CurrentCignaPolicy N/A

Somatropin (Growth Hormone) prior authorization and coverage criteria

Cigna coverage and prior authorization criteria for somatropin (various branded somatropin products) for pediatric and adult indications, with documentation and specialist prescribing/consultation requirements.

Policy Summary

PayerCigna

PolicySomatropin (Growth Hormone) prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeMultiple revisions (criteria added, revised, clarified)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (tests, growth data, genetic or karyotype results, and specialist consultation notes) as specified for the indication to support approval.

SourceLink

POLICY UPDATE CHANGES

Chronic Kidney Disease in a Child or Adolescent: added requirement that patient has or had CKD defined by GFR < 60 mL/min and added persistent growth failure definition for initial therapy.

Noonan syndrome: added confirmatory genetic testing criteria and allowed clinical diagnosis when genetic testing is non-diagnostic with examples of clinical features.

Prader-Willi syndrome: updated diagnostic requirement to identification of abnormal DNA methylation of chromosome 15q11.2-q13.

Short Stature Homeobox (SHOX) deficiency: added requirement for chromosome analysis demonstration for continuation criteria and changed initial baseline height threshold from <3rd percentile to <5th percentile.

Child born small for gestational age: added criteria defining SGA as birth weight/length >2 SD below mean and requirement of insufficient catch-up growth before age 2–4 years for eligibility.

Turner syndrome: added requirement that diagnosis be confirmed by karyotype analysis.

Short Bowel Syndrome in adults: added criterion that patient is dependent on intravenous parenteral nutrition for initial therapy.

HIV with wasting (Serostim): added requirement that patient has tried one appetite stimulant or anabolic agent or that such agents are contraindicated.

Wording updated: 'The medication has been prescribed by or in consultation with an endocrinologist' applied across applicable diagnoses.

>=1 yearTypical approval duration for many indications

6 monthsInitial approval duration for idiopathic short stature trial

≥2Common response threshold for continued therapy

Coverage Criteria and Medical Necessity

General policy statement

Prior authorization is recommended; approvals are directed to a clinician and require submission of documentation. For several indications somatropin must be prescribed by or in consultation with a specialist (typically an endocrinologist).

ALL of the following

Medication is one of the listed somatropin products (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton)
Documentation as specified in the indication criteria must be provided (chart notes, stimulation test results, IGF-1 levels, growth velocity data, imaging, genetic test results, prescription records); previously submitted documentation from a prior review satisfies this requirement
Documentation may include chart notes, prescription claims records, prescription receipts, and/or other information

ALL of the following

Reviews will be directed to a clinician for verification of criteria and approvals are issued for the duration specified in the criteria (months/years)
When required by the indication, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., endocrinologist; some indications allow nephrologist consultation)

I. Growth hormone deficiency (GHD) in a child or adolescent — Initial therapy

Approve for 1 year if patient meets ONE of the following A or B. For initial therapy under A approve if at least ONE of i–v is met:

ALL of the following

A) Initial therapy
- i. Typical diagnostic testing + specialist
  - ALL of the following
    Medication prescribed by or in consultation with an endocrinologist
- ii. Brain radiation or tumor resection
  - ANY of the following
    ALL of the following

IV. Chronic kidney disease in children/adolescents

Approve for 1 year if ALL A–D are met:

ref": "b0_3

title": "III. Growth hormone deficiency in an adult or transition adolescent"

Products, Brand References, and Not Medically Necessary Uses

Drugs covered under policy (by brand name)NDC/nameCovered

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

Other branded somatropin referenced (not in primary listed group)NDC/nameExperimental

Serostim

somatropin subcutaneous injection (EMD Serono) - listed in header but appears distinct indication (note: Serostim often used for HIV wasting)

Products mentioned in policy (brands)NDC|mixed

Genotropin	somatropin subcutaneous injection - Pfizer (listed product)
Humatrope	somatropin subcutaneous injection - Eli Lilly
Norditropin	somatropin subcutaneous injection - Novo Nordisk
Nutropin AQ	somatropin subcutaneous injection - Genentech
Omnitrope	somatropin subcutaneous injection - Sandoz
Saizen	somatropin subcutaneous injection - EMD Serono
Serostim	somatropin subcutaneous injection - EMD Serono (separate criteria)
Zomacton	somatropin subcutaneous injection - Ferring

Not Medically Necessary IndicationsICD-10|neutralNot Covered

Aging/Anti-Aging	Somatropin not indicated for anti-aging, somatopause, improving functional status in elderly
Athletic enhancement / body building	Somatropin not indicated for athletic performance enhancement
Acute critical illness	Somatropin not covered for acute critical illness due to increased mortality
Central precocious puberty	GH not routinely recommended for central precocious puberty
Chronic fatigue syndrome	No evidence of GHD; not covered
Congenital adrenal hyperplasia	Experimental; not covered outside trials
Constitutional delay of growth and puberty	Somatropin does not increase adult height; not covered
Corticosteroid-induced short stature	Not covered (insufficient long-term data)
Fibromyalgia	Not covered (insufficient evidence of benefit)
HIV-associated adipose redistribution syndrome (HARS)	Somatropin not indicated for HARS

1–10 of 13

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What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is recommended for somatropin prescriptions; all reviews are directed to a clinician and approvals are issued for the durations specified in the policy criteria (months/years).

Documentation Required

Documentation required for diagnostic and continuation elements

Providers must submit documentation as specified for each indication; previously submitted documentation from a prior review satisfies the requirement.

Chart notes and prescription records
Growth hormone stimulation test results
Serum IGF-1 (age- and gender-adjusted) and IGFBP-3 where applicable

Numeric Thresholds and Policy Definitions

Policy thresholds and cutoffs

Peak GH cutoff for 2 stimulation tests (children/adolescents)< 10 ng/mL on both tests

Macimorelin (Macrilen) diagnostic cutoff (adults)Peak GH < 2.8 ng/mL (≥4 GH levels over ≥90 minutes); BMI ≤ 40 kg/m2

Insulin tolerance test adult cutoff (ITT)Peak GH ≤ 5.0 mcg/L (≥3 GH levels over ≥60 minutes with adequate hypoglycemia)

Glucagon stimulation test adult cutoffPeak GH ≤ 3.0 mcg/L (≥3 GH levels over ≥180 minutes) with BMI < 25 kg/m2; alternative BMI-specific cutoffs apply per pretest probability

Arginine test cutoff (if ITT and glucagon contraindicated)Peak GH ≤ 0.4 mcg/L (≥3 GH levels over ≥120 minutes)

Idiopathic short stature baseline height thresholdStandard deviation score (SDS) ≤ -2.25 (≤ 1.2 percentile); baseline height ≤ 1.2 percentile

Clinical and Administrative Background

Somatropin (recombinant human growth hormone) is FDA‑approved for multiple pediatric and adult indications including pediatric and adult growth hormone deficiency (GHD), idiopathic short stature, Turner syndrome, Prader‑Willi syndrome, SHOX deficiency, children born small for gestational age who fail to have catch‑up growth, growth failure associated with chronic kidney disease, Noonan syndrome, and for HIV‑associated wasting or cachexia under the branded Serostim product. (See product list: Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton, and Serostim.)

Diagnosis of GHD and many transition/adult evaluations rely on growth hormone stimulation testing. The policy references the insulin tolerance test (ITT) as the gold standard but notes contraindications (e.g., ischemic heart disease, seizure disorders, advanced age) and recognizes alternatives including the glucagon stimulation test and the macimorelin (Macrilen) oral test. Macimorelin diagnostic trials used sampling at 30, 45, 60, and 90 minutes and a peak GH < 2.8 ng/mL confirms adult GHD in patients with BMI ≤ 40 kg/m2; safety and performance are not established for BMI > 40 kg/m2.

Specified adult/transition stimulation test cutoffs account for BMI and test type: for ITT a diagnostic peak GH threshold is ≤ 5.0 mcg/L; for the glucagon test the policy uses peak GH cutoffs of ≤ 3.0 mcg/L when BMI < 25 kg/m2 (or when BMI 25–30 kg/m2 with high pretest probability), ≤ 1.0 mcg/L when BMI 25–30 kg/m2 with low pretest probability or when BMI > 30 kg/m2. If ITT and glucagon are contraindicated in the transition setting, an arginine test with peak GH ≤ 0.4 mcg/L may be used. (These thresholds are required for adult/transition diagnostic pathways and retesting after paediatric therapy.)

In children/adolescents, diagnostic criteria for GHD include provocation testing thresholds used in the pediatric pathway: two stimulation tests with agents such as levodopa, insulin‑induced hypoglycemia, arginine, clonidine, or glucagon with peak GH < 10 ng/mL on both tests, or one test with peak GH < 10 ng/mL plus clinical risk factors (e.g., downward deviation across major height percentiles, low IGF‑1/IGFBP‑3, very low peak GH as defined by prescriber, post‑craniopharyngioma resection, optic nerve hypoplasia, GH gene deletion).

Policy Update Changes

Annual Revision (date not provided in brief)revised

Growth Hormone Deficiency in a Child or Adolescent: wording changed from 'patient has panhypopituitarism' to 'patient has multiple pituitary hormone deficiencies'; removed some structural imaging criteria (pituitary stalk agenesis, empty sella, sellar/suprasellar mass lesion, or ectopic posterior pituitary bright spot).

Annual Revision (date not provided in brief)added

Chronic Kidney Disease in a Child or Adolescent: added requirement that patient has or had CKD defined by GFR < 60 mL/min and added persistent growth failure definition for initial therapy; replaced prior creatinine clearance-based criterion.

Annual Revision (date not provided in brief)added

Policy Summary

PayerCigna

PolicySomatropin (Growth Hormone) prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeMultiple revisions (criteria added, revised, clarified)

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

At least one growth hormone stimulation test with levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon

Peak GH on at least one test < 10 ng/mL

Deficiency in at least one other pituitary hormone (ACTH, TSH, gonadotropin, or prolactin)

Medication prescribed by or in consultation with an endocrinologist

iii. Congenital hypopituitarism

ANY of the following
- ALL of the following
  - One growth hormone stimulation test with listed agents
  - Peak GH on at least one test < 10 ng/mL
- Deficiency in at least one other pituitary hormone (ACTH, TSH, gonadotropin, or prolactin)
- Imaging triad: ectopic posterior pituitary AND pituitary hypoplasia with abnormal stalk
Medication prescribed by or in consultation with an endocrinologist

iv. Multiple pituitary hormone deficiencies

ANY of the following
- Three or more pituitary hormone deficiencies (GH, ACTH, TSH, gonadotropins counted as one, or prolactin)
- ALL of the following
  - One growth hormone stimulation test with listed agents
  - Peak GH on at least one test < 10 ng/mL
Medication prescribed by or in consultation with an endocrinologist

v. Hypophysectomy

History of hypophysectomy (surgical removal of pituitary gland)

B) Continuing somatropin therapy (established ≥ 10 months)

ALL of the following
- Patient < 12 years: height increased ≥ 2 cm/year in the most recent year
ALL of the following
- Patient ≥ 12 and < 18 years: height increased ≥ 2 cm/year in the most recent year
- Patient's epiphyses are open
ALL of the following
- Patient ≥ 18 years: height increased ≥ 2 cm/year in the most recent year
- Patient's epiphyses are open
- Mid-parental height has not been attained

Height and growth velocity data (baseline and interval-specific)

Relevant imaging (e.g., pituitary MRI) and genetic test results

Documentation Required

Specialist prescribing/consultation requirement

The medication must be prescribed by or in consultation with an endocrinologist for most covered indications; some indications (e.g., chronic kidney disease) allow prescription by or consultation with a nephrologist.

Denial Risk

Denial risk if used for non‑FDA approved cosmetic or anti‑aging purposes

Endocrinologist must certify somatropin is not being used for anti‑aging, athletic enhancement, cosmetic uses, or body building; federal law prohibits dispensing for non‑FDA approved purposes and pharmacies may decline to dispense.

Documentation Required

Genetic or laboratory confirmation when required

Supply genetic or laboratory confirmation when the indication requires it; clinical diagnosis is acceptable where the criteria allow.

Noonan: confirmatory pathogenic variant in listed genes (BRAF, KRAS, MAP2K1, MRAS, NRAS, PTPN11, RAF1, RASA2, RIT1, RRAS2, SOS1, SOS2; or heterozygous/biallelic variants in LZTR1)
Prader‑Willi: identification of abnormal DNA methylation of chromosome 15q11.2‑q13
Turner: karyotype (chromosome analysis) confirming diagnosis
SHOX: chromosome analysis demonstrating SHOX deficiency

Prior Authorization

Prior authorization for somatropin

Prior authorization approvals are issued for the durations specified in the criteria: commonly 1 year for many pediatric and adult GHD indications, 6 months for Serostim in HIV wasting, and 1 month for short bowel adult indication; evidence of meeting diagnostic and continuation criteria must be provided.

Documentation Required

Growth monitoring

Document baseline height percentile and serial growth velocity over the specified intervals; these data are used for initiation and continuation decisions.

Baseline height percentile (many pediatric indications require < 5th percentile)
Height velocity over 3 months for infants (≤1 year) or 6 months for children/adolescents for CKD/persistent growth failure
Annualized height velocity (e.g., ≥ 2 cm/year) for continuation decisions

Documentation Required

Specialist involvement

Restate that somatropin must be prescribed by or in consultation with an endocrinologist for most indications; nephrologist consultation or prescribing is allowed for chronic kidney disease indications.

Documentation Required

HIV wasting prerequisites

For Serostim (HIV-associated wasting), document prerequisites before approval.

Patient has been on antiretroviral therapy (ART) ≥ 30 days prior to starting Serostim and will continue ART during treatment
Patient has tried one appetite stimulant or anabolic agent (e.g., megestrol acetate, dronabinol, oxandrolone) or such agents are contraindicated
Serostim is not being used solely to treat alterations in body fat distribution (lipodystrophy/HARS)

Continuing therapy response (height velocity)Increase ≥ 2 cm/year in the most recent year

Chronic kidney disease definition for therapyGFR < 60 mL/min

Small for gestational age (SGA) definitionBirth weight and/or birth length > 2 SD below the mean (< -2 SD) for gestational age and gender

Serostim (HIV wasting) weight/BMI thresholdsDocumented unintentional weight loss ≥ 10% OR weight < 90% of lower limit of ideal body weight OR BMI ≤ 20 kg/m2

Definitions from policy

Epiphyses openGrowth plates not fused; clinically or radiographically assessed to determine potential for further linear growth.

Mid-parental heightFather's height plus mother's height divided by 2, plus 2.5 inches if male or minus 2.5 inches if female.

Persistent growth failure (CKD)Baseline height < 5th percentile AND baseline height velocity below the 25th percentile over 3 months for infants (≤1 year) or 6 months for children/adolescents.

Established on somatropinPatient has been receiving somatropin therapy for ≥ 10 months.

Small for gestational age (SGA)Birth weight and/or birth length > 2 standard deviations below the mean (< -2 SD) for gestational age and gender.

Clinical context and specialist involvement: because somatropin therapy and diagnostic evaluation require specialized interpretation and monitoring, the policy expects that somatropin be prescribed by or in consultation with an endocrinologist for most indications (some indications such as CKD may allow nephrologist consultation). Documentation required with prior authorization includes stimulation test results, IGF‑1 measurements, growth velocity data, imaging or genetic test results where applicable, and prior treatment attempts for HIV wasting when Serostim is requested.

For pediatric indications aimed at increasing linear growth, the policy emphasizes measurable response thresholds for continuation: an increase in height velocity of ≥ 2 cm/year in the most recent year is the common response criterion for continued therapy, and many pediatric baseline initiation thresholds use height < the 5th percentile (or SDS ≤ -2.25 for idiopathic short stature). Chronic kidney disease eligibility references a GFR < 60 mL/min and persistent growth failure definitions tied to baseline height < 5th percentile and height velocity below the 25th percentile over specified intervals (3 months for infants, 6 months for children/adolescents).

Noonan syndrome: added confirmatory genetic testing criteria and allowed clinical diagnosis when genetic testing is non-diagnostic with examples of clinical features.

Annual Revision (date not provided in brief)added

Prader-Willi syndrome: updated diagnostic requirement to identification of abnormal DNA methylation of chromosome 15q11.2-q13.

Annual Revision (date not provided in brief)revised

Annual Revision (date not provided in brief)added

Child born small for gestational age: added criteria defining SGA as birth weight/length >2 SD below mean and requirement of insufficient catch-up growth before age 2–4 years for eligibility.

Annual Revision (date not provided in brief)added

Turner syndrome: added requirement that diagnosis be confirmed by karyotype analysis.

Annual Revision (date not provided in brief)added

Short Bowel Syndrome in adults: added criterion that patient is dependent on intravenous parenteral nutrition for initial therapy.

Annual Revision (date not provided in brief)revised

HIV with wasting (Serostim): added requirement that patient has tried one appetite stimulant or anabolic agent or that such agents are contraindicated; removed prior off-Serostim 1-month washout requirement.

Annual Revision (date not provided in brief)clarifiedLatest

Wording standardized across applicable diagnoses: 'The medication has been prescribed by or in consultation with an endocrinologist' applied broadly (administrative wording change; not material).