CurrentCentenePolicy HIMPA.161

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

Coverage and prior authorization criteria for recombinant human growth hormone products (somatropin and long-acting analogs including somapacitan/Sogroya, somatrogon/Ngenla, lonapegsomatropin/Skytrofa and various somatropin brands) across pediatric and adult indications, dosing limits, required prescribers, documentation and disallowed indications for Centene-affiliated health plans.

Policy Summary

PayerCentene

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

Policy CodePolicy HIMPA.161

Change TypeMultiple additions and dosing/criteria updates (e.g., added Ngenla, Skytrofa; Sogroya label updates)

Effective DateJan 1, 2022

Next Review Date

Key ActionProvider must obtain prior authorization and submit supporting documentation (office notes, labs, imaging, genetic tests, growth chart measurements) for somatropin and specified long-acting GH products.

POLICY UPDATE CHANGES

Added Ngenla to policy.

Added Skytrofa to policy and updated references; added Genotropin/Genotropin Miniquick as CO-preferred with Norditropin and Humatrope, and redirection to Zomacton if shortages.

For HIV-associated wasting/cachexia, added options for meeting criteria based on weight or BMI.

RT4: per updated label for Sogroya added pediatric extension for GHD and new strength; added Sogroya-specific pediatric age limit, dosing, and Appendix C contraindications.

1Q 2025 annual review: no significant changes; references reviewed and updated.

9Initial approval indication groups

6Continued therapy groups

Diagnoses NOT authorized (listed)

MultipleProducts listed

3HCPCS/unclassified codes listed

Coverage Summary

This policy (HIMPA.161) is a Centene coverage criteria for Human Growth Hormone products, effective 01.01.22 with last review on 02.25. The subject is Human Growth Hormone (hGH) and the policy status is CURRENT. Coverage stance: covered_with_criteria. Prior authorization is required and providers must submit supporting documentation per the policy. The policy scope covers recombinant human growth hormone (somatropin) formulations and long-acting GH analogs including somapacitan (Sogroya), somatrogon (Ngenla), and lonapegsomatropin (Skytrofa), with specified indication- and product-specific criteria and limits.

Quick thresholds & dosing caps

GH stimulation test — childrenTwo stimulation tests with peak serum GH < 10 µg/mL

GH stimulation test — adultsTwo fasting a.m. stimulation tests with peak serum GH < 5 µg/mL (one test acceptable for SBS)

IGF‑I testing windowIGF‑I test for dosing/continuation must be conducted within the last 90 days

Pediatric continued therapy height responseHeight increase ≥ 2 cm in the last year documented by 2 measurements ≤ 1 year apart

Sogroya (somapacitan) weekly dose cap0.16 mg/kg once weekly (adult regimen referenced as up to 8 mg once weekly maximum)

Ngenla (somatrogon) weekly dose cap0.66 mg/kg once weekly (maximum 0.66 mg/kg/week)

Skytrofa (lonapegsomatropin) weekly dose cap0.24 mg/kg per week

Somatropin agents weekly dose cap (children)Generally ≤ 0.30 mg/kg per week for somatropin agents (product/indication‑specific maxima vary)

Initial Medical Necessity Criteria

Initial Approval Criteria - General

Prior authorization is required and provider must submit supporting documentation. The requested product must be a somatropin formulation unless otherwise specified.

Top-level eligible diagnosis groups (any): Neonatal hypoglycemia due to GHD; Pediatric GHD with short stature/growth failure (open epiphyses); Genetic disorders with short stature/growth failure (PWS, TS, NS, SHOX deficiency); Chronic kidney disease with growth failure (children); Born small for gestational age (SGA) with short stature/growth failure (children); Idiopathic short stature (ISS) (children); Growth hormone deficiency - adults and transition patients (closed epiphyses); Short bowel syndrome (SBS) - adults; HIV-associated wasting/cachexia - adults; Other diagnoses/indications (see off-label policy references).

Provider must submit documentation such as office notes, labs, imaging, genetic tests and growth chart measurements per policy requirements.

A. Growth Hormone Deficiency with Neonatal Hypoglycemia (off-label)

Must meet ALL of the following:

ALL of the following

Continued Therapy / Renewal Criteria

Diagnoses / Indications NOT Authorized

Diagnoses/Indications NOT authorized

Coverage is NOT authorized for the following diagnoses/indications unless the request is for an FDA‑approved indication or an off‑label use that is explicitly supported by the plan's off‑label coverage policy (see HIM.PA.154).

Constitutional delay of growth and puberty (constitutional short stature)

Familial short stature

Obesity or use for weight loss / cosmetic enhancement

Adult short stature not related to HIV‑associated wasting/cachexia or not meeting FDA‑approved adult GHD criteria

Other non‑FDA indications unless supported by HIM.PA.154

Coding

Products referenced (drug names - clinical list, not exhaustive billing codes in this part)mixed

Somapacitan	Sogroya (long-acting GH analog)
Somatrogon	Ngenla (long-acting GH analog)
Lonapegsomatropin	Skytrofa (long-acting GH analog)
Somatropin	Multiple brands: Genotropin, Norditropin, Humatrope, Omnitrope, Nutropin, Saizen, Zomacton, Zorbtive, Serostim

HCPCS / Misc coding referencedHCPCS/mixed

J2941
C9399	Unclassified drugs or biologics
J3590	Unclassified biologics

Billing Rule

Use appropriate HCPCS for somatropin

When billing for somatropin products, the policy references specific HCPCS/unclassified codes as informational only. Codes listed include J2941, C9399, and J3590; inclusion of these codes does not guarantee coverage and providers should follow current coding guidance.

J2941
C9399 (Unclassified drugs or biologics)
J3590 (Unclassified biologics)

Provider Actions / Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for somatropin and specified long‑acting GH products. Obtain PA before therapy and submit supporting documentation such as office chart notes, laboratory results, imaging reports, genetic test results, and growth chart measurements to demonstrate criteria are met.

Documentation Required

Required documentation for pediatric growth criteria

Provide SD/height/date/age (in months) within the required windows (e.g., within the last 90 days) and serial height measurements with dates and ages spaced as specified by indication: two heights ≥6 months apart within the last year for certain percentile decelerations, two heights ≥1 year apart within the last year for 1‑year velocity assessments, or two heights ≥2 years apart within the last two years for sustained 2‑year velocity assessments.

Background and Evidence

This Centene clinical policy defines medical necessity and prior authorization requirements for multiple recombinant human growth hormone formulations and long-acting analogs across pediatric and adult indications. It incorporates diagnostic testing thresholds (e.g., GH stimulation test peaks of 10 ug/mL in children and 5 ug/mL in adults where specified), growth metrics and short stature/growth failure definitions (WHO/CDC SD-based height and growth velocity thresholds), prescriber specialty requirements (pediatric endocrinologist for most pediatric indications; endocrinologist for adult GHD; gastroenterologist for SBS; HIV specialist for HIV-associated wasting), and product-specific dosing limits and age/weight restrictions (examples: Skytrofa pediatric age ≥ 1 year and weight ≥ 11.5 kg with dose ≤ 0.24 mg/kg/week; Ngenla pediatric age ≥ 3 years with dose ≤ 0.66 mg/kg/week; Sogroya pediatric age ≥ 2.5 years and adult weekly dosing up to 8 mg once weekly; somatropin agents pediatric limits typically ≤ 0.30 mg/kg/week, adult somatropin daily dosing ~ 0.4 mg/day with titration and upper guidance).

Evidence / Reference	Details
Primary guideline citation
Fleseriu M et al., Endocrine Society guideline (2016) cited for adult dosing/regimen adjustments
Product labeling updated
Genotropin Prescribing Information August 2024; Humatrope December 2023; Ngenla June 2023; additional labels listed with access dates Nov 1, 2024

Definitions / Abbreviations

Term	Definition
GF
growth failure
GHD
growth hormone deficiency
IGF-I
insulin-like growth factor-I
IGFBP-3
insulin-like growth factor binding protein-3
SGA
small for gestational age
PWS
Prader-Willi syndrome
TS
Turner syndrome
NS
Noonan syndrome
SHOX
short stature homeobox-containing gene deficiency
ISS
idiopathic short stature
SBS
short bowel syndrome
SD
abbreviation used in document context; likely single-dose
MD
multidose

Revision History

07.06.23RT4 - added product

RT4: added Ngenla to policy.

05.17.23RT4 - label update

RT4: per updated Sogroya label added pediatric extension for GHD, new strength, Sogroya-specific pediatric age limit, dosing, and Appendix C contraindications.

02.241Q 2024 annual review / policy revision

1Q 2024 annual review: for HIV-associated wasting/cachexia added options to meet criteria based on weight or BMI.

Policy Summary

PayerCentene

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

Policy CodePolicy HIMPA.161

Change TypeMultiple additions and dosing/criteria updates (e.g., added Ngenla, Skytrofa; Sogroya label updates)

Effective DateJan 1, 2022

Next Review Date

On This Page

Request is for a somatropin formulation

Prescribed by or in consultation with a pediatric endocrinologist

Serum GH concentration < 5 ug/L< 5 ug/L

Imaging shows hypothalamic-pituitary abnormality

imaging supportive

One of: Evidence of additional pituitary hormone deficiency or other qualifying endocrine findings

Deficiency of ≥1 anterior pituitary hormone other than GH (e.g., ACTH, TSH, LH, FSH, prolactin) or other qualifying endocrine findings per chart documentation

Requested product is not prescribed concurrently with Increlex (mecasermin)

B. Growth Hormone Deficiency with Short Stature/Growth Failure - Children (open epiphyses)

Must meet ALL of the following:

ALL of the following

Diagnosis of GHD
Prescribed by or in consultation with a pediatric endocrinologist
Age < 18 years
Age/product specific requirements
If request is for Sogroya: age ≥ 2.5 years; Skytrofa: age ≥ 1 year and weight ≥ 11.5 kg; Ngenla: age ≥ 3 years; if age > 10 years, open epiphysis on X-ray
Diagnostic evidence (one of): One of: Low IGF-I; Low IGFBP-3; OR other diagnostic evidence
Other evidence includes two GH stimulation tests with peak < 10 ug/mL; prior surgery/radiotherapy to hypothalamic-pituitary region; deficiency of ≥3 pituitary hormones; imaging showing hypothalamic-pituitary abnormality; or GHD-specific mutation
Short stature or growth failure criteria (one of): Short stature or growth failure definitions
Short stature: height > 2 SD below mean for age/sex (SD, height, date, age in months within last 90 days required). Growth failure (GF): height deceleration across two growth chart percentiles representing >1 SD below mean (two measurements ≥6 months apart within last year) OR growth velocity 2 SD below mean over 1 year (two measurements ≥1 year apart within last year) OR growth velocity 1.5 SD below mean sustained over 2 years (two measurements ≥2 years apart within last two years). If GF option used, member must meet one of the growth velocity criteria.
Requested product is not prescribed concurrently with Increlex (mecasermin)
Product substitution requirement (if not requesting Norditropin/Humatrope/Genotropin/Genotropin Miniquick): Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects or contraindications; if unavailable (e.g., shortages), use Omnitrope vial or Zomacton unless adverse effects/contraindications
Dose limit - one of product-specific limits: Dose limits
For Skytrofa: ≤ 0.24 mg/kg/week; Ngenla: ≤ 0.66 mg/kg/week; Sogroya: ≤ 0.16 mg/kg/week; somatropin agents: ≤ 0.30 mg/kg/week

Genetic Disorders with Short Stature/Growth Failure - Children

Must meet ALL of the following:

ALL of the following

Diagnosis of PWS, TS, NS, or SHOX deficiency confirmed by genetic test
Request is for a somatropin formulation
Prescribed by or in consultation with a pediatric endocrinologist
Age < 18 years
If age > 10 years, open epiphysis on X-ray
Short stature or growth failure criteria (one of): Short stature or growth failure definitions
Short stature: height >2 SD below mean for age/sex (1.5 SD if TS); or GF defined by height deceleration or velocity criteria as in pediatric GHD
Requested product is not prescribed concurrently with Increlex (mecasermin)
Product substitution requirement: Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects or contraindications; if unavailable due to shortages, use Omnitrope vial or Zomacton
Dose limits by genetic diagnosis: Dose limits vary by diagnosis
PWS: ≤ 0.24 mg/kg/week; TS and NS: ≤ 0.5 mg/kg/week; SHOX deficiency: ≤ 0.35 mg/kg/week

Chronic Kidney Disease (CKD) with Growth Failure - Children

Must meet ALL of the following:

ALL of the following

Diagnosis of CKD
Request is for a somatropin formulation
Prescribed by or in consultation with a pediatric endocrinologist or nephrologist
Age < 18 years
If age > 10 years, open epiphysis on X-ray
CKD disease criteria (one of): One of: GFR ≤ 60 mL/min/1.73 m2 for ≥ 3 months; dialysis dependent; diagnosis of nephropathic cystinosis
One of transplant/history criteria: History of kidney transplant ≥ 1 year ago
Short stature or growth failure criteria: Short stature: height ≥ 2 SD below mean for age/sex or GF defined by growth deceleration/velocity criteria (documentation windows as specified)
SD/height/date/age within last 90 days required; serial measurements per velocity criteria
Requested product is not prescribed concurrently with Increlex (mecasermin)
Product substitution requirement: Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects or contraindications; if unavailable, use Omnitrope vial or Zomacton
Dose does not exceed 0.35 mg/kg per week≤ 0.35 mg/kg/week

E. Born Small for Gestational Age (SGA) with Short Stature/Growth Failure - Children

Must meet ALL of the following:

ALL of the following

Diagnosis of SGA
Request is for a somatropin formulation
Prescribed by or in consultation with a pediatric endocrinologist
Age < 18 years
If age > 10 years, open epiphysis on X-ray
Birth weight or length ≥ 2 SD below the mean for gestational age (SD, birth weight/length, and gestational age required)≥ 2 SD below mean
Current height ≥ 2 SD below mean for age and sex measured within the last year at ≥ 2 years of age (SD/height/date/age required)≥ 2 SD below mean
Requested product is not prescribed concurrently with Increlex (mecasermin)
Product substitution requirement: Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects/contraindications; if unavailable, use Omnitrope vial or Zomacton
Dose does not exceed 0.48 mg/kg per week≤ 0.48 mg/kg/week

F. Idiopathic Short Stature (ISS) - Children

Must meet ALL of the following:

ALL of the following

Diagnosis of ISS
Request is for a somatropin formulation
Prescribed by or in consultation with a pediatric endocrinologist
Age < 18 years
If age > 10 years, confirmation of open epiphysis on X-ray
Height and predicted adult height criteria: Height ≥ 2.25 SD below mean for age/sex (SD/height/date/age within last 90 days required) AND predicted adult height ≤ 63 inches for males and < 59 inches for femalesHeight ≤ -2.25 SD; predicted height thresholds
Rule-outs: Familial (genetic) short stature, short stature related to GHD/genetic disease/CKD/SGA, and constitutional delay of growth and puberty must be ruled out
Examples: bone age and parental heights as documented
Requested product is not prescribed concurrently with Increlex (mecasermin)
Product substitution requirement: Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects/contraindications; if unavailable, use Omnitrope vial or Zomacton
Dose does not exceed 0.30 mg/kg per week≤ 0.30 mg/kg/week

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

Must meet ALL of the following:

ALL of the following

Diagnosis of GHD
Request is for a somatropin or somapacitan formulation
Prescribed by or in consultation with an endocrinologist
Diagnostic testing (one of): Diagnostic testing for adults
Two fasting a.m. GH stimulation tests with peak < 5 ug/mL (accepted stimulants include macimorelin [Macrilen] or combination of two stimulants such as arginine + glucagon) OR one low IGF-I plus imaging showing hypothalamic-pituitary abnormality or deficiency of ≥3 pituitary hormones
Age ≥ 18 years OR closed epiphysis on X-ray
Requested product is not prescribed concurrently with Increlex (mecasermin)
Product substitution requirement: Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects/contraindications; if unavailable, use Omnitrope vial or Zomacton
Dose limits (one of): Adult dose limits and Sogroya-specific dosing
For Sogroya: 8 mg once weekly; for somatropin agents: dose does not exceed 0.4 mg/day (may adjust by 0.2 mg/day every 4-6 weeks to maintain normal IGF-I; doses >1.6 mg/day would be uncommon)

H. Short Bowel Syndrome (SBS) - Adults

Must meet ALL of the following:

ALL of the following

Diagnosis of SBS
Request is for a somatropin formulation
Prescribed by or in consultation with a gastroenterologist
Age ≥ 18 years
Patient is dependent upon and receiving intravenous nutrition
Product substitution requirement: Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects/contraindications; if unavailable, use Omnitrope vial or Zomacton
One fasting a.m. GH stimulation test with peak serum level < 5 ug/mL (accepted stimulants: Macrilen or combination such as arginine + glucagon)< 5 ug/mL
Dose does not exceed & mg per day (policy indicates an upper daily limit placeholder to be confirmed)
Placeholder for daily cap (confirm actual cap in product-specific section)

HIV-Associated Wasting/Cachexia - Adults

Must meet ALL of the following:

ALL of the following

Diagnosis of HIV
Request is for a somatropin formulation
Prescribed by or in consultation with a physician specializing in HIV management
Age ≥ 18 years
One of the weight/BMI criteria: One of: Unintentional weight loss ≥ 10% in last 12 months while on antiretroviral therapy; BMI < 20 kg/m2; Weight ≤ 90% of the lower limit of ideal body weight
Policy requires member currently on antiretroviral therapy
Failure of at least 2 pharmacologic therapies from two separate classes unless contraindicated or adverse effects (see Appendix B)
Product substitution requirement: Step therapy / product substitution
Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects/contraindications; if unavailable, use Omnitrope vial or Zomacton
Dose does not exceed 6 mg per day≤ 6 mg/day

J. Other diagnoses/indications

Must meet ALL of the following general requirements and referral rules:

ALL of the following

Product substitution requirement: Member must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless adverse effects or contraindications; if unavailable due to shortages, use Omnitrope vial or Zomacton
Prior authorization may be required for Norditropin, Humatrope, Genotropin, Genotropin Miniquick, Omnitrope, and Zomacton
If drug had a recent label change or is non-formulary, follow HIM.PA.33, HIM.PA.103, or HIM.PA.154 as applicable; for off-label uses not listed, refer to off-label use policy HIM.PA.154

Denial Risk

Non-covered indications risk

Claims submitted for the indications listed above are subject to denial unless documentation demonstrates the indication is an FDA‑approved use or is supported under the plan’s off‑label coverage policy (HIM.PA.154). Refer to product labeling and clinical guidelines when preparing documentation to support medical necessity.

Documentation Required

Endocrine testing documentation

Include endocrine testing details: GH stimulation test results with peak values and the stimulant used (e.g., arginine, clonidine, glucagon, macimorelin), IGF‑I and IGFBP‑3 serum levels, and pertinent imaging reports (hypothalamic‑pituitary imaging) when applicable.

Documentation Required

Prescriber specialty requirement

Prescriber specialty requirements vary by indication: pediatric indications generally must be prescribed by or in consultation with a pediatric endocrinologist; adult GHD requires an endocrinologist; short bowel syndrome requires prescription by or consultation with a gastroenterologist; HIV‑associated wasting requires a physician specializing in HIV management.

Billing Rule

Product substitution/step requirement

Step/ product substitution requirement: members must use Norditropin, Humatrope, and Genotropin (or Genotropin Miniquick) unless clinically significant adverse effects or contraindications exist. If those products are unavailable (for example, due to shortages), members must use Omnitrope vial or Zomacton as the fallback.

Documentation Required

Follow dosing regimens and brand-specific dosing

Follow product‑specific dosing regimens and maximum doses as specified in the policy and product labeling. Prescribers should adhere to the indicated maximums for each product and indication (for example, PWS 0.24 mg/kg/week; adult somatropin titration to maintain IGF‑I with typical somatropin adult dosing 0.4 mg/day and adjustment increments; and the listed weekly limits for long‑acting agents). Reference FDA prescribing information and guideline‑based dosing when determining doses and monitoring.

06.06.24Per June SDC - product additions and formulary updates

Added Skytrofa to policy; added Genotropin/Genotropin Miniquick as CO-preferred along with Norditropin and Humatrope; added redirection to Zomacton if shortages; P&T Approval Date 08.24 noted.

02.251Q 2025 annual reviewLatest

1Q 2025 annual review: no significant changes; references reviewed and updated.