Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual

Policy #:

2023037

Category:

Pharmacy

Initiated:

August 2023

Last Review:

August 2026

Pegcetacoplan Intravitreal (e.g., Syfovre)

Description:

The policy applies to the following medication: Pegcetacoplan Intravitreal (e.g., Syfovre).

Policy/
Coverage:

Effective November 28, 2026

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Pegcetacoplan Intravitreal (e.g., Syfovre) meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes or for members with contracts without Primary Coverage Criteria, is considered Medically Necessary and is covered when member receives a “recommended” determination from criteria review in InterQual® for (service/procedure) based on diagnosis and requested product.

Click the following link to view the specific criteria in InterQual®: https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc

Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria

Pegcetacoplan intravitreal (e.g., Syfovre) does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered for any indication or circumstance not described as covered.

For members with contracts without Primary Coverage Criteria, Pegcetacoplan intravitreal (e.g., Syfovre), is considered not Medically Necessary and is not covered or is investigational for any indication or circumstance not described as covered. Not Medically Necessary or Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Click the following link to view the specific criteria in InterQual®: https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc

Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Please refer to a separate policy on Maximum Dosage and Frequency (policy #2025031) for pharmacologic/biologic medications.

Effective August 06, 2025 to November 27, 2026

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Pegcetacoplan Intravitreal (e.g., Syfovre) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:

INITIAL APPROVAL:

1. Individual has a diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration; AND

2. Diagnosis has been verified as geographic atrophy secondary to age-related macular degeneration; AND

3. Pegcetacoplan intravitreal will not be used for the following situations:

a. Individual has geographic atrophy that is secondary to a condition other than age-related macular degeneration (including but not limited to Stargardt disease, cone rod dystrophy or toxic maculopathies); OR

b. Individual has a history of or active choroidal neovascularization or wet age-related macular degeneration; OR

c. Individual has an ocular or periocular infection or intraocular inflammation; AND

4. Must be administered by or under the supervision of an ophthalmologist.

CONTINUATION OF THERAPY:

1. Individual continues to meet the initial approval criteria; AND

2. Individual experiences objective benefit from continued treatment as defined by vision stabilization or improvement in vision.

Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria

Pegcetacoplan intravitreal (e.g., Syfovre) for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, Pegcetacoplan intravitreal (e.g., Syfovre), for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

POLICY GUIDELINES

There should be an absence of unacceptable toxicity resulting from the treatment (e.g., endophthalmitis and retinal detachments, retinal vasculitis and/or retinal vascular occlusion, neovascular AMD, intraocular inflammation, increased intraocular pressure (IOP).

DOSAGE AND ADMINISTRATION

For FDA labeled indications, Pegcetacoplan intravitreal (e.g., Syfovre) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified below.

The recommended dose of pegcetacoplan intravitreal (e.g., Syfovre) is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.

Pegcetacoplan intravitreal is available as 150 mg/mL in a single-dose vial.

Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Effective September 4, 2024 to August 5, 2025

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

1. Individual has a diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration; AND

2. Diagnosis has been verified as geographic atrophy secondary to age-related macular degeneration; AND

3. Pegcetacoplan intravitreal will not be used for the following situations:

a. Individual has geographic atrophy that is secondary to a condition other than age-related macular degeneration (including but not limited to Stargardt disease, cone rod dystrophy or toxic maculopathies); OR

b. Individual has a history of or active choroidal neovascularization or wet age-related macular degeneration; OR

c. Individual has an ocular or periocular infection or intraocular inflammation; AND

4. Must be administered by or under the supervision of an ophthalmologist; AND

5. Must be dosed in accordance with the FDA label.

Dosage and Administration

Dosing per FDA Guidelines

The recommended dose of pegcetacoplan intravitreal (e.g., Syfovre) is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.

Pegcetacoplan intravitreal is available as 150 mg/mL in a single-dose vial.

Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Effective August 14, 2023 to September 3, 2024

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Pegcetacoplan (e.g., Syfovre), for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) or any other indication, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, pegcetacoplan (e.g., Syfovre), for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) or any other indication, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:

After full review and evaluation, the InterQual® Criteria has been adopted in full as Coverage Policy.

InterQual® Criteria are derived from the systematic, continuous review and critical appraisal of the most current evidence-based literature and include input from independent panel of clinical experts. To generate the most appropriate recommendations, a comprehensive literature review of the clinical evidence was conducted. Sources searched included PubMed, Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Reviews, AHRQ Technology Assessments, the Cochrane Library, Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations, FDA Drug Prescribing Information, and the National Institute of Health and Care Excellence (NICE). Other medical literature databases, medical content providers, data sources, regulatory body websites, and specialty society resources may also have been used. Relevant studies were assessed for risk of bias following principles described in the Cochrane Handbook. The resulting evidence was assessed for consistency, directness, precision, effect size, and publication bias. Observational trials were also evaluated for the presence of a dose-response gradient and the likely effect of plausible confounders.

CPT/HCPCS:

References:

See InterQual® for list of references.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants.