Growth Hormone (GH) and Growth Hormone Antagonists
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Clinical coverage rules for somatropin products, weekly GH formulations, Serostim, and related GH antagonists for Aetna commercial medical plans; includes indications, initial and continuation criteria, and precertification requirements that affect participating providers and members.
FDA approved once-weekly somapacitan (Sogroya) for adult growth hormone deficiency and subsequently expanded labeling to pediatric patients aged 2.5 years and older.
FDA approved once-weekly lonapegsomatropin (Skytrofa) for pediatric GHD (age ≥1 year, weight ≥11.5 kg) based on the phase 3 heiGHt trial.
Coverage Criteria and Indications
Initial Therapy - Pediatric GH Deficiency
Covered when EITHER of the following pathways is met:
Per Somatropin products pediatric criteria
Initial Therapy - Other Pediatric Indications
Selected pediatric indications covered when ALL indication-specific entry requirements are met:
SGA criteria and dosing considerations
Turner dosing rationale
Require genetic confirmation when available
Safety constraints and monitoring per labeling
Use is indication-specific and requires documentation
Initial / Continuation Therapy - Adult GH Deficiency
Covered when ANY one of the defined adult diagnostic pathways is met:
Typical pathway for adult-onset AGHD
Alternate pathway when IGF-1 strongly low
Clinical pathway that may obviate repeat stimulation testing
Per policy appendices and adult criteria
Initial/Continuation Therapy - Serostim (HIV wasting)
Serostim (somatropin) is covered for HIV-associated wasting/cachexia when ALL criteria are met:
Continuation requires current BMI < 27 kg/m2 and ongoing receipt of Serostim (not samples)
Initial/Continuation Therapy - Somapacitan-beco (Sogroya)
Somapacitan-beco (Sogroya) coverage mirrors standard GH diagnostic pathways — separate pediatric and adult entries:
Pediatric somapacitan age threshold per labeling
Dose initiation typically 1.5 mg weekly and titration by IGF-1 with max 8 mg weekly
Initial/Continuation Therapy - Lonapegsomatropin-tcgd (Skytrofa)
Lonapegsomatropin-tcgd (Skytrofa) coverage for pediatric GHD (members >= 1 year) requires EITHER neonatal diagnosis OR the specified diagnostic/anthropometric pathway:
Continuation requires open epiphyses and growth rate >2 cm/year unless justified
Per Skytrofa continuation rules
Somapacitan (Sogroya) — selected adult diagnostic criteria snippets
Selected adult diagnostic pathways and thresholds used with somapacitan (examples):
BMI-stratified glucagon cutoffs per policy
Alternative non-stimulation diagnostic pathway
Used when structural/genetic diagnosis established
Lonapegsomatropin (Skytrofa) — Initial and Continuation pediatric criteria
Skytrofa pediatric initial and continuation summary (members ≥1 year):
Neonatal pathway
Anthropometric and testing pathway
Continuation criteria
Macimorelin (Macrilen) — adult diagnostic test criteria
Macimorelin (Macrilen) stimulation testing is medically necessary when ALL criteria are met:
Macimorelin diagnostic cutpoint: stimulated GH < 2.8 ng/mL confirms AGHD
Pegvisomant (Somavert) — acromegaly
Pegvisomant (Somavert) is covered for acromegaly when ALL initial approval criteria are met; continuation requires biochemical response:
Pegvisomant indicated after inadequate first-line therapies
LFT monitoring before and monthly for first 6 months, then every 6 months
Initial diagnostic criteria for adult GH deficiency
Diagnostic confirmation and initiation of adult GH therapy require clinical context plus biochemical testing:
In adults with history of hypothalamic-pituitary disease or cranial irradiation generally only one provocative test is needed; childhood-onset cases usually require two tests unless profoundly low IGF-1
Adult GH dosing and monitoring
Adult GH dosing and monitoring expectations for initiation and titration:
IGF-1 guided titration and monthly assessment recommended
GH for short bowel syndrome
Zorbtive (GH) for short bowel syndrome (SBS) — coverage when used with optimal nutritional support:
Treatment duration limited to 4 weeks per labeling; used with specialized nutritional program
Once-weekly somapacitan (Sogroya)
Somapacitan (Sogroya) — once-weekly adult GH replacement coverage highlights:
Monitoring of IGF-I SDS and clinical response required
Indications and key monitoring/usage considerations
Indications and monitoring considerations (summary of covered uses and safety signals):
Refer to product-specific sections for exact age and testing requirements
Safety signals include transaminase elevations with pegvisomant (~9% in long-term reports) and PWS respiratory risk
Cystic fibrosis — evidence and recommendation
Cystic fibrosis — evidence summary and policy conclusion:
Policy advises more rigorous long-term RCTs prior to routine use
Prader-Willi syndrome — approval and safety constraints
Prader-Willi syndrome — covered when genetic confirmation and safety evaluations are documented:
Monitor for airway symptoms and interrupt treatment for obstruction or infection
SHOX deficiency — evidence
SHOX deficiency — entry requires molecular confirmation plus growth criteria:
Genetic confirmation recommended for prior authorization
SGA — efficacy and metabolic risk considerations
SGA — covered when entry criteria and monitoring are met; metabolic risks considered:
Long-term metabolic effects uncertain; surveillance recommended
Exemptions allow earlier start in severe hypoglycemia/malnutrition/hypotonia
Noonan syndrome — approval and clinical entry criteria
Noonan syndrome — covered when short stature and study-like inclusion criteria are documented:
Document baseline bone age, growth velocity, and glucose status
SRS — consensus practical guidance
Silver‑Russell syndrome (SRS) — consensus guidance applied under SGA indication:
Policy applies SRS guidance within SGA coverage
Turner syndrome — dosing considerations
Turner syndrome — coverage requirements and typical dosing considerations:
Consider adjunct oxandrolone in selected cases per literature
18p deletion syndrome — evaluation and individualized therapy
Other rare indications — individualized consideration where evidence/case reports support endocrine evaluation and therapy:
Require genetic/cytogenetic documentation and baseline endocrine evaluation
Other indications — coverage stance (summarized)
Summary coverage stances for additional indications (high-level):
Refer to detailed policy sections for each indication
Other indications — evidence summaries and insurer stance
Evidence summaries and insurer stance for selected other indications:
Document GC dose/duration and monitoring plan
Not routinely covered
Contractual noncoverage rather than medical necessity
Implant osseointegration (preclinical evidence)
Preclinical evidence summaries (example):
Preclinical evidence only
Rotator cuff repair (RCT evidence)
Rotator cuff repair — randomized human trial evidence summary:
Not medically necessary outside trials
IVF / Endometrial receptivity / Poor ovarian responders (systematic reviews and RCTs)
IVF / endometrial receptivity / poor ovarian responders — heterogeneous evidence:
Require indication-specific protocol and justification for prior authorization
Oral health in children with GHD
Oral health in children with GHD — observational findings:
Clinical significance and implications for dental care require further study
Neurotrophic / retinal injury (preclinical)
Neurotrophic / retinal injury — preclinical mechanistic evidence:
Preclinical data only; not clinical coverage criteria
Primary IGF‑1 deficiency (neurosecretory defect)
Primary IGF‑1 deficiency (neurosecretory defect) — clinical characterization relevant to consideration of therapy:
Some cohorts report ~20% prevalence among isolated SS children
Other/Investigational Indications — generally not established
Other/Investigational indications — not established for routine coverage:
Require prior authorization with indication-specific evidence if requested
Conditions with limited supportive evidence
Conditions with limited supportive evidence — small series where GH may help:
Evidence limited to small cohorts
PHP-Ia (preliminary evidence)
PHP‑Ia — preliminary evidence and recommended documentation when considered:
Prior authorization should include rationale and pre-treatment metrics
Crohn's disease (insufficient evidence)
Crohn's disease — randomized trial evidence does not support routine use:
Consider not medically necessary absent additional supportive evidence and nutritional therapy
Skeletal dysplasias (limited benefit)
Skeletal dysplasias — limited benefit noted in available literature:
Not expected to normalize adult height
Thalassemia (small RCT evidence)
Thalassemia — small RCT evidence with modest short-term growth effects:
Evidence moderate certainty but limited by sample size and duration
Traumatic brain injury (preliminary evidence)
Traumatic brain injury (TBI) — preliminary data support further study but not routine coverage:
Consider only in trial settings or with detailed justification
Testing criteria (children and adults)
Testing criteria — recommendations for provocative testing in children and adults:
Per UpToDate and policy guidance
Appendix C lists congenital defects where testing may be unnecessary
Refer to policy Appendix C for full list
FDA-approved indications and payer note
FDA‑approved indications and payer note (summary):
Appendix L reference
Aetna considers all indications not explicitly listed in this policy for growth hormone products to be experimental and investigational. This applies to somatropin brands and related agents unless a specific indication and coverage criteria are provided elsewhere in the bulletin. (See policy sections for product‑specific criteria and appendices.)
The policy lists a broad set of indications that Aetna considers experimental and investigational. Examples include but are not limited to: adolescent transgender transitioning to male, amyotrophic lateral sclerosis (ALS), anti‑aging, burn injuries, chronic catabolic states (including inflammatory bowel disease), chronic fatigue syndrome, congestive heart failure, Crohn’s disease, HIV‑associated lipodystrophy, hypochondroplasia, hypophosphatemia (X‑linked), implant osseointegration, rotator cuff repair/healing, improvement of oral health, intra‑uterine growth restriction not meeting SGA criteria, infertility/IVF adjuncts, neurosecretory dysfunction/IGF‑1 deficiency, skeletal dysplasias (e.g., achondroplasia), traumatic brain injury, thalassemia, and many other listed conditions. These uses are considered investigational because effectiveness has not been established in the published evidence summarized in the policy.
Growth hormone therapy is contraindicated in patients with active malignant disease. Other important exclusions per accepted labeling include benign intracranial hypertension (pseudotumor cerebri) and proliferative or pre‑proliferative diabetic retinopathy. The policy also notes hypersensitivity to GH or excipients and recommends discontinuation of GH if pregnancy is confirmed.
In pediatric patients, GH is contraindicated in the presence of active malignancy. The policy further highlights controversy and cautions regarding the safety of GH within the first one to two years following treatment for leukemia, medulloblastoma, ependymoma, or other tumors; clinicians should document oncologic history and consider safety implications when evaluating post‑treatment children for GH therapy.
For Prader‑Willi syndrome (PWS), the FDA labeling and policy warn of serious respiratory risks. GH is contraindicated in PWS patients who are severely obese or who have severe respiratory impairment. The policy requires evaluation for upper‑airway obstruction and sleep apnea before initiation and ongoing monitoring; treatment should be interrupted for signs of airway compromise or respiratory infection.
Use of GH for acute catabolic states (for example, critically ill, perioperative, or severe burn patients) is explicitly not recommended. Randomized trials in critically ill populations demonstrated an increased mortality signal with GH treatment, and such indications should be avoided outside of controlled clinical research.
The policy summarizes trial evidence showing that GH for amyotrophic lateral sclerosis (ALS) does not provide survival or functional benefit. Given the lack of efficacy, GH use for ALS is not supported outside of research settings.
Administration of GH as an anti‑aging therapy in otherwise healthy older adults is not supported by the evidence and is not FDA‑approved. Published trials report only modest body‑composition changes with increased adverse events; routine use for rejuvenation is not recommended and should be limited to clinical trials.
Aetna considers GH treatment for HIV‑associated lipodystrophy to be experimental and investigational. Although some trials of GH‑axis agents have shown reductions in visceral adipose tissue and increases in lean body mass, effects on clinical outcomes, safety signals, and durability are uncertain; GH for this indication may be denied.
Use of GH as an adjunct to in‑vitro fertilization (IVF) or to improve endometrial receptivity in routine IVF is not supported by high‑certainty evidence. Systematic reviews and meta‑analyses report heterogeneous results across poor‑responder and thin endometrium populations, with inconsistent effects on live‑birth rates; routine use is considered investigational without clear protocol‑level justification.
Growth hormone therapy for intrauterine growth restriction (IUGR) is unsupported by controlled trial evidence. A Cochrane review found no eligible trials reporting clinical fetal or perinatal outcomes, and clinical use for IUGR is not established.
In skeletal dysplasias (for example, achondroplasia), GH may produce some increase in growth velocity but typically does not produce sufficient gain to approach normal adult height. Therefore GH is generally not expected to normalize stature in these conditions and is considered of limited benefit.
Aetna does not cover growth hormone for idiopathic short stature (ISS). The policy clarifies that ISS is not considered an illness or disease under many benefit plans; accordingly coverage for GH in ISS is typically unavailable and denials in that context are contractual rather than medical‑necessity based.
The cited reference material in the policy includes prescribing information, clinical trials, and systematic reviews that support the policy text. These reference‑only sections summarize sources but do not, by themselves, establish additional exclusions beyond those explicitly stated in the main policy sections.
This Clinical Policy Bulletin provides a general description of Aetna’s coverage approach and is intended to assist in administering plan benefits. It does not constitute an insurance contract or guarantee of payment; coverage is subject to the member’s benefit plan terms and any applicable medical necessity determinations.
The policy considers additional laboratory testing to identify “partial” GH deficiency or to diagnose other GH‑axis bioactivity abnormalities in children without classic GH deficiency to be not medically necessary. This includes overnight inpatient testing for spontaneous GH secretion. Measurement of IGF‑I is considered appropriate for assessing adequacy of therapy, but diagnosis must be corroborated by provocative GH testing.
Because Aetna does not consider idiopathic short stature to be an illness or disease, the policy states that GH treatment for ISS is typically not covered under benefit plans that limit coverage to treatment of disease, illness, or injury. Such denials reflect benefit design rather than medical necessity criteria.
Use of GH to treat age‑related declines in endogenous GH — marketed as a rejuvenation strategy — is not supported by long‑term evidence of safety or sustained clinical benefit. The policy notes small, short‑term improvements in lean mass and bone mass but highlights unknown long‑term oncologic and other risks; this use is not recommended.
For cystic fibrosis, randomized trials report short‑term improvements in anthropometric measures (height, weight, lean body mass) and some pulmonary function outcomes; however, evidence quality is low and no prospective studies have evaluated linear growth to final adult height. Routine rhGH use in CF to improve final height or long‑term clinical outcomes is not established.
GH for anti‑aging in otherwise healthy elderly persons is unsupported. Randomized trials show limited benefit and increased adverse events; routine clinical use for anti‑aging is not recommended and should be confined to clinical research.
The evidence for GH as a treatment for chronic fatigue syndrome is insufficient. Systematic reviews identify only small, inconclusive trials and conclude that effectiveness has not been demonstrated, so GH for chronic fatigue syndrome is considered not medically necessary.
Aetna considers GH for idiopathic short stature (ISS) to be not medically necessary in most cases. While GH can produce modest increases in final height (generally 2–7 cm in trials), ISS is regarded as an enhancement of appearance rather than treatment of disease; coverage is therefore not supported absent a covered diagnosis.
Randomized controlled evidence does not support routine administration of rhGH after rotator cuff repair to improve healing or clinical outcomes. A multicenter RCT of sustained‑release rhGH found no statistically significant benefit on repair failure rate, functional scores, range of motion, or pain; GH for this indication is therefore not supported outside of further research.
Long‑term GH therapy for a variety of miscellaneous adult conditions (such as age‑related bone loss without hypopituitarism, chronic catabolic states, obesity, osteoporosis unrelated to GH deficiency, or other non‑GH‑deficiency indications) is not supported by consistent evidence of clinically meaningful benefit and is not routinely recommended.
In children with Crohn’s disease and short stature, randomized trial data are limited and at the doses studied did not demonstrate a statistically significant stimulation of growth. The policy recommends considering nutritional optimization and addressing inflammatory disease control before pursuing GH, and regards GH monotherapy for Crohn’s‑related growth failure as not established.
Before concluding that an indication is not medically necessary, refer to the main policy sections for the specific Not Medically Necessary criteria. The policy directs reviewers to the established coverage criteria and to supporting documentation requirements when assessing requests for indications that are uncommon or have limited evidence.
Relevant Codes and Thresholds
| E23.0 | Hypopituitarism |
| E22.0 | Acromegaly and pituitary gigantism |
| P05.10 | Newborn small for gestational age |
| Q96.0 | Turner's syndrome |
| R62.52 | Short stature (child) [covered for SHOX deficiency in children whose epiphyses are not closed] |
| F64.0 | Gender identity disorders [transitioning to male] |
| G12.21 | Amyotrophic lateral sclerosis |
| I50.20 | Congestive heart failure |
| Q87.11 | Prader-Willi syndrome |
| Q87.19 | Other congenital malformation syndromes predominantly associated with short stature |
| Q89.2 | Congenital malformations of other endocrine glands |
| Q96.0-Q96.9 | Turner's syndrome |
| R62.52 | Short stature (child) |
| R62.7 | Adult failure to thrive |
| R64 | Cachexia |
| T66.xxx+ | Radiation sickness, unspecified |
| Z92.3 | Personal history of irradiation |
| E66.0-E66.9 | Overweight and obesity (listed as not covered for indications in CPB) |
| E34.30-E34.39 | Short stature due to endocrine disorder [Laron syndrome] (listed as not covered) |
| F30.10-F33.9 | Episodic mood disorders (listed as not covered) |
| G12.21 | Amyotrophic lateral sclerosis (listed as not covered) |
Authorization, Documentation, and Monitoring Requirements
Precertification Required for Serostim and Somavert
Precertification is required for Serostim (somatropin for HIV wasting) and Somavert (pegvisomant) for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to obtain precertification. Include a completed Statement of Medical Necessity (SMN) or use Aetna's Specialty Pharmacy Precertification forms when applicable.
- Precertify Serostim/Somavert: call (866) 752-7021 or fax (888) 267-3277
- Submit Statement of Medical Necessity (SMN) or Specialty Pharmacy Precertification form
Prior Authorization Recommended — Congestive Heart Failure
Aetna recommends prior authorization for therapies where evidence is mixed or evolving. For congestive heart failure (CHF), meta-analyses suggest potential benefit but confirmatory large trials are lacking; prior authorization is recommended to ensure appropriate patient selection and documentation.
- CHF: prior authorization recommended given mixed meta-analysis evidence
Prior Authorization for Non‑Standard Indications
Prior authorization is required for non-standard or off-label indications (e.g., thalassemia, traumatic brain injury, HIV lipodystrophy, idiopathic short stature, other adult miscellaneous conditions). These indications are often considered experimental/investigational or require robust justification and documentation of prior therapies.
- Non-standard indications (thalassemia, TBI, HIV lipodystrophy, ISS, etc.) require prior authorization with strong clinical rationale
- Many of these indications are considered experimental/investigational and may be denied
Prior Authorization References and Resources
Refer to the main policy and references for specific prior authorization processes, code lists, and clinical criteria. The References section and product prescribing information cited throughout the policy support medical necessity determinations.
- Consult policy references and product prescribing information for authorization criteria
- Use Clinical Policy Bulletin references when preparing documentation
Prior Authorization Requirements and Documentation
Prior authorization requirements include indication-specific clinical documentation: diagnosis, treatment history, laboratory and imaging data, and documentation of trials of alternative therapies or contraindications when applicable. Failure to obtain required prior authorization or precertification may result in denial of payment.
- Provide indication-specific protocol and justification (e.g., acromegaly, IVF adjuncts, PWS safety screening)
- Include pretreatment IGF-1, provocative test results, genetic testing when relevant, bone age/epiphyses status, and prior therapy details
Precertification Requirement and Contractual Note
A formal precertification requirement applies; failure to precertify Serostim or Somavert when required may lead to denial. Precertification is a contractual requirement in applicable plan designs.
- Precertification is contractual for certain medications — obtain before treatment
Contractual and Experimental/Investigational Exclusions
Some indications are subject to contractual exclusions or are deemed experimental/investigational (e.g., idiopathic short stature, HIV lipodystrophy). Coverage may vary by benefit plan; when a diagnosis is not a disease under the plan definition (for example ISS), denial is a contractual determination rather than a medical necessity decision.
- Contractual exclusions: ISS often not covered under plans that cover only disease/injury
- Experimental/investigational indications may be denied
ICD‑10 Exclusions May Trigger Denial
Certain ICD‑10 diagnosis codes are listed as not covered for indications in this policy. Use the ICD-10 code lists in the policy when submitting authorizations; inappropriate codes may trigger denial.
- ICD-10 exclusions include (not all-inclusive): I50.* (congestive heart failure codes), E66.* (obesity), G12.21 (ALS), P05.2 (IUGR), and many others listed in the CPT/ICD section
- Ensure submitted ICD-10 codes align with covered indications in the CPB
Pegvisomant (Somavert) — Liver Function and Imaging Monitoring
For patients receiving pegvisomant (Somavert) for acromegaly, monitor liver function tests (LFTs) before treatment, monthly for the first six months, and every six months thereafter due to reports of elevated transaminases and idiosyncratic chronic active hepatitis.
- LFTs: baseline, monthly x6 months, then every 6 months
- Pituitary MRI every 6 months as indicated to monitor for tumor growth
Acute Catabolism — Not Recommended; Denial Risk
Growth hormone is not recommended for acute catabolic states (e.g., critically ill, perioperative, burn patients) because trials showed increased mortality in GH-treated critically ill patients. Such use carries a high denial risk.
- Acute catabolism (critically ill, burns, perioperative) — GH contraindicated due to increased mortality in trials
- Denial risk for acute catabolic indications
Uncertain Efficacy May Trigger Denial — Evidence‑Sensitive Indications
Use of GH for indications with uncertain or low-quality evidence (for example adjunctive GH in IVF, some miscellaneous adult conditions, HIV-associated trunkal obesity) may trigger denial or require strong justification and prior authorization.
- Adjunctive GH to improve IVF outcomes: evidence uncertain/low certainty — require prior optimization and justification
- HIV-associated truncal obesity/lipodystrophy: considered experimental by Aetna
Intra‑Uterine Growth Restriction (IUGR) — Lack of Evidence
There is insufficient evidence to support GH for intrauterine growth restriction (IUGR); clinical use is not supported and prior authorization is unlikely to be approved for this indication.
- IUGR: lack of evidence; GH not supported for clinical use
GH Stimulation Testing Requirements in Adults
In adults, GH-stimulation testing requirements depend on clinical context. Testing is not required in patients with ≥3 pituitary hormone deficiencies and low IGF-1 or in specific congenital/structural conditions. Testing is required for acquired causes (pituitary tumors, surgery, irradiation, TBI, infiltrative disease, etc.). Consult Appendix C for detailed criteria.
- Adults: no stimulation test required if ≥3 pituitary hormone deficiencies and low IGF-1 or specified congenital/structural defects
- Adults: stimulation testing required for acquired causes (e.g., pituitary adenoma, cranial irradiation, TBI, surgery)
Coverage Exception Noted — Idiopathic Short Stature (ISS)
Aetna specifically notes that idiopathic short stature (ISS) is generally not covered by most plans because it is not considered a disease; ISS denials are contractual exceptions rather than medical necessity denials. Providers should verify member benefits and document plan limitations when applicable.
- ISS: typically not a covered benefit — contractual denial possible
- Verify member-specific plan provisions
This Section Contains Only References — Not Authorization Criteria
This section contains references only and is not a substitute for authorization criteria. Use the References and product prescribing information cited in the policy to support authorization requests; references do not by themselves authorize coverage.
- References and PIs are provided to support clinical rationale but do not constitute authorization
Clinical Policy Bulletins Are Not Offers of Coverage
Clinical Policy Bulletins are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. They are a partial, general description of plan benefits; providers remain responsible for treatment decisions and must verify plan-specific coverage.
- CPBs are not offers of coverage; they do not replace the benefit contract
- Providers are responsible for medical advice and for verifying member benefits
IGF‑1 Monitoring and Dosing Documentation
Document IGF-1 monitoring, dose titration, injection-site rotation, and adverse event surveillance in the medical record. For adults, start at low GH doses and titrate monthly using IGF-1 levels to guide dosing. For once-weekly agents, follow product-specific titration schedules and IGF-1 monitoring protocols.
- Record baseline and follow-up IGF-1 values referenced to age/sex laboratory ranges
- Document monthly assessments during titration and subsequent monitoring per product labeling
- Rotate injection sites and record any adverse events
18p Deletion Syndrome — Genetic and Endocrine Documentation Required
For rare genetic conditions such as 18p deletion syndrome, include genetic testing reports and endocrine evaluations when requesting authorization for GH therapy. Demonstrate response when possible (growth metrics) and provide specialist endocrinology consultation notes.
- Attach genetic testing results (e.g., cytogenetic/SNP array) and endocrine evaluation
- Provide pre- and on-treatment growth data showing response to therapy
Glucocorticoid‑Induced Growth Failure — Documentation Expectations
For glucocorticoid-induced growth failure, document duration and dose of glucocorticoid therapy, baseline growth metrics, and GH treatment duration and response. Clinical data from registries demonstrate response often requires >12 months of combined therapy; include monitoring of glucose and metabolic parameters.
- Document GC dose/duration and baseline/follow-up height/height velocity and IGF-1
- Monitor glucose, insulin, and HbA1c as indicated during GH therapy
Serostim Authorization — Alternative Therapy Trial and Documentation
For Serostim (HIV wasting), document that the member is on antiretroviral therapy and has had trial of alternative therapies with suboptimal response or documented contraindication/intolerance. Record pretreatment BMI (<18.5 kg/m2) and ongoing monitoring for continuation criteria (BMI <27 kg/m2 for continued therapy).
- Serostim initial: on ART, trial of alternatives or contraindication, pretreatment BMI <18.5 kg/m2
- Serostim continuation: currently on ART, receiving Serostim, current BMI <27 kg/m2
- Alternative therapies to document prior trial: cyproheptadine, dronabinol, megestrol, testosterone if hypogonadal
Therapy Sequencing for Acromegaly and Pegvisomant Step Therapy
For acromegaly, document sequencing of therapies: prior inadequate response to surgery or radiotherapy (or clinical reason surgery/radiation not appropriate) before initiating pegvisomant (Somavert). For pegvisomant, provide baseline IGF-1 and planned monitoring (IGF-1 response, LFTs, pituitary imaging).
- Document prior surgery and/or radiotherapy and response before Somavert
- Provide baseline IGF-1 and plan for IGF-1 and LFT monitoring and pituitary MRI surveillance
Trial and Titration Expectations — GH and Once‑Weekly Agents
Expectation for trial and titration: start GH at low dose in adults and titrate monthly based on clinical response and IGF-1. For once-weekly agents (e.g., somapacitan, lonapegsomatropin), follow product-specific initiation and titration schedules and IGF-1-guided dosing adjustments.
- Adult GH start: low dose (e.g., 0.1–0.4 mg/day) with monthly assessments
- Once-weekly agents: follow labeled initiation and titration intervals; titrate to IGF-1 targets
SGA/SRS and Pegvisomant Step and Termination Guidance
For pegvisomant step/termination guidance and for SGA/SRS therapy, follow consensus dosing and termination considerations: use recommended dosing ranges, titrate to IGF-1 targets, and consider stopping GH when growth velocity thresholds or bone age criteria are met per consensus statements.
- SGA/SRS: follow consensus for dosing and termination (e.g., stop when height velocity <2 cm/year and bone age >14F/>17M)
- Pegvisomant: titrate to normalize IGF-1 and reassess need for continuation
Step Therapy Considerations and Requirement to Optimize Standard Treatments
Consider step therapy or alternative less costly treatments before GH in conditions where alternatives exist (e.g., constitutional delay: consider testosterone/anabolics in males or low‑dose estrogen in females). Document trials of standard optimization before authorizing GH adjuncts for IVF or Crohn's disease-related growth failure.
- Constitutional delay: document trial of alternatives prior to GH
- IVF adjuncts: require optimization of standard IVF protocols before GH
- Crohn's disease: ensure nutritional optimization prior to GH
HIV‑Associated Truncal Obesity and Alternative Therapies
For HIV-associated truncal obesity and lipodystrophy, sequence treatments and document prior trials. Aetna considers GH for HIV lipodystrophy experimental; alternative therapies (see Appendix E) should be trialed and documented when managing HIV‑related wasting vs truncal obesity.
- HIV‑associated truncal obesity: GH considered experimental for lipodystrophy — document rationale if requested
- Alternative agents for HIV wasting/loss of lean mass: cyproheptadine, dronabinol (Marinol), megestrol acetate, testosterone if hypogonadal
Adult Miscellaneous Conditions — Prior Authorization Likely
For adult miscellaneous conditions where evidence is limited (e.g., age‑related bone loss, chronic catabolic states), prior authorization is likely required and long‑term GH therapy is generally not recommended without strong justification and supporting data.
- Adult miscellaneous conditions: limited evidence; prior authorization and strong justification required
- Long‑term GH therapy not routinely supported for many adult indications
Alternative Therapies for HIV Wasting (Appendix E)
Appendix E lists alternative therapies for HIV wasting which should be trialed prior to Serostim when appropriate: cyproheptadine, dronabinol (Marinol), megestrol acetate (Megace), and testosterone therapy if hypogonadal.
- Appendix E alternatives: cyproheptadine; dronabinol (Marinol); megestrol acetate (Megace); testosterone if hypogonadal
Background and Scope
Background: Growth hormone (somatropin) products are FDA‑approved for pediatric and adult growth hormone deficiency and selected other conditions (for example, Turner syndrome, Prader‑Willi syndrome, small for gestational age, short‑bowel syndrome, and HIV‑associated wasting). Long‑acting weekly GH formulations (e.g., somapacitan, lonapegsomatropin) and GH receptor antagonists (pegvisomant) have product‑specific approvals and safety considerations summarized in the policy. The bulletin outlines diagnostic requirements, testing thresholds, age/weight limits, dosing and monitoring expectations, and contraindications for these agents.
Policy Revisions and Notes
FDA approved pediatric label expansion for somapacitan (Sogroya) for treatment of pediatric patients aged 2.5 years and older based on the REAL4 trial showing comparable annualized height velocity to daily somatropin.
FDA approved once-weekly somapacitan (Sogroya) for replacement of endogenous growth hormone in adults with growth hormone deficiency based on the REAL1 trial.
FDA approved lonapegsomatropin (Skytrofa) for pediatric growth hormone deficiency for children ≥1 year and ≥11.5 kg based on the phase 3 heiGHt trial (approval noted in policy background).
Policy effective date for Aetna’s Clinical Policy Bulletin on growth hormone therapies as recorded in the policy metadata.
Policy last reviewed on 2023-07-28 per the document metadata.
Policy core summary dates: this Clinical Policy Bulletin is effective as of 08/14/1997, with the last review on 07/28/2023 and the next review scheduled for 03/28/2024.
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