CurrentViva Health PlanPolicy IC-0697

Syfovre (pegcetacoplan) Intravitreal Therapy

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This policy governs prior authorization, dosing, and medical-necessity coverage for intravitreal Syfovre in adults with geographic atrophy secondary to age-related macular degeneration.

Policy Summary

PayerViva Health Plan

PolicySyfovre (pegcetacoplan) Intravitreal Therapy

Policy CodePolicy IC-0697

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit baseline assessments documenting best corrected visual acuity, fundus autofluorescence imaging, and optical coherence tomography.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsPrior-authorization validity

30 mgMaximum dose every 25 days

15 mgDose per affected eye

18 yearsMinimum approval age

8Covered diagnosis codes

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CurrentViva Health PlanPolicy IC-0697

Syfovre (pegcetacoplan) Intravitreal Therapy

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0697 alerts

Get alerted when Policy IC-0697 changes without checking for updates manually.

Monitor payer policy activity

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This policy governs prior authorization, dosing, and medical-necessity coverage for intravitreal Syfovre in adults with geographic atrophy secondary to age-related macular degeneration.

Policy Summary

PayerViva Health Plan

PolicySyfovre (pegcetacoplan) Intravitreal Therapy

Policy CodePolicy IC-0697

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit baseline assessments documenting best corrected visual acuity, fundus autofluorescence imaging, and optical coherence tomography.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsPrior-authorization validity

30 mgMaximum dose every 25 days

15 mgDose per affected eye

18 yearsMinimum approval age

8Covered diagnosis codes

Coverage Criteria

Initial Therapy

Covered for initial authorization when ALL of the following criteria are met.

Initial approval criteria

Age and baseline assessment: The member is at least 18 years of age and has baseline assessments documenting best corrected visual acuity (BCVA), fundus autofluorescence (FAF) imaging, and optical coherence tomography (OCT).Age >= 18 years
Universal criteria: The member has no FDA-labeled contraindication to pegcetacoplan; Syfovre will not be used in combination with another intravitreal complement inhibitor; and the member does not have category 5 or higher visual impairment or blindness (no light perception to total blindness).
Examples of contraindications include ocular or periocular infection, active intraocular inflammation, and hypersensitivity to pegcetacoplan or any Syfovre excipient.
Geographic atrophy indication: The member has geographic atrophy defined by one or more zones of well-demarcated retinal pigment epithelium and/or choriocapillaris atrophy; the disease is secondary to age-related macular degeneration (AMD); and conditions other than AMD have been ruled out.
Examples of alternative conditions include Stargardt disease, cone-rod dystrophy, and toxic maculopathies.

Continuation Therapy

Covered for renewal when ALL of the following criteria are met.

Renewal criteria

Continued eligibility: The member continues to meet the relevant universal and indication-specific criteria identified for initial approval.
Tolerability: There is no unacceptable toxicity from the drug that cannot be adequately treated.
Examples include endophthalmitis, retinal detachment, retinal vasculitis or retinal vascular occlusion, neovascular (wet) AMD or choroidal neovascularization, intraocular inflammation, and increased intraocular pressure.
Clinical response: The member has experienced disease stabilization or a slowed rate of disease progression while on therapy compared with the pretreatment baseline, measured by BCVA, FAF, or OCT.Response measured by BCVA, FAF, or OCT

Initial coverage excludes members with an FDA-labeled contraindication to Syfovre, including ocular or periocular infection, active intraocular inflammation, or hypersensitivity to pegcetacoplan or any Syfovre excipient. Coverage also excludes concurrent use with another intravitreal complement inhibitor and members with category 5 or higher visual impairment or blindness, defined as no light perception through total blindness.

Coverage is limited to geographic atrophy secondary to age-related macular degeneration (AMD). The geographic atrophy phenotype must include one or more zones of well-demarcated retinal pigment epithelium and/or choriocapillaris atrophy, and alternative causes must be ruled out, including Stargardt disease, cone-rod dystrophy, and toxic maculopathies.

Coding and Administration Limits

Covered HCPCS CodeHCPCSCovered

J2781

Injection, pegcetacoplan, 1 mg; 1 billable unit = 1 mg

Covered NDCNDCCovered

73606-0020-xx

Syfovre 15 mg/0.1 mL solution for injection in a single-dose vial

Covered Diagnosis CodesICD-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

Maximum billable units30 billable units (30 mg) every 25 days; based on administration to both eyes

Geographic atrophy dose and frequencyAdminister 15 mg (0.1 mL of 150 mg/mL solution) by intravitreal injection to each affected eye once every 25 to 60 days. Each vial and syringe should only be used for the treatment of a single eye.

Provider Requirements and Authorization Risks

Prior Authorization

Obtain 12-month prior authorization

Syfovre requires prior authorization. Initial authorization is valid for 12 months (365 days), and renewal authorization may be issued every 12 months (365 days).

Billing Rule

Follow dose and administration limits

Administer 15 mg (0.1 mL of the 150 mg/mL solution) by intravitreal injection to each affected eye once every 25 to 60 days. Each vial and syringe must be used for treatment of a single eye, and billing must remain within the maximum of 30 billable units (30 mg) every 25 days for both eyes.

Policy Background

Syfovre® (pegcetacoplan) is an intravitreal therapy covered under this policy for adults with geographic atrophy associated with age-related macular degeneration. Coverage requires documentation that the geographic atrophy phenotype is present, is secondary to AMD, and is not attributable to another condition.

Key Definitions

Geographic Atrophy

DefinitionA phenotype of geographic atrophy having one or more zones of well-demarcated retinal pigment epithelium and/or choriocapillaris atrophy

Retinal structureRetinal pigment epithelium (RPE)

Choroidal structureChoriocapillaris

Category 5 or Higher Visual Impairment or Blindness

DefinitionNo light perception or total blindness

Visual impairment categoryCategory 5 or higher

Coverage relevanceCategory 5 or higher visual impairment or blindness is excluded from initial coverage

Policy Summary

PayerViva Health Plan

PolicySyfovre (pegcetacoplan) Intravitreal Therapy

Policy CodePolicy IC-0697

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit baseline assessments documenting best corrected visual acuity, fundus autofluorescence imaging, and optical coherence tomography.

SourceLink

On This Page

Maintenance need and frequency discussion: Continued administration is necessary for maintenance treatment of the condition, and the member and provider have discussed the potential decrease in administration frequency.

Documentation Required

Submit baseline ophthalmic assessments

Submit baseline assessments documenting best corrected visual acuity (BCVA), fundus autofluorescence (FAF) imaging, and optical coherence tomography (OCT).

Documentation Required

Document qualifying geographic atrophy

Document the geographic atrophy phenotype, its secondary relationship to age-related macular degeneration, and that other causes of geographic atrophy have been ruled out.

Documentation Required

Document clinical response for renewal

For renewal, submit evidence of continued eligibility, absence of inadequately controlled toxicity, and disease stabilization or slowed progression compared with the pretreatment baseline. Measure response using BCVA, FAF, or OCT.

Documentation Required

Document the maintenance-treatment discussion

Document that continued administration is necessary for maintenance treatment and that the member and provider discussed the potential decrease in frequency of administrations.

Denial Risk

Screen for FDA-labeled contraindications

Authorization may be denied when the member has an FDA-labeled contraindication, including ocular or periocular infection, active intraocular inflammation, or hypersensitivity to pegcetacoplan or any Syfovre excipient.

Denial Risk

Avoid concurrent complement inhibitor therapy

Authorization may be denied when Syfovre will be used in combination with another intravitreal complement inhibitor therapy.

Denial Risk

Confirm visual impairment is below category 5

Authorization may be denied for a member with category 5 or higher visual impairment or blindness, defined as no light perception or total blindness.

Denial Risk

Rule out unsupported geographic atrophy etiologies

Authorization may be denied when geographic atrophy is not secondary to age-related macular degeneration or when alternative causes have not been ruled out, including Stargardt disease, cone-rod dystrophy, or toxic maculopathies.

Denial Risk

Assess and control treatment toxicity

Renewal may be denied for unacceptable toxicity that cannot be adequately treated. Examples include endophthalmitis, retinal detachment, retinal vasculitis or vascular occlusion, neovascular AMD or choroidal neovascularization, intraocular inflammation, and increased intraocular pressure.

Denial Risk

Demonstrate treatment response for renewal

Renewal may be denied when treatment has not stabilized disease or slowed progression compared with the pretreatment baseline, as measured by BCVA, FAF, or OCT. Renewal may also be denied when continued administration is not necessary for maintenance treatment.