CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Sogroya (somapacitan-beco) for Growth Hormone Deficiency

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Pharmacy prior authorization coverage for once-weekly Sogroya in Georgia Medicaid for pediatric patients aged 2.5 years and older with growth hormone deficiency-related growth failure and adults with growth hormone deficiency.

Policy Summary

PayerCareSource Georgia

PolicySogroya (somapacitan-beco) for Growth Hormone Deficiency

Policy CodePolicy GA-MED-P-366579

Change TypeRevised with material coverage changes

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionDocument a six-month trial and failure of Omnitrope 5.8 mg vial before requesting Sogroya authorization.

SourceLink

POLICY UPDATE CHANGES

Pediatric growth hormone deficiency coverage criteria were added.

Adult growth hormone deficiency diagnostic requirements were revised to include pathways that may not require stimulation testing and to require specified IGF-1 results.

Glucagon stimulation test criteria were added for adult growth hormone deficiency.

The required Omnitrope trial was increased to six months and the adult initial authorization period was reduced to six months.

Active malignancy was added as an exclusion for initial authorization.

Insulin tolerance test and Macrilen thresholds were corrected to micrograms per liter.

Pharmacy PABenefit status

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CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Sogroya (somapacitan-beco) for Growth Hormone Deficiency

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Policy Summary

PayerCareSource Georgia

PolicySogroya (somapacitan-beco) for Growth Hormone Deficiency

Policy CodePolicy GA-MED-P-366579

Change TypeRevised with material coverage changes

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionDocument a six-month trial and failure of Omnitrope 5.8 mg vial before requesting Sogroya authorization.

SourceLink

POLICY UPDATE CHANGES

Pediatric growth hormone deficiency coverage criteria were added.

Adult growth hormone deficiency diagnostic requirements were revised to include pathways that may not require stimulation testing and to require specified IGF-1 results.

Glucagon stimulation test criteria were added for adult growth hormone deficiency.

The required Omnitrope trial was increased to six months and the adult initial authorization period was reduced to six months.

Active malignancy was added as an exclusion for initial authorization.

Insulin tolerance test and Macrilen thresholds were corrected to micrograms per liter.

Pharmacy PABenefit status

Minimum pediatric age

18+ yearsAdult criteria age

6 monthsAdult initial approval

12 monthsPediatric approval

8 mg weeklyAdult maximum dose

Coverage Criteria

Adult Initial Therapy

Covered when all general requirements and one qualifying diagnostic pathway are met.

Adult initial therapy

Qualifying adult diagnostic pathway
- Genetic or structural defect pathway: Member has a genetic or structural brain hypothalamic-pituitary defect that does not require testing, as identified in Appendix B.
- Three-axis deficiency pathway: Member has a hypothalamic-pituitary defect, IGF-1 less than -2 standard deviations for age and gender, and deficiencies in at least three pituitary axes.IGF-1 < -2 SD; at least 3 pituitary-axis deficiencies
- One-test pathway: Member has a hypothalamic-pituitary defect, IGF-1 less than -2 standard deviations for age and gender, and a suboptimal response to one pretreatment stimulation test: ITT peak serum growth hormone concentration <5 µg/L with laboratory results and reference ranges; Macrilen peak serum growth hormone concentration <2.8 µg/L; or GST meeting the applicable BMI and pretest-probability cutoff.IGF-1 < -2 SD; one failed test
- Idiopathic isolated GHD pathway: Member has idiopathic isolated GHD; IGF-1 between 0 and -2 or less than -2 standard deviations for age and gender; human growth hormone therapy has been discontinued for at least one month; and the member has a suboptimal response to two pretreatment stimulation tests using the specified ITT, Macrilen, or GST criteria.Two failed tests; prior growth hormone therapy stopped ≥1 month

Adult Continuation Therapy

Covered for adult continuation when the renewal laboratory requirement is met.

Adult continuation therapy: Member's current IGF-1 level is within -2 and +2 standard deviations for age and gender, with laboratory results and the laboratory reference range submitted.IGF-1 within -2 to +2 SD

Approval is for an additional 12 months.

Pediatric Initial Therapy

Covered when all pediatric initial-authorization requirements are met.

Pediatric initial therapy

Qualifying pediatric diagnostic pathway
- Congenital hypopituitarism pathway: Member was diagnosed with congenital hypopituitarism as a newborn and had hypoglycemia with serum GH concentration ≤5 µg/L plus at least one additional pituitary hormone deficiency or the classical imaging triad of ectopic posterior pituitary, pituitary hypoplasia, and abnormal stalk.GH ≤5 µg/L during hypoglycemia
- Hypothalamic-pituitary defect pathway: Member has a hypothalamic-pituitary defect and at least one additional pituitary hormone deficiency.At least 1 additional pituitary hormone deficiency

Pediatric Continuation Therapy

Covered for pediatric continuation when all renewal requirements are met.

Pediatric continuation therapy: Member has a growth rate of at least 2 cm per year and, if aged 12 years or older, has radiographic evidence that the epiphyses remain open.Growth rate ≥2 cm/year

Approval is for an additional 12 months.

Initial authorization is excluded when the member has a history of active malignancy. This exclusion applies to both adult and pediatric initial Sogroya requests.

Conditions or indications not listed in this policy are excluded from medical necessity consideration under this policy. Refer requests for other indications to the Off-Label policy as directed.

Sogroya is not medically necessary for the treatment of conditions or indications that are not listed in this document.

Clinical Thresholds and Laboratory Criteria

Adult insulin tolerance test

PopulationAdults with growth hormone deficiency

TestInsulin tolerance test (ITT)

Peak serum growth hormone threshold< 5 µg/L

Adult Macrilen test

PopulationAdults with growth hormone deficiency

TestMacrilen stimulation test

Peak serum growth hormone threshold< 2.8 µg/L

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required for Sogroya

Sogroya (somapacitan-beco) requires pharmacy prior authorization before coverage. Submit documentation showing that the applicable adult or pediatric criteria are met.

Benefit type: Pharmacy prior authorization required.
Sogroya is indicated for pediatric members aged 2.5 years and older with growth failure due to inadequate endogenous GH secretion and for adults with growth hormone deficiency.

Step Therapy

Six-Month Omnitrope Trial Required

Before Sogroya can be authorized, the member must complete and fail a six-month trial of Omnitrope 5.8 mg vial. Include documentation of the trial and failure with the authorization request.

Applies to both adult and pediatric authorization pathways.
The Omnitrope trial is a prerequisite to initial Sogroya authorization.

Therapy Background

Sogroya (somapacitan-beco) is a once-weekly, subcutaneous growth hormone replacement therapy administered by injection under the skin. The policy covers pediatric growth failure caused by inadequate endogenous growth hormone secretion in members aged 2.5 years and older, and growth hormone deficiency in adults. Adult and pediatric coverage pathways require applicable diagnostic evidence and distinguish initial authorization from reauthorization requirements.

Clinical Definitions

Hypothalamic-pituitary defect

DefinitionA hypothalamic-pituitary defect is an acquired or congenital abnormality involving the hypothalamic-pituitary region.

Acquired examplesCNS tumor or neoplasm, surgery, radiation, chemotherapy, CNS infection, CNS infarction, inflammatory or infiltrative lesions, and head trauma.

Congenital examplesGenetic mutations affecting GHRH, GH, the GH receptor, or pituitary transcription factors; optic nerve hypoplasia; empty sella syndrome; ectopic posterior pituitary; and pituitary aplasia or hypoplasia.

Pituitary hormones

DefinitionPituitary hormones other than growth hormone

HormonesAdrenocorticotropic hormone (ACTH), antidiuretic hormone (ADH), follicle stimulating hormone (FSH), and luteinizing hormone (LH)

Initial Authorization Criteria

Adult Initial Authorization

Initial adult authorization requires all of the following, including one qualifying diagnostic pathway.

Adult initial authorization

Qualifying adult diagnostic pathway
- Genetic or structural defect pathway: Member has a genetic or structural brain hypothalamic-pituitary defect that does not require testing, as identified in Appendix B.
- Three-axis deficiency pathway: Member has a hypothalamic-pituitary defect, IGF-1 less than -2 standard deviations for age and gender, and deficiencies in at least three pituitary axes.IGF-1 < -2 SD; at least 3 pituitary-axis deficiencies

Reauthorization Criteria

Adult Reauthorization

Adult reauthorization requires the following current laboratory result.

Adult reauthorization: Member's current IGF-1 level is within -2 and +2 standard deviations for age and gender, with laboratory results and reference range submitted.IGF-1 within -2 to +2 SD

Additional approval is for 12 months.

Pediatric Reauthorization

Pediatric reauthorization requires evidence of continued growth response and open epiphyses when applicable.

Pediatric reauthorization: Member has a growth rate of at least 2 cm per year and, if aged 12 years or older, has radiographic evidence that the epiphyses remain open.Growth rate ≥2 cm/year

Additional approval is for 12 months.

Required Prior Therapy

Step	Required medication	Requirement	Duration
1	Omnitrope 5.8 mg vial	Documented trial and failure before Sogroya authorization	6 months

Dose and Quantity Parameters

Adult Sogroya dosing

MedicationSogroya (somapacitan-beco)

Initial dose1.5 mg subcutaneously once weekly

Maximum weekly dose8 mg subcutaneously once weekly

Pediatric Sogroya dosing

MedicationSogroya (somapacitan-beco)

PopulationPediatric members

Weight-based dose0.16 mg/kg subcutaneously once weekly

Administration

Billing Rule

Administer Sogroya once weekly by subcutaneous injection

Administer Sogroya by injection under the skin once weekly.

Adult initial dose: 1.5 mg subcutaneously once weekly, not to exceed 8 mg once weekly.
Pediatric dose: 0.16 mg/kg subcutaneously once weekly.

Policy Summary

PayerCareSource Georgia

PolicySogroya (somapacitan-beco) for Growth Hormone Deficiency

Policy CodePolicy GA-MED-P-366579

Change TypeRevised with material coverage changes

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionDocument a six-month trial and failure of Omnitrope 5.8 mg vial before requesting Sogroya authorization.

SourceLink

On This Page

Stimulation-test pathway:

Member has two pretreatment stimulation tests with peak serum growth hormone concentration less than 10 ng/mL, with laboratory results and reference ranges submitted.

Two tests; peak GH <10 ng/mL

Adult GST threshold

PopulationAdults with BMI <25 kg/m2

TestGlucagon stimulation test (GST)

Peak serum growth hormone threshold<3 µg/L

Adult GST threshold

PopulationAdults with BMI 25 to 30 kg/m2 and high pretest probability

TestGlucagon stimulation test (GST)

Peak serum growth hormone threshold<3 µg/L

Adult GST threshold

PopulationAdults with BMI >30 kg/m2

TestGlucagon stimulation test (GST)

Peak serum growth hormone threshold<1 µg/L

Adult GST threshold

PopulationAdults with BMI 25 to 30 kg/m2 and low pretest probability

TestGlucagon stimulation test (GST)

Peak serum growth hormone threshold<1 µg/L

Adult diagnostic IGF-1

PopulationAdults undergoing diagnostic evaluation

Laboratory measureIGF-1, interpreted by age and gender

Diagnostic threshold< -2 standard deviations

Adult reauthorization IGF-1

PopulationAdults seeking reauthorization

Laboratory measureCurrent IGF-1 with laboratory reference range

Required rangeWithin -2 and +2 standard deviations for age and gender

Pediatric congenital hypopituitarism

PopulationNewborns diagnosed with congenital hypopituitarism

Clinical conditionHypoglycemia

Serum GH threshold≤5 µg/L during hypoglycemia

Pediatric stimulation testing

PopulationPediatric members undergoing diagnostic evaluation

Required test countTwo pretreatment stimulation tests

Peak serum growth hormone threshold<10 ng/mL

Pediatric pretreatment height

PopulationPediatric members before treatment

MeasurePretreatment height with growth charts

Required threshold>2 standard deviations below the mean for age and gender

Pediatric pretreatment height velocity

PopulationPediatric members before treatment

MeasurePretreatment height velocity with growth charts

Required thresholdBelow the 25th percentile for age and gender

Pediatric reauthorization growth rate

PopulationPediatric members seeking reauthorization

MeasureGrowth rate

Required thresholdAt least 2 cm/year

Prior Authorization

Macrilen Requires Prior Authorization

Macrilen may be used as one of the adult pretreatment growth hormone stimulation tests. Macrilen itself requires prior authorization.

Macrilen criterion: peak serum growth hormone concentration <2.8 µg/L.
Other adult stimulation-test options include ITT and glucagon stimulation testing, as applicable.

Documentation Required

Adult Diagnostic Documentation

For adult initial authorization, the member must be at least 18 years old and the medication must be prescribed by, or in consultation with, an endocrinologist. Document an applicable adult growth hormone deficiency pathway and all required laboratory and diagnostic findings.

Genetic or structural hypothalamic-pituitary defect: testing is not required when the defect meets the policy criteria.
Pathway requiring three pituitary-axis deficiencies: document a hypothalamic-pituitary defect, IGF-1 <−2 standard deviations for age and gender, and deficiencies in at least three pituitary axes.
Pathway requiring one stimulation test: document a hypothalamic-pituitary defect, IGF-1 <−2 standard deviations for age and gender, and a suboptimal response to one pretreatment test. ITT requires peak GH <5 µg/L with laboratory results and reference ranges; Macrilen requires peak GH <2.8 µg/L; GST thresholds vary by BMI and pretest probability.
Idiopathic isolated GHD pathway: document idiopathic isolated GHD, IGF-1 from 0 to −2 or <−2 standard deviations for age and gender, discontinuation of human growth hormone therapy for at least one month, and suboptimal responses to two pretreatment stimulation tests.
For the two-test pathway, use the policy ITT, Macrilen, or GST thresholds; include laboratory results and reference ranges where required.

Documentation Required

Adult Renewal Laboratory Documentation

For adult renewal, submit current laboratory documentation supporting continued therapy, including the member’s current IGF-1 result and the laboratory reference range.

Ensure the IGF-1 result is current at the time of renewal submission.
Include the applicable age- and gender-based reference range.

Documentation Required

Pediatric Diagnostic and Growth Documentation

For pediatric initial authorization, the member must be at least 2.5 years old and the medication must be prescribed by, or in consultation with, an endocrinologist. Submit documentation of an approved diagnostic pathway and the required growth and treatment records.

Congenital hypopituitarism diagnosed at birth: document hypoglycemia with serum GH ≤5 µg/L and either at least one additional pituitary hormone deficiency or the classical imaging triad.
Other hypothalamic-pituitary defect pathway: document the defect and at least one additional pituitary hormone deficiency.
Stimulation-test pathway: document two pretreatment stimulation tests with peak serum GH <10 ng/mL and include laboratory results with reference ranges.
Submit a pretreatment height >2 standard deviations below the mean and pretreatment height velocity below the 25th percentile for age and gender; growth charts are required.
Provide the member’s weight for dose calculation. For members age 12 or older, include radiographic evidence that the epiphyses are open.

Documentation Required

Pediatric Renewal Documentation

For pediatric reauthorization, document an ongoing growth response and, when applicable, that the epiphyses remain open.

Growth rate must be at least 2 cm per year.
For members age 12 or older, submit x-ray results showing radiographic evidence of open epiphyses.

Denial Risk

Unlisted Indications Are Not Medically Necessary

Sogroya is not medically necessary for conditions or indications that are not listed in this policy. Requests for another indication must be evaluated under the applicable off-label policy or process.

Do not submit an unlisted indication as covered GHD without supporting policy criteria.
Refer other indications to the Off-Label policy.

Denial Risk

No Active Malignancy Required

Initial Sogroya authorization requires documentation that the member does not have a history of active malignancy.

Applies to both adult and pediatric initial authorization.
Include the malignancy history assessment in the clinical documentation submitted for prior authorization.

Step Therapy

Document Omnitrope Trial and Failure

Both adult and pediatric members must have a documented six-month trial and failure of Omnitrope 5.8 mg vial before initial Sogroya authorization. Missing or incomplete step-therapy documentation may result in denial.

Adult initial authorization: include the six-month Omnitrope 5.8 mg vial trial and failure.
Pediatric initial authorization: include the six-month Omnitrope 5.8 mg vial trial and failure.
The requirement applies in addition to the applicable diagnostic, growth, laboratory, and safety criteria.

Additional hormonesOxytocin, prolactin, and thyroid stimulating hormone (TSH)

Growth hormone stimulation test

DefinitionA pretreatment test used to assess stimulated peak serum growth hormone concentration

Included test typeInsulin tolerance test (ITT)

Other included test typesMacrilen or glucagon stimulation testing (GST)

Member has a hypothalamic-pituitary defect, IGF-1 less than -2 standard deviations for age and gender, and a suboptimal response to one pretreatment stimulation test: ITT peak serum growth hormone concentration <5 µg/L with laboratory results and reference ranges; Macrilen peak serum growth hormone concentration <2.8 µg/L; or GST meeting the applicable BMI and pretest-probability cutoff.

IGF-1 < -2 SD; one failed test

Idiopathic isolated GHD pathway: Member has idiopathic isolated GHD; IGF-1 between 0 and -2 or less than -2 standard deviations for age and gender; human growth hormone therapy has been discontinued for at least one month; and the member has a suboptimal response to two pretreatment stimulation tests using the specified ITT, Macrilen, or GST criteria.Two failed tests; prior growth hormone therapy stopped ≥1 month

Pediatric Initial Authorization

Initial pediatric authorization requires all of the following, including one qualifying diagnostic pathway.

Pediatric initial authorization

Qualifying pediatric diagnostic pathway
- Congenital hypopituitarism pathway: Member was diagnosed with congenital hypopituitarism as a newborn and had hypoglycemia with serum GH concentration ≤5 µg/L plus at least one additional pituitary hormone deficiency or the classical imaging triad of ectopic posterior pituitary, pituitary hypoplasia, and abnormal stalk.GH ≤5 µg/L during hypoglycemia
- Hypothalamic-pituitary defect pathway: Member has a hypothalamic-pituitary defect and at least one additional pituitary hormone deficiency.At least 1 additional pituitary hormone deficiency
- Stimulation-test pathway: Member has two pretreatment stimulation tests with peak serum growth hormone concentration less than 10 ng/mL, with laboratory results and reference ranges submitted.Two tests; peak GH <10 ng/mL