CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Growth hormone (somatropin) coverage for pediatric and adult indications

Defines clinical indications, required documentation, initial and continuation authorization criteria, and covered compendial uses for growth hormone (somatropin) products (e.g., Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton). Applies to FDA-approved indications and specified compendial uses when all criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGrowth hormone (somatropin) coverage for pediatric and adult indications

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization documentation including diagnostic tests, growth charts, IGF-1 levels, genetic/karyotype results when applicable, and required continuation data per policy.

POLICY UPDATE CHANGES

No material clinical or coverage changes to policy (has_material_change = false).

12 monthsTypical authorization length (pediatric/adult)

12 weeksAuthorization length for HIV-associated wasting

8 weeksLifetime authorization for SBS when PN dependent

≥1Required provocative GH tests

Coverage Summary

This policy covers recombinant human growth hormone (somatropin) for FDA-approved pediatric and adult indications and specified compendial uses when all approval criteria are met and no contraindications exist. Covered FDA-approved indications include GH deficiency (pediatric and adult), and pediatric conditions such as Turner syndrome, small for gestational age (SGA), Noonan syndrome, Prader-Willi syndrome, SHOX deficiency, and chronic kidney disease (CKD). Compendial uses covered when criteria are met include short bowel syndrome (SBS), HIV-associated wasting/cachexia, and growth failure associated with congenital adrenal hyperplasia, cerebral palsy, cystic fibrosis, and Russell-Silver syndrome.

Referenced somatropin products include Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, and Zomacton, and the policy applies to these growth hormone products for the listed indications. High-level policy scope defines required documentation, initial and continuation authorization criteria (typical pediatric/adult authorization length 12 months; HIV-associated wasting typically 12 weeks; SBS lifetime total 8 weeks), and thresholds for provocative GH testing and IGF-1 as specified in the policy.

Typical authorization length (pediatric/adult)12 months

HIV-associated wasting authorization length12 weeks

Short bowel syndrome lifetime authorization8 weeks

Required provocative GH tests≥1 (varies by indication); 2 often required for adults/pediatrics

Pediatric GH test peak threshold< 10 ng/mL

Adult ITT GH peak threshold< 5 ng/mL

Macrilen GH peak threshold< 2.8 ng/mL

Glucagon stimulation GH peak threshold (high pretest prob/BMI <30)< 3.0 ng/mL

Glucagon stimulation GH peak threshold (low pretest prob/BMI ≥25)< 1.0 ng/mL

IGF-1 thresholds> 2 SD below mean (supports deficiency) or between 0 to 2 SD below mean (adjunctive in some adult criteria)

SGA birth weight threshold< 2500 g at gestational age > 37 weeks

HIV-associated wasting BMI (initial)< 18.5 kg/m2

HIV-associated wasting BMI (continuation)< 27 kg/m2

Coding

Growth hormone products referencedmixedCovered

Genotropin	somatropin product (Pfizer)
Humatrope	somatropin product (Eli Lilly)
Norditropin	somatropin product (Novo Nordisk)
Nutropin AQ	somatropin product (Genentech)
Omnitrope	somatropin product (Sandoz)
Saizen	somatropin product (EMD Serono)
Zomacton	somatropin product

Growth hormone products referencedmixedCovered

Genotropin	somatropin product (Pfizer)
Humatrope	somatropin product (Eli Lilly)
Norditropin	somatropin product (Novo Nordisk)
Nutropin AQ	somatropin product (Genentech)
Omnitrope	somatropin product (Sandoz)
Saizen	somatropin product (EMD Serono)
Zomacton	somatropin product

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization documentation must be submitted to initiate review for initial and continuation requests.

Pretreatment growth hormone provocative test results (laboratory report or medical record documentation)
Growth chart
Pretreatment and/or current IGF-1 level with laboratory-specific normal ranges
Diagnostic karyotype results for Turner syndrome and genetic test results for Prader‑Willi when applicable
Diagnostic molecular/genetic analyses for SHOX deficiency when applicable
Prior authorization approval letter and date of prior authorization; typical authorization lengths: 12 months (typical pediatric/adult), 12 weeks for HIV-associated wasting, lifetime total of 8 weeks for SBS

Documentation Required

Submit pretreatment provocative GH test results and IGF-1

Provide laboratory reports or medical record documentation for pretreatment pharmacologic provocative GH test(s) and pretreatment/current IGF-1; include the lab-specific normal ranges with the reports.

Pretreatment pharmacologic provocative GH tests (e.g., insulin tolerance test, glucagon stimulation test, Macrilen, or other pharmacologic stimulation tests)
Pretreatment and/or current IGF-1 laboratory report with laboratory-specific normal ranges

Documentation Required

Provide genetic and karyotype testing when indicated

Submit diagnostic genetic testing results when clinically indicated: karyotype for Turner syndrome, genetic testing for Prader‑Willi syndrome, and molecular/genetic analyses confirming SHOX deficiency.

Diagnostic karyotype results confirming Turner syndrome
Diagnostic genetic test results confirming Prader‑Willi syndrome (e.g., 15q11.2 deletion, maternal uniparental disomy, imprinting defects/translocations/inversions)
Diagnostic molecular or genetic analyses confirming SHOX deficiency

Documentation Required

Provide continuation treatment information

For continuation requests, submit treatment duration and recent treatment and growth data to document ongoing benefit or eligibility.

Total duration of treatment (approximate duration acceptable)
Date of last dose administered
Growth rate data (e.g., pediatric growth rate > 2 cm/year unless clinically justified)
For Prader‑Willi syndrome: evidence that body composition and psychomotor function have improved or stabilized on GH therapy

Background and Evidence

The policy references product labeling and established appendices for clinical context and testing requirements. Product labeling and prescribing information for the listed somatropin products are cited in the reference section and are used to inform clinical criteria and thresholds.

Appendices include: Appendix A (examples of hypothalamic/pituitary/CNS disorders), Appendix B (pituitary hormone definitions other than growth hormone), Appendix C (requirements and contextual guidance for GH-stimulation testing in adults, including when testing is/ is not required), and Appendix D (BMI calculation and classification). These appendices are referenced for diagnostic context, testing requirements, and BMI thresholds used in HIV-associated wasting criteria.

Evidence sources include multiple somatropin package inserts and clinical guideline documents. The reference list explicitly cites package inserts for Genotropin, Norditropin, Humatrope, Nutropin AQ, Omnitrope, and Saizen, and peer-reviewed guidance and guideline sources such as the Endocrine Society, AACE/ACE guidance, and NICE documents that informed testing thresholds, diagnostic definitions, and clinical-use recommendations incorporated into this policy.

Definitions & Thresholds

Epiphyses are open (definition)Bone growth plates not fused; confirmation by X-ray or, if X-ray not available, noted in record

IGF-1 (definition)Insulin-like growth factor-1 laboratory value; lab-specific normal ranges required for interpretation

Pediatric GH peak cutoff< 10 ng/mL

Adult ITT cutoff< 5 ng/mL

Macrilen cutoff< 2.8 ng/mL

Glucagon cutoff (BMI <30, high pretest probability)< 3.0 ng/mL

Glucagon cutoff (BMI ≥25, low pretest probability)< 1.0 ng/mL

IGF-1 cutoffs for use> 2 SD below mean (supports deficiency) or 0 to 2 SD below mean (used with single provocative test)

SGA birth weight< 2500 g at gestational age > 37 weeks

BMI thresholds (HIV-associated wasting)Initial: < 18.5 kg/m2; Continuation: < 27 kg/m2

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGrowth hormone (somatropin) coverage for pediatric and adult indications

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization documentation including diagnostic tests, growth charts, IGF-1 levels, genetic/karyotype results when applicable, and required continuation data per policy.

On This Page

OpenPayer

Growth hormone (somatropin) coverage for pediatric and adult indications

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions

Background and Evidence

Definitions & Thresholds

Revision History