CurrentCignaPolicy IP0375

Skytrofa (lonapegsomatropin) — Coverage Criteria for Growth Hormone Deficiency

Defines prior authorization, medical necessity, and reauthorization criteria for coverage of Skytrofa (lonapegsomatropin) for pediatric and adult growth hormone deficiency under Cigna-administered plans.

Policy Summary

PayerCigna

PolicySkytrofa (lonapegsomatropin) — Coverage Criteria for Growth Hormone Deficiency

Policy CodePolicy IP0375

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; initial approvals require prescription by or consultation with an endocrinologist and documentation per criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1 yrminimum pediatric age for indication

10 ng/mLpediatric GH stimulation cutoff

2.8 ng/mLMacrilen adult cutoff

IP0375Policy Number

1 yradult initial approval

Pediatric Growth Hormone Deficiency — Initial Therapy

Skytrofa is considered medically necessary when ALL of the following are met for pediatric patients:

Pediatric GHD initial criteria: A. At least 1 year of age but less than 18 years of age.

Diagnostic pathways (ONE of the following)

1. Two stimulation tests + auxology
- a. Diagnostic evaluation & stimulation testing: Diagnostic evaluation showing other pituitary hormone deficiencies have been ruled out and/or corrected prior to testing; AND at least TWO growth hormone stimulation tests (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with both tests showing peak GH response < 10 ng/mL.
- b. Auxologic evaluation: Auxologic evaluation (stature and growth velocity) meeting ONE of: (i) height >2 SD below mean for age/sex and either one-year height velocity >1 SD below mean, or if ≥2 years old a drop >0.5 SD over one year; (ii) one-year height velocity >2 SD below mean; (iii) height velocity >1.5 SD below mean sustained over two years.
2. Cranial or whole body irradiation: Cranial or whole body irradiation.
3. CNS pathology or tumor resection: BOTH: (a) defined central nervous system pathology (e.g., empty sella, interruption of pituitary stalk, pituitary hypoplasia, craniofacial defects, pituitary or hypothalamic tumor) OR tumor resection; AND (b) ONE of: a single GH stimulation test with peak GH < 10 ng/mL OR deficiency in at least ONE other pituitary hormone.
4. Congenital hypopituitarism: Congenital hypopituitarism.
5. Multiple pituitary hormone deficiencies: Multiple pituitary hormone deficiencies with THREE or more pituitary hormone deficiencies (GH, ACTH, TSH, gonadotropins [LH/FSH counted as one], or prolactin) AND ONE GH stimulation test with peak GH < 10 ng/mL.
6. Hypophysectomy: Hypophysectomy (surgical removal of the pituitary gland).

Prescriber and product requirements: C. Medication prescribed by, or in consultation with, an endocrinologist; D. Preferred product criteria met.

Adult or Transition Adolescent Growth Hormone Deficiency — Initial Therapy

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

A. Endocrinologist certification: The endocrinologist must certify that growth hormone therapy is not being prescribed for anti-aging, athletic enhancement, or bodybuilding.

B. Diagnosis of GHD: Patient has a diagnosis of growth hormone deficiency that is either: (i) childhood-onset; OR (ii) adult-onset due to pituitary/hypothalamic disease, pituitary surgery, cranial radiation, tumor treatment, traumatic brain injury, or subarachnoid hemorrhage.

C. Diagnostic evidence (at least ONE of i–iii)

i. Perinatal/congenital defects: Known perinatal insults or congenital/genetic defects (documentation required).
ii. Multiple pituitary deficiencies with low IGF-1:

Reauthorization / Continuation Criteria (Pediatric)

Continuation is medically necessary when initial criteria met AND beneficial response demonstrated:

Pediatric reauthorization: 1) If <12 years: Height increase ≥2 cm/year in the most recent year; OR 2) If 12–17 years: BOTH (a) height increase ≥2 cm/year in the most recent year AND (b) epiphyses are open.

The FDA has not approved human growth hormone for anti-aging, longevity, cosmetic, or performance enhancement purposes. Use of Skytrofa (lonapegsomatropin) for these non‑approved indications is prohibited. Federal law prohibits dispensing human growth hormone for nonapproved purposes, and pharmacies may decline to dispense prescriptions they believe are intended for anti‑aging, cosmetic, performance enhancement, or similar uses. An endocrinologist must certify that therapy is not being prescribed for these non‑approved purposes as required by the coverage criteria.

Diagnostic Thresholds and Coding Notes

inv-05: Macrilen diagnostic threshold — peak < 2.8 ng/mL with BMI ≤ 40 kg/m2

Macrilen (macimorelin) adult diagnostic cutoffPeak GH < 2.8 ng/mL confirms adult GHD when BMI ≤ 40 kg/m2

Sampling timeframeObtain at least 4 GH levels in a 90-minute timeframe (excluding time zero) after macimorelin administration

BMI limitationClinical performance and safety not established for BMI > 40 kg/m2; threshold applies only when BMI ≤ 40 kg/m2

inv-06: Pediatric stimulation test threshold — Peak GH < 10 ng/mL on stimulation testing (two tests)

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

Number of tests for initial pediatric diagnosisAt least TWO GH stimulation tests required (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) when following pathway requiring two tests

Single-test pathwayA single GH stimulation test with peak < 10 ng/mL can satisfy criteria in specific pediatric pathways (e.g., CNS pathology/tumor resection or hypophysectomy)

inv-13: Macrilen (macimorelin) diagnostic threshold — adult GHD confirmation at peak < 2.8 ng/mL for BMI ≤ 40 kg/m2

Macrilen (macimorelin) adult confirmationA maximally stimulated serum GH level < 2.8 ng/mL after macimorelin administration confirms adult GHD for patients with BMI ≤ 40 kg/m2

Sampling scheduleMeasure GH at the 30, 45, 60, and 90 minute time points (clinical trials used these time points)

ApplicabilityTest validated in adults aged 18–66 years with BMI 16–40 kg/m2; not established for BMI > 40 kg/m2

Authorization, Documentation, and Billing 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 approvals are provided for the duration noted in the policy. Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated. hGH is FDA‑approved only for specified indications; it is not approved for anti‑aging, longevity, cosmetic or performance enhancement. Federal law prohibits dispensing hGH for nonapproved purposes; pharmacies may decline to dispense prescriptions they believe are for such uses.

All prior authorization requests will be reviewed by a clinician.
Initial approval requires specialty prescriber (physician specializing in the treated condition).
Approvals are issued for the duration specified in the policy.

Step Therapy

Step Therapy / Preferred Product Trials

Certain employer, individual/family, and standard/performance plans require trials of preferred somatropin products before coverage of Skytrofa. Examples: trials of Genotropin or Omnitrope (or other specified daily somatropin products) for pediatric and adult patients as detailed in plan-specific drug list criteria. Exceptions are allowed when documented intolerance or formulation‑related allergy/adverse reaction prevents continued use of the preferred product(s). Documentation of prior trial(s) and reasons for inability to use preferred products is required.

Employer, Individual/Family, and Standard/Performance drug list plans may require one or more trials of specified somatropin products before Skytrofa.
Documentation required for prior inadequate efficacy (e.g., 12 months of daily somatropin with growth <2 cm/year) or for intolerance/formulation‑related reactions.
Meeting criteria with a trial of any daily growth hormone product(s) counts regardless of formulary status.

Documentation Required

Documentation Requirements

Documentation is required where noted in the coverage criteria. Acceptable documentation may include, but is not limited to: chart notes, laboratory tests, claims records, and other clinical information. Specific documentation examples called for in the criteria include evidence of prior product trials, growth rate measurements, and prescriber rationale for formulation‑related intolerance or allergy.

Provide chart notes or clinical records documenting prior somatropin trials and outcomes (e.g., duration and growth rate).
Document intolerance or formulation‑related allergy/serious adverse reaction with supporting clinical rationale.
Include laboratory tests or other records when specified in the criteria.

Denial Risk

Claims Coding and Coverage

Claims submitted for services that are not accompanied by covered diagnosis and/or procedure codes under this Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate and current codes as of the date of service. Reimbursement is not allowed for services billed for conditions or diagnoses excluded by the member's benefit plan or this policy.

Claims without covered diagnosis/procedure codes under this policy will be denied as not covered.
Use the most appropriate codes effective on the date of service.
Coverage is determined by the applicable benefit plan document; plan exclusions supersede this policy when present.

Drug and Indication Background

Lonapegsomatropin (Skytrofa) is a long‑acting prodrug of somatropin formulated for once‑weekly administration. It is indicated for treatment of growth hormone deficiency in pediatric patients and for replacement therapy in adults with growth hormone deficiency. In pediatric patients the product is indicated for patients aged ≥ 1 year who meet the documented diagnostic and auxologic criteria for growth hormone deficiency; the pediatric indication also requires a minimum weight typically at or above the label‑specified threshold used in clinical studies.

Because evaluation and management of growth hormone deficiency and monitoring of therapy require specialized expertise, prior authorization is required for benefit coverage and initial prescribing must be by, or in consultation with, a clinician who specializes in the treated condition (e.g., an endocrinologist). Documentation such as stimulation test results, IGF‑1 levels, and auxologic measurements must be provided as noted in the policy to support medical necessity.

Definitions and Diagnostic Criteria

inv-12: Growth hormone deficiency (GHD) — definition and etiologies summary

Definition of GHDA condition of inadequate endogenous GH secretion occurring in children and adults due to congenital, structural, radiation, surgical, traumatic, or idiopathic causes

Pediatric consequencesLeads to impaired growth; somatropin therapy is used to increase final adult height and normalize growth in children with GHD

Adult consequencesAssociated with abnormalities in substrate metabolism, body composition, and physical/psychosocial function; somatropin replacement improves these outcomes

Common etiologiesCongenital/genetic defects, pituitary/hypothalamic disease, cranial irradiation, tumor treatment, traumatic brain injury, subarachnoid hemorrhage, surgical resection

inv-13: Macrilen (macimorelin) diagnostic threshold — peak stimulated serum GH < 2.8 ng/mL after macimorelin for BMI ≤ 40 kg/m2

Macimorelin diagnostic cutoff (adult/transition)Peak stimulated serum GH < 2.8 ng/mL after macimorelin confirms GHD for patients with BMI ≤ 40 kg/m2

Required samplingObtain at least four GH measurements during a 90-minute period (exclude time zero) following macimorelin administration

BMI and age considerationsValidated in adults 18–66 years with BMI 16–40 kg/m2; not established for BMI > 40 kg/m2

iii. Failed stimulation testing (ONE of the following tests)

Insulin tolerance test (≥3 GH levels over ≥60 minutes, excluding time 0) with adequate hypoglycemia achieved and peak GH ≤ 5.0 mcg/L.
Glucagon stimulation test BMI <25: Glucagon stimulation test (≥3 GH levels over ≥180 minutes) with peak GH ≤ 3.0 mcg/L and BMI < 25 kg/m2.
Glucagon stimulation test BMI 25–30 high pretest probability: Glucagon stimulation test with peak GH ≤ 3.0 mcg/L and BMI ≥ 25 and ≤ 30 kg/m2 with high pretest probability of GHD.
Glucagon stimulation test BMI 25–30 low pretest probability: Glucagon stimulation test with peak GH ≤ 1.0 mcg/L and BMI ≥ 25 and ≤ 30 kg/m2 with low pretest probability of GHD.
Glucagon stimulation test BMI >30: Glucagon stimulation test with peak GH ≤ 1.0 mcg/L and BMI > 30 kg/m2.
Macimorelin (Macrilen) test: Macimorelin test (≥4 GH levels over ≥90 minutes, excluding time 0) with peak GH < 2.8 ng/mL (mcg/L) and BMI ≤ 40 kg/m2.
Arginine test alternative: If insulin tolerance and glucagon tests are contraindicated, arginine test (≥3 GH levels over ≥120 minutes, excluding time 0) with peak GH ≤ 0.4 mcg/L meets criteria.

OpenPayer

Skytrofa (lonapegsomatropin) — Coverage Criteria for Growth Hormone Deficiency

Coverage and Medical Necessity Criteria

Diagnostic Thresholds and Coding Notes

Authorization, Documentation, and Billing Requirements

Drug and Indication Background

Definitions and Diagnostic Criteria