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mhn Human Growth Hormone Coverage Update | OpenPayer

ModifiedmhnPolicy CP.CPA.353

Human Growth Hormone (Somapacitan, Somatrogon, Somatropin, Lonapegsomatropin-tcgd)

Governs prior authorization and medical necessity criteria for multiple human growth hormone formulations (analogs and recombinant) for pediatric and adult indications; applies to commercial line of business members covered by the payer.

Policy Summary

Payermhn

PolicyHuman Growth Hormone (Somapacitan, Somatrogon, Somatropin, Lonapegsomatropin-tcgd)

Policy CodePolicy CP.CPA.353

Change TypeMultiple material updates (product additions, removals, HIV criteria revision)

Effective DateJan 1, 2022

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation (office notes, lab results, growth measurements or IGF-1) demonstrating the member meets the listed indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Removed Zorbtive from the policy due to market discontinuation.

Removed criteria for short bowel syndrome due to lack of support by AGA.

For HIV-associated wasting, added option for unintentional weight loss of ≥ 5% in the last 6 months while on antiretroviral therapy and removed use of ideal body weight criteria per 2024 consensus statement.

Added several newer products and formulations (e.g., Skytrofa cartridge strengths, Ngenla, Sogroya pediatric extensions) and updated prescribing label references.

10+hGH products listed

9Initial approval groups

4Continuing approval groups

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

inv-01: Initial Therapy

Initial approval is organized into the following indication groups:

Initial Approval Categories: A. Growth Hormone Deficiency with Neonatal Hypoglycemia (off-label); B. Growth Hormone Deficiency with Short Stature/Growth Failure - Children (open epiphyses); C. Genetic Disorders with Short Stature/Growth Failure - Children; D. Chronic Kidney Disease with Growth Failure - Children; E. Born Small for Gestational Age with Short Stature/Growth Failure - Children; F. Idiopathic Short Stature - Children; G. Growth Hormone Deficiency - Adults and Transition Patients (closed epiphyses); H. HIV-Associated Wasting/Cachexia - Adults; I. Other diagnoses/indications

inv-02: Continuation Therapy

Continuing approval is organized into the following groups:

Continuation Approval Categories: A. All Pediatric Indications (open epiphyses); B. Growth Hormone Deficiency - Adults and Transition Patients (closed epiphyses); C. HIV-Associated Wasting/Cachexia - Adults; D. Other diagnoses/indications

inv-03: Initial Approval — Neonatal hypoglycemia due to GHD (pediatric, off-label)

Covered when ALL of the following are met

Neonatal GHD initial criteria: 1. Diagnosis of neonatal hypoglycemia due to GHD; 2. Request is for a somatropin formulation; 3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Age ≤ 1 month; 5. Serum GH concentration ≤ 5 µg/L; 6. Either imaging shows hypothalamic‑pituitary abnormality OR deficiency of ≥1 anterior pituitary hormone other than GH; 7. Requested product is not prescribed concurrently with Increlex (mecasermin); 8. If request is NOT for Norditropin or Humatrope then one of: a) member must use Norditropin and Humatrope; b) if both are unavailable use Omnitrope vial unless contraindicated/adverse effects; c) all three are contraindicated or cause significant adverse effects; 9. Dose does not exceed 0.30 mg/kg per week.

inv-04: Initial Approval — Pediatric GHD with short stature/growth failure

Covered when ALL of the following are met

Pediatric GHD criteria: 1. Diagnosis of GHD; 2. Prescribed by or in consultation with a pediatric endocrinologist; 3. Age < 18 years; 4. Skytrofa: age ≥1 year and weight ≥11.5 kg if requested; 5. Sogroya: age ≥2.5 years if requested; 6. Ngenla: age ≥3 years if requested; 7. If age >10 years, open epiphysis on x‑ray; 8. Low IGF‑I or low IGFBP‑3 serum level; 9. One of: a) two GH stimulation tests with peak ≤10 µg/mL; b) deficiency of ≥3 pituitary hormones; c) prior surgery or radiotherapy to hypothalamic‑pituitary region; d) imaging shows hypothalamic‑pituitary abnormality; e) GHD‑specific mutation; 10. Short stature or growth failure documented per policy (SS: >2 SD below mean with measurements within last 90 days; GF: defined growth velocity or deceleration criteria with required serial measurements); 11. Not prescribed concurrently with Increlex (mecasermin); 12. If request is NOT for Norditropin or Humatrope then preferred product pathway applies (Norditropin/Humatrope, or Omnitrope vial if shortages) unless contraindicated; 13. Dose limits by product: Ngenla 0.66 mg/kg once weekly; Skytrofa 0.24 mg/kg once weekly; Sogroya 0.16 mg/kg once weekly; somatropin agents up to 0.30 mg/kg per week.

inv-05: Initial Approval — Genetic disorders with short stature (PWS, TS, NS, SHOX deficiency) — Children

Covered when ALL of the following are met

Genetic short stature criteria: 1. Genetic test confirming PWS, TS, NS, or SHOX deficiency; 2. Request for somatropin formulation (or somapacitan for NS); 3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Age < 18 years; 5. If age >10 years, open epiphysis on x‑ray; 6. Short stature (>2 SD below mean; >1.5 SD if TS) OR growth failure per policy serial measurement criteria; 7. Not prescribed concurrently with Increlex (mecasermin); 8. Preferred product pathway applies if request is NOT for Norditropin or Humatrope (Norditropin/Humatrope, or Omnitrope vial if shortages) unless contraindicated; 9. Dose limits: for somatropin agents PWS ≤0.24 mg/kg/week; TS/NS ≤0.5 mg/kg/week; SHOX deficiency ≤0.35 mg/kg/week; Sogroya for NS ≤0.24 mg/kg once weekly.

inv-06: Initial Approval — Chronic Kidney Disease with growth failure — Children

Covered when ALL of the following are met

CKD pediatric criteria: 1. Diagnosis of chronic kidney disease (CKD); 2. Request is for a somatropin formulation; 3. Prescribed by or in consultation with a pediatric endocrinologist or nephrologist; 4. Age < 18 years; 5. If age >10 years, open epiphysis on x‑ray; 6. One of: GFR <60 mL/min/1.73 m2 for ≥3 months, dialysis dependence, nephropathic cystinosis, or history of kidney transplant ≥1 year; 7. Short stature (>2 SD below mean) or growth failure per serial measurement criteria; 8. Not prescribed concurrently with Increlex (mecasermin); 9. Preferred product pathway applies if request is NOT for Norditropin or Humatrope; 10. Dose does not exceed 0.35 mg/kg per week.

inv-07: Initial Approval — Born small for gestational age (SGA) — Children

Covered when ALL of the following are met

SGA criteria: 1. Diagnosis of small for gestational age (SGA); 2. Request for somatropin or somapacitan formulation; 3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Age ≥2 years and <18 years; 5. If age >10 years, open epiphysis on x‑ray; 6. Birth weight or length >2 SD below mean for gestational age (documentation required including gestational age); 7. Current height >2 SD below mean measured within last year; 8. Not prescribed concurrently with Increlex (mecasermin); 9. Preferred product pathway applies if request is NOT for Norditropin or Humatrope; 10. Dose limits: somatropin agents ≤0.48 mg/kg/week OR Sogroya ≤0.24 mg/kg once weekly.

inv-08: Initial Approval — Idiopathic short stature (ISS) — Children

Covered when ALL of the following are met

ISS pediatric criteria: 1. Diagnosis of idiopathic short stature (ISS); 2. Request for somatropin or somapacitan formulation; 3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Age < 18 years; 5. If age >10 years, confirmation of open epiphysis on x‑ray; 6. Height >2.25 SD below mean for age and sex (measurements within last 90 days) AND predicted adult height <63 in males or <59 in females; 7. Exclusion of short stature due to GHD, genetic disease, CKD, SGA and exclusion of familial short stature and constitutional delay of growth and puberty per policy; 8. Not prescribed concurrently with Increlex (mecasermin); 9. Preferred product pathway applies if request is NOT for Norditropin or Humatrope; 10. Dose limits: somatropin agents ≤0.5 mg/kg/week OR Sogroya ≤0.24 mg/kg once weekly.

inv-09: Initial Approval — Growth hormone deficiency — Adults and transition patients

Covered when ALL of the following are met

Adult/transition GHD criteria: 1. Diagnosis of growth hormone deficiency (GHD); 2. Request for somatropin, somapacitan, or lonapegsomatropin formulation; 3. Prescribed by or in consultation with an endocrinologist; 4. Age ≥18 years OR closed epiphysis on x‑ray; 5. Member has not received somatropin therapy for ≥1 month prior to GH/IGF‑I testing; 6. One of: a) two fasting a.m. GH stimulation tests with peak ≤5 µg/mL; b) one fasting a.m. GH stimulation test ≤5 µg/mL plus low IGF‑I; c) low IGF‑I plus imaging abnormality OR ≥3 pituitary hormone deficiencies OR GHD‑specific mutation; 7. Not prescribed concurrently with Increlex (mecasermin); 8. If request is NOT for Norditropin or Humatrope then preferred product pathway applies (Norditropin/Humatrope, or Omnitrope vial if shortages) unless contraindicated; 9. Dose limits: Sogroya 8 mg once weekly; somatropin agents ~0.4 mg/day with incremental adjustments (doses >1.6 mg/day uncommon); Skytrofa 6.3 mg once weekly.

inv-10: Initial Approval — HIV-associated wasting/cachexia — Adults

Covered when ALL of the following are met

HIV wasting criteria: 1. Diagnosis of HIV; 2. Request is for a somatropin formulation; 3. Prescribed by or in consultation with a physician specializing in HIV management; 4. Age ≥18 years; 5. One of: a) unintentional weight loss ≥10% in last 12 months while on antiretroviral therapy; b) unintentional weight loss ≥5% in last 6 months while on antiretroviral therapy; c) BMI ≤20 kg/m2; 6. Failure of ≥2 pharmacologic therapies from two separate drug classes unless contraindicated; 7. Member is currently on antiretroviral therapy; 8. Preferred product pathway applies if request is NOT for Norditropin or Humatrope; 9. Requested duration does not exceed 12 months; 10. Dose does not exceed 6 mg per day.

inv-11: Initial Approval — Other diagnoses/indications — limited circumstances

Covered under limited circumstances

Other uses: 1. If request is NOT for Norditropin or Humatrope then preferred product pathway applies (Norditropin/Humatrope, or Omnitrope vial if shortages) unless contraindicated or adverse effects; 2. If the drug had a recent label change within last 6 months not reflected in this policy, follow CP.CPA.190 formulary/non‑formulary routing as applicable; 3. If the requested use is not specifically listed under section III and criterion 2 does not apply, follow the off‑label use policy CP.CPA.09.

inv-12: Continued Therapy — Pediatric and Adult

Covered when ALL of the following are met for continuation

Pediatric continued therapy: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies; 2. Age <18 years OR open epiphysis on x‑ray; 3. Documented growth response: for neonatal hypoglycemia after ≥2 years therapy height increase ≥2 cm in last year documented by two height measurements ≤1 year apart; for other pediatric diagnoses height increase ≥2 cm in last year documented by two height measurements ≤1 year apart; 4. If dose increase requested, new dose must not exceed agent‑specific weekly maxima (Ngenla 0.66 mg/kg; Skytrofa 0.24 mg/kg; Sogroya up to 0.16 mg/kg for GHD or 0.24 mg/kg for Born SGA/NS/ISS; somatropin agents per indication up to listed maxima).

Adult continued therapy: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies; 2. Member is responding positively to therapy.

inv-13: Continued Therapy — Pediatric

Covered when ALL of the following are met:

Pediatric continued therapy (detailed): 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR enrolled in continuity of care state/product; 2) Age <18 years OR open epiphyses on x‑ray; 3) Height increase ≥2 cm in the last year documented by two height measurements taken no more than 1 year apart (dates and measurements required); 4) If dose increase requested, new dose must not exceed agent‑specific weekly maxima: Ngenla 0.66 mg/kg; Skytrofa 0.24 mg/kg; Sogroya 0.16 mg/kg for GHD (0.24 mg/kg for Born SGA/NS/ISS); somatropin agents: GHD up to 0.30 mg/kg/week; PWS 0.24 mg/kg/week; TS/NS/ISS up to 0.5 mg/kg/week; SHOX/CKD 0.35 mg/kg/week; Born SGA 0.48 mg/kg/week.

inv-14: Continued Therapy — Adult and Transition Patients

Covered when ALL of the following are met:

Adult/Transition continued therapy: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR enrolled in continuity of care state/product; 2) Member is responding positively to therapy; 3) IGF‑1 test conducted within last 90 days to guide dosing: a) if low IGF‑1 and dose increase requested, new dose must not exceed agent‑specific absolute limits (e.g., Sogroya 8 mg weekly; somatropin formulations incremental increase >0.2 mg/day with total ≤1.6 mg/day; Skytrofa 6.3 mg weekly); b) if IGF‑1 normal, requested dose is same or lower; c) if IGF‑1 elevated, dose has been titrated downward.

inv-15: Continued Therapy — HIV-associated wasting

Covered when ALL of the following are met:

HIV-associated wasting continued therapy: 1) Member is currently receiving medication via benefit or previously met initial approval criteria OR continuity of care applies; 2) Member is responding positively to therapy; 3) Member has not received ≥12 months of therapy; 4) If dose increase requested, new dose does not exceed 6 mg per day.

inv-16: Other Diagnoses/Indications — covered when BOTH criteria met

Covered when BOTH of the following are met:

Other diagnoses fallback: 1) If request is NOT for Norditropin or Humatrope then member must use Norditropin and Humatrope preferentially (or Omnitrope vial if those are unavailable) unless contraindicated or adverse effects occur; 2) If the drug has had a label change within last 6 months not reflected in this policy follow CP.CPA.190 formulary/non‑formulary routing OR if the requested use is not listed and criterion 2a does not apply refer to the off‑label use policy CP.CPA.09.

inv-17: Policy update criteria summary

Policy updates and indication‑specific notes:

Product/formulation updates: Added Ngenla, Skytrofa cartridge strengths and adult indication, Sogroya pediatric extensions and dosing updates; Sogroya pediatric contraindications updated in appendices.

Removals: Removed Zorbtive from policy due to market discontinuation; removed short bowel syndrome indication due to lack of AGA support.

HIV-associated wasting criteria revision: Updated HIV criteria to include unintentional weight loss ≥5% in the last 6 months while on antiretroviral therapy (in addition to ≥10% in 12 months or BMI ≤20 kg/m2) and removed ideal body weight criteria per 2024 consensus guidance.

Diagnoses and indications that are not authorized for coverage are collected in Section III of this policy. Providers should refer to Section III for the formal list of exclusions when preparing prior authorization requests or claims submissions.

Section III of the policy enumerates the diagnoses and indications for which coverage is NOT authorized. This section is the authoritative source for explicit non-covered uses and should be consulted when a requested indication is not described in the coverage criteria.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless there is sufficient supporting documentation consistent with the payer's off‑label use policy (CP.CPA.09). Examples of not-authorized non‑FDA uses include constitutional delay of growth and puberty, familial short stature, adult short stature or altered body habitus associated with antiviral therapy (other than HIV‑associated wasting/cachexia), and obesity or enhancement for non‑medical reasons.

The short bowel syndrome indication has been removed from this policy and is not authorized for coverage. This change was made following review and is documented in the policy update notes (removal due to lack of AGA guideline support).

As noted elsewhere, Section III lists diagnoses and indications that are not authorized for coverage; consult Section III to confirm whether a specific requested use is excluded.

The policy explicitly lists certain exclusions. Key examples include constitutional delay of growth and puberty, familial short stature, adult short stature or altered body habitus related to antiviral therapy (except for HIV‑associated wasting/cachexia), and obesity or enhancement of body mass/strength for non‑medical reasons.

Zorbtive has been removed from the policy because it is no longer on the market. Related coverage criteria for indications that were specific to Zorbtive (for example, short bowel syndrome) have been removed and are no longer supported by this policy.

Coding & Test Thresholds

Referenced HCPCS/CodesHCPCS

J2941	Injection, somatropin, 1 mg.
C9399	Unclassified drugs or biologics.
J3590	Unclassified biologics.

HIV-associated weight loss / BMI thresholds (HIV-associated wasting)

Unintentional weight loss (12 months)>= 10% unintentional weight loss in the last 12 months while on antiretroviral therapy

Unintentional weight loss (6 months)>= 5% unintentional weight loss in the last 6 months while on antiretroviral therapy

Body mass index (BMI)BMI <= 20 kg/m2

GH stimulation test thresholds for children and adults

Pediatric GH stimulation testingTwo GH stimulation tests with peak serum levels <= 10 µg/mL

Adult/Transition GH testing — option ATwo fasting a.m. GH stimulation tests with peak serum levels <= 5 µg/mL

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed human growth hormone (hGH) products. Providers must obtain prior authorization (PA) before dispensing therapies including somapacitan (Sogroya), somatrogon (Ngenla), somatropin products (e.g., Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Zomacton), lonapegsomatropin (Skytrofa), and others noted in policy.

PA required for listed hGH products and many somatropin formulations
Some products (Norditropin, Humatrope, Omnitrope) may have PA specifics or redirection rules

Documentation Required

Documentation Required to Avoid Denial

Providers must submit clinical documentation to demonstrate that the member meets all approval criteria. Failure to provide required supporting documentation may lead to denial.

Office chart notes, clinic visit notes, and consultation notes

Background

Human growth hormone formulations include both analogs and recombinant somatropin products and are used for pediatric growth failure from multiple etiologies and for replacement in adults with growth hormone deficiency. Specific products and their FDA‑approved age/indication limits are referenced throughout the policy and inform coverage determinations; providers should consult product prescribing information and the policy when preparing authorization requests.

Definitions & Abbreviations

Key abbreviations

CKDChronic kidney disease

GFGrowth failure

GHDGrowth hormone deficiency

HIVHuman immunodeficiency virus

ISSIdiopathic short stature

Open epiphyses definition / requirement

DefinitionOpen epiphyses: radiographic confirmation of open growth plates (x-ray) required for many pediatric indications when age > 10 years

Revision History

2026-03-16RT4 updateLatest

Sogroya label updated to add new pediatric indications for short stature born SGA, growth failure associated with Noonan syndrome, and idiopathic short stature.

2025-11-061Q 2026 annual review

Removed Zorbtive from the policy due to market discontinuation; removed criteria for short bowel syndrome due to lack of AGA support; for HIV-associated wasting added an option for unintentional weight loss ≥5% in the last 6 months while on antiretroviral therapy and removed ideal body weight criteria per 2024 consensus statement.