ModifiedCignaPolicy IP0375

Skytrofa

Defines prior authorization, medical necessity criteria, and product-specific formulary requirements for Skytrofa (weekly human growth hormone) for pediatric and adult growth hormone deficiency under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySkytrofa

Policy CodePolicy IP0375

Change TypePreferred product and plan-specific step therapy updatescriteria clarifications

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of diagnostic testing, prescriber specialty (endocrinologist), and required prior trials of specified daily somatropin products when applicable.

SourceLink

POLICY UPDATE CHANGES

Updated Individual and Family plan preferred product requirements.

Updated the Employer Plans preferred product requirements.

Removed preferred product requirements from the Standard, Value and Legacy formularies.

Added wording 'at least' to the requirement for two growth hormone stimulation tests < 10 ng/mL and added criterion related to continuation of therapy if mid-parental height has not been obtained.

Updated Acute Critical Illness, Central Precocious Puberty and Infertility information in Conditions Not Covered.

Prior authAuthorization requirement

≥1 yrPediatric minimum age

1 yrAdult approval duration

≥2.5–<18

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Pediatric plan age range (I&F)

≥2 cm/yrReauth benefit threshold

Genotropin/OmnitropeComparator products

Coverage and Medical Necessity Criteria

Initial therapy — Pediatric GHD

Covered when ALL of the following are met

Age: At least 1 year of age but less than 18 years of ageage >=1 and <18

[[chunk 9]]

Diagnostic criteria: One of: (1) BOTH: diagnostic evaluation (other pituitary deficiencies ruled out/corrected AND at least TWO GH stimulation tests with peak <10 ng/mL) AND auxologic evaluation meeting specified height/velocity abnormalities; OR (2) cranial or whole body irradiation; OR (3) central nervous system pathology or tumor resection with either one GH stimulation test with peak <10 ng/mL or deficiency in at least one other pituitary hormone; OR (4) congenital hypopituitarism; OR (5) multiple pituitary hormone deficiencies with >=3 deficiencies and one GH stimulation test peak <10 ng/mL; OR (6) hypophysectomy.see text

[[chunk 9],[chunk 10]]

Prescriber: Medication prescribed by, or in consultation with, an endocrinologistprovider specialty: endocrinologist

[[chunk 11]]

Preferred product criteria met per plan-specific tablessee plan drug list tables

[[chunk 11],[chunk 17]]

Initial therapy — Adult or Transition Adolescent GHD

Approve for 1 year if ALL of the following are met (A–E)

Prescriber attestation: Endocrinologist certifies therapy is not for anti-aging, athletic enhancement, or bodybuildingattestation required

[[chunk 11]]

Diagnosis: Patient has diagnosis of GHD from childhood onset OR adult onset due to pituitary/hypothalamic disease, surgery, radiation, tumor treatment, TBI, or SAHdiagnostic documentation required

[[chunk 11]]

Prescriber: Medication prescribed by or in consultation with an endocrinologistprovider specialty: endocrinologist

Plan-specific product trial and step therapy criteria

Plan-specific additional criteria that may be required

Employer Advantage/Value/Total Savings Plans (pediatrics): Patients ≥2.5 to <18 years must meet either: (A) adherence to daily somatropin with inadequate efficacy after 12 months (growth <2 cm/year) with trial of Genotropin or Omnitrope; OR (B) trial of both Genotropin and Omnitrope with inability to continue due to formulation inactive-ingredient-related allergy/intolerancedocumented trials as specified

[[chunk 17],[chunk 18]]

Standard/Performance Drug List Plans: Children <3 years are eligible; children ≥3 to <18 may need trial of Ngenla for 6 months or documented intolerance to Ngenladocumented trial or intolerance

[[chunk 18]]

Individual and Family Plans: Patients ≥2.5 to <18 years require similar trial of daily somatropin products (Genotropin or Omnitrope) or documented inability to use both due to inactive ingredient differences; adults ≥18 require trials of Genotropin and Omnitrope with documented intolerance/ allergy

Initial Therapy / Plan-specific step criteria

Covered when ONE of the plan-specific criteria sets below is met (age and trial requirements differ by plan):

Individual and Family Plans - pediatric (≥2.5 to <18 years): Patient is ≥2.5 years to <18 years AND (A OR B): A) Patient adhered to daily somatropin and after 12 months had growth <2 cm/year documented with trial of ONE product: Genotropin or Omnitrope; OR B) Patient tried BOTH Genotropin AND Omnitrope and cannot continue either due to formulation difference in inactive ingredients causing significant allergy/serious adverse reaction per prescriber with documentation.

Employer Drug Lists - pediatric/adult rules: For children: either A) trial of one daily somatropin (Genotropin or Omnitrope) for 12 months with inadequate efficacy (growth <2 cm/year) documented; OR B) tried both Genotropin and Omnitrope with prescriber-documented formulation intolerance to both. For patients ≥18 years: must have tried both Genotropin and Omnitrope and be unable to continue both due to formulation-related allergy/serious adverse reaction with documentation.

Standard/Performance Drug List Plans: Patient meets ONE: 1) Patient <3 years of age; OR 2) Patient ≥3 to <18 years and (a) has tried Ngenla for 6 months, OR (b) has experienced an intolerance with Ngenla documented; OR 3) Patient ≥18 years of age (additional criteria not fully included in this segment).

Reauthorization / Continuation Therapy

Covered for continuation when ALL the following are met:

Reauthorization - Pediatric (≥1 year): Initial medical necessity criteria are met AND beneficial response is demonstrated by: for <12 years, height increase ≥2 cm in the most recent year; for 12–17 years, BOTH height increase ≥2 cm in the most recent year AND open epiphyses.

Use of human growth hormone (hGH) products for anti-aging, longevity, cosmetic, performance enhancement, or sports medicine purposes is prohibited. These are not FDA‑approved indications for hGH; federal law prohibits dispensing hGH for nonapproved uses and pharmacies may decline to fill such prescriptions. Prior authorization reviews are clinician-directed and initial approvals require specialist involvement to verify appropriate indications.

Skytrofa (lonapegsomatropin) is not covered for a range of non‑growth‑hormone‑deficiency (non‑GHD) and off‑label indications. Examples include acute critical illness after surgery, multiple accidental trauma, or with acute respiratory failure; anti‑aging/somatopause; athletic ability enhancement; central precocious puberty; chronic fatigue syndrome; congenital adrenal hyperplasia; constitutional delay of growth and puberty; corticosteroid‑induced short stature; fibromyalgia; HIV‑associated adipose redistribution; infertility; obesity; osteoporosis; and other off‑label uses (for example, celiac disease, chromosomal anomalies, cystic fibrosis, muscular dystrophy, skeletal dysplasias, spinal cord defects). Requests for Skytrofa for these conditions will be considered not medically necessary.

Dispensing human growth hormone for non‑FDA‑approved purposes (including anti‑aging, performance enhancement, and cosmetic use) is not allowed and may result in denial. Federal law prohibits distribution or dispensing of somatropin for nonapproved uses, and pharmacies that fail to comply may be subject to criminal penalties.

Skytrofa is contraindicated and considered not medically necessary for acute critical illness due to complications following open‑heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure because use in these settings is associated with an increased risk of mortality.

Use of Skytrofa for anti‑aging, improving functional status in elderly patients, or somatopause is not medically necessary. Somatropin is not FDA‑approved for these indications, long‑term efficacy and safety data are lacking, and federal law prohibits distribution or dispensing for non‑FDA‑approved purposes.

Diagnostic Cutoffs, Tests, and Code References

No explicit CPT/HCPCS/ICD codes listed in this segmentmixed

No codes listed

No explicit CPT/HCPCS/ICD-10 codes listed in this document segmentmixed

No codes listed

Macrilen (macimorelin) diagnostic cutoff

Macrilen (macimorelin) diagnostic cutoffPeak GH < 2.8 ng/mL (2.8 mcg/L) with BMI ≤ 40 kg/m2

Specimen timing for MacrilenObtain at least 4 growth hormone levels over a 90-minute timeframe (excluding time zero)

BMI safety noteDiagnostic performance not established for BMI > 40 kg/m2

Pediatric GH stimulation cutoff

Pediatric GH stimulation cutoffPeak GH < 10 ng/mL on stimulation testing

Number of tests generally requiredAt least two GH stimulation tests are generally required for pediatric diagnosis (both showing peak <10 ng/mL)

Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Skytrofa. All reviews will be directed to a clinician (pharmacist or nurse) for verification of criteria. Initial approval requires the medication to be prescribed by, or in consultation with, a physician who specializes in the condition being treated. Approvals are provided for the duration noted in the policy. Documentation is required where noted in the criteria and may include chart notes, laboratory tests, claims records, and/or other information.

Prior authorization required for Skytrofa
Reviews directed to a clinician for verification
Initial approval requires prescription by or consultation with a specialty physician

Prior Authorization

Plan-Specific Prior Authorization Nuances

Certain employer, plan, or client-level drug lists impose additional step therapy or product trial requirements beyond the base criteria. These plan-specific rules may include age limits, required duration of prior product trials, or required specific products to be tried prior to coverage of Skytrofa. Verify the member's specific plan or employer drug list prior to submission.

Drug Background and Context

Skytrofa (lonapegsomatropin) is a long‑acting, weekly prodrug of somatropin formulated for once‑weekly administration. It is indicated for pediatric patients ≥1 year of age (meeting weight and diagnostic criteria) with growth failure due to growth hormone insufficiency, and for adult growth hormone replacement when medically indicated. Long‑acting GH formulations have demonstrated noninferiority to daily somatropin for pediatric annualized height velocity, but dosing is product‑specific and not directly milligram‑equivalent between formulations. Prior authorization is required and reviews are clinician‑directed; initial prescribing must be by or in consultation with a specialist experienced in treating the condition (typically an endocrinologist).

Key Terms and Definitions

Lonapegsomatropin / Skytrofa

Lonapegsomatropin / Skytrofa definitionA prodrug of somatropin formulated for weekly administration as a long-acting human growth hormone therapy

Indications overviewIndicated for pediatric patients ≥1 year with growth failure due to GH insufficiency and for adult GH replacement

Dosing noteDosing is product-specific and not directly milligram-equivalent to daily somatropin formulations

Transition adolescent

Transition adolescent definitionPeriod after growth completion when need for continued GH replacement is reassessed to attain full skeletal and muscle maturation

Policy implicationTransition adolescents are evaluated with adult/transition diagnostic criteria and may be approved for up to 1 year if criteria met

Policy Summary

PayerCigna

PolicySkytrofa

Policy CodePolicy IP0375

Change TypePreferred product and plan-specific step therapy updatescriteria clarifications

Effective DateOct 1, 2025

Next Review Date

SourceLink

On This Page

Preferred product criteria met per plan-specific tablessee plan drug list tables

[[chunk 16],[chunk 17]]

documented trials as specified

Acceptable stimulation agentsLevodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon

Insulin tolerance test adult cutoff

Insulin tolerance test (adult) cutoffPeak GH ≤ 5.0 mcg/L

Sampling timeframeObtain at least 3 GH levels over a 60-minute timeframe (excluding time zero) with adequate hypoglycemia achieved

Retesting requirementPatient should be off GH therapy for at least 1 month before retesting

Glucagon stimulation test cutoffs (adult/transition)

Glucagon stimulation test (BMI <25) cutoffPeak GH ≤ 3.0 mcg/L (BMI < 25 kg/m2)

Glucagon test (BMI 25–30) interpretationPeak GH ≤ 3.0 mcg/L may be used if prescriber considers high pretest probability; otherwise adjusted cutoff ≤ 1.0 mcg/L for low pretest probability

Glucagon test (BMI >30) cutoffPeak GH ≤ 1.0 mcg/L for BMI > 30 kg/m2

Sampling timeframeObtain at least 3 GH levels over a 180-minute timeframe (excluding time zero)

Arginine test cutoff (when other tests contraindicated)

Arginine stimulation test cutoffPeak GH ≤ 0.4 mcg/L (used when insulin tolerance and glucagon tests are contraindicated)

Sampling timeframeObtain at least 3 GH levels over a 120-minute timeframe (excluding time zero)

Documentation noteA prior arginine test with peak ≤ 0.4 mcg/L meets criteria for a negative stimulation test

Height velocity

Height velocity thresholdHeight velocity ≥ 2 cm/year

Use in reauthorizationFor reauthorization, height increase ≥2 cm/year is required for benefit demonstration in children <12 years and for 12–17 years along with open epiphyses

Auxologic data roleHeight velocity is part of auxologic evaluation for pediatric diagnostic criteria (used with stature/SD thresholds)

Inadequate efficacy trial duration for daily somatropin

Inadequate efficacy trial duration (daily somatropin)12 months with growth rate < 2 cm/year constitutes inadequate efficacy

Plan-specific exception (Ngenla)For Standard/Performance plans, a 6-month trial of Ngenla may be acceptable instead of 12 months

Documentation requirementTrial duration and growth measurements must be documented; receipt of sample product does not satisfy trial requirement

Plan- or employer-level drug list criteria may add age limits or additional restrictions
Confirm plan-specific requirements before submitting an authorization request

Prior Authorization

Prior Authorization Requirements — Prior Trials Required

Many plans require documented trials of specified daily somatropin products per the plan-specific step rules. Documentation must include which product(s) were used and the duration and outcome of the trial(s). Receipt of sample product does not satisfy trial requirements.

Documentation of prior product trials required (chart notes, claims, or prescriptions)
Sample product receipt does not meet trial requirements

Step Therapy

Step Therapy / Product Trial Requirements

Certain employer and plan drug lists require trials of specific daily somatropin products (for example, Genotropin, Omnitrope, or Ngenla) before Skytrofa will be approved. The exact sequence and duration vary by plan: some plans require a 12‑month trial of a single product (e.g., Genotropin or Omnitrope) with documented inadequate efficacy, others require trials of both Genotropin and Omnitrope, and some Standard/Performance lists require trial of Ngenla for 6 months or documentation of intolerance.

Genotropin and/or Omnitrope frequently required as prior trials
Some plans require trial of Ngenla for 6 months or documentation of intolerance
Trials must include duration and efficacy/intolerance documentation

Step Therapy

Step Therapy and Product Trial Logic

Step therapy logic: for pediatric patients (≥2.5 to <18 years) many Employer and Individual plans allow Skytrofa only if the patient has adhered to daily somatropin and had inadequate efficacy (e.g., 12 months growth <2 cm/year) with ONE daily product (Genotropin or Omnitrope), or has tried BOTH Genotropin and Omnitrope and cannot continue each because of clinically significant reactions to differing inactive ingredients. For adults, some plans require trials of both Genotropin and Omnitrope with documented intolerance to inactive ingredients. Standard/Performance lists may require Ngenla trials or intolerance documentation. Ensure prior-trial documentation specifies product, duration, and reason for failure/intolerance.

Pediatric (≥2.5 to <18): inadequate efficacy after 12 months with Genotropin or Omnitrope OR trials of both Genotropin and Omnitrope with documented intolerance to inactive ingredients
Adults: trials of both Genotropin and Omnitrope with documented intolerance to inactive ingredients may be required
Standard/Performance plans: Ngenla trial for 6 months or intolerance documentation may apply
Documentation must include product name, trial duration, growth data, and reason for intolerance/failure

Documentation Required

Required Prior Trial Documentation

Documentation of prior trials must be provided and include the specific daily somatropin product(s) used, dates or duration of the trial(s), and objective outcomes (e.g., growth rate <2 cm/year) or documented intolerance/adverse reaction tied to inactive ingredients. Chart notes, lab results, and claims history are acceptable forms of documentation.

Specify product name(s), trial start/end dates or duration, and objective efficacy measures (e.g., growth <2 cm/year)
Document intolerance or serious adverse reaction and link to formulation/inactive ingredient when claimed
Chart notes, labs, or claims may be used as supporting documentation

Documentation Required

Reauthorization Documentation

For reauthorization of pediatric patients (≥1 year) continued benefit requires demonstration of clinical benefit: for patients <12 years a height increase ≥2 cm in the most recent year; for ages 12–17 both a height increase ≥2 cm/year and open epiphyses are required. Reauthorization requests must include documentation (height measurements, growth charts, and radiographic evidence of open epiphyses when applicable).

Age <12 years: ≥2 cm/year height increase in most recent year required
Ages 12–17: ≥2 cm/year height increase and open epiphyses required
Submit growth charts, height measurements, and epiphyseal status documentation for reauthorization

Denial Risk

Exclusion-Triggered Denial Risk

Requests for Skytrofa for off-label or excluded conditions listed in the policy (for example: anti‑aging, athletic performance enhancement, central precocious puberty, fibromyalgia, obesity, osteoporosis, and other off‑label uses enumerated in the policy) may be denied. Federal law prohibits dispensing somatropin for non‑FDA approved uses. Verify that the submitted diagnosis is a covered indication and include supporting documentation; absent a covered diagnosis or required documentation, the request will be denied.

Requests for excluded/off‑label indications are subject to denial
Claims submitted without a covered diagnosis or required documentation will be denied
Federal law prohibits distribution for non‑FDA approved uses

Testing considerationsTransition adolescents should follow the retesting guidance (off GH therapy ≥1 month) prior to stimulation testing

Beneficial response (pediatric reauthorization)

Beneficial response — pediatric reauthorization (<12 years)Height increase ≥ 2 cm/year in the most recent year

Beneficial response — pediatric reauthorization (12–17 years)Height increase ≥ 2 cm/year in the most recent year PLUS open epiphyses

Reauthorization requirementInitial medical necessity criteria must continue to be met in addition to documented beneficial response