CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Skytrofa (lonapegsomatropin) for pediatric growth hormone deficiency — Coverage Criteria

Covers use of Skytrofa for pediatric patients with growth failure due to growth hormone deficiency when specified clinical and documentation criteria are met; applies to Neighborhood Health Plan of Rhode Island Medicaid population.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkytrofa (lonapegsomatropin) for pediatric growth hormone deficiency — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, growth metrics, open epiphyses, diagnostic confirmation, and prior daily GH therapy failure.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=1 yrminimum age

>=11.5 kgminimum weight

Peak <10 ng/mLprovocative GH threshold

Epiphyses openskeletal maturity

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Coverage Criteria for Skytrofa (lonapegsomatropin)

Initial therapy — pediatric GH deficiency

Covered when ALL of the following are met for pediatric patients:

Age and weight: Patient is at least 1 year of age and weighs at least 11.5 kg

Diagnostic confirmation: Either: (a) member was diagnosed with GH deficiency as a neonate with supporting medical records (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or MRI) OR (b) two pretreatment pharmacologic provocative GH tests with both results demonstrating peak GH < 10 ng/mL OR a documented pituitary/CNS disorder and a pretreatment IGF-1 > 2 SD below the mean

See Appendix A for examples of pituitary/CNS disorders

Growth and skeletal criteria: For members < 2.5 years at initiation: pretreatment height > 2 SD below mean and slow growth velocity; For members ≥ 2.5 years at initiation: either pretreatment height > 2 SD below mean and 1-year height velocity > 1 SD below mean, OR pretreatment 1-year height velocity > 2 SD below mean; epiphyses are open

Exclusions and prior therapy: No diagnosis of intracranial tumor growth, psychosocial dwarfism, idiopathic short stature, or history/presence of malignant disease; documentation of treatment failure with at least one daily growth hormone product

Examples of prior treatment failure include claims evidence of inadequate adherence or injection site reactions

Continuation therapy

Continuation therapy covered when ALL of the following are met:

Skeletal maturity: Epiphyses are open (confirmed by X-ray or X-ray not available)

Coverage is excluded for members with a diagnosis of intracranial tumor growth, psychosocial dwarfism, idiopathic short stature, or a history or presence of malignant disease. Documentation that the member does not have any of these diagnoses is required for authorization.

Requests for uses outside the FDA‑approved pediatric indication (pediatric patients ≥ 1 year of age who weigh at least 11.5 kg with growth failure due to inadequate endogenous GH secretion) are considered experimental/investigational and not medically necessary. Only the FDA‑approved pediatric indication and recognized compendial uses are eligible for coverage.

Key Clinical Thresholds and Eligibility Metrics

inv-05: Provocative GH test peak

Provocative GH test peakPeak GH < 10 ng/mL

Test requirementBoth provocative pharmacologic tests must demonstrate peak GH < 10 ng/mL

ContextUsed as diagnostic confirmation of pediatric GH deficiency for initial authorization

inv-06: Minimum age

Minimum ageAt least 1 year of age

Policy scopeApplies to pediatric patients considered for Skytrofa (lonapegsomatropin)

Authorization note

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization — 12‑month approval

Prior authorization may be granted for a 12‑month period when initial or continuation clinical criteria are met, including age/weight thresholds, diagnostic confirmation, growth metrics, open epiphyses, exclusion of contraindicated diagnoses, and prior treatment failure with a daily GH product.

Step Therapy

Prior GH therapy required

Approval requires documentation of treatment failure with at least one daily growth hormone product prior to approval of Skytrofa.

Treatment failure may be based on claims review of inadequate adherence or documentation of injection site reactions.

Background on Skytrofa

Skytrofa (lonapegsomatropin) is a long‑acting growth hormone formulation indicated for pediatric patients with growth failure due to inadequate endogenous growth hormone secretion. The policy applies to pediatric members who are at least 1 year of age and weigh at least 11.5 kg, and requires documentation of diagnostic confirmation, growth measures, open epiphyses, and exclusion of contraindicated diagnoses prior to authorization.

Definitions and Examples

inv-15: Pituitary/CNS disorders (examples)

Congenital genetic abnormalitiesKnown mutations in GHRH receptor, GH gene, GH receptor, or pituitary transcription factors; perinatal insults

Congenital structural abnormalitiesOptic nerve hypoplasia/septo-optic dysplasia; agenesis of corpus callosum; empty sella; ectopic posterior pituitary; pituitary aplasia/hypoplasia; pituitary stalk defect; anencephaly/prosencephaly; other mid-line defects; vascular malformations

Acquired structural abnormalitiesCNS tumors (e.g., craniopharyngioma, glioma, pituitary adenoma); cysts (Rathke cleft, arachnoid); surgery; radiation; chemotherapy; CNS infections; infarction; inflammatory or infiltrative lesions; head trauma; aneurysmal subarachnoid hemorrhage

inv-16: Provocative GH testing threshold

Supporting diagnostic noteTwo pretreatment pharmacologic provocative GH tests with peak GH < 10 ng/mL support the diagnosis of GH deficiency

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkytrofa (lonapegsomatropin) for pediatric growth hormone deficiency — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, growth metrics, open epiphyses, diagnostic confirmation, and prior daily GH therapy failure.

SourceLink

On This Page

Age requirement is verified as part of prior authorization documentation

inv-07: Minimum weight

Minimum weightAt least 11.5 kg

Policy scopeWeight requirement applies at initiation of therapy for pediatric patients

Authorization noteWeight is documented in prior authorization request

inv-16: Provocative GH testing threshold

Diagnostic thresholdTwo pretreatment pharmacologic provocative GH tests with peak GH < 10 ng/mL support diagnosis of GH deficiency

Alternative diagnostic pathwayOr documented pituitary/CNS disorder plus pretreatment IGF-1 > 2 SD below the mean

ApplicationRequired for initial authorization when not diagnosed as neonate

Documentation Required

Required documentation

Submit supporting clinical records including growth charts for pediatric patients, medical records to support neonatal GH deficiency when claimed, pretreatment provocative GH test results or documentation of a pituitary/CNS disorder with IGF‑1, pretreatment height and height‑velocity data, and evidence that epiphyses are open.

For neonatal GH deficiency: medical records such as hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or MRI results.
For diagnostic confirmation: two pretreatment pharmacologic provocative GH tests with peak GH < 10 ng/mL OR documented pituitary/CNS disorder and pretreatment IGF‑1 > 2 SD below the mean.
Evidence epiphyses are open (X‑ray confirmation or X‑ray not available).

Note

Prescriber specialty requirement

Therapy must be prescribed by or in consultation with an endocrinologist or pediatric endocrinologist.

Denial Risk

Non‑approved indications considered investigational

Requests for indications other than the FDA‑approved pediatric indication or compendial uses are considered experimental/investigational and are not medically necessary.

Denial Risk

Exclusionary diagnoses may trigger denial

A diagnosis of intracranial tumor growth, psychosocial dwarfism, idiopathic short stature, or history/presence of malignant disease may lead to denial or exclusion of coverage.

UsageThis criterion is one option for diagnostic confirmation when not diagnosed as neonate

DocumentationResults of both provocative tests must be provided in prior authorization request