Last Review Date: 09/05/2024

Date of Origin: 04/04/2023

Dates Reviewed: 04/2023, 10/2023, 09/2024

1. Length of Authorization

Coverage will be provided annually and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC unit]:

• Syfovre 150 mg/mL single-dose vial: 1 vial per eye every 25 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• 30 billable units (30 mg) every 25 days

(Max units are based on administration to BOTH eyes)

3. Initial Approval Criteria ^1,2

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Patient has a baseline assessment for all the following: best corrected visual acuity (BCVA), fundus autofluorescence (FAF) imaging, and optical coherence tomography (OCT); AND

Universal Criteria ^1,6

• Patient is free of ocular and/or periocular infections; AND
• Patient does not have active intraocular inflammation; AND

• Will not be used in combination with other intravitreal complement inhibitor therapies (e.g., avacincaptad pegol); AND
• Patient does not have category 5, or higher, visual impairment or blindness (i.e., no light perception-total blindness); AND

Geographic Atrophy (GA) † ^1-3

• The patient has a diagnosis of GA as defined by a phenotype of central geographic atrophy having 1 or more zones of well demarcated retinal pigmented epithelium (RPE) and/or choriocapillaris atrophy; AND
• Disease is secondary to age-related macular degeneration (AMD); AND
• Conditions other than AMD have been ruled out (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.)

† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,2

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and indication-specific relevant criteria as identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: endophthalmitis, retinal detachment, retinal vasculitis and/or retinal vascular occlusion, neovascular (wet) AMD or choroidal neovascularization, intraocular inflammation (e.g., vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare), increased intraocular pressure, etc.; AND
• Patient has had disease stabilization or slowing of the rate of disease progression while on therapy compared to pre-treatment baseline as measured by any of the following:
  • Best corrected visual acuity (BCVA)
  • Fundus Autofluorescence (FAF)
  • Optical Coherence Tomography (OCT); AND
• Continued administration is necessary for the maintenance treatment of the condition and the patient and provider have discussed potential decrease in frequency administrations.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J2781 – Injection, pegcetacoplan, intravitreal, 1mg; 1 billable unit = 1 mg

NDC:

• Syfovre 15 mg/0.1 mL solution for injection in a single-dose vial: 73606-0020-xx

7. References

1. Syfovre [package insert]. Waltham, MA; Apellis Pharmaceuticals, Inc.; November 2023. Accessed July 2024.
2. Goldberg R, Heier JS, Clifton-Wykoff C, et al. Efficacy of intravitreal pegcetacoplan in patients with geographic atrophy (GA): 12-month results from the phase 3 OAKS and DERBY studies. Investigative Ophthalmology & Visual Science June 2022, Vol.63, 1500.
3. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP – Update 2019. Oct 2019. (Interim update March 2022).
4. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks - 2023. December 2023.
5. Chandra S, McKibbin M, Mahmood S, et al. The Royal College of Ophthalmologists Commissioning guidelines on age macular degeneration: executive summary. Eye 36, 2078–2083 (2022). https://doi.org/10.1038/s41433-022-02095-2
6. Dandona L, Dandona R. Revision of visual impairment definitions in the International Statistical Classification of Diseases. BMC Med. 2006 Mar 16;4:7. doi: 10.1186/1741-7015-4-7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1435919/

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):  N/A

Medical Necessity Criteria

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