CurrentUnitedHealthcarePolicy N/A

Human Growth Hormone and Related Growth-Stimulating Products — Coverage Criteria

Governs authorization and reauthorization criteria for somatropin and select growth hormone/IGF-1 products (e.g., Skytrofa, Sogroya, Increlex) for specified pediatric and adult diagnoses in NC; includes diagnostic testing, required documentation, exclusions, and reauthorization response thresholds.

Policy Summary

PayerUnitedHealthcare

PolicyCoverage criteria for somatropin and related growth-stimulating products

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit required growth documentation and diagnostic test results (IGF-1 or GH stimulation tests) to obtain a 12-month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period issued for covered indications

>=2 cm/yrheight increase required for pediatric reauthorization

4 weeksmaximum authorization for Zorbtive

IGF-1/GH testIGF-1 or stimulation testing required

>=2 cm/yr

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Increlex reauthorization growth requirement

Coverage Criteria for Somatropin and Related Products

GH deficiency / Panhypopituitarism — initial approval

Covered when ALL of the following are met:

Diagnosis requirement: One of the following diagnoses is present: (a) Panhypopituitarism OR (b) Other diagnosis for which somatropin is indicated, provided therapy is NOT used in combination with aromatase inhibitors (e.g., anastrozole, letrozole) or androgens (e.g., testosterone enanthate, testosterone cypionate).none

concomitant use with listed agents excludes approval

Product-specific reauthorization — Skytrofa, Somatropin, Sogroya

Reauthorization for Skytrofa, Somatropin, and Sogroya is approved when ALL of the following are met:

Reauthorization requirements: (1) Documentation of IGF-1 obtained within the past 12 months; AND (2) One of the following diagnoses: panhypopituitarism OR other diagnosis not treated in combination with aromatase inhibitors or androgens.IGF-1 within 12 months

Authorization typically issued for 12 months

Prader-Willi syndrome — initial and reauthorization

Initial therapy is covered when ALL of the following are met; reauthorization requires demonstrated response.

Prader-Willi initial: (1) Diagnosis of Prader-Willi syndrome AND (2) Diagnosis confirmed by genetic testing AND (3) ONE of the following: (a) Patient < 18 years with evidence of growth failure documented by growth charts showing decelerating growth velocity, documentation of length/height and weight including percentiles/SD scores, and calculated growth velocity; OR (b) Patient ≥ 18 years of age.none

Authorization issued for 12 months; excludes patients with active malignancy, severe obesity (weight >225% of ideal body weight), or severe respiratory impairment

Prader-Willi reauthorization: For patients < 18 years: documented height increase of at least 2 cm/year over the previous year as evidenced by prior and current heights with dates, calculated growth velocity, and growth charts; expected adult height not attained with documentation of expected adult height goal. For patients ≥ 18 years: documentation of positive clinical response (e.g., reduction in fat mass, increase in lean body mass, improved strength/exercise tolerance).>= 2 cm/year for pediatric reauthorization

Authorization issued for 12 months

SGA-associated growth failure

Covered when ALL of the following are met:

SGA initial: (1) Diagnosis of growth failure associated with being small for gestational age (SGA) AND (2) Diagnosis confirmed by: (a) birth growth charts for gestational age showing birth length and/or weight ≥ 2 SD below the mean; (b) infant growth charts from birth to 24–36 months showing lack of catch-up growth (length/weight remained ≥ 2 SD below mean); (c) documentation that current length/height and/or weight remains ≥ 2 SD below mean for age and gender; and (d) calculated growth velocity.≥ 2 SD below mean at birth and persistent through 24–36 months

Authorization issued for 12 months

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

Authorization issued for 12 months

Turner and Noonan syndromes — initial and reauthorization

Covered when ALL of the following are met:

Initial diagnosis options: Either: (a) Turner syndrome with diagnosis confirmed by genetic testing OR (b) Noonan syndrome with diagnosis confirmed by clinical features consistent with Noonan syndrome (examples provided in policy).none

Genetic confirmation required for Turner; clinical features required for Noonan

Initial growth documentation: Documentation of growth charts showing decelerating growth velocity; documentation of length/height and weight including percentiles/SD scores; calculated growth velocity; documentation of open epiphyses within the last 12 months; Tanner staging ≤ 4.Tanner ≤ 4; open epiphyses within 12 months

Authorization issued for 12 months

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

Initial therapy — SHOX deficiency

Covered when ALL of the following are met:

SHOX initial criteria: (1) Diagnosis of SHOX gene deficiency confirmed by genetic testing; (2) Growth charts demonstrating decelerating growth velocity and documentation of length/height and weight with percentiles/SD scores; (3) Calculated growth velocity; (4) Documentation of open epiphyses within the last 12 months; (5) Tanner stage ≤ 4.

Authorization issued for 12 months

Initial therapy — Growth failure with chronic renal insufficiency

Covered when ALL of the following are met:

Chronic renal insufficiency initial criteria: (1) Diagnosis of chronic renal insufficiency AND (2) Patient has not yet had a renal transplant; AND documentation of growth charts with evidence of growth velocity deceleration, documentation of length/height and weight including percentiles/SD scores, calculated growth velocity, documentation of open epiphyses within the last 12 months, and Tanner stage ≤ 4.

Authorization issued for 12 months

Initial and reauthorization therapy — Idiopathic short stature

Initial therapy is covered when ALL of the following are met; reauthorization requires response criteria.

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

Authorization issued for 12 months

Initial and reauthorization therapy — Severe Primary IGF-1 Deficiency (Increlex)

Covered when ALL of the following are met for initial approval; reauthorization requires documented growth response and absence of concurrent GH therapy.

PIGFD initial criteria: (1) Diagnosis of severe primary IGF-1 deficiency (PIGFD); (2) Height below -3.0 SD mean for age and gender; (3) IGF-1 below -3.0 SD mean for age and gender; (4) Other causes of low IGF-1 ruled out (e.g., GH deficiency, undernutrition, hepatic disease); (5) Growth charts demonstrating decelerating growth and calculated growth velocity; (6) Either unresponsiveness to a trial of GH therapy OR documentation of one of the following supportive genetic/laboratory findings: very low/undetectable GHBP; very low/undetectable GHR mutations known to cause Laron syndrome; GH1 gene deletion; GH-neutralizing antibodies; STAT5b mutation; or IGF-1 gene deletion/mutation; AND (7) Patient will not be treated with concurrent growth hormone therapy.height and IGF-1 < -3.0 SD

Authorization issued for 12 months

PIGFD reauthorization: Height increase ≥ 2 cm/year over the previous year documented by prior 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 not treated with concurrent growth hormone therapy.>= 2 cm/year

Initial and reauthorization therapy — HIV-associated cachexia (Serostim)

Covered when ALL initial Serostim criteria are met; reauthorization requires documented positive response.

Serostim initial criteria: (1) Diagnosis of HIV-associated wasting syndrome or cachexia; (2) Involuntary weight loss > 10%; (3) Either chronic diarrhea (≥2 loose stools daily for >30 days) OR both chronic weakness and fever; (4) Symptoms lasting ≥ 30 days; (5) Absence of other concurrent conditions causing findings; (6) A nutritional evaluation completed since onset of wasting; (7) Antiretroviral therapy optimized to decrease viral load.>10% involuntary weight loss

Authorization issued for 3 months

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

Authorization issued for 6 months

Initial therapy — Short Bowel Syndrome (Zorbtive)

Covered when ALL of the following are met:

Zorbtive initial criteria: (1) Diagnosis of Short Bowel Syndrome; (2) Patient is currently receiving specialized nutritional support (e.g., intravenous parenteral nutrition, fluids, and micronutrient supplements); AND (3) Patient has not previously received 4 weeks of treatment with Zorbtive.

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

Increlex reauthorization

Reauthorization for Increlex is 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 prior and current height with dates, calculated growth velocity, and growth chart for age and gender; (2) Expected adult height not yet obtained and documentation of expected adult height goal; (3) Patient is not treated with concurrent growth hormone therapy.>= 2 cm/year

Authorization issued for 12 months

Diagnostic evidence for IGF-1 deficiency or GH insensitivity — supportive findings

Coverage may be supported by documentation of ONE of the following findings:

Severe primary IGF-1 deficiency / GH insensitivity evidence: Very low or undetectable level of GH binding protein (GHBP); very low or undetectable level of GHR mutations known to cause Laron syndrome/GH insensitivity; GH1 gene deletion (GHD type 1A); GH-neutralizing antibodies; STAT5b gene mutation; IGF-1 gene deletion or mutation.

These findings support the diagnosis of severe PIGFD or GH insensitivity

For the "other diagnosis" pathway, therapy must not be used concurrently with specific agents. Requests will be excluded if the patient is receiving aromatase inhibitors (for example, anastrozole or letrozole) or androgens (for example, testosterone enanthate or testosterone cypionate). Authorization for eligible indications in this pathway will be issued for 12 months when all other criteria are met.

Patients with Prader‑Willi syndrome are not eligible for therapy when any of the following are present: active malignancy, severe obesity defined as weight > 225% of ideal body weight, or severe respiratory impairment. When Prader‑Willi criteria are met and none of these exclusions apply, authorizations are issued for 12 months.

Certain branded growth hormone products are noted as typically excluded from coverage. The policy lists Genotropin, Humatrope, Nutropin, Saizen, Sogroya, and Zomacton as commonly excluded; plan‑specific exclusion status should be confirmed when submitting a request.

Plan‑specific step or tried/failed requirements may apply to some branded growth hormone products that are typically excluded. Providers should verify the member’s plan rules because tried/failed criteria or plan exclusions can affect authorization of these branded agents.

Use of Zorbtive (for short bowel syndrome) is limited to an initial authorization of 4 weeks. Continuation beyond 4 weeks will not be authorized because administration for more than 4 weeks has not been adequately studied.

Diagnostic and Test Thresholds

Stimulation test peak GH thresholds

GHRH+ARG (GH-releasing hormone-arginine)Peak GH ≤ 11 µg/L

Glucagon stimulation test (GST)Peak GH ≤ 3 ng/mL

MacimorelinPeak GH ≤ 2.8 ng/mL

Pediatric reauthorization — height velocity

Pediatric reauthorization height velocity requirementHeight increase of at least 2 cm per year over the previous year documented with prior and current heights, dates, and calculated growth velocity

Documentation requiredPrevious and current length/height with dates and calculated growth velocity

Supporting charts

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Authorization will be issued for 12 months when criteria are met. Prior authorization is required for Increlex (mecasermin) initial and reauthorization requests; initial approval requires meeting all indication-specific clinical criteria and confirmatory testing as specified (e.g., IGF-1, genetic testing, GH tests) and documentation that other causes have been ruled out.

Prior authorization period: typical 12 months when criteria met
Increlex initial authorization: must meet all indication-specific criteria and confirm genetic/biochemical diagnoses where required

Prior Authorization

Reauthorization Growth Response

Reauthorization for growth therapies (Somatropin formulations, Skytrofa, Sogroya, Increlex) requires documentation of an adequate response to therapy. For pediatric growth indications the plan generally requires a height increase of at least 2 cm over the prior 12 months. Reauthorization will be issued for 12 months when response criteria are satisfied.

Reauthorization growth response threshold: ≥ 2 cm height increase in prior year
Reauthorization period: 12 months when response documented

Initial Therapy Criteria by Indication

Initial therapy nodes — top-level initial approval criteria

Initial therapy authorization will be issued when ALL indication-specific initial criteria are met:

Top-level initial approvals: Includes indication-specific initial criteria for Prader-Willi syndrome, SGA-associated growth failure, Turner syndrome and Noonan syndrome, and other covered diagnoses per policy; each diagnosis has documentation and testing requirements as specified in the respective sections.

Authorizations typically issued for 12 months

SHOX initial — somatropin approval

SHOX deficiency initial approval requires all of the following:

SHOX initial: Diagnosis of SHOX gene deficiency confirmed by genetic testing; growth charts with evidence of growth velocity deceleration; documentation of length/height and weight including percentiles/SD; calculated growth velocity; documentation of open epiphyses within the last 12 months; Tanner stage ≤ 4.

Authorization issued for 12 months

Reauthorization and Continuation Criteria

Reauthorization / continuation — general criteria

Reauthorization / continuation is approved when ALL of the following are met:

General reauthorization: Documentation of IGF-1 within the past 12 months for certain products (Skytrofa, Somatropin, Sogroya) where required AND demonstration of clinical or growth response as specified for the indication (e.g., ≥ 2 cm/year height increase in pediatric patients).IGF-1 within 12 months; >= 2 cm/year for pediatrics

Authorizations typically issued for 12 months

Continuation therapy — reauthorization growth response

Continuation therapy requires objective evidence of growth response and unmet adult height goal:

Somatropin/Increlex continuation: Height increase of at least 2 cm/year documented with prior and current heights and dates, calculated growth velocity, and growth chart; expected adult height not attained with documentation of expected adult height goal. For Increlex, patient must not be treated with concurrent growth hormone therapy.

Step Therapy and Product Exclusions

Step	Requirement
1	Not to be used in combination with aromatase inhibitors (e.g., anastrozole, letrozole) or androgens (e.g., testosterone enanthate, testosterone cypionate) for the 'other diagnosis' pathway.

Step	Requirement
1	Genotropin, Humatrope, Nutropin, Saizen, Sogroya, and Zomacton are typically excluded from coverage; plan-specific tried/failed criteria may apply.

Step	Requirement
1	Certain branded growth hormone products (e.g., Genotropin, Humatrope, Nutropin, Saizen, Sogroya, Zomacton) are typically excluded and may require prior attempted alternatives or tried/failed criteria per plan specifications.

Definitions and Test Interpretations

GH stimulation tests and peak GH thresholds

Accepted GH stimulation testsGHRH+ARG (GHRH+arginine), Glucagon stimulation test (GST), Macimorelin

GHRH+ARG cutoffPeak GH ≤ 11 µg/L

Glucagon cutoffPeak GH ≤ 3 ng/mL

Severe Primary IGF-1 Deficiency (PIGFD) — definition and criteria

Definition — Severe Primary IGF-1 Deficiency (PIGFD)Diagnosis characterized by height below -3.0 SD and IGF-1 below -3.0 SD for age and gender with other causes ruled out

Supporting evidenceMay include unresponsiveness to GH trial or genetic/laboratory confirmations (e.g., very low/undetectable GHBP, GHR mutations, GH1 gene deletion, GH-neutralizing antibodies, STAT5b mutation, IGF-1 gene deletion)

Background and Rationale

This section summarizes the clinical and laboratory elements used to determine medical necessity across covered indications. Authorization decisions rely on objective measures such as biochemical confirmation (IGF‑1 level or standardized GH stimulation testing), documented growth parameters (prior and current length/height with dates, growth charts, and calculated growth velocity), and genetic confirmation when required by the diagnosis. For pediatric reauthorization, demonstration of treatment response—typically a documented height increase of at least 2 cm/year—and evidence that expected adult height has not yet been attained are required. Documentation requirements and specific thresholds vary by indication; refer to the indication‑specific criteria for details.

Policy Summary

PayerUnitedHealthcare

PolicyCoverage criteria for somatropin and related growth-stimulating products

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit required growth documentation and diagnostic test results (IGF-1 or GH stimulation tests) to obtain a 12-month authorization.

SourceLink

On This Page

Authorization issued for 12 months

Growth chart for length/height for age and gender must be provided

Prader‑Willi — severe obesity exclusion

Severe obesity exclusion for Prader-WilliWeight > 225 percent of ideal body weight

Other Prader-Willi exclusionsActive malignancy and severe respiratory impairment also exclude approval

Authorization noteAuthorization will be issued for 12 months when criteria are met

Minimum annual height increase for reauthorization

Minimum annual height increase for reauthorization>= 2 cm per year over the previous year as documented by prior and current heights, dates, and calculated growth velocity

Evidence to submitPrevious and current height with dates, calculated growth velocity, and growth chart for height for age and gender

Expected adult heightDocumentation that expected adult height not attained and expected adult height goal must be provided where specified

Predicted adult height threshold (Idiopathic Short Stature)

Context for useRequired for idiopathic short stature initial approval along with growth documentation and GH deficiency ruled out

Severe Primary IGF-1 Deficiency (PIGFD) — height and IGF‑1 thresholds

Height threshold for Severe PIGFDHeight below -3.0 standard deviations (SD) mean for age and gender

IGF-1 threshold for Severe PIGFDIGF-1 below -3.0 SD mean for age and gender

Additional requirementOther causes of low IGF-1 must be ruled out and growth charts with decelerating velocity provided

Serostim — involuntary weight loss requirement

Serostim involuntary weight loss requirementInvoluntary weight loss > 10%

Symptom durationSymptoms lasting ≥ 30 days (intermittent or constant)

Initial authorization durationAuthorization will be issued for 3 months when criteria are met

Increlex reauthorization — growth threshold

Increlex reauthorization height velocity requirementHeight increase of at least 2 cm per year over the previous year documented with prior and current heights, dates, and calculated growth velocity

Additional Increlex reauthorization criteriaExpected adult height not obtained and documentation of expected adult height goal; patient not treated with concurrent growth hormone therapy

Authorization durationAuthorization will be issued for 12 months when criteria are met

Documentation Required

Required Growth and Anthropometric Documentation for Reauthorization

Reauthorization requests must include comprehensive growth and anthropometric documentation demonstrating response: previous and current heights/lengths with dates, calculated growth velocity, and growth charts for length/height for age and gender. For some indications include expected adult height documentation and evidence adult height not yet attained.

Previous length/height and date obtained
Current length/height and date obtained
Calculated growth velocity and method
Growth charts for length/height for age and gender
Documentation of expected adult height and goal (when required)

Documentation Required

Genetic or Clinical Confirmation Required

Many diagnoses require genetic or clinical confirmation prior to approval. Examples: Turner syndrome and Prader‑Willi syndrome require genetic confirmation; SHOX deficiency, SGA, and other disorders require the specified diagnostic testing or clinical evidence per indication.

Genetic confirmation required: Turner syndrome, Prader‑Willi syndrome, SHOX deficiency (per indication)
Clinical confirmation/diagnostic testing as specified for each indication (e.g., IGF‑1 levels, GH stimulation testing, birth weight/length for SGA)

Documentation Required

Required Growth and Developmental Documentation

Providers must document prior and current growth/development data as part of initial and continuation approvals: growth charts showing deceleration, length/height and weight with percentiles or SD scores, calculated growth velocity, Tanner staging and open epiphyses documentation when listed, and other indication‑specific developmental items.

Growth charts for length/height and weight with evidence of growth velocity deceleration
Length/height and weight with percentiles or standard deviation scores
Calculated growth velocity
Open epiphyses documentation within past 12 months (when required)
Tanner stage when required (e.g., ≤4)

Prior Authorization

Increlex — Prior Authorization, Reauthorization, and Concurrency Restrictions

Increlex reauthorization has additional concurrency restrictions: patient must not be treated with concurrent growth hormone therapy. Reauthorization requires the standard growth response documentation (≥2 cm/year, prior/current heights with dates, calculated velocity, growth chart) and evidence expected adult height not attained.

Increlex concurrency rule: No concurrent growth hormone therapy at initial or reauthorization
Reauthorization documentation: previous/current height with dates, calculated growth velocity, growth chart for height for age and gender
Expected adult height documentation required for continuation

Denial Risk

Concomitant Therapy Exclusions

Concomitant therapy exclusions: growth therapies will be denied or not authorized if used in combination with excluded concurrent agents for certain indications. Examples include aromatase inhibitors (e.g., anastrozole, letrozole) and androgens (e.g., testosterone esters) when prohibited by the specific indication.

Do not prescribe concurrently with aromatase inhibitors (e.g., Arimidex, Femara) when indication excludes their use
Do not prescribe concurrently with androgens (e.g., Delatestryl, Depo‑Testosterone) when indicated exclusion applies
Requests may be denied if excluded concomitant therapies are documented

Step Therapy

Product Exclusions and Step Therapy

Product exclusions and step therapy: certain branded growth hormone products (Genotropin, Humatrope, Nutropin, Saizen, Sogroya, Zomacton) are typically excluded from coverage or subject to plan‑specific tried/failed criteria. Refer to the member's plan for product‑specific coverage, step therapy, or trial requirements.

Typically excluded products: Genotropin, Humatrope, Nutropin, Saizen, Sogroya, Zomacton
Tried/Failed criteria or step therapy may be in place—check plan specifics for required prior use or step exceptions

Denial Risk

Documentation and Concurrency Denial Risks

Missing required documentation or evidence of concurrent excluded therapies creates denial risk. Examples include absent GH stimulation test results or IGF‑1 documentation when required, lack of prior/current height data or growth velocity calculation, or evidence of prohibited concurrent GH or other therapies for Increlex requests.

Denial risk if GH stimulation test results or IGF‑1 within required timeframe are not provided
Denial risk if previous/current height with dates and calculated growth velocity are not documented
Denial risk if concurrent prohibited therapy is present for indications that forbid it (e.g., Increlex with GH)

Chronic renal insufficiency initial — somatropin approval

Chronic renal insufficiency initial approval requires all of the following:

CRI initial: Diagnosis of chronic renal insufficiency with no prior renal transplant; growth charts showing decelerating growth velocity; documentation of length/height and weight with percentiles/SD; calculated growth velocity; documentation of open epiphyses within last 12 months; Tanner stage ≤ 4.

Authorization issued for 12 months

Serostim initial — HIV-associated cachexia

Serostim initial approval requires all of the following:

Serostim initial: Diagnosis of HIV-associated wasting or cachexia; involuntary weight loss >10%; either chronic diarrhea (≥2 loose stools daily for >30 days) OR both chronic weakness and fever; symptoms ≥30 days; absence of other causes; nutritional evaluation completed; optimized antiretroviral therapy.>10% weight loss

Authorization issued for 3 months

Zorbtive initial — short bowel syndrome

Zorbtive initial approval requires all of the following:

Zorbtive initial: Diagnosis of Short Bowel Syndrome; patient currently receiving specialized nutritional support (e.g., parenteral nutrition, fluids, micronutrient supplements); patient has not previously received 4 weeks of Zorbtive.

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

Increlex initial — PIGFD

Increlex initial approval requires all of the following:

Increlex initial: Diagnosis of severe primary IGF-1 deficiency; height < -3.0 SD for age/gender; IGF-1 < -3.0 SD for age/gender; other causes excluded; growth charts with decelerating velocity and calculated growth velocity; either unresponsiveness to GH trial OR supportive genetic/laboratory evidence (e.g., very low/undetectable GHBP, GHR mutations, GH1 gene deletion, GH-neutralizing antibodies, STAT5b mutation, IGF-1 gene deletion); patient not treated with concurrent growth hormone therapy.height and IGF-1 < -3.0 SD

Authorization issued for 12 months

Initial therapy — authorization period and concurrency rule

General initial therapy guidance:

Initial authorization guidance: Authorization will be issued for 12 months when indication-specific initial criteria are met. Patient must not be treated with concurrent growth hormone therapy where specified (e.g., Increlex).

Authorization typically issued for 12 months

Increlex continuation — reauthorization requirements

Increlex-specific continuation requirements:

Increlex continuation: (1) Height increase ≥ 2 cm/year over the previous year as documented by prior and current height with dates, calculated growth velocity, and growth chart; (2) Expected adult height not yet obtained with documentation of expected adult height goal; (3) Patient is not treated with concurrent growth hormone therapy.>= 2 cm/year

Authorization issued for 12 months

Treatment concurrency rulePatient must not be treated with concurrent growth hormone therapy for Increlex

SHOX deficiency — definition (genetic confirmation)

SHOX deficiency definitionShort‑stature homeobox (SHOX) gene deficiency confirmed by genetic testing

DocumentationGrowth charts showing deceleration in growth velocity, heights/weights with percentiles/SD, calculated growth velocity, open epiphyses within last 12 months, Tanner stage ≤ 4

Authorization noteAuthorization issued for 12 months when criteria are met

Essential — classification used in policy

Policy classification — essentialUnitedHealthcare defines 'essential' use as therapy to treat a deficiency as part of chronic disease management (PPACA implications)

Effect on benefit capsIf diagnosis is essential, annual dollar caps for growth hormone may be overridden; nonessential uses remain subject to caps

Examples — essential usesPediatric growth hormone deficiency, adult growth hormone deficiency, transition phase adolescent patients, HIV-associated wasting, short bowel syndrome, severe primary IGF-1 deficiency

Nonessential — classification used in policy

Policy classification — nonessentialUses considered nonessential include replacement therapy where deficiency is not noted and certain syndromic growth indications per policy

Examples — nonessential usesGrowth failure in children small for gestational age, chronic renal insufficiency, Turner syndrome, Noonan syndrome, SHOX deficiency, Prader‑Willi syndrome, idiopathic short stature (not currently covered)

Benefit cap implicationNonessential diagnoses may be subject to plan benefit caps for growth hormone therapy