CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sogroya (somapacitan-beco) coverage for growth hormone deficiency

Covers indications, prescriber requirements, and medical necessity criteria for Sogroya (somapacitan-beco) for pediatric and adult growth hormone deficiency for Medicaid members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySogroya (somapacitan-beco) coverage for growth hormone deficiency

Policy CodePolicy N/A

Change TypeNo material change

Effective Date03/01/2024

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic test results, growth charts, and documentation of prior GH product failure for pediatric requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

Adults & ≥2.5yage groups

Provocative GH cutoffsdiagnostic thresholds

Endocrinologyprescriber requirement

Coverage Criteria for Sogroya (somapacitan-beco)

Pediatric Initial Therapy

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

Pediatric initial criteria

Diagnostic entry pathways
- Neonatal diagnosis pathway: Member was diagnosed with GH deficiency as a neonate. Medical records must be available to support the diagnosis (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or MRI).
- Provocative testing or pituitary/CNS disorder pathway: Member has either two pretreatment pharmacologic provocative GH tests with both results demonstrating a peak GH level < 10 ng/mL OR has a documented pituitary or CNS disorder and a pretreatment IGF-1 level > 2 standard deviations below the mean.
  Refer to Appendix A for pituitary/CNS disorders.
Growth criteria (one required)
- Height and velocity: Pretreatment height is >2 SD below the mean AND 1-year height velocity is >1 SD below the mean.
- Velocity alone: Pretreatment 1-year height velocity is >2 SD below the mean.
Skeletal maturity: Epiphyses are open.
Confirmed by X-ray or other clinical assessment.
Prior GH product failure: Documentation of treatment failure with at least one daily growth hormone product (e.g., inadequate adherence or injection site reactions).

Adult Initial Therapy

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

Adult diagnostic options

Two-test pathway: Member has had two pretreatment pharmacologic provocative GH tests with both results demonstrating deficient GH responses using test-specific cutoffs (e.g., ITT ≤ 5 ng/mL; Macrilen < 2.8 ng/mL; glucagon criteria by BMI) AND a low pretreatment IGF-1 between 0 to 2 SD below the mean for age and gender.
See policy for specific test cutoffs and BMI‑based glucagon thresholds.
One-test plus low IGF-1 pathway: Member has had one pretreatment pharmacologic provocative GH test demonstrating a deficient GH response per listed cutoffs AND a pretreatment IGF-1 level more than 2 SD below the mean for age and gender.
Organic disease with multiple hormone deficiencies: Member has organic hypothalamic‑pituitary disease with ≥3 documented pituitary hormone deficiencies and a pretreatment IGF-1 more than 2 SD below the mean for age and gender.
Refer to Appendix B for pituitary hormones.
Genetic or structural defects: Member has genetic or structural hypothalamic‑pituitary defects (refer to Appendix C).
Childhood-onset GH deficiency: Member has childhood-onset GH deficiency and a congenital abnormality of the CNS, hypothalamus or pituitary (refer to Appendix C).

Pediatric Continuation Therapy

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

Pediatric continuation criteria

Skeletal maturity: Epiphyses are open (confirmed by X‑ray or X‑ray unavailable).
Growth rate: Member's growth rate is >2 cm/year unless there is a documented clinical reason for lack of efficacy (e.g., on treatment <1 year or nearing final adult height/late puberty).

Adult Continuation Therapy

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

Adult continuation options

Two-test continuation: Member had two pretreatment provocative GH tests showing deficient responses by specified cutoffs and a low pretreatment IGF‑1 (0 to 2 SD below mean), and current IGF‑1 is not elevated for age and gender.
See policy for specific test cutoffs and BMI‑based glucagon thresholds.
One-test continuation: Member had one pretreatment provocative GH test showing deficient response and a pretreatment IGF‑1 >2 SD below the mean, and current IGF‑1 is not elevated for age and gender.
Organic disease continuation: Member has organic hypothalamic‑pituitary disease with ≥3 pituitary hormone deficiencies and low pretreatment IGF‑1 >2 SD below mean, and current IGF‑1 is not elevated for age and gender.
Refer to Appendix B.
Genetic/structural or childhood-onset continuation: Member has genetic or structural hypothalamic‑pituitary defects or childhood‑onset GH deficiency with congenital CNS/pituitary abnormality and current IGF‑1 is not elevated for age and gender.
Refer to Appendix C.

Requests for Sogroya (somapacitan-beco) for indications other than the FDA‑approved uses are considered experimental/investigational and are not covered. The FDA‑approved indications are replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) and treatment of pediatric patients aged ≥2.5 years with growth failure due to inadequate GH secretion; use outside these indications may be denied.

Diagnostic Thresholds and Growth Metrics

Provocative GH test cutoffs

Insulin tolerance test (ITT)Peak GH ≤ 5 ng/mL

Macrilen (macimorelin)Peak GH < 2.8 ng/mL

Glucagon stimulation test (BMI ≤ 30 or BMI < 25 with high pretest probability)Peak GH ≤ 3.0 ng/mL

Glucagon stimulation test (BMI ≥ 25 or BMI > 30 with low pretest probability)Peak GH ≤ 1.0 ng/mL

Pediatric provocative testing thresholdTwo pretreatment pharmacologic provocative GH tests with both peak GH < 10 ng/mL

Pediatric growth metrics

Age requirementPediatric patients aged ≥ 2.5 years

Height and velocity (option 1)Pretreatment height > 2 SD below the mean AND 1-year height velocity > 1 SD below the mean

Height velocity (option 2)Pretreatment 1-year height velocity > 2 SD below the mean

Skeletal maturityEpiphyses are open

Prior GH product failureDocumentation of treatment failure with at least one daily growth hormone product

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Pediatric initial prior authorization — up to 12 months

Prior authorization may be granted for up to 12 months when pediatric initial criteria are met for members aged 2.5 years or older, including documentation of neonatal diagnosis OR either two pretreatment provocative GH tests both with peak GH < 10 ng/mL OR a documented pituitary/CNS disorder with pretreatment IGF‑1 >2 SD below the mean, growth criteria (height/velocity) and open epiphyses, and prior failure with at least one daily growth hormone product.

Age ≥ 2.5 years and documentation of diagnosis (neonatal diagnosis pathway or testing/pathology pathway).
Two provocative GH tests with peak GH < 10 ng/mL OR pituitary/CNS disorder plus pretreatment IGF‑1 >2 SD below mean.
Growth criteria: pretreatment height >2 SD below mean AND 1‑year height velocity >1 SD below mean OR 1‑year height velocity >2 SD below mean.
Epiphyses open.
Documentation of treatment failure with at least one daily GH product.

Prior Authorization

Adult initial prior authorization — up to 12 months

Prior authorization may be granted for up to 12 months for adults when documentation meets any of the listed adult diagnostic options, including the two-test pathway (two provocative tests meeting specified test-specific cutoffs plus low pretreatment IGF‑1) or other listed exceptions (one-test with IGF‑1 >2 SD below mean, organic hypothalamic‑pituitary disease with ≥3 hormone deficiencies, genetic/structural defects, or childhood‑onset deficiency).

Two pretreatment provocative GH tests with deficient responses per test-specific cutoffs (e.g., ITT ≤5 ng/mL, Macrilen <2.8 ng/mL, glucagon thresholds) and low pretreatment IGF‑1 (0 to 2 SD below mean).
Or one-test pathway with pretreatment IGF‑1 >2 SD below mean, or other listed diagnostic exceptions (organic disease, genetic/structural defects, childhood‑onset).

Step Therapy

Pediatric step therapy requirement — prior failure required

Pediatric members must have documentation of treatment failure with at least one daily growth hormone product prior to approval of Sogroya.

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

Documentation Required

Required documentation — growth charts and diagnosis

Provide growth charts for pediatric or adult patients with GH deficiency for initial requests; for continuation requests, documentation of the member's diagnosis must be provided.

Include pediatric growth charts showing height and velocity for initial pediatric requests.
For continuation, submit documentation of the original diagnostic criteria and current clinical status.

Documentation Required

Diagnostic documentation — provocative tests, IGF‑1, imaging

Submit pretreatment diagnostic testing and records with the prior authorization: provocative GH test results, pretreatment IGF‑1 levels, and pituitary/CNS imaging or documentation of pituitary/hypothalamic disease as applicable.

Two or one pretreatment pharmacologic provocative GH test results with numeric cutoffs as specified (e.g., ITT ≤5 ng/mL, Macrilen <2.8 ng/mL, glucagon thresholds).
Pretreatment IGF‑1 levels and any pituitary/CNS imaging or records documenting hypothalamic‑pituitary disease.

Denial Risk

Non‑approved indications — potential denial for experimental/investigational uses

Requests for indications other than the FDA‑approved pediatric and adult GHD indications or listed compendial uses are considered experimental/investigational and not medically necessary and may be denied.

Sogroya is indicated only for adults with GHD and pediatric patients aged 2.5 years and older with growth failure due to inadequate GH secretion; all other indications are not covered.

Definitions and Diagnostic Criteria

Adult growth hormone deficiency (GHD) — diagnostic definitions

Definition (general)Adult GHD documented by deficient responses on provocative GH tests with defined numeric cutoffs and a low pretreatment IGF-1 (0 to 2 SD below mean) or by specific clinical criteria (eg, multiple pituitary hormone deficiencies, structural/genetic defects)

Two-test diagnostic pathwayTwo pretreatment pharmacologic provocative GH tests with deficient responses per test-specific cutoffs (eg, ITT ≤ 5 ng/mL; Macrilen < 2.8 ng/mL; glucagon ≤ 3.0 or ≤ 1.0 ng/mL by BMI) AND low pretreatment IGF-1 (0 to 2 SD below mean)

One-test plus low IGF-1One pretreatment provocative GH test with a deficient response per listed cutoffs AND pretreatment IGF-1 > 2 SD below the mean for age and gender

Clinical/structural exceptionsOrganic hypothalamic-pituitary disease with ≥3 pituitary hormone deficiencies, genetic or structural defects, or childhood-onset GHD with congenital CNS/pituitary abnormality can meet diagnostic criteria

Pediatric growth hormone deficiency (GHD) — diagnostic criteria

Age thresholdDiagnosis applies to children aged ≥ 2.5 years

Neonatal diagnosis pathwayDiagnosis confirmed if member was diagnosed with GH deficiency as a neonate with supporting records (eg, hypoglycemia with random GH, multiple pituitary hormone deficiency, MRI)

Two-failed provocative testsTwo pretreatment pharmacologic provocative GH tests with both peak GH < 10 ng/mL

Pituitary/CNS disorder plus low IGF-1Documented pituitary or CNS disorder and pretreatment IGF-1 > 2 SD below the mean, plus required growth/epiphyseal criteria

Clinical Background

Sogroya (somapacitan-beco) is a long‑acting growth hormone approved for replacement of endogenous growth hormone in adults with GHD and for the treatment of pediatric patients aged 2.5 years and older with growth failure due to inadequate GH secretion. Indications and coverage are limited to these FDA‑approved uses; all other indications are considered experimental/investigational and not medically necessary.