered when the following is met:
Approval: 12 months
Continuation Therapy - Adult GHD
Continuation covered when ANY of the following are met (parallels initial adult GHD criteria):
Approval: 12 months
Non-Formulary Exception Criteria; Continuation for HIV-associated wasting/cachexia
Non-Formulary Exception Criteria and selected continuation indication
Non-Formulary Exception Pathways (multi-branch)
- Branch b (example): Patient has 1 pretreatment pharmacologic provocative GH test demonstrating deficient GH responses as one of: (1) ITT or another provocative GH test with peak ≤5 ng/mL; (2) Macrilen peak <2.8 ng/mL; (3) Glucagon stimulation test peak ≤3 ng/mL for BMI ≤30 kg/m2 with high pretest probability or BMI <25 kg/m2; (4) Glucagon stimulation test peak ≤1 ng/mL for BMI ≥25 kg/m2 with low pretest probability or BMI >30 kg/m2; AND pretreatment IGF-1 >2 SD below the mean for age/gender; AND current IGF-1 level is not elevated for age/gender.
- Branch c (organic disease): Organic hypothalamic-pituitary disease with ≥3 documented pituitary hormone deficiencies and a low pre-treatment IGF-1 >2 SD below the mean for age/gender; current IGF-1 is not elevated for age/gender.≥3 pituitary hormone deficiencies
Refer to Appendices A and B
Certain growth hormone products have product- and age-specific coverage limitations. Ngenla will only be covered for pediatric growth hormone deficiency in patients 3 years of age and older. Skytrofa will only be covered for growth hormone deficiency in adults and pediatric patients 1 year of age and older who weigh at least 11.5 kg. Sogroya will only be covered for growth hormone deficiency in adults and pediatric patients 2.5 years of age and older. Ngenla, Skytrofa, and Sogroya will not be covered for any indication other than their specified pediatric/adult GHD approvals. Additionally, Serostim is excluded from the preferred product requirement (it is indicated for HIV-associated wasting/cachexia).
Growth hormone therapy is considered not medically necessary for patients who do not meet the criteria set forth in this policy.
Requests for growth hormone therapy that do not satisfy the policy criteria will be treated as not medically necessary and may be denied.
Patients who do not meet the specified approval criteria are considered not medically necessary candidates for growth hormone therapy; members receiving samples or assistance must meet initial approval criteria to continue therapy.
Procedures, Tests, and Thresholds
Prior Authorization, Documentation, and Formulary Steps
Prior authorization required; use preferred agents first
Prior authorization is required for initial and continuation requests; providers must submit required diagnostic documentation and use the plan's preferred growth hormones (Norditropin or Omnitrope) prior to non-preferred products except where specific exceptions apply (e.g., Nutropin/Nutropin AQ for CKD). Serostim is excluded from the preferred-product requirement. Age and indication limits apply for long-acting products (Ngenla, Skytrofa, Sogroya).
- Submit prior authorization for both initial and continuation therapy.
- Use Norditropin or Omnitrope before non-preferred growth hormones unless an exception applies.
- Serostim is excluded from the preferred-product step.
- Long-acting products (Ngenla, Skytrofa, Sogroya) have indication- and age-specific coverage limits.
Non‑formulary exception: indication, dosing, and prior alternative failure required
To request a non‑formulary exception, document that the medication is for an FDA‑approved indication or supported by accepted compendia, that dosing is within labeling/compendia guidelines, and that all covered formulary alternatives were ineffective, not tolerated, or contraindicated. Quantity limits apply to Sogroya formulations.
- Provide evidence of FDA‑approved or compendia‑supported indication.
- Confirm prescribed dose/quantity is within FDA labeling or compendia dosing guidance.
- Document prior formulary alternative failures, adverse events (with severity), dosages and durations, or contraindications.
- Sogroya quantity limits: 5 mg pen = 4/28 days; 10 mg pen = 4/28 days; 15 mg pen = 2/28 days.
Required trial of preferred products (Norditropin or Omnitrope) before non‑preferred
A trial/use of one of the plan's preferred growth hormones (Norditropin or Omnitrope) is required before coverage of non‑preferred growth hormones, with specific exceptions for Nutropin/Nutropin AQ in CKD and other indicated exceptions noted in the policy.
- Norditropin or Omnitrope must be tried prior to non‑preferred products unless an exception applies (e.g., Nutropin/Nutropin AQ for CKD).
- Serostim is not subject to the preferred‑product requirement.
Document failure/intolerance/contraindication to all formulary alternatives
Coverage of a non‑formulary drug requires documentation that all covered formulary alternatives were ineffective, not tolerated, or contraindicated; chart notes must detail prior treatments, adverse events, dosages and durations, or contraindications.
- Provide chart notes or documentation of prior treatment failure, severity of adverse events, and prior dosage/duration.
- If alternatives are contraindicated, document the clinical reason.
Required documentation for prior authorization (tests, growth chart, dosing history)
Submit medical records supporting the diagnosis (including growth chart), pretreatment GH provocative test results, pretreatment and/or current IGF‑1 level, and diagnostic genetic/karyotype results when applicable; for continuation requests include total duration of treatment, date of last dose, prior approval details and prior authorization approval letter. BMI documentation may be required for adult GHD.
- Medical records supporting diagnosis and growth chart.
- Laboratory reports of pretreatment GH provocative test(s) and IGF‑1.
- Diagnostic karyotype for Turner syndrome; genetic test results for Prader‑Willi or SHOX deficiency.
- For continuation: total duration of treatment, date of last dose, approving plan/PBM, date of prior authorization, and prior authorization approval letter.
- BMI documentation may be required for adult GHD.
Non‑formulary exception documentation: indication, compendia support, and labeled dosing
For a non‑formulary exception, provide documentation that the requested drug is used for an FDA‑approved indication or is supported by recognized compendia, that dosing falls within labeling or compendia guidance, and chart notes document prior formulary alternative failures or contraindications.
- Evidence of FDA‑approved indication or compendia support (e.g., AHFS, Micromedex).
- Dose/quantity must be within FDA labeling or compendia dosing guidelines.
- Chart notes documenting prior alternative failures, adverse events (with severity), dosages and durations, or contraindications.
Requests not meeting policy criteria may be denied
Requests that do not meet the policy criteria for growth hormone therapy will be considered not medically necessary and may be denied.
- Ensure submitted documentation directly meets the specific coverage criteria to avoid denial.
Therapy considered not medically necessary if criteria not met; samples/assistance recipients affected
Growth hormone therapy is considered not medically necessary for patients who do not meet the criteria set forth in this policy; members currently receiving samples or patient‑assistance must meet initial approval criteria or risk denial.
- Members on samples or manufacturer assistance must satisfy initial approval criteria to continue receiving therapy.
Key Definitions and Testing Guidance
Clinical Background
Growth hormone (somatropin and related formulations) is FDA‑approved for multiple pediatric and adult indications including pediatric and adult growth hormone deficiency, Turner syndrome, Noonan syndrome, small for gestational age (SGA), Prader‑Willi syndrome, chronic kidney disease (CKD)–related growth failure, idiopathic short stature (ISS), SHOX deficiency, short bowel syndrome, and HIV‑associated wasting/cachexia. Some long‑acting formulations have age‑ and indication‑specific approvals and will only be covered for the age ranges and indications described above.
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