CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Syfovre (pegcetacloplan) (Intravitreal) — Coverage Criteria

Policy governs coverage and clinical criteria for Syfovre (pegcetacloplan) intravitreal injections to treat geographic atrophy (GA) secondary to age-related macular degeneration for Neighborhood Health Plan members (Medicaid, Commercial, Medicare).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySyfovre (pegcetacloplan) (Intravitreal) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2023

Next Review DateJun 11, 2025

Key ActionSubmit prior authorization for an initial 6-month approval and document baseline BCVA, FAF, and OCT with lesion measurements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15 mgrecommended per-eye dose

30 unitsmax billed units (both eyes)

6 monthsinitial auth length

BCVA ≥24min visual acuity

≥2.5–≤17.5 mm2lesion size eligibility

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Coverage Criteria for Syfovre (pegcetacloplan)

Initial Approval — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Approval Criteria: Patient is at least 18 years of age; prescribed by or in consultation with a retina specialist; baseline assessments completed including best corrected visual acuity (BCVA), fundus autofluorescence (FAF) imaging, and optical coherence tomography (OCT); free of ocular and/or peri-ocular infection; no active intraocular inflammation; not category 6 or higher visual impairment (no light perception); no history of or active choroidal neovascularization (CNV) in the eye(s) to be treated; chart notes or medical records confirm diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with characteristic phenotype; other causes of GA (e.g., Stargardt disease, cone-rod dystrophy, toxic maculopathies) have been ruled out; total GA lesion size is ≥2.5 and ≤17.5 mm2 (if multifocal, at least one focal lesion ≥1.25 mm2); BCVA ≥24 ETDRS letters (approximately 20/320 Snellen); Syfovre will not be used in combination with other intravitreal complement inhibitor therapies; Medicare members with prior receipt of this medication within the past 365 days are exempt from step therapy requirements.see individual node texts

All conditions required

Renewal — Renewal criteria — Covered when ALL of the following are met

Renewal criteria — Covered when ALL of the following are met

Renewal Criteria: Patient is at least 18 years of age; prescribed by or in consultation with a retina specialist; continues to meet the initial approval criteria; absence of unacceptable toxicity from the drug (examples: endophthalmitis, retinal detachment, neovascular/wet AMD or choroidal neovascularization, intraocular inflammation [e.g., vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells/flare], increased intraocular pressure, etc., that cannot be adequately treated); evidence of disease stabilization or slowing of progression (e.g., smaller increases in total GA lesion area, reduction in total GA lesion area) measured by FAF, OCT, or BCVA; continued administration is necessary for maintenance and the patient and provider have discussed potential decrease in administration frequency.clinical assessment per imaging/BCVA

All conditions required

Use of Syfovre at a dose or for a clinical indication that is not recognized as medically accepted by standard compendia (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or supported by peer‑reviewed literature is considered investigational and is not covered.

Coverage excludes administration of Syfovre in eyes with active intraocular inflammation or active ocular or peri‑ocular infection, in eyes with category 6 (no light perception) visual impairment, or in eyes with a history of or active choroidal neovascularization (CNV) in the eye to be treated. These conditions must be absent for coverage to be approved.

Coding and Clinical Eligibility Details

HCPCS codesHCPCSCovered

J2781

Injection, pegcetacoplan, 1 mg

NDCNDCCovered

73606-0020-xx

Syfovre 15 mg/0.1 mL Solution for Injection in a Single-dose Vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

H35.3113	Nonexudative age-related macular degeneration, right eye advanced atrophic without subfoveal involvement
H35.3114	Nonexudative age-related macular degeneration, right eye advanced atrophic with subfoveal involvement
H35.3123	Nonexudative age-related macular degeneration, left eye advanced atrophic without subfoveal involvement
H35.3124	Nonexudative age-related macular degeneration, left eye advanced atrophic with subfoveal involvement
H35.3133	Nonexudative age-related macular degeneration, bilateral eye advanced atrophic without subfoveal involvement
H35.3134	Nonexudative age-related macular degeneration, bilateral eye advanced atrophic with subfoveal involvement
H35.3193	Nonexudative age-related macular degeneration, unspecified eye advanced atrophic without subfoveal involvement
H35.3194	Nonexudative age-related macular degeneration, unspecified eye advanced atrophic with subfoveal involvement

GA lesion size

Total GA lesion areaMust be ≥2.5 mm² and ≤17.5 mm²

Multifocal GA requirementIf GA is multifocal, at least one focal lesion must be ≥1.25 mm²

Anatomic confirmationDiagnosis must show characteristic phenotype with ≥1 zone of well-demarcated RPE and/or choriocapillaris atrophy

Dose per administration

Recommended dose per eye15 mg (0.1 mL of 150 mg/mL solution) intravitreal

Administration frequencyOnce every 25 to 60 days per treated eye

RouteIntravitreal injection to each affected eye

Prior Authorization, Documentation, and Renewal Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is for 6 months; approvals may be renewed every 6 months.

Initial approval duration: 6 months
Renewal frequency: every 6 months
Prescriptions must be by or in consultation with a retina specialist

Step Therapy

Step Therapy Note

Medicare members who have previously received this medication within the past 365 days are exempt from Step Therapy requirements.

Exemption applies only to Medicare members with prior receipt within 365 days

Denial Risk

Triggers for Denial / Non‑renewal

Coverage will be denied or not renewed when required baseline assessments are missing or when specified exclusionary clinical conditions are present.

Missing baseline assessments: BCVA, FAF, or OCT
Active ocular or peri-ocular infection
Active intraocular inflammation
History of or active choroidal neovascularization (CNV) in the eye(s) to be treated
Diagnosis not confirmed as GA secondary to AMD or alternative etiologies not ruled out (e.g., Stargardt disease, cone-rod dystrophy, toxic maculopathies)
Total GA lesion size outside allowed range (must be ≥2.5 and ≤17.5 mm2; if multifocal, at least one lesion ≥1.25 mm2)
Unacceptable drug-related toxicity (e.g., endophthalmitis, retinal detachment, neovascular AMD/CNV, intraocular inflammation, uncontrolled increased intraocular pressure) may trigger non-renewal

Background

Syfovre (pegcetacoplan) is approved for the treatment of geographic atrophy (GA) secondary to age‑related macular degeneration (AMD). Phase 3 trials (OAKS and DERBY) demonstrated reductions in GA lesion growth with monthly and every‑other‑month dosing, though they did not show prevention of visual acuity decline; the trials also identified safety risks including increased rates of neovascular (wet) AMD, endophthalmitis, retinal detachment, intraocular inflammation, and elevations in intraocular pressure. The recommended per‑eye dose is 15 mg (0.1 mL) administered intravitreally at intervals of approximately every 25 to 60 days.

Definitions and Clinical Measures

GA secondary to AMD

DefinitionGeographic Atrophy (GA) secondary to age-related macular degeneration (AMD): focal areas of well-demarcated retinal pigment epithelium (RPE) and/or choriocapillaris atrophy consistent with GA phenotype

Indication contextSyfovre (pegcetacloplan) is approved to treat GA secondary to AMD based on phase 3 trial evidence

Exclusion examples to considerOther causes of GA (e.g., Stargardt disease, cone-rod dystrophy, toxic maculopathies) must be ruled out

BCVA (ETDRS)

BCVA threshold (ETDRS)Best corrected visual acuity ≥24 ETDRS letters (approximately 20/320 Snellen)

Measurement methodBCVA must be measured using ETDRS charts at baseline and for renewals as indicated

Role in eligibilityBCVA requirement is one of multiple initial-approval criteria that must be met