CurrentNeighborhood Health Plan of Rhode IslandPolicy 1742-A

Growth Hormone (somatropin) coverage for pediatric and adult indications

Defines authorization criteria (initial and continuation) for somatropin (brand and generic somatropin products) across FDA-approved pediatric and adult indications and selected compendial uses; lists required documentation and diagnostic criteria for approval for 12-month authorizations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGrowth Hormone (somatropin) coverage for pediatric and adult indications

Policy CodePolicy 1742-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit required documentation for authorization: growth chart, pretreatment or current IGF-1 lab report (with lab reference ranges), and indication-specific diagnostic tests (e.g., GH stimulation tests or genetic/karyotype results).

POLICY UPDATE CHANGES

No material clinical/coverage changes.

9Covered Indications (listed pediatric/adult and compendial)

12 monthsAuthorization Duration

2Typical pretreatment GH tests (pediatric)

Coverage Summary

Policy number 1742-A covers somatropin (growth hormone) products (brand and generic) for FDA-approved pediatric and adult indications and selected compendial uses. The policy scope defines authorization criteria for initial and continuation requests and requires documentation to support diagnoses. The coverage stance is covered_with_criteria and when criteria are met authorizations may be granted for 12 months.

Quick facts & thresholds

Authorization Duration12 months

Covered Indications (count)9

Required pretreatment GH provocative tests (typical pediatric)2

Peak GH — Pediatric provocative testing threshold< 10 ng/mL

Peak GH — Insulin Tolerance Test (adult)< 5 ng/mL

Macrilen (adult) peak≤ 2.8 ng/mL

Glucagon stimulation test (adult) — BMI >25 kg/m2, low pretest probability< 1.0 ng/mL

Glucagon stimulation test (adult) — BMI <30 kg/m2, high pretest probability< 3.0 ng/mL

Provider Actions & Documentation

Prior Authorization

Prior authorization required

Authorization documentation (including diagnosis-specific genetic or karyotype testing when required) must be submitted to initiate review; approvals are issued for 12 months.

Approvals issued for 12 months

Documentation Required

Provide growth chart and IGF-1

Submit growth chart and pretreatment or current IGF-1 laboratory report; include laboratory-specific reference ranges.

Include laboratory-specific reference ranges
Submit growth chart

Documentation Required

Provide GH-stimulation test results for initial requests

For initial requests, submit pretreatment pharmacologic provocative GH test results (two tests for many indications) or neonatal diagnostic documentation as applicable.

Two tests for many indications
neonatal diagnostic documentation when applicable

Documentation Required

Continuation documentation

For continuation, provide date of last dose, total duration of treatment, prior authorization approval letter and date, and evidence of growth or stabilization per indication (e.g., growth rate > 2 cm/year or improved body composition in Prader-Willi).

date of last dose
total duration
prior authorization approval letter and date
evidence of growth or stabilization (e.g., >2 cm/year)

Initial Therapy Criteria (By Indication)

Covered FDA-Approved Pediatric Indications (Initial Authorization - 12 months)

Authorization of 12 months may be granted when the listed indication criteria are met:

Pediatric indications

Pediatric growth hormone (GH) deficiency
- Neonate criteria OR provocation testing criteria
  - ALL of the following
    Member is a neonate or has diagnosis of GH deficiency as a neonate (e.g., hypoglycemia with random GH level; evidence of multiple pituitary hormone deficiency; MRI results)
  - ALL of the following
    Two pretreatment pharmacologic provocative GH tests with both results demonstrating a peak GH level < 10 ng/mL< 10 ng/mL
    For members < 2.5 years at initiation: pretreatment height is > 2 SD below the mean and growth velocity is slow> 2 SD below the mean
    A documented pituitary or CNS disorder (see Appendix A) and a pretreatment IGF-1 level > 2 SD below the mean> 2 SD below the mean
    Appendix A disorders
  - ALL of the following
    Pretreatment 1-year height velocity is > 2 SD below the mean> 2 SD below the mean
    Epiphyses are open
  - ALL of the following
    Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean> 2 SD below; > 1 SD below
    Epiphyses are open
Small for gestational age (SGA)
- Birth criteria (one required)
  - Birth weight or length less than 3rd percentile for gestational age< 3rd percentile
  - Birth weight < 2500 g at gestational age > 37 weeks< 2500 g
  - Birth weight or length ≥ 2 SD below the mean for gestational age≥ 2 SD below the mean
- Member failed to manifest catch-up growth by age 2 (pretreatment height > 2 SD below the mean)> 2 SD below the mean
Growth failure associated with CKD, cerebral palsy, congenital adrenal hyperplasia, cystic fibrosis, or Russell-Silver syndrome
- For members ≥ 2.5 years at initiation: pretreatment height is ≥ 2 SD below the mean and growth velocity is slow≥ 2 SD below the mean
- Pretreatment height is ≥ 2 SD below the mean and 1-year height velocity is ≥ 1 SD below the mean≥ 2 SD below; ≥ 1 SD below
- For members < 2.5 years at initiation
  - Pretreatment 1-year height velocity is ≥ 2 SD below the mean≥ 2 SD below the mean
- Epiphyses are open
Prader-Willi syndrome
- ALL of the following
  - Diagnosis confirmed by genetic testing demonstrating ANY of: deletion in chromosomal 15q11.2-q13 region; imprinting defects, translocations, or inversions involving chromosome 15; maternal uniparental disomy in chromosome 15
Noonan syndrome
- Pretreatment height is ≥ 2 SD below the mean and 1-year height velocity is ≥ 1 SD below the mean≥ 2 SD below; ≥ 1 SD below
- ANY of the following
  - Pretreatment 1-year height velocity is ≥ 2 SD below the mean≥ 2 SD below the mean
  - Epiphyses are open
SHOX deficiency
- ANY of the following
  - Diagnosis of SHOX deficiency confirmed by molecular or genetic analyses
  - Pretreatment height is ≥ 2 SD below the mean and 1-year height velocity is ≥ 1 SD below the mean≥ 2 SD below; ≥ 1 SD below
- Pretreatment 1-year height velocity is ≥ 2 SD below the mean≥ 2 SD below the mean
- Epiphyses are open

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Covered FDA-Approved Pediatric Indications (Initial Authorization - 12 months)

Adult Growth Hormone Deficiency (Initial Authorization - 12 months)

Authorization of 12 months may be granted when ANY of the following criteria is met:

ITT pathway
- Insulin tolerance test (ITT) with a GH level < 5 ng/mL peak< 5 ng/mL
- Member has had 2 pretreatment pharmacologic provocative GH tests and both results demonstrated deficient GH responses defined as any of listed thresholds
Two pretreatment pharmacologic provocative GH tests demonstrating deficient GH responses defined as any of the following:
- Macrilen with a peak GH level of 2.8 ng/mL≤ 2.8 ng/mL

General Documentation Requirements

Submission of the following information is necessary to initiate the authorization review (where applicable):

ALL of the following

Growth chart
Pretreatment or current insulin-like growth factor-1 (IGF-1) level (laboratory report or medical record documentation)Laboratory-specific reference ranges must be provided
Laboratory-specific reference ranges must be provided
For initial requests: Pretreatment growth hormone provocative test result(s) (laboratory report or medical record documentation)
Typically two tests for many indications
For initial requests: Support for diagnosis of neonatal GH deficiency (medical documentation, laboratory report; or imaging report)

Continuation Therapy Criteria (12 months)

Continuation of Therapy (12 months)

Authorization of 12 months may be granted for continuation when ALL of the following criteria are met (by indication groups):

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Continuation of Therapy (12 months)

Applicable Codes

Applicable drugs (brand and generic somatropin products)NDC|mixedCovered

Genotropin	somatropin (brand)
Humatrope	somatropin (brand)
Norditropin	somatropin (brand)
Nutropin AQ	somatropin (brand)
Omnitrope	somatropin (brand)
Saizen	somatropin (brand)
Zomacton	somatropin (brand)

Clinical Evidence

Primary evidence sources cited include FDA package inserts for somatropin products (Humatrope, Nutropin AQ, Norditropin, Omnitrope, Saizen, and others) and clinical guideline and consensus references such as the Growth Hormone Research Society, Endocrine Society, American Association of Clinical Endocrinologists (AACE), NICE, and additional peer-reviewed literature and consensus statements.

Clinical definitions

Epiphyses are open (definition)Skeletal growth plates not fused; confirmation by X-ray or X-ray not available

IGF-1 (term)Insulin-like growth factor-1; interpret using laboratory-specific reference ranges to determine SD from the mean

Documentation notePretreatment or current IGF-1 laboratory report must be submitted with lab-specific reference ranges

Background

This policy covers both brand and generic somatropin products (e.g., Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton) for FDA-approved pediatric and adult indications and select compendial uses. It references diagnostic thresholds for provocative growth hormone testing and IGF‑1 interpretation (laboratory-specific reference ranges required) and requires submission of supporting documentation for initial and continuation requests. For certain syndromic diagnoses, diagnostic genetic or karyotype test results must be provided (for example, karyotype for Turner syndrome, molecular/genetic testing for SHOX deficiency, and genetic testing confirming Prader‑Willi syndrome).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGrowth Hormone (somatropin) coverage for pediatric and adult indications

Policy CodePolicy 1742-A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

Pretreatment age is ≥ 2 years≥ 2 years

Glucagon stimulation test with a peak GH level < 1.0 ng/mL in patients with BMI > 25 kg/m2 and a low pretest probability of GHD OR BMI > 30 kg/m2< 1.0 ng/mL

BMI >25 (low pretest prob) or BMI >30

Glucagon stimulation test with a peak GH level < 3.0 ng/mL in patients with BMI < 30 kg/m2 and a high pretest probability of GHD OR BMI < 25 kg/m2< 3.0 ng/mL

BMI <30 (high pretest prob) or BMI <25

IGF-1 with one provocative test

Member has a pretreatment IGF-1 level 0 to 2 SD below the mean for age and gender0 to 2 SD below the mean
Laboratory-specific reference ranges must be provided
Member has had a pretreatment pharmacologic provocative GH test that demonstrated deficient GH responses as defined in adult testing criteriaper adult thresholds

Severe IGF-1 with organic hypothalamic-pituitary disease

Member has a pretreatment IGF-1 level > 2 SD below the mean for age and gender> 2 SD below the mean
Member has organic hypothalamic-pituitary disease (e.g., suprasellar mass with previous surgery and cranial irradiation) with ≥ 3 documented pituitary hormone deficiencies (see Appendix B)≥ 3 deficiencies
Appendix B hormones

Genetic/structural or childhood-onset pathways

Member has genetic or congenital structural hypothalamic-pituitary defects (see Appendix C)
Appendix C
Member has childhood-onset GH deficiency and a congenital abnormality of the CNS, hypothalamus or pituitary (see Appendix C)
Appendix C

Adult Growth Hormone Deficiency (Initial Authorization - 12 months)

For initial requests: Diagnostic genetic test results in Prader-Willi syndrome (where applicable)

For initial requests: Diagnostic karyotype results in Turner syndrome (where applicable)

For initial requests: Diagnostic molecular or genetic test results in SHOX deficiency (where applicable)

For continuation requests: Date of last dose administered

For continuation requests: Total duration of treatment (approximate duration acceptable)

For continuation requests: Approving health plan/pharmacy benefit manager prior authorization approval letter and date

General Documentation Requirements

OpenPayer

Growth Hormone (somatropin) coverage for pediatric and adult indications

Coverage Summary

Provider Actions & Documentation

Initial Therapy Criteria (By Indication)

Continuation Therapy Criteria (12 months)

Applicable Codes

Clinical Evidence

Background

Revision History