ModifiedCignaPolicy N/A

Growth Disorders - Skytrofa Prior Authorization Policy

This Cigna coverage policy governs prior authorization and medical necessity criteria for Skytrofa (lonapegsomatropin) for pediatric and adult/transition growth hormone deficiency patients under prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyGrowth Disorders - Skytrofa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria and documentation updates (adult/transition added; pediatric continuation modified)

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of diagnostic testing and endocrinologist prescription or consultation per the criteria.

SourceLink

POLICY UPDATE CHANGES

Added criterion for Growth Hormone Deficiency in an Adult or Transition Adolescent and documentation requirements for this diagnosis.

Removed age <18 criterion and added criterion related to continuation of therapy if mid-parental height has not been obtained.

Wording 'at least' was added to the requirement for two growth hormone stimulation tests < 10 ng/mL and updated evaluation wording to require prescription by or consultation with an endocrinologist.

≥1 yrminimum pediatric age

1 yrtypical approval duration

<10 ng/mLpediatric stimulation cutoff

≤5.0

ITT peak GH threshold

≤0.4Arginine test threshold

ListConditions Not Covered

Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered as medically necessary for FDA‑approved indications when specified diagnostic and prescriber criteria are met.

Pediatric GHD (≥1 year) - Approval for 1 year

A) Initial therapy with any GH agent
- i. Diagnostic testing and prescriber
  - a) GH stimulation testing criteria: (1) At least two GH stimulation tests (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with peak GH response to both tests < 10 ng/mL; OR (2) At least one GH stimulation test with peak GH < 10 ng/mL AND at least one risk factor for GHD (examples include downward deviation across height percentiles, low growth velocity, low IGF‑1/IGFBP3, very low provocative GH response, history of craniopharyngioma resection, optic nerve hypoplasia, GH gene deletion)peak GH < 10 ng/mL
    Examples of risk factors listed in policy
  - b) Prescriber: Medication prescribed by or in consultation with an endocrinologist
- ii. Post brain radiation or tumor resection
  - a) Diagnostic evidence: (1) One GH stimulation test (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with peak GH < 10 ng/mL; OR (2) deficiency of at least one other pituitary hormonepeak GH < 10 ng/mL (if testing)
  - b) Prescriber: Medication prescribed by or in consultation with an endocrinologist
- iii. Congenital hypopituitarism
  - a) Diagnostic evidence: (1) One GH stimulation test with peak GH < 10 ng/mL; OR (2) deficiency in at least one other pituitary hormone; OR (3) imaging triad of ectopic posterior pituitary with pituitary hypoplasia and abnormal stalkpeak GH < 10 ng/mL (if testing)
  - b) Prescriber: Medication prescribed by or in consultation with an endocrinologist
- iv. Multiple pituitary hormone deficiencies
  - a) Diagnostic evidence: (1) Three or more pituitary hormone deficiencies; OR (2) One GH stimulation test with peak GH < 10 ng/mLpeak GH < 10 ng/mL (if testing)
  - b) Prescriber: Medication prescribed by or in consultation with an endocrinologist
- v. Hypophysectomy: Patient has had a hypophysectomy (surgical removal of the pituitary gland)
  Prescriber requirement applies (see policy)
B) Currently receiving or switching to Skytrofa: Patient established on therapy ≥10 months; approve if one of: (i) <12 years with height increase ≥2 cm/year; OR (ii) 12–<18 years with height increase ≥2 cm/year AND open epiphyses; OR (iii) ≥18 years with height increase ≥2 cm/year AND open epiphyses AND mid‑parental height not attainedheight increase ≥ 2 cm/year
Midparental height calculation defined in policy

Adult or Transition Adolescent GHD - Approval for 1 year

A) Prescriber certification: Endocrinologist must certify GH therapy is not being prescribed for anti‑aging, athletic enhancement, or bodybuilding
Documentation required
B) Diagnosis of GHD: Patient has diagnosis of GHD 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
Documentation required
C) Diagnostic evidence: One of: (i) known perinatal insults or congenital/genetic defects (documentation required); OR (ii) three or more prior pituitary hormone deficiencies AND low age/gender‑adjusted IGF‑1 prior to GH therapy AND exclusion of other causes of low IGF‑1; OR (iii) negative response to at least ONE standard GH stimulation test as detailed in policy (documentation required)see stimulation test thresholds in policy
Documentation required

Initial/Retesting Criteria

Covered when ALL of the following are met for Growth Hormone Deficiency in a Pediatric Patient (≥1 year of age) or Transition adolescent:

Overall requirements: Patient has been off growth hormone therapy for at least 1 month before retesting; medication prescribed by or in consultation with an endocrinologist; documentation required for all elements.

Obtain documentation that patient was off GH ≥1 month prior to retesting

Acceptable stimulation test responses: Patient meets at least ONE of the specified stimulation test peak GH thresholds listed below

Obtain at least 3 GH levels during the test; exclude timeframe zero

Insulin tolerance test (i): Insulin tolerance test with adequate hypoglycemia and at least 3 GH levels with peak response ≤ 5.0 mcg/L≤ 5.0 mcg/L

Obtain ≥3 GH samples over at least 60 minutes (not including time zero)

Use of human growth hormone agents, including Skytrofa (lonapegsomatropin), for anti-aging, longevity, cosmetic, or performance enhancement is not an FDA-approved indication and is not appropriate. Federal law prohibits dispensing somatropin for non‑FDA‑approved uses, and pharmacies may decline to dispense prescriptions they believe are intended for such purposes. Prior authorization reviews require documentation and specialist involvement as described in the criteria.

Skytrofa and somatropin are considered not medically necessary for a number of non‑growth hormone deficiency indications. Explicit examples include: (1) acute critical illness (post open‑heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure) due to increased mortality risk; (2) aging/anti‑aging or somatopause and to improve functional status in elderly patients; (3) athletic performance enhancement/bodybuilding in non‑athletes; (4) central precocious puberty; (5) chronic fatigue syndrome; (6) congenital adrenal hyperplasia outside controlled trials; (7) constitutional delay of growth and puberty; (8) fibromyalgia; (9) infertility; (10) obesity; and (11) osteoporosis

Skytrofa is contraindicated and not medically necessary for use in patients with acute critical illness after open‑heart surgery, abdominal surgery, multiple accidental trauma, or in those with acute respiratory failure because of an observed increased risk of mortality in these settings.

Somatropin (and by extension Skytrofa when used outside of labeled indications) is not indicated for aging/anti‑aging or for treating somatopause or to improve functional status in elderly patients. Such uses are not FDA‑approved, lack long‑term safety and efficacy data, and federal law prohibits dispensing somatropin for non‑approved purposes.

Somatropin and related agents are not indicated for athletic performance enhancement or bodybuilding in non‑athletes. These are non‑FDA‑approved uses and distribution or dispensing for these purposes is prohibited by federal law.

Additional conditions for which routine use of growth hormone is not recommended or is considered not medically necessary include central precocious puberty (routine GH use in this setting is not recommended), chronic fatigue syndrome (no evidence of GHD), congenital adrenal hyperplasia outside of clinical trials, constitutional delay of growth and puberty, fibromyalgia, infertility, obesity, and osteoporosis. Evidence is limited or does not support routine GH therapy for these indications.

Diagnostic and Test Thresholds

Covered/Relevant Codes referenced elsewhere in policy (none listed in this excerpt)mixed

No codes listed

Macrilen diagnostic cutoff

Macrilen (macimorelin) diagnostic cutoffPeak GH < 2.8 ng/mL (2.8 mcg/L) — meets criteria for a negative response

BMI consideration for MacrilenApplicable when patient BMI ≤ 40 kg/m2 as noted in policy context

Sampling requirements referenceMacrilen testing requires obtaining at least 4 GH levels over a 90 minute timeframe (not including time zero) per policy note

Pediatric GH stimulation cutoff

Pediatric GH stimulation cutoffPeak GH < 10 ng/mL on stimulation testing (two tests or one plus risk factors) — used to define a negative response in pediatric criteria

Acceptable stimulation agents

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization
Prior Authorization Required
Prior Authorization Required. Initial authorization requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., endocrinologist). All reviews will be directed to a clinician (pharmacist or nurse) for verification of criteria. Approvals are provided for the duration specified in the criteria.
Initial approval requires prescription by or consultation with a specialist (endocrinologist)
All reviews directed to a clinician (pharmacist or nurse) for verification
Approvals are time-limited as noted in the criteria

Documentation Required
Documentation Requirements
Documentation is required as noted in the criteria and may include chart notes, prescription claims records, prescription receipts, and/or other information. If required documentation was previously submitted and received during an earlier coverage review, the documentation requirement is considered satisfied.

Drug Background and Scope

Skytrofa (lonapegsomatropin) is a long‑acting prodrug of somatropin developed for weekly human growth hormone replacement. It is FDA‑approved for treatment of pediatric patients ≥ 1 year of age with growth failure due to inadequate endogenous GH secretion (and for adults with GH deficiency under labeled indications). Prior authorization is recommended for Skytrofa; initial prescription or review should involve a clinician with specialty expertise (e.g., endocrinologist) and documentation of diagnostic testing and criteria is required.

Key Definitions

Skytrofa (lonapegsomatropin)

DefinitionSkytrofa (lonapegsomatropin) is a long-acting prodrug of somatropin used as a weekly human growth hormone replacement for pediatric and adult growth hormone deficiency

Indications summaryIndicated for pediatric patients ≥ 1 year who weigh at least 11.5 kg with growth failure due to inadequate endogenous GH secretion, and for adults with GH deficiency

Pharmacologic classLong-acting somatropin prodrug administered weekly

Transition adolescent

Transition adolescent — definitionThe period in adolescence after growth is completed when need for continued GH replacement into adulthood is assessed; encompasses attainment of adult muscle and bone composition and adult height

Documentation requirement

Policy Summary

PayerCigna

PolicyGrowth Disorders - Skytrofa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria and documentation updates (adult/transition added; pediatric continuation modified)

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of diagnostic testing and endocrinologist prescription or consultation per the criteria.

SourceLink

On This Page

D) Additional transition adolescent documentation: For transition adolescents, retesting requirements apply including being off GH for ≥1 month before retesting and meeting specified stimulation test cutoffs

Patients must be off GH ≥1 month before retesting; see stimulation test thresholds

Glucagon stimulation test (ii–v): Glucagon stimulation test with at least 3 GH levels over ≥180 minutes (not including time zero) with peak response thresholds varying by BMI and pretest probability≤ 3.0 or ≤ 1.0 mcg/L depending on BMI/pretest probability

See subcriteria for BMI‑specific thresholds

Glucagon sub‑criteria: (ii) peak ≤ 3.0 mcg/L AND BMI < 25 kg/m2; OR (iii) peak ≤ 3.0 mcg/L AND BMI 25–30 kg/m2 with high pretest probability; OR (iv) peak ≤ 1.0 mcg/L AND BMI 25–30 kg/m2 with low pretest probability; OR (v) peak ≤ 1.0 mcg/L AND BMI > 30 kg/m2≤ 3.0 or ≤ 1.0 mcg/L depending on BMI/pretest probability

Obtain ≥3 GH samples over ≥180 minutes (not including time zero)

Arginine test (vi): If both ITT and glucagon are contraindicated, arginine test with at least 3 GH levels over ≥120 minutes (not including time zero) with peak response ≤ 0.4 mcg/L≤ 0.4 mcg/L

Use only when ITT and glucagon contraindicated; obtain ≥3 samples over ≥120 minutes

Levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon

Prescriber requirementMedication must be prescribed by or in consultation with an endocrinologist

Insulin tolerance test cutoff (adult)

Insulin tolerance test (adult) cutoffPeak GH ≤ 5.0 mcg/L (negative response) with adequate hypoglycemia

Sampling timeframeObtain at least 3 GH levels over a ≥60 minute timeframe (excluding time zero)

Documentation noteRequires demonstration of adequate hypoglycemia during the test

Insulin Tolerance Test peak GH

Insulin tolerance test peak GH thresholdPeak GH ≤ 5.0 mcg/L (negative response) — insulin tolerance testing requires at least 3 GH levels over ≥60 minutes

Excludes time zeroGH levels should not include the timeframe zero measurement

Use when appropriateConsidered an acceptable standard GH stimulation test in adults/transition patients as specified

Glucagon stimulation test peak GH for BMI <25

Glucagon test cutoff (BMI <25)Peak GH ≤ 3.0 mcg/L with at least 3 GH levels over ≥180 minutes (excluding time zero)

Sampling timeframeObtain at least 3 GH levels over a ≥180 minute timeframe (not including time zero)

Use contextApplied for retesting after ≥1 month off GH therapy in pediatric/transition criteria

Glucagon stimulation test peak GH for BMI 25–30 with high pretest probability

Glucagon test cutoff (BMI 25–30, high pretest probability)Peak GH ≤ 3.0 mcg/L with at least 3 GH levels over ≥180 minutes (excluding time zero)

Pretest probability rolePrescriber must state a high pretest probability of GHD for this threshold to apply

Sampling requirementAt least 3 GH levels over ≥180 minutes (not including time zero)

Glucagon stimulation test peak GH for BMI 25–30 with low pretest probability

Glucagon test cutoff (BMI 25–30, low pretest probability)Peak GH ≤ 1.0 mcg/L with at least 3 GH levels over ≥180 minutes (excluding time zero)

Prescriber assessmentApplied when prescriber indicates a low pretest probability of GHD

Test durationObtain at least 3 GH levels across ≥180 minutes (not including time zero)

Glucagon stimulation test peak GH for BMI >30

Glucagon test cutoff (BMI >30)Peak GH ≤ 1.0 mcg/L with at least 3 GH levels over ≥180 minutes (excluding time zero)

Obesity considerationLower cutoff reflects impact of higher BMI on GH response

Sampling timeframeAt least 3 GH levels over ≥180 minutes (not including time zero)

Arginine test peak GH if ITT and glucagon contraindicated

Arginine test cutoff when ITT and glucagon contraindicatedPeak GH ≤ 0.4 mcg/L with at least 3 GH levels over a ≥120 minute timeframe (excluding time zero)

Use caseUsed only if both insulin tolerance test and glucagon stimulation test are contraindicated

Sampling requirementObtain at least 3 GH levels during the ≥120 minute test period (not including time zero)

Documentation may include chart notes, prescription claims records, prescription receipts, and other supporting information
Previously received documentation from prior coverage reviews meets the requirement

Documentation Required
Required Documentation and Prescriber
Required documentation and prescriber. For growth hormone therapy approvals, documentation must demonstrate the appropriate diagnostic testing and clinical findings as specified in the criteria (e.g., stimulation test results, off-therapy intervals, IGF-1 results, and clinical risk factors). The medication must be prescribed by or in consultation with an endocrinologist for applicable indications.
Evidence of appropriate growth hormone stimulation testing with test type, dates, and peak GH values per the criteria
Documentation of any required off-therapy interval before retesting (e.g., off GH therapy ≥1 month where specified)
IGF-1 and IGFBP-3 results and exclusion of other causes of low IGF-1 when required
Clinical notes supporting risk factors or pituitary deficiencies when applicable
Prescriber certification that therapy is not for anti-aging or performance enhancement (adult indication)
Medication prescribed by or in consultation with an endocrinologist

Note
Initial Therapy Options
Initial therapy options and approval durations. For pediatric patients (≥1 year) initial therapy with any growth hormone agent may be approved when the pediatric-specific criteria are met (including stimulation testing thresholds or documented risk factors). Approvals are generally for 1 year when criteria are satisfied. For adults or transition adolescents, approval is for 1 year when all adult-specific criteria are met and required documentation is provided.
Pediatric initial therapy: approve for 1 year if patient meets the pediatric criteria (stimulation testing or documented risk factors)
Adult/transition adolescent initial therapy: approve for 1 year if all adult criteria (A–D) are met, including prescriber certification and diagnostic documentation

Denial Risk
Denial Triggers
Denial Triggers. Claims lacking covered diagnosis/procedure codes or missing required documentation will be denied. Requests for indications considered not medically necessary will be denied.
Claims submitted without covered diagnosis or procedure codes under the applicable coverage policy will be denied
Requests not accompanied by required documentation (chart notes, test results, prescriber consultation evidence) will be denied
Requests for uses listed under Conditions Not Covered will be denied

Denial Risk
Not Medically Necessary Indications
Not Medically Necessary Indications. Skytrofa is considered not medically necessary for any uses not supported by the policy criteria. Examples include acute critical illness (e.g., after open-heart surgery, multiple accidental trauma, acute respiratory failure), aging/anti‑aging, improving functional status in the elderly, somatopause, chronic fatigue syndrome, fibromyalgia, infertility, obesity, osteoporosis, and other non‑FDA‑approved cosmetic or performance enhancement uses.
Acute critical illness (post‑operative critical illness, multiple trauma, or acute respiratory failure) — contraindicated
Aging, anti‑aging, or longevity indications — not covered
Cosmetic or performance enhancement (including bodybuilding, athletic enhancement) — not covered
Other conditions listed in policy (e.g., somatopause, chronic fatigue syndrome, fibromyalgia, infertility, obesity, osteoporosis) — not medically necessary

Transition adolescents require documentation including retesting off GH for ≥1 month before stimulation testing

ScopeApplies when assessing continuation of GH therapy into adulthood under adult/transition criteria

Transition period

Transition period — clinical definitionThe time from late puberty to establishment of adult muscle and bone composition, encompassing attainment of adult height

Relevance to testingTransition period patients are subject to the same stimulation test thresholds and retesting requirements as adults/transition adolescents

Retesting timingPatient must be off growth hormone therapy for at least 1 month before retesting

Stimulation test sampling

Stimulation test sampling requirementObtain at least 3 GH levels during the stimulation test (except Macrilen which requires ≥4 levels) — excludes timeframe zero

Timeframes by testITT: ≥60 minutes; Glucagon: ≥180 minutes; Arginine: ≥120 minutes (all not including time zero)

PurposeEnsures adequate sampling to determine peak GH response for diagnostic thresholds