CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Growth Hormone Without Iss 1742 A Sgm P2024

Defines medical necessity criteria, required documentation, initial and continuation authorization periods, and covered indications for growth hormone therapies (somatropin products) including pediatric and adult GHD, Turner, Noonan, SGA, Prader-Willi, CKD-associated growth failure, SHOX deficiency, HIV wasting/cachexia, and short bowel syndrome.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGrowth Hormone Without Iss 1742 A Sgm P2024

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit required documentation (diagnostic tests, growth chart, IGF-1 levels, genetic/karyotype results where applicable) to initiate prior authorization for initial and continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

12 monthsTypical authorization period (many indications)

12 weeksHIV-associated wasting initial authorization

8 weeksShort bowel syndrome lifetime total

≥1Required provocative GH tests

Coverage stance: covered_with_criteria for recombinant human growth hormone (somatropin) products when the specified medical necessity criteria and documentation requirements are met and no contraindications/exclusions apply.

Scope summary: Defines medical necessity criteria, required documentation, initial and continuation authorization periods, and covered indications for somatropin across 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–associated growth failure, SHOX deficiency, HIV-associated wasting/cachexia (compendial), and short bowel syndrome (compendial).

Typical authorization periods (from plan statistics and criteria): 12 months for many pediatric and adult indications and for most continuations; 12 weeks for initial HIV-associated wasting/cachexia approvals; and a total lifetime authorization of 8 weeks for short bowel syndrome when criteria are met.

Subject: Growth hormone (somatropin) coverage for multiple pediatric and adult indications; multiple branded somatropin products and compendial uses are included under the criteria.

Key thresholds & quick facts

Typical authorization period12 months

HIV initial authorization12 weeks

SBS total lifetime authorization8 weeks lifetime

Required provocative GH tests≥1 (varies by scenario; 1 or 2 tests required per criteria)

Pediatric peak GH diagnostic thresholdPeak GH < 10 ng/mL

Adult peak GH (ITT) thresholdITT peak GH ≤ 5 ng/mL

IGF-1 diagnostic cutoffsLow: 0 to 2 SD below mean; Very low: > 2 SD below mean

Medical Necessity Criteria

General Indications

Growth hormone indications (FDA and compendial) are covered when approval criteria are met and no contraindications/exclusions exist.

ANY of the following

Pediatric growth failure due to GH deficiency
Pediatric Turner syndrome
Pediatric Noonan syndrome
Small for gestational age (SGA)
Prader-Willi syndrome
Chronic kidney disease (CKD) associated growth failure
SHOX deficiency
Cerebral palsy-associated growth failure (compendial)
Congenital adrenal hyperplasia-associated growth failure (compendial)
Cystic fibrosis-associated growth failure (compendial)
Russell-Silver syndrome (compendial)
Adults with childhood-onset or adult-onset GH deficiency
HIV-associated wasting/cachexia (compendial)
Short bowel syndrome (compendial)

Documentation required for prior authorization (initial and continuation where applicable)

Submission of the following is necessary to initiate prior authorization review:

ALL of the following

Medical records supporting the diagnosis of neonatal GH deficiency (when applicable)
Pretreatment growth hormone provocative test result(s) (laboratory report or medical record documentation)
Growth chart
Pretreatment and/or current IGF-1 level (laboratory report) — laboratory-specific normal ranges must be provided
Diagnostic karyotype results for Turner syndrome (when applicable)

A. Pediatric Growth Hormone (GH) Deficiency - Initial authorization

Authorization of 12 months may be granted when EITHER criteria 1 or 2 is met:

ANY of the following

Member is a neonate or was diagnosed with GH deficiency as a neonate
Medical records must support neonatal GH deficiency (e.g., hypoglycemia with random GH, multiple pituitary hormone deficiency, chart notes, or MRI)
ALL of the following
- Either of
  - Two pretreatment pharmacologic provocative GH tests with both results demonstrating peak GH < 10 ng/mL< 10 ng/mL
  - Documented pituitary or CNS disorder and pretreatment IGF-1 > 2 SD below the mean

B. Small for Gestational Age (SGA) - Initial authorization

Authorization of 12 months may be granted when ALL criteria are met:

ALL of the following

Birth criteria (one of)
- Birth weight < 2500 g at gestational age > 37 weeks< 2500 g
- Birth weight or length < 3rd percentile for gestational age
- Birth weight or length ≥ 2 SD below the mean for gestational age≥ 2 SD below mean
Pretreatment age is ≥ 2 years

C. Turner Syndrome - Initial authorization

Authorization of 12 months may be granted when ALL criteria are met:

ALL of the following

Diagnosis confirmed by karyotyping
Pretreatment height < 5th percentile for age< 5th percentile
Epiphyses are open

D. Growth Failure associated with CKD, Cerebral Palsy, Congenital Adrenal Hyperplasia, Cystic Fibrosis, or Russell-Silver Syndrome - Initial authorization

Authorization of 12 months may be granted when ALL criteria are met:

ALL of the following

For < 2.5 years at initiation: If < 2.5 years at initiation: pretreatment height > 2 SD below mean AND growth velocity is slow
For ≥ 2.5 years at initiation, one of
- Pretreatment height > 2 SD below mean AND 1-year height velocity > 1 SD below mean
- Pretreatment 1-year height velocity > 2 SD below mean
Epiphyses are open

E. Prader-Willi Syndrome - Initial authorization

Authorization of 12 months may be granted when diagnosis was confirmed by genetic testing demonstrating ANY of the following:

ANY of the following

Deletion in chromosomal 15q11.2-q13 region
Maternal uniparental disomy in chromosome 15
Imprinting defects, translocations, or inversions involving chromosome 15

F. Noonan Syndrome - Initial authorization

Authorization of 12 months may be granted when BOTH criteria are met:

ALL of the following

Height/velocity requirement
- Pretreatment height > 2 SD below mean AND 1-year height velocity > 1 SD below mean
- Pretreatment 1-year height velocity > 2 SD below mean
Epiphyses are open

G. SHOX Deficiency - Initial authorization

Authorization of 12 months may be granted when ALL criteria are met:

ALL of the following

Diagnosis confirmed by molecular or genetic analyses
Height/velocity requirement
- Pretreatment height > 2 SD below mean AND 1-year height velocity > 1 SD below mean
- Pretreatment 1-year height velocity > 2 SD below mean
Epiphyses are open

H. Adult Growth Hormone (GH) Deficiency - Initial authorization

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

ANY of the following

Option 1 (2 provocative tests)
- Deficient GH response definitions (examples): Insulin tolerance test (ITT) with peak GH ≤ 5 ng/mL; Macrilen with peak GH < 2.8 ng/mL; Glucagon stimulation test peak GH ≤ 3.0 ng/mL in patients with BMI ≤ 30 kg/m2 and high pretest probability or BMI < 25 kg/m2; Glucagon peak GH ≤ 1.0 ng/mL in patients with BMI ≥ 25 kg/m2 and low pretest probability or BMI > 30 kg/m2varies by test and BMI/pretest probability
Option 2 (1 provocative test with very low IGF-1): Member has had 1 pretreatment pharmacologic provocative GH test demonstrating deficient GH response AND member has pretreatment IGF-1 level > 2 SD below the mean for age and genderIGF-1 > 2 SD below mean

I. HIV-Associated Wasting/Cachexia - Initial authorization

Authorization of 12 weeks may be granted when ALL criteria are met:

ALL of the following

Trialed and experienced suboptimal response to alternative therapies or has contraindication/intolerance to alternatives (e.g., cyproheptadine, dronabinol, megestrol acetate, or testosterone if hypogonadal)
Member is currently on antiretroviral therapy
BMI is < 18.5 kg/m2 prior to starting GH< 18.5 kg/m2

J. Short Bowel Syndrome - Initial authorization

Authorization of a lifetime total of 8 weeks may be granted when:

ALL of the following

Member has short bowel syndrome and depends on intravenous parenteral nutrition for nutritional support
Growth hormone will be used in conjunction with optimal management of SBS

IV. Continuation of Therapy - Pediatric Indications

Authorization of 12 months may be granted for continuation when ALL criteria are met:

ALL of the following

Member is currently receiving the requested medication or another growth hormone product indicated for the pediatric indication
Epiphyses are open (confirmed by X-ray or X-ray not available)
Member's growth rate is > 2 cm/year unless a documented clinical reason for lack of efficacy exists (e.g., on treatment < 1 year, nearing final adult height/late puberty)> 2 cm/year

IV. Continuation of Therapy - Prader-Willi

Authorization of 12 months may be granted when BOTH criteria are met:

ALL of the following

Member is currently receiving the requested medication or another growth hormone product indicated for Prader-Willi syndrome
Member's body composition and psychomotor function have improved or stabilized in response to GH therapy

IV. Continuation of Therapy - Adult GHD

Authorization of 12 months may be granted when ANY of the listed continuation scenarios are met:

ANY of the following

Member is currently receiving the requested medication or another GH product indicated for adult GHD; had 2 pretreatment provocative GH tests demonstrating deficient responses; has a low pretreatment IGF-1 (between 0 to 2 SD below mean); and current IGF-1 level is not elevated for age and gender
Deficient GH response definitions as in initial adult criteria
Member is currently receiving the requested medication or another GH product indicated for adult GHD; had 1 pretreatment provocative GH test demonstrating deficient response; has pretreatment IGF-1 > 2 SD below mean; and current IGF-1 level is not elevated for age and genderIGF-1 > 2 SD below mean
Member is currently receiving the requested medication or another GH product indicated for adult GHD; has organic hypothalamic-pituitary disease with ≥ 3 documented pituitary hormone deficiencies and low pretreatment IGF-1 > 2 SD below mean; and current IGF-1 level is not elevated for age and gender

IV. Continuation of Therapy - HIV-associated wasting/cachexia

Authorization of 12 weeks may be granted when ALL criteria are met:

ALL of the following

Member is currently receiving the requested medication or another GH product indicated for HIV-associated wasting/cachexia
Member is diagnosed with HIV-associated wasting/cachexia
Member is currently on antiretroviral therapy
Member is currently receiving GH excluding samples or manufacturer's patient assistance programs
Current BMI is < 27 kg/m2< 27 kg/m2

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Submit required documentation to initiate prior authorization for initial and continuation requests. Required items include diagnostic test reports (pretreatment provocative GH test results and IGF-1 laboratory reports), a current growth chart, and genetic or karyotype confirmation when applicable (e.g., Turner, Prader-Willi, SHOX). Provide laboratory-specific IGF-1 reference ranges with the IGF-1 result to allow interpretation versus age/gender norms.

Pretreatment provocative GH test results (laboratory report or medical record)
Pretreatment and/or current IGF-1 level with laboratory-specific reference ranges
Growth chart
Diagnostic karyotype or genetic test results when applicable (Turner, Prader-Willi, SHOX)

Documentation Required

Provocative GH testing documentation

Provide pretreatment provocative GH testing documentation. Number of tests and peak GH cutoffs depend on indication and scenario: pediatric diagnosis may require two pretreatment pharmacologic provocative GH tests with both peaks < 10 ng/mL. For adult GHD, definitions include ITT peak GH ≤ 5 ng/mL, Macrilen peak < 2.8 ng/mL, and glucagon stimulation test cutoffs that vary by BMI and pretest probability (≤ 3.0 ng/mL or ≤ 1.0 ng/mL as specified). Also include the laboratory report showing IGF-1 with lab-specific reference ranges so SD from the mean can be determined.

Pediatric: two provocative tests with peak GH < 10 ng/mL (when required)
Adult: ITT ≤ 5 ng/mL; Macrilen < 2.8 ng/mL; glucagon ≤ 3.0 ng/mL or ≤ 1.0 ng/mL depending on BMI and pretest probability
Submit lab report with IGF-1 and laboratory-specific reference ranges

Documentation Required

Epiphyseal status confirmation

Confirm epiphyseal status for pediatric initial and continuation requests. Epiphyses must be open; confirmation should be by X-ray. If an X-ray is not available, note that X-ray is not available but the requirement still applies.

X-ray confirmation that epiphyses are open
If X-ray not available, document that X-ray is not available (epiphyseal openness still required)

Prior Authorization

Continuation documentation

For continuation requests submit documentation of total duration of treatment (approximate acceptable), date of last dose administered, prior authorization/approval details and approval letter. Provide evidence of ongoing efficacy where required — for pediatric indications this includes growth rate > 2 cm/year unless a clinical reason for lack of efficacy exists; for Prader‑Willi include improvement or stabilization in body composition and psychomotor function.

Total duration of treatment
Date of last dose administered
Approving health plan/pharmacy benefit manager, date of prior authorization/approval, and prior authorization approval letter
Evidence of ongoing efficacy (e.g., growth rate > 2 cm/year for pediatric; body composition and psychomotor improvement/stabilization for Prader‑Willi)

Prior Authorization

HIV-specific requirements

For HIV-associated wasting/cachexia prior authorization, document prior trial and suboptimal response to alternative therapies or contraindication/intolerance to them, verify the member is currently on antiretroviral therapy, and provide BMI at baseline. Initial BMI requirement is < 18.5 kg/m2; for continuation, current BMI must be < 27 kg/m2. Ensure documentation of prior alternatives tried (e.g., cyproheptadine, dronabinol, megestrol acetate, or testosterone if hypogonadal).

Documentation of trial and inadequate response to alternative therapies or contraindication/intolerance
Current antiretroviral therapy status
Baseline BMI < 18.5 kg/m2 for initiation
Current BMI < 27 kg/m2 for continuation

Coding

Product examples listed in specialty guideline managementmixed

Genotropin	somatropin product example
Humatrope	somatropin product example
Norditropin	somatropin product example
Nutropin AQ	somatropin product example
Omnitrope	somatropin product example
Saizen	somatropin product example
Zomacton	somatropin product example

Background and Evidence

Background: This specialty guideline management document governs use of somatropin products and describes the scope of specialty guideline management for growth hormone therapy, covering FDA-approved and compendial indications when approval criteria are met.

Diagnostic testing referenced: Prior authorization requires pretreatment pharmacologic provocative GH tests (e.g., insulin tolerance test, Macrilen, glucagon stimulation) with specified peak GH cutoffs and pretreatment/current IGF-1 levels with laboratory-specific reference ranges provided to interpret SD from the mean.

Genetic confirmation: For syndromic indications the policy requires confirmatory testing where applicable (e.g., diagnostic karyotype for Turner syndrome, molecular/genetic testing for Prader‑Willi and SHOX deficiency) as part of documentation to support authorization.

Clinical measures: The criteria use anthropometric and growth measures including pretreatment height and growth velocity thresholds (>2 SD below mean for many pediatric indications, 1-year height velocity thresholds) and requirement that epiphyses are open for most pediatric approvals (confirmation by X‑ray or allowance if X‑ray not available).

Compendial uses: Compendial indications (e.g., HIV-associated wasting/cachexia and short bowel syndrome) are included but have time-limited or specified conditions — HIV-associated wasting initial approval criteria and a 12-week authorization; short bowel syndrome may receive a lifetime total of 8 weeks when dependent on parenteral nutrition and used with optimal SBS management.

Evidence: The policy references multiple package inserts and guideline publications. Examples of products and sources cited include the package inserts for Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, and Zomacton, and multiple guideline and consensus publications (e.g., international consensus statements and Endocrine Society/AACE guidance).

Definitions

Epiphyses are open: Skeletal growth plates have not fused; confirmation may be by X‑ray or, if an X‑ray is not available, the requirement still applies for pediatric initial and continuation approvals.

Pretreatment IGF-1: The insulin‑like growth factor‑1 level measured prior to initiating therapy; laboratory‑specific reference ranges must be provided to determine standard deviations from the mean for age and gender.

Provocative GH test: Pharmacologic stimulation tests (examples include the insulin tolerance test [ITT], Macrilen, and glucagon stimulation test) with specified peak GH cutoffs used in the policy to define deficient responses; lab reports of the test and numeric peak GH results are required for prior authorization.

Numeric diagnostic thresholds (compact)

Peak GH — pediatric diagnostic< 10 ng/mL

Peak GH — adult ITT≤ 5 ng/mL

Peak GH — Macrilen< 2.8 ng/mL

Peak GH — Glucagon (BMI ≤30 or BMI <25)≤ 3.0 ng/mL

Peak GH — Glucagon (BMI ≥25 / low pretest prob. or BMI >30)≤ 1.0 ng/mL

IGF-1 cutoffsLow: 0 to 2 SD below mean; Very low: > 2 SD below mean

Pediatric height threshold> 2 SD below mean

SGA birth weight criteriaBirth weight < 2500 g at gestational age > 37 weeks OR <3rd percentile OR ≥ 2 SD below mean

HIV BMI thresholdsInitiation: BMI < 18.5 kg/m2; Continuation: BMI < 27 kg/m2

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGrowth Hormone Without Iss 1742 A Sgm P2024

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Diagnostic genetic test results for Prader-Willi syndrome (when applicable)

Diagnostic molecular/genetic test results for SHOX deficiency (when applicable)

Continuation-specific

Total duration of treatment (approximate acceptable)
Date of last dose administered
Approving health plan/pharmacy benefit manager
Date of prior authorization/approval
Prior authorization approval letter

IGF-1 > 2 SD below mean

Refer to Appendix A for pituitary/CNS disorders

For < 2.5 years at initiation: For members < 2.5 years: pretreatment height > 2 SD below mean AND growth velocity is slowheight > 2 SD below mean

For ≥ 2.5 years at initiation, one of

Pretreatment height > 2 SD below mean AND 1-year height velocity > 1 SD below mean
Pretreatment 1-year height velocity > 2 SD below mean

Failed to manifest catch-up growth by age 2 (pretreatment height > 2 SD below mean)height > 2 SD below mean

Member has organic hypothalamic-pituitary disease with ≥ 3 documented pituitary hormone deficiencies and low pretreatment IGF-1 > 2 SD below mean (see Appendix B)IGF-1 > 2 SD below mean

Member has genetic or structural hypothalamic-pituitary defects (see Appendix C)

Member has childhood-onset GH deficiency and congenital CNS/hypothalamic/pituitary abnormality (see Appendix C)

IGF-1 > 2 SD below mean

Member is currently receiving the requested medication or another GH product indicated for adult GHD; has genetic or structural hypothalamic-pituitary defects; and current IGF-1 level is not elevated for age and gender

Refer to Appendix C

Member is currently receiving the requested medication or another GH product indicated for adult GHD; has childhood-onset GH deficiency and a congenital CNS/hypothalamic/pituitary abnormality; and current IGF-1 level is not elevated for age and gender

Refer to Appendix C

OpenPayer

Growth Hormone Without Iss 1742 A Sgm P2024

Coverage Summary

Medical Necessity Criteria

Provider Actions & Documentation Requirements

Coding

Background and Evidence

Definitions

Revision History