CurrentCignaPolicy N/A

Growth Disorders - Ngenla Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Ngenla (somatrogon-ghla) for treatment of pediatric growth hormone deficiency and lists non-covered uses. Affects pediatric patients, prescribing clinicians, and Cigna reviewers.

Policy Summary

PayerCigna

PolicyGrowth Disorders - Ngenla Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revisions and operational update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age, GH stimulation test results (peak GH values), endocrinologist prescription/consultation, and growth response to support approval.

SourceLink

POLICY UPDATE CHANGES

The policy statement was updated to state that all reviews will be directed to a clinician (i.e., pharmacist or nurse) for verification of criteria.

The wording 'at least' was added to the requirement for two growth hormone stimulation tests < 10 ng/mL; 'evaluated by an endocrinologist' updated to 'prescribed by or in consultation with an endocrinologist.'

Criterion specifying the result of a growth hormone stimulation test to be < 10 ng/mL was added (and prior wording about laboratory reference range was removed).

≥3 to <18FDA-approved age range

1 yearInitial authorization length

<10 ng/mLPeak GH threshold

≥10 months

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Established therapy requirement

≥2 cm/yrContinuation response

Coverage Criteria for Ngenla (somatrogon)

Initial and Continuation Therapy Criteria

Covered when ONE of the following high-level options (A or B) is met for pediatric patients ≥ 3 to < 18 years — approve for 1 year:

Main options: Option A: Initial therapy with any growth hormone agent OR Option B: Currently receiving or switching to Ngenla (established ≥ 10 months)

See detailed subcriteria below

A) Initial Therapy — path i

a - GH stimulation or risk factor: (1) At least two growth hormone stimulation tests performed with levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon AND the peak GH response to both tests is < 10 ng/mL; OR (2) At least one growth hormone stimulation test performed with the listed agents AND the peak GH response to at least one test is < 10 ng/mL AND the patient has at least one risk factor for growth hormone deficiency (examples listed)< 10 ng/mL
Examples of risk factors include: downward deviation across two major height percentiles, growth rate less than expected for age/gender, low IGF-1 and/or IGFBP-3, very low peak GH as defined by prescriber, growth velocity < 10th percentile, status post craniopharyngioma resection, optic nerve hypoplasia, GH gene deletion.
b - prescriber: Medication prescribed by or in consultation with an endocrinologist

A) Initial Therapy — path ii (brain radiation/tumor resection)

a - testing or other pituitary deficiency: (1) One growth hormone stimulation test with levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon AND the peak GH response to at least one test is < 10 ng/mL; OR (2) Deficiency in at least one other pituitary hormone (ACTH, TSH, or gonadotropin deficiency counted as one, or prolactin)< 10 ng/mL
b - prescriber: Medication prescribed by or in consultation with an endocrinologist

A) Initial Therapy — path iii (congenital hypopituitarism)

a - diagnostic options: (1) One growth hormone stimulation test with listed agents AND peak GH response to at least one test is < 10 ng/mL; OR (2) Deficiency in at least one other pituitary hormone; OR (3) Imaging triad of ectopic posterior pituitary and pituitary hypoplasia with abnormal stalk< 10 ng/mL
b - prescriber: Medication prescribed by or in consultation with an endocrinologist

A) Initial Therapy — path iv (multiple pituitary hormone deficiencies)

a - diagnostic options: (1) Three or more pituitary hormone deficiencies; OR (2) One growth hormone stimulation test with listed agents AND peak GH response to at least one test is < 10 ng/mL< 10 ng/mL
b - prescriber: Medication prescribed by or in consultation with an endocrinologist

A) Initial Therapy — path v: Patient has had a hypophysectomy

Also requires medication prescribed by or in consultation with an endocrinologist per initial therapy paths

B) Currently receiving or switching to Ngenla

i - age < 12 years: Patient's height has increased by ≥ 2 cm in the most recent year
ii - age ≥ 12 and < 18 years
- a - height response: Patient's height has increased by ≥ 2 cm in the most recent year
- b - epiphyses: Patient's epiphyses are open

The policy lists specific non-covered clinical uses for Ngenla. The following uses are explicitly considered not medically necessary: Athletic Ability Enhancement; Central Precocious Puberty (CPP); Congenital Adrenal Hyperplasia (CAH); and Constitutional Delay of Growth and Puberty. The list may not be all-inclusive and will be updated as new published data become available.

Ngenla is considered not medically necessary for any use not listed in the covered criteria. Examples of non-covered uses include athletic performance enhancement, treatment of central precocious puberty, management of congenital adrenal hyperplasia, and treatment of constitutional delay of growth and puberty.

Key Clinical Thresholds and Coding Metrics

inv-04: Peak GH on stimulation testing — threshold used in criteria

Peak GH thresholdPeak growth hormone response on stimulation testing < 10 ng/mL

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

Number of tests for definitive diagnosis (initial path i)At least two stimulation tests with peak GH < 10 ng/mL OR one test plus risk factor(s)

inv-05: Duration established on prior GH therapy to qualify as 'currently receiving or switching' — therapy duration requirement

Required established therapy durationPatient must have been established on prior growth hormone therapy for ≥ 10 months to qualify as 'currently receiving or switching'

Applies to

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required — 1 year approvals

Prior authorization is required for Ngenla; when the patient meets the policy criteria for the FDA‑approved pediatric GHD indication, approvals are provided for 1 year.

Step Therapy

Therapy sequencing — initiation, continuation, or switch allowed

Policy permits initiation of therapy as initial treatment with any growth hormone agent, and allows continuation or switching to Ngenla for patients who have been established on prior growth hormone therapy for ≥ 10 months.

Documentation Required

Required documentation for prior authorization

Definitions

inv-12: Ngenla (somatrogon-ghla) — drug definition and mechanism (long-acting hGH analog summary)

Generic name and codeNgenla (somatrogon-ghla)

Molecular descriptionhGH analog with three added copies of a C-terminal peptide, increasing half-life

Mechanism of actionBinds growth hormone receptor to initiate changes in growth and metabolism

Clinically relevant propertyLong-acting formulation designed to prolong half-life compared with daily somatropin

inv-13: Growth Hormone Deficiency (GHD) — definition and clinical context

DefinitionGrowth Hormone Deficiency (GHD) — inadequate secretion of growth hormone leading to growth failure; may be congenital or acquired (e.g., due to radiation or tumor)

Background

Ngenla (somatrogon-ghla) is a long-acting human growth hormone analog constructed from the amino acid sequence of native human growth hormone with added C-terminal peptide copies to extend its half-life. It binds the growth hormone receptor to stimulate growth and metabolism and is indicated for treatment of growth failure due to inadequate growth hormone secretion in pediatric patients aged ≥ 3 to < 18 years. Long-acting GH formulations have demonstrated noninferiority to daily somatropin for annualized height velocity, but product-specific dosing and pharmacokinetic/pharmacodynamic characteristics differ and doses are not directly interchangeable.

Policy Summary

PayerCigna

PolicyGrowth Disorders - Ngenla Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revisions and operational update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age, GH stimulation test results (peak GH values), endocrinologist prescription/consultation, and growth response to support approval.

SourceLink

On This Page

Patients switching to Ngenla from another GH agent or currently receiving Ngenla

Authorization implicationMeeting this duration is part of the B) continuation/switch pathway for approval (approve for 1 year if other response criteria met)

inv-06: Height velocity response for continuation — response threshold

Continuation response thresholdHeight increase ≥ 2 cm in the most recent year (height velocity)

Age-specific requirement (<12 years)For patients < 12 years: height increase ≥ 2 cm/year required

Age-specific requirement (≥12 to <18 years)For patients ≥ 12 and < 18 years: height increase ≥ 2 cm/year AND open epiphyses required

Submit documentation that demonstrates the patient meets age and diagnostic/testing requirements, including results of growth hormone stimulation testing (number of tests and peak GH values), prescriber specialty, and growth response or relevant pituitary history as applicable.

Patient age (≥ 3 to < 18 years) and indication
Number and agents used for GH stimulation tests and peak GH results (e.g., levodopa, insulin-induced hypoglycemia, arginine, clonidine, glucagon)
Presence of risk factors or other pituitary hormone deficiencies, history of brain radiation/tumor resection or hypophysectomy when relevant
Medication prescribed by or in consultation with an endocrinologist
For continuation: documented height increase (≥ 2 cm/year) and open epiphyses when age ≥ 12

Denial Risk

Denial triggers — missing codes or non‑covered uses

Claims or requests that lack covered diagnosis/procedure codes or do not meet the policy criteria will be denied as not covered; dispensing for non‑FDA‑approved uses (e.g., performance enhancement) is considered not medically necessary and will be denied.

Claims submitted without covered code(s) under the policy will be denied as not covered
Uses not listed in covered criteria (e.g., anti‑aging, performance enhancement, CPP, CAH, constitutional delay) are not medically necessary

Clinical consequenceLeads to impaired growth; somatropin therapy is used to increase final adult height and normalize growth

Context in policyPolicy addresses pediatric GHD (FDA indication: ≥ 3 to < 18 years) and criteria for initiation or continuation of GH therapy

Associated diagnostic testingDiagnosis supported by GH stimulation testing (agents: levodopa, insulin-induced hypoglycemia, arginine, clonidine, glucagon) and other clinical risk factors