CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Skytrofa (lonapegsomatropin) — Pediatric Growth Hormone Deficiency Coverage Criteria

Policy governing coverage of Skytrofa (lonapegsomatropin) for pediatric patients with growth hormone deficiency for Neighborhood Health Plan of Rhode Island (Medicaid scope). It specifies prescriber requirements, initial and continuation approval criteria, and exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkytrofa (lonapegsomatropin) — Pediatric Growth Hormone Deficiency Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization (typically 12 months) and document age ≥1 year, weight ≥11.5 kg, diagnostic testing, growth charts, and open epiphyses.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period for initial and continuation approvals

>=1 yrminimum patient age for treatment initiation

>=11.5 kgminimum patient weight for treatment initiation

<10 ng/mLGH peak threshold on two provocative tests for diagnosis

Coverage Criteria for Skytrofa (lonapegsomatropin)

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.

Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Age/weight: Patient is at least 1 year of age and weighs at least 11.5 kgage >= 1 year; weight >= 11.5 kg

See FDA-approved indication and documentation requirements

Diagnosis: Growth failure due to inadequate secretion of endogenous growth hormone (pediatric GH deficiency) documented

FDA‑approved indication; growth charts required

Diagnostic evidence: Either two pretreatment pharmacologic provocative GH tests with GH peak < 10 ng/mL OR a documented pituitary/CNS disorder (Appendix A) with a pretreatment IGF‑1 ≥2 standard deviations below the meanGH peak < 10 ng/mL; IGF‑1 <= -2 SD

See Appendix A for examples of pituitary/CNS disorders

Severity and skeletal maturity: Pretreatment height > 2 standard deviations below the mean and abnormal growth velocity per age-specific criteria, and epiphyses are openheight > 2 SD below mean; 1‑year height velocity 1 SD below mean (or >2 SD below mean for initiation age ≥2.5 years); open epiphyses

Age-specific velocity criteria and open epiphyses required

Exclusions/contraindications: No diagnosis of intracranial tumor growth, psychosocial dwarfism, idiopathic short stature, or active/past malignant disease

These diagnoses exclude coverage

Prior therapy/step requirement: Documentation of treatment failure or intolerance to at least one daily growth hormone product may be required (claims or medical record evidence)

Step therapy requirement may apply

Continuation Therapy — Covered for continuation when ALL of the following are met:

Covered for continuation when ALL of the following are met:

Ongoing diagnosis documentation: Documentation of the member's diagnosis of pediatric GH deficiency is provided

Provide growth charts and supporting medical records

Skeletal maturity: Epiphyses remain open (confirmed by X‑ray when available)open epiphyses

X‑ray confirmation if available

Clinical response: Member demonstrates improved growth rate (> 2 cm/year) unless a documented clinical reason explains lack of efficacy (e.g., <1 year on treatment, hypopituitarism)> 2 cm/year unless exception

Exceptions must be documented

Not Medically Necessary / Experimental Uses

Not medically necessary / Investigational: All indications other than the FDA‑approved and compendial uses listed (pediatric GH deficiency as specified) are considered experimental/investigational and are not medically necessary

See FDA‑approved indications and exclusions

Coverage is excluded when there is documentation of any of the following diagnoses: intracranial tumor growth, psychosocial dwarfism, idiopathic short stature, or a history or presence of malignant disease. These conditions are listed as exclusions to approval for pediatric growth hormone therapy and must be absent for coverage to be granted.

Any indication for use of this medication other than the specified FDA‑approved and compendial pediatric indications is considered experimental/investigational and not medically necessary. Requests for coverage for indications not listed in the approved uses will be denied.

Clinical Thresholds and Diagnostic Criteria

inv-06: Minimum age and weight

Minimum agePatient must be at least 1 year of age

Minimum weightPatient must weigh at least 11.5 kg

Authorization periodPrior authorization may be granted for 12 months when criteria are met

inv-07: Provocative GH test threshold

Provocative GH testingDiagnosis may be established with two pretreatment pharmacologic provocative GH tests

GH peak thresholdBoth tests must demonstrate a GH peak < 10 ng/mL

Alternate diagnostic pathwayOR documented pituitary/CNS disorder plus pretreatment IGF-1 ≥2 SD below the mean

inv-08: Pretreatment height threshold

Pretreatment height criterionPretreatment height is more than 2 standard deviations below the mean (height >2 SD below mean)

Age-specific noteFor initiation at ≥2.5 years, pretreatment height still must be >2 SD below the mean

DocumentationHeight measurements should be documented on growth charts

inv-09: Growth velocity thresholds

Primary growth velocityPretreatment 1-year height velocity 1 SD below the mean

Alternative for older childrenFor members ≥2.5 years at initiation, 1-year height velocity >2 SD below the mean meets the threshold

Continuation responseFor continuation, member should demonstrate growth rate >2 cm/year unless a clinical reason for lack of efficacy is documented

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for SKYTROFA (lonapegsomatropin-tcgd). A 12-month prior authorization may be granted when approval criteria are met; requests must include documentation that the member meets the applicable clinical criteria (see Required clinical documentation).

Authorization duration: up to 12 months
Ensure documentation supports diagnosis and baseline measures (see documentation callout)

Denial Risk

Age/Weight Not Met — Denial Risk

Treatment initiation will not meet documented indications for members under 1 year of age or who weigh less than 11.5 kg. Requests for patients not meeting the minimum age/weight criteria will be denied.

Minimum age: 1 year
Minimum weight: 11.5 kg

OpenPayer

Skytrofa (lonapegsomatropin) — Pediatric Growth Hormone Deficiency Coverage Criteria

Coverage Criteria for Skytrofa (lonapegsomatropin)

Clinical Thresholds and Diagnostic Criteria

Provider Requirements and Prior Authorization

Definitions and Appendix A Disorders

Background