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Centene human growth hormone Prior Auth Update | OpenPayer

ModifiedCentenePolicy HIM.PA.161

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

Defines prior authorization requirements, indications, and approval criteria for multiple human growth hormone (hGH) formulations for pediatric and adult indications; applies to providers requesting coverage under Centene lines of business.

Policy Summary

PayerCentene

PolicyHuman Growth Hormone prior authorization and coverage (clinical/medical policy)

Policy CodePolicy HIM.PA.161

Change TypeMaterial updates — added product, removed discontinued product, revised HIV criteria, extended approval duration

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific documentation (growth metrics, labs, imaging) and evidence of prior trials when step therapy applies.

SourceLink

POLICY UPDATE CHANGES

Added Ngenla to the policy.

Removed Zorbtive from the policy due to market discontinuation.

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

Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition.

9+Distinct initial indication categories

4Continuing approval categories

12 monthsTypical approval duration

NC

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Coverage Criteria and Clinical Necessity

inv-01: Initial Therapy

Covered when the specific initial approval criteria for the listed diagnosis/indication are met and documentation is provided:

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

Detailed subcriteria per category are in subsequent sections of the policy not included in this chunk

inv-03: Initial Approval Criteria - overview

Covered when the specified indication-specific criteria are met for the chosen diagnosis group.

Initial indication groups: A through I (list of covered indication categories) as enumerated in section I

See individual indication nodes for detailed AND/OR logic

inv-04: A. GHD with Neonatal Hypoglycemia (off-label) - Initial

Covered when ALL of the following are met:

Neonatal GHD 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. One of: imaging showing hypothalamic-pituitary abnormality OR deficiency of ≥1 other anterior pituitary hormone; 7. The requested product is not prescribed concurrently with Increlex (mecasermin); 8. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, member must trial Norditropin, Humatrope, and Genotropin/Genotropin Miniquick (or Omnitrope vial/Zomacton if unavailable or contraindicated); 9. Dose does not exceed 0.30 mg/kg per week; 10. Approval duration: 12 months.

inv-05: B. GHD with Short Stature/Growth Failure - Children (open epiphyses) - Initial

Covered when ALL of the following are met:

Pediatric GHD eligibility: 1. Diagnosis of GHD; 2. Prescribed by or in consultation with a pediatric endocrinologist; 3. Age < 18 years; 4. Product-specific minimum age/weight when applicable (Skytrofa: ≥1 year and ≥11.5 kg; Sogroya: ≥2.5 years; Ngenla: ≥3 years); 5. If age > 10 years, open epiphysis on x-ray; 6. One of: low IGF‑I OR low IGFBP‑3; 7. One of: two GH stimulation tests with peak serum ≤10 µg/mL, OR deficiency of ≥3 pituitary hormones, OR prior hypothalamic-pituitary surgery/radiotherapy, OR imaging abnormality, OR GHD-specific mutation; 8. One of: short stature (height >2 SD below mean) with recent documentation OR growth failure per defined velocity/decile criteria with required measurements and timing; 9. The requested product is not prescribed concurrently with Increlex (mecasermin); 10. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, trial/step requirements apply (or Omnitrope vial/Zomacton if unavailable); 11. 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 0.30 mg/kg per week.

Required growth documentation (SD, heights, dates, ages in months) and test types/timeframes are specified in policy chunks 22–24.

inv-06: C. Genetic Disorders with Short Stature/Growth Failure - Children

Covered when ALL of the following are met:

Genetic short stature eligibility: 1. Genetic confirmation of 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. One of: short stature (>2 SD below mean; >1.5 SD if TS) OR growth failure per defined metrics with required measurement timing; 7. The requested product is not prescribed concurrently with Increlex (mecasermin); 8. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, trial/step requirements apply (or Omnitrope vial/Zomacton if unavailable); 9. Dose limits: for somatropin agents PWS ≤0.24 mg/kg/week; TS/NS ≤0.5 mg/kg/week; SHOX ≤0.35 mg/kg/week; Sogroya for NS ≤0.24 mg/kg once weekly.

inv-07: D. Chronic Kidney Disease with Growth Failure - Children

Covered when ALL of the following are met:

CKD 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 OR dialysis-dependent OR nephropathic cystinosis OR history of kidney transplant ≥1 year; 7. One of: short stature (>2 SD) OR growth failure per defined metrics with required measurement timing; 8. The requested product is not prescribed concurrently with Increlex (mecasermin); 9. Dose does not exceed 0.35 mg/kg per week; 10. Step therapy provisions apply if not requesting preferred products.

inv-08: E. 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 is for a 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); 7. Current height >2 SD below mean measured within the last year (documentation required); 8. The requested product is not prescribed concurrently with Increlex (mecasermin); 9. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, trial/step requirements apply (or Omnitrope vial/Zomacton if unavailable); 10. Dose limits: somatropin agents up to 0.48 mg/kg/week OR Sogroya up to 0.24 mg/kg once weekly.

inv-09: F. Idiopathic Short Stature (ISS) - Children

Covered when ALL of the following are met:

ISS criteria: 1. Diagnosis of idiopathic short stature (ISS); 2. Request is for a somatropin or somapacitan formulation; 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. Member meets both: height >2.25 SD below mean (documentation within 90 days) AND predicted adult height <63 inches (males) or <59 inches (females); 7. Exclusion of GHD, genetic disease, CKD, SGA, familial short stature, and constitutional delay; 8. The requested product is not prescribed concurrently with Increlex (mecasermin); 9. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, trial/step requirements apply (or Omnitrope vial/Zomacton if unavailable); 10. Dose limits: somatropin agents up to 0.5 mg/kg/week OR Sogroya up to 0.24 mg/kg once weekly.

inv-10: G. Growth Hormone Deficiency - Adults and Transition Patients (closed epiphyses)

Covered when ALL of the following are met:

Adult/transition GHD criteria: 1. Diagnosis of GHD; 2. Request is for a 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: two fasting a.m. GH stimulation tests peak ≤5 µg/mL OR one fasting a.m. GH stimulation test peak ≤5 µg/mL plus one low IGF‑I OR one low IGF‑I plus imaging abnormality OR ≥3 pituitary hormone deficiencies OR GHD-specific mutation; 7. The requested product is not prescribed concurrently with Increlex (mecasermin); 8. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, trial/step requirements apply (or Omnitrope vial/Zomacton if unavailable); 9. Dose limits: Sogroya 8 mg once weekly; somatropin agents ~0.4 mg/day with titration up to ~1.6 mg/day uncommon beyond that; Skytrofa 6.3 mg once weekly.

inv-11: H. 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: unintentional weight loss ≥10% in last 12 months while on antiretroviral therapy OR unintentional weight loss ≥5% in last 6 months while on antiretroviral therapy OR BMI ≤20 kg/m2; 6. Failure of at least 2 pharmacologic therapies from two separate drug classes unless contraindicated; 7. Member is currently on antiretroviral therapy; 8. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, trial/step requirements apply (or Omnitrope vial/Zomacton if unavailable); 9. Requested duration does not exceed 12 months; 10. Dose does not exceed 6 mg per day.

inv-12: I. Other diagnoses/indications

Covered when the following are met:

Other uses: 1. If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, trial/step requirements apply (or Omnitrope vial/Zomacton if unavailable); 2. If recent label change within 6 months not reflected in this policy, navigate to formulary/no-coverage or non-formulary policies (HIM.PA.33 or HIM.PA.103) or off-label policy HIM.PA.154 as applicable; 3. Approval duration up to 12 months total.

inv-13: Initial therapy — HIV-associated wasting/cachexia

HIV-associated wasting/cachexia (initial therapy): covered when ALL of the following are met

HIV-wasting-initial: Member meets one of: unintentional weight loss ≥10% in last 12 months on ART, or ≥5% in last 6 months on ART, or BMI ≤20 kg/m2.

previous_treatment: Failure of at least 2 pharmacologic therapies from two separate drug classes unless contraindicated.

on_ART: Member is currently on antiretroviral therapy.

product_step: If request is not for Norditropin/Humatrope/Genotropin/Genotropin Miniquick, member must have used Norditropin, Humatrope, and Genotropin/Genotropin Miniquick unless contraindicated; if unavailable, use Omnitrope vial or Zomacton.

inv-02: Continuation Therapy

Covered renewals subject to meeting continuing approval criteria:

Continuing Approval Categories: II.A All Pediatric Indications (open epiphyses); II.B Growth Hormone Deficiency - Adults and Transition Patients (closed epiphyses); II.C HIV-Associated Wasting/Cachexia - Adults; II.D Other diagnoses/indicationsrefer to full policy for clinical metrics and monitoring intervals

Continuation-specific lab/height/response criteria not provided in this excerpt

inv-14: Continued therapy — Pediatric

Continued therapy — Pediatric indications (open epiphyses): covered when ALL of the following are met

continuity_or_prior: Member currently receiving medication via Centene or previously met initial approval criteria, or continuity of care applies.

age_or_epiphysis: Age < 18 years OR open epiphysis on x-ray.

height_response: For neonatal hypoglycemia: after ≥2 years of somatropin, height has increased ≥2 cm in the last year documented by two measurements; for all other pediatric diagnoses: height has increased ≥2 cm in the last year documented by two measurements (dates and values required).

dose_increase_limits: If request is for a dose increase, new dose must not exceed formulation-specific weekly limits: Ngenla ≤0.66 mg/kg once weekly; Skytrofa ≤0.24 mg/kg once weekly; Sogroya ≤0.16 mg/kg once weekly for GHD (or ≤0.24 mg/kg once weekly for Born SGA/NS/ISS indications); somatropin agents per indication up to specified mg/kg/week limits (e.g., 0.30–0.50 mg/kg/week).

inv-15: Continued therapy — Adult and transition GHD

Continued therapy — Adult and transition GHD (closed epiphyses): covered when ALL of the following are met

continuity_or_prior_adult: Member currently receiving medication via Centene or previously met initial approval criteria, or continuity of care applies.

positive_response: Member is responding positively to therapy.

IGF1_and_dosing: IGF‑1 test within 90 days: if low and request is for a dose increase, new dose does not exceed product-specific limits (Sogroya 8 mg once weekly; somatropin formulations incremental increases >0.2 mg/day with total doses >1.6 mg/day uncommon; Skytrofa 6.3 mg once weekly). If IGF‑1 normal, requested dose is same or lower; if elevated, dose has been titrated downward.

inv-16: Continued therapy — HIV-associated wasting/cachexia (adults)

Continued therapy — HIV-associated wasting/cachexia (adults): covered when ALL of the following are met

continuity_or_prior_HIV: Member currently receiving medication via Centene or previously met initial approval criteria, or continuity of care applies.

positive_response_HIV: Member is responding positively to therapy.

treatment_duration_limit: Member has not received ≥12 months of therapy.

dose_increase_limit_HIV: If request is for a dose increase, new dose does not exceed 6 mg per day.

inv-17: Other diagnoses/indications

Other diagnoses/indications (initial or continued): covered when BOTH conditions are met

product_step_other: If request is NOT for Norditropin, Humatrope, Genotropin, or Genotropin Miniquick, member must have used Norditropin, Humatrope, and Genotropin/Genotropin Miniquick unless contraindicated; if unavailable, use Omnitrope vial or Zomacton.

policy_navigation: If the drug has undergone a recent label change within the last 6 months not reflected in this policy, follow the formulary/no-coverage policy (HIM.PA.33) or non-formulary policy (HIM.PA.103) as appropriate; if the requested use is not listed in section III and criterion 2a does not apply, refer to off-label policy HIM.PA.154.

inv-18: Selected Dosing and Coverage Criteria (partial, from this document segment)

Coverage and dosing guidance by product and indication (selected examples present in this portion of the document).

Pediatric PWS dosing: Genotropin, Norditropin, Omnitrope indicated for PWS at 0.24 mg/kg/week (maximum 0.24 mg/kg/week)0.24 mg/kg/week

chunk 54

SGA dosing (selected products): Genotropin, Humatrope, Norditropin for SGA: some products up to 0.48 mg/kg/week (max 0.48 mg/kg/week)0.48 mg/kg/week

chunk 54

TS dosing (selected products): Genotropin, Humatrope, Norditropin, Nutropin dosing ranges vary by product (examples: 0.33–0.47 mg/kg/week depending on product)see regimens

This policy defines the initial approval framework for human growth hormone (hGH) therapies. Coverage for initial therapy is provided when the member meets the specific indication‑ and product‑level criteria enumerated in Section I (A–I) and appropriate clinical documentation is submitted. The initial categories include neonatal GHD with hypoglycemia, pediatric GHD and other pediatric growth failure conditions (genetic disorders, CKD, SGA, ISS), adult and transition GHD, HIV‑associated wasting/cachexia, and other diagnoses/indications. Detailed subcriteria (diagnosis confirmation, required tests, age/weight limits, stepwise product redirection, and dosing thresholds) are specified within each indication’s criteria in the full policy.

Continued therapy (renewal) approvals are governed by Section II. Continuation categories mirror the initial groups and include: All Pediatric Indications (open epiphyses), Growth Hormone Deficiency — Adults and Transition Patients (closed epiphyses), HIV‑Associated Wasting/Cachexia — Adults, and Other diagnoses/indications. Renewals require documentation of prior approval or current receipt of therapy and evidence of clinical response or pre‑specified monitoring (for example, documented height velocity in children or IGF‑1 monitoring in adults) as described in the continuation criteria.

Section III lists diagnoses and indications that are not authorized for coverage. Examples explicitly included in that section are constitutional delay of growth and puberty, familial (genetic) short stature, adult short stature or altered body habitus associated with antiviral therapy (other than HIV‑associated wasting/cachexia), and obesity treatment or non‑medical enhancement of body mass/strength. The full list of non‑covered indications and the off‑label evaluation process are described in Section III and related policy references.

Short bowel syndrome (SBS) criteria were removed from this policy during the 1Q 2026 review after consideration of available guidance; the policy states SBS criteria were removed due to lack of support by the American Gastroenterological Association (AGA).

Coverage determinations under this clinical policy remain subject to the member’s applicable coverage documents and to law. Providers should note that coverage decisions are applied within the terms, conditions, exclusions, and limitations of the member’s evidence of coverage, certificate of coverage, policy, or contract; discrepancies between plan documents and this policy are governed by applicable legal or regulatory requirements.

The policy references a Section III containing diagnoses/indications considered not medically necessary (NMN), but the explicit, itemized NMN list is located in that section of the full policy. Where a requested use is not listed in Section I and is not specifically addressed in Section III, the request should be evaluated per the off‑label/non‑formulary guidance referenced (e.g., HIM.PA.154, HIM.PA.33, HIM.PA.103) as applicable.

When a requested use is not an FDA‑approved indication covered within Section I, or is otherwise not listed in Section III, providers must follow the policy’s off‑label evaluation pathway. Non‑FDA approved uses that are not specifically addressed by this policy are not authorized unless sufficient clinical documentation of safety and efficacy is provided in accordance with the plan’s off‑label use policy (HIM.PA.154) or other applicable formulary/non‑formulary guidance.

Per the off‑label policy HIM.PA.154, non‑FDA indications are not authorized without adequate supporting documentation. The clinical policy reiterates that requests for uses not listed in Section I should be considered under off‑label or non‑formulary policies and may be denied if the required evidence is not provided. Failure to document meeting the off‑label policy requirements may result in non‑authorization.

Criteria clarifications are included in policy updates and may affect coverage decisions. Examples of potential noncoverage or denial triggers include failure to meet indication‑specific clinical metrics (for example, pediatric ISS height/predicted height requirements or adult positive response criteria for continuation), not following required stepwise redirection to preferred products, or exceeding dosing thresholds. The policy history documents material changes such as removal of Zorbtive, removal of SBS criteria, addition of Ngenla, expansion of HIV wasting weight‑loss options, and extension of initial approval duration — all of which impact interpretation and application of the coverage criteria.

Products, Dosing Limits, and Codes

Products requiring prior authorization (product-level group)mixed

HCPCS/NDC unspecified

hGH analogs: somapacitan-beco (Sogroya), somatrogon-ghla (Ngenla); rhGH formulations: somatropin (Genotropin, Humatrope, Norditropin, Nutropin AQ NuSpin, Omnitrope, Saizen, Serostim, Zomacton), lonapegsomatropin-tcgd (Skytrofa)

Referenced products (no explicit codes in excerpt)mixed

NDCs not listed

Referenced products include Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Zomacton, Skytrofa, Sogroya, Ngenla, Serostim (NDCs and specific billing codes not enumerated in this excerpt)

HCPCS Codes referencedHCPCS

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

age/weight thresholds per product

Skytrofa (lonapegsomatropin)Pediatric: age ≥1 year AND weight ≥11.5 kg

Sogroya (somapacitan)Pediatric: age ≥2.5 years

Ngenla (somatrogon)Pediatric: age ≥3 years

Serostim (for HIV wasting)Adults only: age ≥18 years

General somatropin formulations (Genotropin, Humatrope, Norditropin, etc.)Pediatric: age <18 years (product-specific minimums apply); Adult: age ≥18 years

GH stimulation test peak levels

Prior Authorization Steps, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for all listed human growth hormone (hGH) products. Providers must submit clinical documentation (office notes, lab results, radiographic reports) demonstrating that the member meets the specific indication criteria.

Affected products include somapacitan (Sogroya), somatrogon (Ngenla), somatropin products (Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Zomacton), and lonapegsomatropin (Skytrofa).
Prior authorization may also be required for Norditropin, Humatrope, Genotropin, Genotropin Miniquick, Omnitrope vial, and Zomacton per policy notes.

Step Therapy

Prior Authorization and Step Therapy Requirements

Step therapy and product-preference requirements apply when requests are not for specified preferred agents. Providers must document trials of preferred products or document clinical justification for bypass (adverse effects, contraindications, or drug shortages).

Preferred agents to trial: Norditropin, Humatrope, Genotropin or Genotropin Miniquick.

Definitions and Abbreviations

Abbreviations

CKDchronic kidney disease

GHDgrowth hormone deficiency

IGF-1insulin-like growth factor-1

IGFBP-3insulin-like growth factor binding protein-3

ISSidiopathic short stature

PWSPrader-Willi syndrome

Open epiphyses / closed epiphyses

Clinical Background

Human growth hormone (hGH) therapies covered by this policy include multiple recombinant somatropin products and long‑acting hGH analogs. These agents are indicated across pediatric growth failure conditions and for replacement in adult growth hormone deficiency; select products (for example, Serostim) have an indication for HIV‑associated wasting/cachexia. Products referenced in the policy include daily somatropin formulations and weekly long‑acting agents (e.g., Skytrofa, Sogroya, Ngenla) and a range of branded somatropin preparations. Prior authorization is required for these products, and coverage is contingent on meeting the indication‑specific initial or continuation criteria described in the policy.

Policy Revision History and Material Changes

2022-10-11annual_review/clarification

1Q 2022 annual review: clarified ISS height requirements; added adult GHD continuation requirement that member is responding positively to therapy; applied template/format changes and added Sogroya 5 mg/1.5 mL formulation.

2023-02-23policy_update

Per 1Q 2023 review: updated Humatrope FDA indication and added requirement that members with HIV-associated wasting be currently on antiretroviral therapy; added redirection to Humatrope and additional stepwise redirection to Omnitrope vial when Norditropin and Humatrope are unavailable.

2025-11-06material_change