CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Somapacitan (Sogroya) — Coverage Criteria for Growth Hormone Deficiency

Covers clinical criteria, prescriber requirements, and continuation/authorization guidance for somapacitan (Sogroya) for pediatric and adult growth hormone deficiency for members under the payer's Medicaid scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomapacitan (Sogroya) — Coverage Criteria for Growth Hormone Deficiency

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit growth charts and required diagnostic documentation (including provocative GH test results or IGF-1) to support authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

≥2.5 yrsFDA-indicated pediatric age

Medicaidscope

Endocrinologistrequired prescriber specialty

Coverage Criteria for Somapacitan (Sogroya)

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inv-01: Initial approval — Pediatric GHD

Authorization of 12 months may be granted when ALL of the following are met:

Pediatric initial criteria: Member is ≥2.5 years with documented pediatric growth hormone deficiency and growth charts are provided.see pediatric height/velocity thresholds

Pretreatment height and 1‑year height velocity criteria or neonatal diagnosis/pituitary/CNS disorder pathways are acceptable; epiphyses must be open.

Diagnostic pathways (one required)

Biochemical testing pathway: Pretreatment height is ≥2 SD below the mean AND 1‑year height velocity is >1 SD below the mean; OR pretreatment 1‑year height velocity is 2 SD below the mean.height & velocity thresholds per policy
Neonatal diagnosis pathway: Member was diagnosed with GH deficiency as a neonate with medical records to support the diagnosis (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or MRI results).
Structural/genetic or pituitary/CNS disorder pathway: Documented pituitary or CNS disorder (refer to Appendix A) AND a pretreatment IGF‑1 level ≥2 standard deviations below the mean for age/gender.IGF‑1 ≤ -2 SD

Therapy step requirement: Documentation of treatment failure with at least one daily growth hormone product based on claims review of inadequate adherence or documentation of injection site or comparable evidence.

inv-02: Initial approval — Adult GHD

Authorization of 12 months may be granted when ANY of the following criteria is met:

Adult initial criteria - biochemical provocation: Two pretreatment pharmacologic provocative GH tests demonstrating deficient GH responses (examples include: Macrilen peak <2.8 ng/mL; ITT peak <5 ng/mL; glucagon stimulation peak <3.0 ng/mL for BMI <30 kg/m2 with high pretest probability; glucagon peak <1.0 ng/mL for BMI >25 kg/m2 with low pretest probability).see provocative GH test thresholds

BMI and pretest probability modify glucagon cutoffs

Adult initial criteria - single test plus low IGF-1: One pretreatment pharmacologic provocative GH test demonstrating a deficient GH response (e.g., Macrilen <2.8 ng/mL peak or ITT <5 ng/mL or glucagon per BMI-specific cutoffs) AND a pretreatment IGF‑1 level >2 SD below the mean for age and gender.IGF‑1 ≤ -2 SD

Adult initial criteria - structural/genetic/clinical: Documentation of genetic or structural hypothalamic–pituitary defects, organic hypothalamic‑pituitary disease with ≥3 documented pituitary hormone deficiencies and low pretreatment IGF‑1 (≤ -2 SD), or childhood‑onset GHD with congenital CNS/pituitary abnormality.IGF‑1 ≤ -2 SD where specified

Adult initial criteria - low IGF-1 with corroborating evidence: Low pretreatment IGF‑1 (more than 2 SD below the mean for age and gender) with current IGF‑1 not elevated for age/gender supports diagnosis.IGF‑1 ≤ -2 SD

inv-03: Continuation of therapy — Pediatric and Adult

Authorization of 12 months may be granted for continuation when the following criteria are met:

Pediatric continuation: Documentation that epiphyses are open (confirmed by X‑ray or if X‑ray not available) AND the member's growth rate is >2 cm/year unless there is documented nearing final adult height or late stages of puberty.>2 cm/year growth rate

Ongoing documentation of benefit required

Adult continuation: Current IGF‑1 level is not elevated for age and gender AND at least one of the following: persistent pretreatment biochemical evidence (two provocative tests with deficient responses), organic hypothalamic‑pituitary disease with ≥3 other pituitary hormone deficiencies and low pretreatment IGF‑1, genetic/structural defects, or childhood‑onset GHD with congenital CNS/pituitary abnormality.current IGF‑1 not elevated; pretreatment IGF‑1 typically ≤ -2 SD

Continuation relies on prior diagnostic evidence and current IGF‑1 status

Clinical Thresholds and Measurement Criteria

Provocative GH test thresholds

Macrilen (macimorelin) peak< 2.8 ng/mL

Insulin tolerance test (ITT) peak< 5 ng/mL

Glucagon stimulation test peak — high pretest probability or BMI <30 kg/m2< 3.0 ng/mL

Glucagon stimulation test peak — low pretest probability and BMI >25 kg/m2< 1.0 ng/mL

Pediatric height and growth velocity criteria

Pretreatment height≥ 2 SD below the mean for age/gender

One‑year height velocity — option 1> 1 SD below the mean (with pretreatment height ≥2 SD below mean)

One‑year height velocity — option 21‑year height velocity ≥ 2 SD below the mean

Epiphyses statusEpiphyses must be open (confirmed by X‑ray or if X‑ray unavailable per documentation)

Provider Requirements, Documentation, and Prior Authorization

Prior Authorization

Prior authorization period — 12 months

Authorization may be granted for 12 months when the specified initial or continuation criteria are met.

Step Therapy

Pediatric step requirement — trial of daily GH

For pediatric patients, provide documentation of treatment failure with at least one daily growth hormone product based on claims review of inadequate adherence or injection‑site documentation before approval.

Claims review showing inadequate adherence to a daily GH product
Documentation of injection‑site issues supporting treatment failure

Documentation Required

Required clinical documentation — growth charts, diagnosis, epiphyses, growth rate

Provide growth charts and documentation of the member's diagnosis; for continuation, include documentation that epiphyses are open and evidence of growth rate (e.g., >2 cm/year unless near final height).

Growth charts for pediatric or adult patients
Diagnostic documentation supporting GH deficiency
For continuation: confirmation epiphyses are open (X‑ray if available) and recent growth rate data

Documentation Required

Laboratory/test documentation — provocative GH tests and IGF‑1

Provide results of pretreatment pharmacologic provocative GH tests and pretreatment IGF‑1 levels as applicable to support diagnosis.

Two pretreatment provocative GH tests for adults (e.g., Macrilen, ITT, glucagon) with documented peak values
Pretreatment IGF‑1 level when indicated (e.g., ≤ −2 SD for some pathways)

Denial Risk

Non‑approved indications — not medically necessary

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

Background

Growth hormone deficiency (GHD) in children presents as growth failure and requires objective documentation for diagnosis. For pediatric patients, the policy requires growth charts demonstrating short stature and growth velocity abnormalities, and corroborating biochemical or clinical evidence of GHD. These diagnostic elements (growth chart documentation plus appropriate biochemical testing or qualifying clinical history) are necessary to establish medical necessity for initiation of Sogroya.