CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Syfovre (pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration

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This policy governs medical prior authorization coverage of intravitreal Syfovre for geographic atrophy secondary to age-related macular degeneration in CareSource Georgia Medicaid members. It establishes initial authorization, reauthorization, dosing, quantity limits, and conditions considered not medically necessary.

Policy Summary

PayerCareSource Georgia

PolicySyfovre (pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration

Policy CodePolicy GA-MED-P-366579

Change TypeAdministrative/reference update

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization for Syfovre (pegcetacoplan).

SourceLink

POLICY UPDATE CHANGES

The policy revision history states that references were updated on 03/10/2025.

12 monthsInitial authorization duration

12 monthsReauthorization duration

4 vials/60 daysQuantity limit

25–60 daysAdministration interval

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CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Syfovre (pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration

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Policy Summary

PayerCareSource Georgia

PolicySyfovre (pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration

Policy CodePolicy GA-MED-P-366579

Change TypeAdministrative/reference update

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization for Syfovre (pegcetacoplan).

SourceLink

POLICY UPDATE CHANGES

The policy revision history states that references were updated on 03/10/2025.

12 monthsInitial authorization duration

12 monthsReauthorization duration

4 vials/60 daysQuantity limit

25–60 daysAdministration interval

≥50 yearsMinimum member age

≥2.5 to ≤17.5 mm²GA area

Coverage Criteria

Initial therapy

Covered for initial authorization when all of the following are met:

Initial authorization criteria

Eligibility and prescriber: The member is at least 50 years of age, and Syfovre is prescribed by or in consultation with an ophthalmologist.Member age ≥50 years
Diagnosis and imaging
- Lesion measurements: The total geographic atrophy area is within the required range.≥2.5 and ≤17.5 mm² (1 and 7 disk areas, respectively)
- Multifocal lesion, when applicable: If the geographic atrophy is multifocal, at least one focal lesion meets the required minimum size.≥1.25 mm² (0.5 disk area)
Visual acuity: Best corrected visual acuity is documented at 24 letters or better using Early Treatment Diabetic Retinopathy Study charts.Approximately 20/320 Snellen equivalent
Excluded conditions absent: The member does not have geographic atrophy secondary to a condition other than age-related macular degeneration and does not have a history of or current evidence of wet age-related macular degeneration.
Dose and quantity: The dosage and administration comply with the policy allowance.15 mg (0.1 mL of 150 mg/mL solution) by intravitreal injection to each affected eye once every 25–60 days; quantity limit of 4 vials per 60 days

Approval is for 12 months when all requirements are met.

Continuation therapy

Covered for reauthorization when the following requirement is met:

Reauthorization: The geographic atrophy lesion growth rate has slowed or stabilized.Slowed or stabilized geographic atrophy lesion growth rate

Approval is for an additional 12 months when this requirement is met.

Not medically necessary indications

Not medically necessary for indications not listed in this policy.

Non-listed indications: Treatment of conditions or indications not listed in this policy is considered not medically necessary.

For any other indication, refer to the Off-Label policy.

Geographic atrophy secondary to any condition other than age-related macular degeneration is excluded from coverage.

A history of or current evidence of wet age-related macular degeneration is excluded from coverage.

Syfovre is considered not medically necessary for the treatment of conditions or indications not listed in this policy. For any other indication, refer to the Off-Label policy.

Clinical and Administration Parameters

Member age requirement

Minimum ageAt least 50 years of age

Authorization stageRequired for initial authorization

Clinical contextApplies to members seeking Syfovre coverage for geographic atrophy secondary to age-related macular degeneration

Total geographic atrophy area threshold

Minimum areaAt least 2.5 mm²

Maximum areaNo more than 17.5 mm²

Disk-area equivalents1 to 7 disk areas, respectively

Authorization and Documentation Guidance

Prior Authorization

Medical Prior Authorization Required

Medical prior authorization is required for Syfovre (pegcetacoplan) under the CareSource Georgia Medicaid pharmacy policy.

Drug: Syfovre (pegcetacoplan)
Benefit status: Medical Prior Authorization Required

Prior Authorization

Initial Authorization: 12-Month Approval

Initial authorization is available for members who meet all coverage requirements below. When approved, coverage is authorized for 12 months, subject to the quantity and administration limits.

Member is at least 50 years of age.
Prescribed by or in consultation with an ophthalmologist.
Documented geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Fundus autofluorescence (FAF) confirms total GA area of ≥ 2.5 and ≤ 17.5 mm² (1 to 7 disk areas); if multifocal, at least one focal lesion is ≥ 1.25 mm² (0.5 disk area).

Therapy and Disease Background

Syfovre (pegcetacoplan) is a complement C3 inhibitor approved for geographic atrophy secondary to age-related macular degeneration. Geographic atrophy is associated with dry AMD and results from macular cell breakdown, producing irreversible lesions that can impair vision or lead to blindness. Clinical studies showed that Syfovre slows geographic atrophy lesion growth, but it does not preserve visual function and may accelerate new-onset wet AMD.

Key Definitions

Geographic atrophy

ConditionGeographic atrophy is a manifestation of dry age-related macular degeneration

Underlying processBreakdown of cells in the macula

Resulting lesionsFormation of irreversible lesions that can impair vision or lead to blindness

Age-related macular degeneration

Forms of AMDAge-related macular degeneration has dry and wet (neovascular) forms

Dry AMDThe form associated with geographic atrophy and generally more common, but progressing more slowly to vision loss

Syfovre indication

Policy Summary

PayerCareSource Georgia

PolicySyfovre (pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration

Policy CodePolicy GA-MED-P-366579

Change TypeAdministrative/reference update

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization for Syfovre (pegcetacoplan).

SourceLink

On This Page

Multifocal geographic atrophy lesion threshold

Multifocal requirementIf geographic atrophy is multifocal, at least one focal lesion must be present

Minimum focal lesion areaAt least 1.25 mm²

Disk-area equivalent0.5 disk area

Best corrected visual acuity requirement

Required acuity24 letters or better

Assessment methodEarly Treatment Diabetic Retinopathy Study (ETDRS) charts

Snellen equivalentApproximately 20/320

Syfovre dose and administration

Dose15 mg, equivalent to 0.1 mL of a 150 mg/mL solution

Route and applicationAdministered by intravitreal injection to each affected eye

Administration intervalOnce every 25 to 60 days

Quantity limit

Quantity limit4 vials per 60 days

Covered medicationSyfovre (pegcetacoplan)

Related dosing intervalAdministration is allowed once every 25 to 60 days

Best corrected visual acuity (BCVA) is 24 letters or better on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (approximately 20/320 Snellen equivalent).

Member does not have GA secondary to a condition other than AMD and has no history or current evidence of wet AMD.

Dose: 15 mg (0.1 mL of 150 mg/mL solution) by intravitreal injection into each affected eye once every 25 to 60 days; quantity limit is 4 vials per 60 days.

Prior Authorization

Reauthorization: Additional 12 Months

Reauthorization is available when the GA lesion growth rate has slowed or stabilized. Each reauthorization may be approved for an additional 12 months.

Required continuation finding: GA lesion growth rate has slowed or stabilized.

Documentation Required

Initial Authorization Documentation

Submit documentation supporting every initial authorization requirement before treatment is approved.

Member age (at least 50 years).
Prescription or consultation by an ophthalmologist.
Diagnosis of GA secondary to AMD.
FAF imaging report documenting total GA area of ≥ 2.5 and ≤ 17.5 mm² (1 to 7 disk areas); for multifocal GA, at least one focal lesion must be ≥ 1.25 mm² (0.5 disk area).
BCVA of 24 letters or better using ETDRS charts, approximately 20/320 Snellen equivalent.
Documentation that GA is not secondary to another condition and that there is no history or current evidence of wet AMD.
Requested dose, frequency, affected eye(s), and quantity within 15 mg per affected eye every 25 to 60 days and 4 vials per 60 days.

Documentation Required

Reauthorization Documentation

For reauthorization, document that the GA lesion growth rate has slowed or stabilized and provide the information needed to support continued treatment.

Documentation of slowed or stabilized GA lesion growth rate.
Current treatment and response information, as applicable.

Denial Risk

Denial Risk: Initial Criteria Not Met

Initial authorization will be denied when any required coverage criterion is not met or cannot be adequately documented.

Member is younger than 50 years.
Syfovre is not prescribed by or in consultation with an ophthalmologist.
GA secondary to AMD is not documented.
FAF findings do not confirm the required lesion size: total GA is outside 2.5–17.5 mm², or, when multifocal, no focal lesion is at least 1.25 mm².
BCVA is worse than 24 ETDRS letters or the required BCVA documentation is absent.
Required clinical documentation is incomplete or insufficient.
Requested dose, frequency, or quantity exceeds the policy limits.

Denial Risk

Denial Risk: Excluded Clinical Conditions

Syfovre is not covered when the member has an excluded clinical condition identified in the initial authorization criteria.

GA secondary to any condition other than AMD.
History or current evidence of wet AMD.

Note

Non-Listed Indications

CareSource considers Syfovre not medically necessary for conditions or indications not listed in this policy. For any other indication, refer to the Off-Label policy.

Non-listed indications are not medically necessary under this policy.
Refer other indications to the Off-Label policy.

Approved for geographic atrophy associated with dry AMD

Wet AMD

DefinitionWet AMD is the neovascular form of age-related macular degeneration

Form of AMDNeovascular, rather than dry, age-related macular degeneration

Coverage relevanceA history of or current evidence of wet AMD is excluded from initial Syfovre authorization