CurrentGeorgia Department of Community HealthPolicy N/A

Georgia Medicaid FFS — Growth Factors Prior Authorization

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Defines prior authorization requirements and medical necessity criteria for select growth factor medications (Voxzogo, Egrifta SV, Increlex) for Georgia Medicaid Fee-For-Service members.

Policy Summary

PayerGeorgia Department of Community Health

PolicyGrowth factors prior authorization for Georgia Medicaid FFS

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization required via OptumRx (1-866-525-5827) for preferred and non-preferred growth factor agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3drugs listed with PA criteria

Varieslength of authorization

OptumRxPA vendor contact

onlinePDL & QLL

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CurrentGeorgia Department of Community HealthPolicy N/A

Georgia Medicaid FFS — Growth Factors Prior Authorization

Customize your policy alerts

Sign up for all Georgia Department of Community Health policy alerts

Know when Georgia Department of Community Health releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines prior authorization requirements and medical necessity criteria for select growth factor medications (Voxzogo, Egrifta SV, Increlex) for Georgia Medicaid Fee-For-Service members.

Policy Summary

PayerGeorgia Department of Community Health

PolicyGrowth factors prior authorization for Georgia Medicaid FFS

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization required via OptumRx (1-866-525-5827) for preferred and non-preferred growth factor agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3drugs listed with PA criteria

Varieslength of authorization

OptumRxPA vendor contact

onlinePDL & QLL

Egrifta SV (tesamorelin) — Approve when ALL specified criteria are met.

Egrifta SV (tesamorelin) is approvable when ALL of the following are met:

Egrifta SV approval: Member is >= 18 years of age with a diagnosis of HIV-associated lipodystrophy; fasting blood glucose < 150 mg/dL (8.33 mmol/L); BMI > 20 kg/m2; and body composition thresholds: for men waist circumference > 95 cm (37.4 in) and waist-to-hip ratio > 0.94; for women waist circumference > 94 cm (37.0 in) and waist-to-hip ratio > 0.88.see individual measures

Increlex (mecasermin) — Approve when EITHER specified set of criteria is met.

Increlex (mecasermin) is approvable under EITHER of the following sets:

Increlex - severe primary IGF-1 deficiency: Member aged 2 to 17 years with severe primary insulin-like growth factor-1 (IGF-1) deficiency, open epiphyses, height standard deviation score (SDS) < -3.0, basal IGF-1 SDS < -3.0, and normal or elevated growth hormone level.age 2-17; height SDS < -3.0; IGF-1 SDS < -3.0

Medication must be prescribed by or in consultation with an endocrinologist.

Increlex - GH deletion with neutralizing antibodies: Member aged 2 to 17 years with diagnosis of growth hormone deletion who have developed neutralizing antibodies to growth hormone and have open epiphyses.age 2-17; open epiphyses

Medication must be prescribed by or in consultation with an endocrinologist.

Voxzogo (vosoritide) — Approve when ALL specified criteria are met.

Voxzogo (vosoritide) is approvable when ALL of the following are met:

Voxzogo approval: Member aged 5 to 17 years with a diagnosis of achondroplasia confirmed by an identifiable FGFR3 mutation and with open epiphyses.age 5-17; genetic confirmation; open epiphyses

Medication must be prescribed by or in consultation with an endocrinologist or geneticist.

Exceptions to the coverage criteria for the growth factor agents listed in this policy are not handled via an alternate appeals pathway and must be requested through the plan prior authorization process. To request an exception, providers should submit a prior authorization through OptumRx. The Prior Authorization process may be initiated by calling OptumRx at 1-866-525-5827.

Coverage for the specific agents addressed in this policy is subject to the drug-specific clinical criteria. Egrifta SV (tesamorelin) is approvable when all listed adult HIV-associated lipodystrophy criteria are met (see fasting glucose, BMI, and sex-specific waist and waist-to-hip thresholds). Increlex (mecasermin) is approvable for pediatric candidates aged 2 to 17 years who meet either the severe primary IGF-1 deficiency criteria (height SDS < -3.0 and basal IGF-1 SDS < -3.0 with normal/elevated GH and open epiphyses) or have growth hormone deletion with neutralizing antibodies and open epiphyses. Voxzogo (vosoritide) is approvable for children aged 5 to 17 years with genetically confirmed achondroplasia (identifiable FGFR3 mutation) and open epiphyses. All requests must include documentation of the required diagnostic and laboratory findings and, where specified, be prescribed by or in consultation with an endocrinologist or geneticist. Exceptions to these coverage criteria are considered only through the prior authorization process via OptumRx.

Listed Agents, Clinical Thresholds, and Coding Data

Listed agentsmixed

Voxzogo (vosoritide)	Preferred agent (requires PA)
Egrifta SV, WR (tesamorelin)	Non-preferred
Increlex (mecasermin)	Non-preferred

Fasting blood glucose (Egrifta SV)

Fasting blood glucose threshold< 150 mg/dL (8.33 mmol/L)

ContextRequired for Egrifta SV approval in members >= 18 years with HIV-associated lipodystrophy

Source noteValue listed in coverage criteria for tesamorelin (Egrifta SV)

Body mass index (Egrifta SV)

BMI threshold> 20 kg/m2

ContextRequired for Egrifta SV approval in members >= 18 years with HIV-associated lipodystrophy

Source noteValue listed in coverage criteria for tesamorelin (Egrifta SV)

Waist circumference — men

Waist circumference (men)> 95 cm (37.4 inches)

ContextOne of the body composition thresholds required for Egrifta SV approval

Source noteSpecified in HIV-associated lipodystrophy criteria

Waist-to-hip ratio — men

Waist-to-hip ratio (men)> 0.94

ContextOne of the body composition thresholds required for Egrifta SV approval

Source noteSpecified in HIV-associated lipodystrophy criteria

Waist circumference — women

Waist circumference (women)> 94 cm (37.0 inches)

ContextOne of the body composition thresholds required for Egrifta SV approval

Source noteSpecified in HIV-associated lipodystrophy criteria

Waist-to-hip ratio — women

Waist-to-hip ratio (women)> 0.88

ContextOne of the body composition thresholds required for Egrifta SV approval

Source noteSpecified in HIV-associated lipodystrophy criteria

Age range — Increlex (mecasermin)

Age range (Increlex)2 to 17 years

ContextApplies to both severe primary IGF-1 deficiency and GH deletion with neutralizing antibodies pathways

Source noteListed in Increlex approval criteria

Height SDS — Increlex

Height SDS threshold (Increlex)< -3.0

ContextRequired for severe primary IGF-1 deficiency pathway; member must also have open epiphyses

Source noteSpecified in Increlex coverage criteria

Basal IGF-1 SDS — Increlex

Basal IGF-1 SDS threshold (Increlex)< -3.0

ContextRequired for severe primary IGF-1 deficiency pathway; GH level must be normal or elevated

Source noteSpecified in Increlex coverage criteria

Age range — Voxzogo (vosoritide)

Age range (Voxzogo)5 to 17 years

ContextMember must have achondroplasia confirmed by FGFR3 mutation and open epiphyses

Source noteListed in Voxzogo approval criteria

Prior Authorization, Prescriber Requirements, and Provider Notices

Prior Authorization

Prior authorization required — submit via OptumRx

Prior authorization is required for both preferred and non-preferred growth factor agents. Initiate PA requests through OptumRx (phone: 1-866-525-5827).

Preferred and non-preferred agents require prior authorization.
The Prior Authorization process may be initiated by calling OptumRx at 1-866-525-5827.

Denial Risk

PA required — lack of PA leads to denial

Failure to obtain prior authorization will result in a denial of coverage. Exceptions to coverage criteria are only considered through the prior authorization process.

Lack of prior authorization will result in denial.
Exceptions to conditions of coverage are considered only through the PA process.

Documentation Required

Prescriber and documentation requirements

Medications must be prescribed by or in consultation with an endocrinologist; Voxzogo may also be prescribed by or in consultation with a geneticist. Document the diagnosing condition and supporting clinical measures per the drug-specific criteria (see coverage criteria).

Increlex: “Medication must be prescribed by or in consultation with an endocrinologist.”
Voxzogo: “Medication must be prescribed by or in consultation with an endocrinologist or geneticist.”
Include documentation of diagnostic confirmation and required laboratory/anthropometric thresholds as specified in the coverage criteria.

Note

Additional provider actions (see PA & documentation rules)

Reserved for additional actionable provider notes; ensure PA is obtained via OptumRx and that prescriber specialty and documentation requirements are met as described above.

Initiate PA through OptumRx at 1-866-525-5827.
Confirm prescriber is an endocrinologist (or geneticist for Voxzogo) and include required clinical documentation.

Definitions and Diagnostic Criteria

Achondroplasia — genetic confirmation

Genetic confirmation requiredAchondroplasia confirmed by an identifiable FGFR3 mutation

ContextRequired for Voxzogo approval in members aged 5 to 17 years with open epiphyses

Source noteSpecified in Voxzogo coverage criteria

Severe primary IGF-1 deficiency — definition

Height SDS thresholdHeight SDS < -3.0

Basal IGF-1 SDS thresholdBasal IGF-1 SDS < -3.0

GH statusNormal or elevated growth hormone level required

HIV-associated lipodystrophy — criteria

Fasting blood glucose< 150 mg/dL (8.33 mmol/L)

BMI> 20 kg/m2

Anthropometric thresholdsMen: waist circumference > 95 cm (37.4 in) and waist-to-hip ratio > 0.94; Women: waist circumference > 94 cm (37.0 in) and waist-to-hip ratio > 0.88

Georgia Medicaid FFS — Growth Factors Prior Authorization

Sign up for all Georgia Department of Community Health policy alerts

Georgia Medicaid FFS — Growth Factors Prior Authorization

Sign up for all Georgia Department of Community Health policy alerts

Medical Necessity and Coverage Criteria

Listed Agents, Clinical Thresholds, and Coding Data

Prior Authorization, Prescriber Requirements, and Provider Notices

Definitions and Diagnostic Criteria

Policy Background and Scope

Policy Revision History