Colorado Rocky Mountain Health Plans Growth Hormone Coverage

Coverage Criteria — Somatropin and Growth-Stimulating Products

Initial therapy — Infants (<12 months)

Covered when ALL of the following are met

Infant age: Infant is < 12 months of age

Evidence of growth failure: Growth charts for length/height and weight for age and gender with evidence of growth velocity deceleration over time; documentation of length/height and weight including percentile and/or standard deviation scores; calculated growth velocity

Diagnostic criteria: Either (a) both: hypothalamic-pituitary defect (e.g., ectopic posterior pituitary, empty sella, hypoplastic pituitary, major congenital malformation, optic nerve hypoplasia, tumor or irradiation) AND deficiency of at least one additional pituitary hormone OR (b) all: neonatal hypoglycemia and/or micropenis; serum GH concentration ≤ 5 μg/L in the first 28 days of life; deficiency of at least one additional pituitary hormone; and classical imaging triad (ectopic posterior pituitary and pituitary hypoplasia with abnormal stalk)

IGF testing: Either IGF-1 (Insulin-like Growth Factor 1) or IGFBP-3 (Insulin Growth Factor Binding Protein-3) below the age and gender adjusted normal range as provided by the physician's lab

Initial therapy — Pediatric GHD

Covered when ALL of the following are met

Diagnosis of pediatric growth hormone deficiency

Skeletal maturity: Documentation of open epiphyses within the last 12 months

Pubertal stage: Tanner stage ≤ 4

Provocative testing: Patient has undergone two provocative GH stimulation tests (choose from arginine, clonidine, glucagon, insulin, levodopa) AND peak GH response to each agent is < 10 mcg/L

Reauthorization — Pediatric and Pediatric GHD

Covered when ALL of the following are met

Growth response: Height increase of at least 2 cm/year over the previous year documented by previous and current length/height with dates, calculated growth velocity, and growth chart for length/height for age and gender>= 2 cm/year

Continued need: Expected adult height not attained AND documentation of expected adult height goal

Transition phase adolescent

Covered when ALL of the following are met

Eligibility criteria: One of: genetic mutation; deficiency of three anterior pituitary hormones (ACTH, TSH, prolactin, FSH/LH); irreversible structural hypothalamic-pituitary disease; OR panhypopituitarism

Biochemical confirmation: Either IGF-1 level below the age and gender adjusted normal range OR after discontinuation of therapy for ≥1 month, one GH stimulation test (ITT, GHRH+ARG, Glucagon stimulation test, or Macimorelin) with specified peak GH thresholdsPeak GH thresholds: ITT ≤ 5.1 µg/L; GHRH+ARG ≤ 11 µg/L; Glucagon ≤ 3 µg/L; Macimorelin ≤ 2.8 ng/mL

Adult growth hormone deficiency — Initial therapy

Covered when ALL of the following are met

Etiology: Diagnosis of adult growth hormone deficiency due to known hypothalamic or pituitary disease OR panhypopituitarism OR history of childhood GHD

Biochemical criteria: Either IGF-1 level below the age and gender adjusted normal range as provided by the physician's lab OR documented alternatives when IGF-1 is not low (see stimulation/alternative criteria in policy)

SHOX deficiency — Initial Therapy

Initial therapy for SHOX deficiency

SHOX initial authorization: All of the following must be met: (1) Diagnosis of SHOX gene deficiency confirmed by genetic testing; (2) Growth charts for length/height and weight with evidence of growth velocity deceleration over time; (3) Documentation of length/height and weight including percentile and/or standard deviation scores; (4) Calculated growth velocity; (5) Documentation of open epiphyses within the last 12 months; (6) Tanner stage ≤ 4

Authorization issued for 12 months

Somatropin — Reauthorization

Reauthorization for somatropin across multiple pediatric indications

Reauthorization: Height increase of at least 2 cm/year over the previous year as documented by previous and current height with dates, calculated growth velocity, and growth chart; AND expected adult height not attained with documentation of expected adult height goal>= 2 cm/year

Authorization for 12 months

Chronic Renal Insufficiency — Initial Therapy

Initial therapy for growth failure associated with chronic renal insufficiency

CRF initial authorization: All of the following: (1) Diagnosis of chronic renal insufficiency; (2) Patient has not yet had a renal transplant; (3) Growth charts for length/height and weight with evidence of growth velocity deceleration over time, documentation of length/height and weight including percentile/SD scores, and calculated growth velocity; (4) Documentation of open epiphyses in the last 12 months; AND (5) Tanner stage ≤ 4

Authorization issued for 12 months

Serostim — Initial and Reauthorization

Serostim for HIV-associated cachexia

Serostim initial: All of the following: diagnosis of HIV-associated wasting syndrome or cachexia; involuntary weight loss > 10%; either chronic diarrhea (≥2 loose stools/day for >30 days) OR both chronic weakness and fever; symptoms lasting ≥30 days; absence of other concurrent causes that could explain findings; completed nutritional evaluation; patient's antiretroviral therapy optimizedweight loss >10%

Initial authorization for 3 months

Serostim reauthorization: Evidence of positive response to therapy (i.e., > 2% increase in body weight and/or body cell mass) AND one of the targets (weight, BCM, or BMI) has not been achieved>2% weight or BCM increase

Reauthorization for 6 months

Zorbtive — Short Bowel Syndrome

Zorbtive for short bowel syndrome

Zorbtive initial: All of the following: diagnosis of short bowel syndrome; patient is currently receiving specialized nutritional support (e.g., intravenous parenteral nutrition, fluids, and micronutrient supplements); and patient has not previously received 4 weeks of treatment with Zorbtive

Authorization issued for 4 weeks; treatment will not be authorized beyond 4 weeks

Idiopathic Short Stature — Initial and Reauthorization

Idiopathic short stature

Idiopathic short stature initial: All of the following: diagnosis of idiopathic short stature; growth charts for length/height and weight with evidence of growth velocity deceleration over time and documentation including percentile/SD and calculated growth velocity; predicted adult height < 5'3" for boys or < 4'11" for girls; documentation that growth hormone deficiency has been ruled out by two provocative GH stimulation tests (arginine, clonidine, glucagon, insulin, levodopa) with GH responses to each agent ≥ 10 mcg/L; Tanner stage ≤ 4GH responses >=10 mcg/L; predicted height thresholds

Authorization issued for 12 months; policy indicates idiopathic short stature is nonessential per payer guidance

Idiopathic reauthorization: Height increase ≥ 2 cm/year with documentation (previous and current heights with dates, calculated growth velocity, growth chart) AND expected adult height not attained with documentation of expected adult height goal>=2 cm/year

Authorization for 12 months

Increlex — Initial and Reauthorization

Severe primary IGF-1 deficiency / Growth hormone gene deletion (Increlex)

Increlex initial: All of the following: skeletal dysplasia ruled out by skeletal measurements or survey; other causes of short stature ruled out; documentation of open epiphyses in the last 12 months; diagnosis of severe primary IGF-1 deficiency (PIGFD) with height below -3.0 SD mean for age and gender and IGF-1 below -3.0 SD mean for age and gender; other causes of low IGF-1 ruled out; growth charts with evidence of growth velocity deceleration and calculated growth velocity; AND either unresponsiveness to a trial of growth hormone therapy OR documentation of one of: very low/undetectable GHBP, GHR mutations, GH1 gene deletion, GH-neutralizing antibodies, STT5b mutation, or IGF-1 gene deletion/mutation; AND patient will not be treated with concurrent growth hormone therapyheight and IGF-1 < -3.0 SD

Authorization issued for 12 months

Increlex reauthorization: Height increase of at least 2 cm/year over the previous year as documented by previous and current heights with dates, calculated growth velocity, and growth chart; expected adult height not obtained with documentation of expected adult height goal; and patient is not treated with concurrent growth hormone therapy>=2 cm/year

Authorization issued for 12 months

Increlex Reauthorization

Reauthorization of Increlex will be approved when ALL of the following are met:

Increlex reauthorization: (1) Height increase of at least 2 cm/year over the previous year as documented by previous and current heights with dates, calculated growth velocity, and growth chart for height for age and gender; (2) Expected adult height not obtained AND documentation of expected adult height goal; (3) Patient is not treated with concurrent growth hormone therapy.height increase >= 2 cm/year

Authorization issued for 12 months

Growth hormone therapy is excluded when used for short stature without a defined pathologic diagnosis or when short stature is due to heredity and not a diagnosed medical condition. The policy states that such uses are not considered sickness or injury and therefore growth hormone is not a covered health service for these scenarios; lack of a documented medical indication may trigger denial of authorization.

Certain branded somatropin products are typically excluded from coverage by plan design. The policy explicitly lists Genotropin, Humatrope, Nutropin, Saizen, Sogroya, and Zomacton as commonly excluded; where exclusions exist, tried/failed criteria may apply per the member's plan and providers should consult plan-specific rules to determine coverage status.

Per plan-specific exclusions, some branded somatropin agents may only be considered when member-specific tried-and-failed requirements are met. The document notes that the listed products (Genotropin, Humatrope, Nutropin, Saizen, Sogroya, Zomacton) are typically excluded and that tried/failed criteria may be in place, so authorization decisions for these brands depend on individual plan provisions.

The policy distinguishes uses that are 'essential' versus 'nonessential' under UnitedHealthcare definitions. Idiopathic short stature is identified as a nonessential use in the policy language, meaning it is not considered treatment of a documented deficiency and is subject to benefit-cap rules rather than automatic essential-benefit treatment.

Within the policy's coverage listings, idiopathic short stature is specifically designated as Nonessential (not currently covered per criteria). The coverage table and PPACA-related notes indicate that idiopathic short stature is not treated as an essential indication and authorization is not provided under the standard criteria for essential GH replacement.

Initial Therapy — Diagnosis-Specific Entry Criteria

Initial therapy rules

Initial authorization criteria differ by population (infant <12 months, pediatric GHD, transition adolescents, adults).

Infant initial: Infant < 12 months AND documented growth failure AND specified pituitary/neonatal diagnostic findings AND IGF-1 or IGFBP-3 below normal

Pediatric GHD initial: Diagnosis of pediatric GHD AND growth failure documentation AND open epiphyses within 12 months AND Tanner ≤ 4 AND two provocative GH stimulation tests with peak GH < 10 mcg/L

Authorization for 12 months

Transition phase initial: One of specified clinical conditions (genetic mutation; deficiency of three anterior pituitary hormones; irreversible structural hypothalamic-pituitary disease; or panhypopituitarism) AND IGF-1 below normal OR single stimulation test with defined peak thresholds

Authorization for 12 months

Continuation / Reauthorization Criteria

Continuation / Reauthorization

Reauthorization/continuation requires documented clinical benefit.

Pediatric/GHD reauthorization: Height increase ≥ 2 cm/year over the previous year documented by previous and current heights with dates, calculated growth velocity, and growth chart; AND expected adult height not attained with documentation of expected adult height goal>= 2 cm/year

Authorization typically for 12 months

Transition phase reauthorization: Documentation of positive response to therapy (e.g., increased lean body mass, exercise capacity, or IGF-1/IGFBP-3 levels)

Authorization typically for 12 months

Continuation/Reauthorization

Reauthorization logic applicable to multiple agents

Provider Actions, Documentation & Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be provided only when the member meets the specified initial therapy criteria. Initial approvals and reauthorizations are typically issued for 12 months unless noted otherwise. Automated approval/denial may occur based on previous claims or medication history, diagnosis codes (ICD-10), and claims logic — use of automated processes varies by program.

Prior authorization required for somatropin, Ngenla, Skytrofa, Sogroya, Increlex, Serostim, Zorbtive and other listed agents when criteria met
Authorizations generally issued for 12 months; Serostim initial authorization issued for 3 months; Zorbtive will not be authorized beyond 4 weeks

Documentation Required

Required Clinical Documentation

Providers must submit complete clinical documentation to support initial and reauthorization requests. Missing documentation may result in denial or delay. Documentation should demonstrate both diagnosis-specific entry criteria and objective evidence of treatment response for reauthorization.

Clinical Thresholds and Key Values

ITT peak GH threshold — ≤ 5.1 µg/L

ITT peak GH threshold≤ 5.1 µg/L

ContextUsed as a diagnostic peak GH cutpoint in transition/adolescent and adult biochemical confirmation testing

Authorization noteMeets specified threshold for a single GH stimulation test per transition-phase criteria

GHRH+ARG peak GH threshold — ≤ 11 µg/L

GHRH+ARG peak GH threshold≤ 11 µg/L

ContextAcceptable peak GH cutpoint for GHRH plus arginine stimulation testing in transition-phase biochemical confirmation

Authorization note

Step Therapy and Product Exclusions

Step	Requirement
0
No step therapy requirements specified in this excerpt.

Step	Requirement
1
Certain branded somatropins (e.g., Genotropin, Humatrope, Nutropin, Saizen, Sogroya, Zomacton) are typically excluded from coverage and may require tried/failed criteria per plan specifics.

Step	Requirement	Failure criteria (if specified)
1
Certain branded products (Genotropin, Humatrope, Nutropin, Saizen, Sogroya, Zomacton) are typically excluded from coverage; plan-specific tried/failed criteria may apply.
Plan-specific tried/failed requirements may apply for typically excluded branded products (refer to plan details).

Definitions and Diagnostic Concepts

Pediatric growth hormone deficiency (GHD) — definition and summary

DefinitionGrowth failure due to inadequate secretion of endogenous growth hormone (GHD) in children

Typical diagnostic requirementsDocumented growth velocity deceleration, open epiphyses, Tanner stage ≤ 4, and two provocative GH stimulation tests with peak GH responses < 10 mcg/L for pediatric GHD

Authorization notePrior authorization required; initial approvals issued for 12 months when criteria met

Severe primary IGF-1 deficiency (PIGFD) — definition and thresholds

DefinitionSevere primary IGF-1 deficiency (PIGFD): diagnosis with height and IGF-1 < -3.0 SD for age/gender after other causes ruled out

Confirmatory evidenceEither unresponsiveness to a GH trial or genetic/biomarker evidence (e.g., very low/undetectable GHBP, GHR mutations, GH1 deletion, GH-neutralizing antibodies, STT5b mutation, IGF-1 gene mutation)

Background and Indications

Somatropin and related products are indicated for growth failure due to inadequate endogenous growth hormone secretion and for multiple pediatric and adult conditions, including pediatric growth hormone deficiency, Turner syndrome, chronic kidney disease (pre‑transplant), short-stature homeobox (SHOX) deficiency, short bowel syndrome (Zorbtive), and HIV-associated wasting (Serostim). Long-acting GH formulations and other growth‑stimulating agents (e.g., Ngenla, Skytrofa, Sogroya, and Increlex for severe primary IGF‑1 deficiency) are included in the program and require diagnosis‑specific criteria and prior authorization.

OpenPayer

Human Growth Hormone and Growth‑Stimulating Products — Coverage Criteria

Coverage Criteria — Somatropin and Growth-Stimulating Products

Initial Therapy — Diagnosis-Specific Entry Criteria

Continuation / Reauthorization Criteria

Provider Actions, Documentation & Authorization Process

Clinical Thresholds and Key Values

Step Therapy and Product Exclusions

Definitions and Diagnostic Concepts

Background and Indications