CurrentCareSourcePolicy N/A

Syfovre (pegcetacoplan) — coverage criteria for geographic atrophy (GA) secondary to AMD

This policy governs prior authorization and medical benefit coverage for Syfovre (pegcetacoplan) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for CareSource members in Arkansas PASSE.

Policy Summary

PayerCareSource

PolicySyfovre (pegcetacoplan) — coverage criteria for GA secondary to AMD

Policy CodePolicy N/A

Change TypeUpdated references

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including age ≥50, FAF imaging confirming GA (total GA area >2.5 and <17.5 mm2), BCVA ≥24 ETDRS letters, and prescriber (or consult) ophthalmologist.

SourceLink

POLICY UPDATE CHANGES

Updated references were noted on 03/10/2025.

12 monthsinitial approval duration

15 mgdose

25-60 daysdosing interval

4 vials/60dquantity limit

≥50min age

Coverage Criteria

inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Authorization: 1) Member is at least 50 years of age; 2) Medication prescribed by or in consultation with an ophthalmologist; 3) Documented diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed by fundus autofluorescence (FAF) imaging; 4) Total GA area > 2.5 and < 17.5 mm2 (1–7 disk areas); 5) Best corrected visual acuity (BCVA) of 24 ETDRS letters or better; 6) No history or current evidence of wet (neovascular) AMD; 7) GA is not secondary to conditions other than AMD; 8) Dosage: 15 mg (0.1 mL of 150 mg/mL) administered by intravitreal injection to each affected eye every 25–60 days (quantity limit: 4 vials per 60 days).

Approval duration: 12 months if all criteria met

inv-02: Continuation Therapy / Reauthorization — Covered for reauthorization when the following is met

Covered for reauthorization when the following is met:

Reauthorization: GA lesion growth rate has slowed or stabilized compared to prior assessments.

Policy Summary

PayerCareSource

PolicySyfovre (pegcetacoplan) — coverage criteria for GA secondary to AMD

Policy CodePolicy N/A

Change TypeUpdated references

Effective DateOct 1, 2025

Next Review DateN/A

SourceLink

On This Page

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Initial Therapy

inv-15: Initial Therapy — detailed initial authorization criteria (mirror of inv-01 where applicable)

Initial authorization is approved when ALL of the following detailed criteria are documented:

Initial: Member is at least 50 years of age;

Initial: Medication is prescribed by or in consultation with an ophthalmologist;

Initial: Documented diagnosis of geographic atrophy (GA) secondary to AMD confirmed by fundus autofluorescence (FAF) imaging;

Initial: Total GA area is > 2.5 and < 17.5 mm2 (approximately 1–7 disk areas);> 2.5 and < 17.5 mm2

Initial: Best corrected visual acuity (BCVA) of 24 ETDRS letters or better (approximately 20/320 Snellen);>= 24 ETDRS letters

Initial: No history or current evidence of wet (neovascular) AMD;

Initial: GA is not secondary to any condition other than AMD;

Initial: Dosage and administration: 15 mg (0.1 mL of 150 mg/mL) administered by intravitreal injection to each affected eye every 25–60 days (quantity limit: 4 vials per 60 days).

Approval duration: 12 months if all initial criteria are met.

Coding and Clinical Measures

Codes referencedmixed

not provided

No specific CPT/HCPCS/NDC codes listed in policy document

inv-06: Total GA area — required lesion size > 2.5 and < 17.5 mm2 (1-7 disk areas)

Required total GA area> 2.5 and < 17.5 mm2 (equivalent to 1 to 7 disk areas)

Measurement methodLesion area measured on fundus autofluorescence (FAF) imaging

ApplicabilityApplies to documented GA secondary to age-related macular degeneration (AMD)

Documentation noteProvider must include FAF images demonstrating total GA area within the specified range

inv-07: BCVA (ETDRS letters) — required >= 24 letters (~20/320 Snellen)

BCVA threshold (ETDRS)>= 24 ETDRS letters

Approximate Snellen equivalentApproximately 20/320 Snellen

Measurement methodBest corrected visual acuity measured using ETDRS charts

Documentation noteRecord ETDRS letter score in the medical record for eligibility determination

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Syfovre (pegcetacoplan) is a medical benefit and requires prior authorization for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Providers must obtain prior authorization before initiating therapy.

Affected drug: Syfovre (pegcetacoplan)
Indication: Geographic atrophy (GA) secondary to AMD
Benefit type: Medical
Effective date: 2025-10-01

Step Therapy

No step therapy or requirement to fail other therapies is specified for Syfovre. There is no mandated trial of alternative medications prior to prior authorization approval.

Step therapy: None required

Documentation Required

Required Documentation

Providers must submit documentation that confirms the diagnosis and baseline disease characteristics to support medical necessity. Provide clear diagnostic imaging and clinical data as listed below.

Patient age (must be ≥ 50 years)
Prescribing clinician: ophthalmologist or documentation of consultation with an ophthalmologist
Diagnosis: documented GA secondary to AMD
Confirmation by fundus autofluorescence (FAF) imaging
Total GA area measured on FAF: > 2.5 mm2 and < 17.5 mm2 (≈ 1–7 disc areas)
Best corrected visual acuity (BCVA) using ETDRS: 24 letters or better (≈ 20/320 Snellen equivalent)
Documentation that GA is not secondary to another condition
Documentation of no history or current evidence of wet (neovascular) AMD
Planned dosage/administration: 15 mg (0.1 mL of 150 mg/mL) intravitreal injection to each affected eye every 25–60 days
Quantity limit evidence: up to 4 vials per 60 days
Duration requested and treatment plan (initial approval up to 12 months if criteria met)

Denial Risk

Triggers for Denial

Common reasons for denial include missing or out-of-range diagnostic evidence, patient ineligibility by age, or presence of exclusionary conditions.

Patient age < 50 years
Diagnosis not confirmed by FAF imaging
Total GA area ≤ 2.5 mm2 or ≥ 17.5 mm2
BCVA worse than 24 ETDRS letters (below required threshold)
Evidence of current or prior wet (neovascular) AMD
GA attributable to a condition other than AMD
Prescriber not an ophthalmologist and no documented ophthalmology consultation
Incomplete treatment plan or missing dosing/administration details

Definitions

inv-13: Geographic atrophy (GA) — definition and confirmation by FAF imaging

DefinitionGeographic atrophy (GA) — irreversible macular lesions caused by cell breakdown in the macula, occurring in dry AMD

Confirmation methodDiagnosis must be confirmed by fundus autofluorescence (FAF) imaging

Associated conditionGA must be secondary to age-related macular degeneration (AMD), not due to other causes

Clinical implicationFAF imaging is required to document lesion area and support eligibility

inv-14: BCVA (ETDRS) — definition and measurement threshold

DefinitionBest corrected visual acuity (BCVA) measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts

Policy threshold>= 24 ETDRS letters required for eligibility

Snellen approximationApproximately 20/320 Snellen equivalent

DocumentationETDRS letter score must be recorded in the medical record

OpenPayer

Syfovre (pegcetacoplan) — coverage criteria for geographic atrophy (GA) secondary to AMD

Coverage Criteria

Initial Therapy

Reauthorization / Continuation Criteria

Coding and Clinical Measures

Provider Actions and Documentation

Background

Definitions

Step Therapy

Quantity Limits

Site of Care and Administration