CurrentAvMedPolicy N/A

Intravitreal complement inhibitors (Izervay, Syfovre) — Prior authorization and clinical criteria

Prior authorization and clinical criteria for coverage of intravitreal complement inhibitor therapies (Izervay/avacincaptad pegol and Syfovre/pegcetacoplan) for members receiving ophthalmology/optometry care.

Policy Summary

PayerAvMed

PolicyIntravitreal complement inhibitors (Izervay, Syfovre) — Prior authorization and clinical criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with prescriber signature and baseline documentation including at least one of BCVA, FAF, or OCT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval period

1 vial/eye/28dIzervay limit

1 vial/eye/25dSyfovre limit

Ophthalmologist/OptometristProvider required

BCVA/FAF/OCT requiredBaseline imaging

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Coverage Criteria

Initial Authorization Criteria

Covered when ALL of the following are met for initial authorization (approval period 12 months):

Provider and diagnosis: Provider is an Optometry Specialist or an Ophthalmologist; member has a diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD); other causes of GA have been ruled out (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies).

Disease phenotype and severity: GA defined by a central phenotype with one or more zones of well-demarcated retinal pigment epithelium (RPE) and/or choriocapillaris atrophy; member does NOT have category 6 or higher visual impairment (no light perception/total blindness).

Baseline objective documentation: Provider has submitted baseline documentation for at least ONE of the following: Best Corrected Visual Acuity (BCVA), Fundus autofluorescence (FAF) imaging, or Optical Coherence Tomography (OCT).

Therapy use limitations: Requested medication will NOT be used in combination with other intravitreal complement inhibitor therapies.

Dosing frequency requested: Provider is requesting one of the following dosing frequencies: Monthly OR Every other month.

Reauthorization Criteria

Reauthorization (12 months) — Covered when ALL applicable criteria are met and documentation provided:

Evidence of benefit or stability: Member has had disease stabilization or a slowing in rate of disease progression while on therapy compared to baseline as measured by at least ONE of: improved or stabilized BCVA, improved or stabilized FAF imaging, or improved or stabilized OCT.

Safety: Member has experienced an absence of unacceptable toxicity from the drug (including but not limited to endophthalmitis, retinal detachment, neovascular (wet) AMD or choroidal neovascularization, intraocular inflammation, increased intraocular pressure) that cannot be adequately treated.

Provider attestation: Provider attests continued administration is necessary for maintenance treatment and that potential decrease in frequency has been discussed if receiving monthly dosing.

Use of intravitreal complement inhibitor therapies in combination is excluded. The requested medication will NOT be used in combination with other intravitreal complement inhibitor therapies; combination administration is not covered and should not be requested.

Members who have category 6 or higher visual impairment (total blindness/no light perception) are not eligible for coverage. The member must NOT have category 6 or greater visual impairment to meet initial or reauthorization criteria.

Provider Actions and Requirements

Prior Authorization

Prior authorization required for J2782 and J2781

Prior authorization is required for Izervay (J2782) and Syfovre (J2781). Requests must be submitted on the AvMed Medical Prior Authorization/Step-Edit form and include the prescriber signature (preprinted stamps not valid).

Drugs: Izervay (avacincaptad pegol) — J2782; Syfovre (pegcetacoplan) — J2781
Prescriber must sign and clearly print name on the request form (preprinted stamps not valid)
Fax completed form to AvMed as directed on the form

Step Therapy

Samples do not meet preauthorization; verify prior therapies

Use of drug samples to initiate therapy does not meet step-edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

If therapy was started with samples, that does not satisfy prior authorization/step-edit requirements
Provide pharmacy claims or chart notes documenting prior therapies when applicable

Documentation Required

Required documentation and baseline data

Submit complete member and prescriber information, drug dosing and diagnosis details, and baseline documentation including at least one of BCVA, FAF imaging, or OCT.

Member identifiers (name, AvMed #, DOB) and prescriber name, signature, contact, and NPI
Drug name/form/strength, dosing schedule, length of therapy, diagnosis and ICD code if applicable
Baseline documentation: Best Corrected Visual Acuity (BCVA) OR Fundus autofluorescence (FAF) OR Optical coherence tomography (OCT)

Denial Risk

Incomplete or illegible requests may be delayed or denied

Incomplete, incorrect, or illegible authorization request information may delay review or result in denial. Failure to provide required documentation (labs, diagnostics, chart notes) or baseline imaging can result in denial.

Ensure all form fields are complete, correct, and legible and that the prescriber signature is present
Provide supporting documentation for any boxes checked on the form (lab results, diagnostics, chart notes) to avoid denial

Background

Geographic atrophy (GA) is an advanced form of age-related macular degeneration characterized by well-demarcated areas of retinal pigment epithelium and/or choriocapillaris atrophy. Intravitreal complement inhibitors (avacincaptad pegol, pegcetacoplan) are administered by an Optometry Specialist or an Ophthalmologist to slow progression. For initial authorization (approval period 12 months), the provider must confirm GA is central in phenotype with one or more zones of RPE and/or choriocapillaris atrophy, that the disease is secondary to age-related macular degeneration (AMD), and that other causes of GA have been ruled out. Baseline objective documentation must include at least one of: Best Corrected Visual Acuity (BCVA), fundus autofluorescence (FAF), or optical coherence tomography (OCT). Requests must also attest the medication will not be used in combination with other intravitreal complement inhibitors and that the member does not have category 6 or higher visual impairment.

OpenPayer

Intravitreal complement inhibitors (Izervay, Syfovre) — Prior authorization and clinical criteria

Coverage Criteria

Coding and Dosing

Provider Actions and Requirements

Background

Definitions

J2782	Izervay (avacincaptad pegol)
J2781	Syfovre (pegcetacoplan)