CurrentCignaPolicy N/A

Syfovre (pegcetacoplan) — Coverage Criteria for Geographic Atrophy

Defines Cigna's prior-authorization and coverage criteria for Syfovre (pegcetacoplan intravitreal injection) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration, and the prescribing/administrative requirements for providers and claims.

Policy Summary

PayerCigna

PolicySyfovre (pegcetacoplan) — Coverage Criteria for Geographic Atrophy

Policy CodePolicy N/A

Change TypeCriteria revisionnew exclusion added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document BCVA (24 ETDRS letters or better OR 20/320 Snellen or better) and that administration is by or under supervision of an ophthalmologist.

SourceLink

POLICY UPDATE CHANGES

BCVA criterion revised to allow either '24 letters or better using ETDRS charts' OR '20/320 or better using the Snellen chart'.

Concomitant use with Izervay (avacincaptad pegol) is explicitly listed as not recommended/ not covered.

15 mgFDA-recommended dose per eye

25–60 daysDosing interval (label)

1 yearInitial approval duration

NC or nationalApplicable state(s)

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Coverage Criteria for Syfovre (pegcetacoplan)

FDA-Approved Indication — Geographic Atrophy

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

FDA-Approved Indication — Geographic Atrophy: A) Patient has geographic atrophy secondary to age-related macular degeneration; AND B) Patient meets ONE of the following (i or ii): i. Patient has a best-corrected visual acuity (BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts; OR ii. Patient has a best-corrected visual acuity (BCVA) of 20/320 or better using the Snellen chart; AND C) The medication is administered by or under the supervision of an ophthalmologist.BCVA: 24 ETDRS letters or better OR 20/320 Snellen or better

Approval duration: 1 year.

Dosing Requirements

Dosing must meet BOTH criteria:

Dosing Requirements: A) The dose is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection for each eye being treated; AND B) The dosing interval is not more frequent than once every 25 days for each eye being treated.15 mg; >=25 days interval

Manufacturer recommended dosing interval referenced as 25–60 days per label.

Syfovre (pegcetacoplan intravitreal injection) is not medically necessary for any use other than treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This includes combined or simultaneous use with other intravitreal complement inhibitors. Specifically, concomitant use with Izervay (avacincaptad pegol intravitreal injection) is explicitly not recommended due to a lack of data supporting combined use.

Use of Syfovre for any indication other than geographic atrophy secondary to AMD is considered not medically necessary and will not be approved under this policy.

Coding and Dose Details

Considered Medically Necessary when policy criteria metHCPCSCovered

J2781

Injection, pegcetacoplan, intravitreal, 1 mg

inv-06: BCVA requirement — Thresholds

BCVA requirementBest-corrected visual acuity (BCVA) of 24 ETDRS letters or better

Alternative BCVA equivalentBest-corrected visual acuity (BCVA) of 20/320 or better on the Snellen chart

Approval conditionPatient must meet ONE of the BCVA options (ETDRS or Snellen) to qualify

inv-07: Dose per administration

Dose per administration15 mg (0.1 mL of 150 mg/mL) administered by intravitreal injection per eye

Administration routeIntravitreal injection to each affected eye

Provider Requirements and Administrative Actions

Prior Authorization

Prior authorization required — 1 year approval if criteria met

Prior authorization is required for prescription benefit coverage of Syfovre. If all listed clinical and dosing criteria are met, approve for a duration of 1 year.

Applicable HCPCS code when billed: J2781

Step Therapy

Concomitant use restriction — Izervay not recommended

Do not sequence or combine Syfovre with other geographic atrophy intravitreal agents; concomitant use with Izervay (avacincaptad pegol) is explicitly not recommended due to lack of supporting data.

No step-therapy sequencing with other GA intravitreal agents is permitted.

Background on Geographic Atrophy

Geographic atrophy (GA) is an advanced, non‑neovascular form of age‑related macular degeneration characterized by localized atrophy of outer retinal tissue with irreversible loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. GA can progress to involve the foveal center and cause severe, permanent vision loss; clinical trials supporting Syfovre enrollment required baseline best‑corrected visual acuity consistent with trial eligibility.

Definitions and Thresholds

inv-14: Geographic atrophy (GA) — Definition

DefinitionGeographic atrophy (GA) is an advanced form of non-neovascular age-related macular degeneration characterized by localized atrophy of outer retinal tissue with irreversible loss of photoreceptors, retinal pigment epithelium, and choriocapillaris

Clinical significanceMay involve the foveal center and cause severe vision loss (e.g., 20/200 or worse)

Indication contextSyfovre is indicated to slow progression of GA secondary to AMD

inv-15: BCVA thresholds

ETDRS threshold24 letters or better on Early Treatment Diabetic Retinopathy Study (ETDRS) charts

Snellen equivalent20/320 or better on the Snellen chart