Vabysmo (faricimab-svoa) Clinical Policy Form

Page 1 of 7 AHP- Vabysmo (faricimab-svoa) 0 PART B DRUG MEDICAL/PHARMACY Effective Date May 15, 2025 Policy # VABYSMO (faricimab-svoa) Vabysmo (faricimab-svoa) Review Date Applicable to: 02/25/2025 Medicare Advantage Commercial Elevance Health HMO Blue Shield Trio Approver’s Name & Title QI & UM Drug Subcommittee Aspire Health Plan applies medical drug clinical criteria as a reference for medical policy information only. Federal and state laws or requirements, contract language, and Plan benefit may take precedence over the application of these clinical criteria. Please consult the applicable certificate or contract for benefit details. This policy is subject to revision at the discretion of the Plan and is therefore subject to change. Refer to the disclaimer section below for more information. POLICY This policy outlines the coverage of Vabysmo (faricimab-svoa) for ophthalmic use. APPLICABLE HCPCS J2777: Injection, faricimab-svoa, 0.1 mg; 1 billable unit = 0.1 mg (Effective 10/01/2022) Available as: Vabysmo SOLN 6MG/0.05ML Injection: 120 mg/mL solution in a single-dose vial. CLINICAL CRITERIA A. INITIAL CRITERIA Vabysmo (faricimab-svoa) may be authorized when ALL of the following are met and supported by clinical documentation: 1. Definitive diagnosis of ONE of the following: a. Neovascular (wet) age-related macular degeneration (nAMD) b. Diabetic macular edema (DME) c. Macular edema following retinal vein occlusion (RVO)

Page 2 of 7 AHP- Vabysmo (faricimab-svoa) AND 2. Exclusion Criteria: a. Active intraocular inflammation; and b. Concurrent ocular or periocular infection; c. Known hypersensitivity to Vabysmo or any of its components. d. Other ocular conditions that, in the opinion of the treating physician, would preclude Vabysmo treatment or confound assessment of its effectiveness. AND 3. Member is not on additional ophthalmic vascular endothelial growth factor (VEGF) inhibitors (i.e., aflibercept, ranibizumab, pegaptanib, bevacizumab). B. REAUTHORIZATION / CONTINUATION OF THERAPY CRITERIA Vabysmo (faricimab-svoa) may be authorized for continuation of therapy when ALL of the following are met: 1. Member continues to meet the initial therapy criteria (as stated above); AND 2. Member has not experienced unacceptable adverse events from intravitreal injections of Vabysmo (faricimab-svoa) (e.g., endophthalmitis, retinal detachments, increased intraocular pressure, arterial thromboembolic events); AND 3. Positive response to therapy documented by ONE or more of the following: a. Improvement or stabilization in best corrected visual acuity (BCVA) or visual field; or b. Reduction in central retinal thickness (as measured by OCT); or c. Other objective measures of disease activity as determined by the treating physician. AND 4. Documentation of the following: a. Administration records with dates and eye(s) administered and dose. b. Adherence to treatment plan.

Page 3 of 7 AHP- Vabysmo (faricimab-svoa) STEP THERAPY Step Therapy Does NOT Apply if: • The member is currently being treated with the requested medication. • The member has received the requested drug within the last 365 days. Step Therapy Applies if: • The member is new to therapy (i.e., has not received the requested drug in the last 365 days). A. PREFERRED PRODUCT(S): AVASTIN (no step therapy required) B. Vabysmo (faricimab-svoa) may be authorized when ALL of the clinical criteria (in the Initial Therapy section above are met) AND the member meets the following criteria: 1. Inadequate response to a trial of the preferred agent, bevacizumab (Avastin); or 2. History of contraindication or adverse event(s) to Avastin (bevacizumab); or 3. Member has been on the requested agent within the past 365 days. DOSAGE AND AUTHORIZATION TIMEFRAMES 1. Recommended Dosage: a. Neovascular (Wet) Age-Related Macular Degeneration (nAMD) • 6 mg (0.05 mL) administered intravitreally every 4 weeks (monthly) for the first four doses. • After the initial four doses, treatment intervals may be extended based on the patient's individual response, up to every 16 weeks. b. Diabetic Macular Edema (DME) • Dose is 6 mg (0.05 mL) administered intravitreally every 4 weeks (monthly) for at least four doses. • After the initial four doses, treatment intervals may be extended based on the patient's individual response, up to every 16 weeks or every 8 weeks. c. Macular Edema Following Retinal Vein Occlusion (RVO) • Dose is 6 mg (0.05 mL) administered intravitreally every 4 weeks (monthly). 2. Authorization Period: a. Initial authorization may be granted for up to 12 months. Reauthorizations must meet continuation of therapy criteria and may be authorized for 12 months. b. The treating physician will determine the appropriate treatment interval for each individual patient based on their response to the medication and their specific needs.

Page 4 of 7 AHP- Vabysmo (faricimab-svoa) 3. Limitations a. Concurrent Anti-VEGF Therapy (Same Eye): Administration of more than one anti- VEGF medication (e.g., aflibercept, pegaptanib, brolucizumab, bevacizumab, ranibizumab, faricimab-svoa) in the same eye during the same treatment session is not considered medically reasonable and necessary. b. Concurrent Anti-VEGF Therapy (Bilateral): While it is not typical to inject one anti- VEGF medication in one eye and a different anti-VEGF medication in the other eye during the same treatment session, if clinically warranted, this practice requires clear documentation in the medical record justifying the medical necessity of this approach. Appropriate right (RT) and left (LT) modifiers must be appended to the corresponding drug codes. c. Injection Frequency: Intravitreal injections for the treatment of macular edema, regardless of the specific anti-VEGF agent used, administered more frequently than every 4 weeks are not covered. This includes alternating anti-VEGF agents every 2 weeks. d. Combination VEGF Inhibitor Therapy: The safety and efficacy of combining multiple VEGF inhibitors for ocular indications in the same eye have not been established. Combination therapy with multiple VEGF inhibitors in the same eye is not considered medically reasonable and necessary and will not be covered. This policy applies to concurrent use of more than one VEGF inhibitor in the same eye, regardless of the specific agents used. DRUG INFORMATION PHARMACOLOGIC CATEGORY: Vascular Endothelial Growth Factor (VEGF) Inhibitor; Angiopoietin-2 (Ang-2) Inhibitor (Vabysmo is a dual inhibitor targeting both VEGF-A and Ang-2) ROUTE OF ADMINISTRATION: Intravitreal injection by a qualified physician. FDA-APPROVED INDICATIONS 1. Neovascular (Wet) Age-Related Macular Degeneration (nAMD). 2. Diabetic Macular Edema (DME). 3. Macular Edema Following Retinal Vein Occlusion (RVO) COMPENDIAL APPROVED (OFF-LABEL) USES: None CONTRAINDICATIONS: Hypersensitivity to faricimab or any component of the formulation; active or suspected ocular or periocular infections; active intraocular inflammation. OTHER CONSIDERATIONS

1. Dosing and Administration Initial recommended dosing: • First 4 doses: Every 4 weeks (monthly) • Maintenance dosing: ― nAMD and DME: May extend to every 8, 12, or 16 weeks based on anatomic and visual outcomes. The decision to extend treatment intervals should be made by the

Page 5 of 7 AHP- Vabysmo (faricimab-svoa) treating physician based on a comprehensive patient assessment.
― RVO: May extend to every 8 weeks based on anatomic and visual outcomes

2. Monitoring Parameters • Visual acuity • Intraocular pressure (before and after injection) • Signs/symptoms of: ― Endophthalmitis ― Retinal detachment ― Retinal breaks ― Intraocular inflammation ― Increased intraocular pressure • Treatment response via anatomic and functional measures CLINICAL SUMMARY / APPENDIX Vabysmo (faricimab) is approved for nAMD and DME based on clinical trial data demonstrating efficacy and safety. Vabysmo targets two pathways involved in these conditions (VEGF and Ang- 2), potentially offering longer-lasting effects. Studies have shown Vabysmo to be effective in improving visual acuity in diverse populations, including those historically underrepresented in clinical trials. Faricimab-svoa has demonstrated noninferiority to aflibercept in pivotal clinical trials:
3. nAMD (TENAYA and LUCERNE Trials): Faricimab-svoa showed noninferior visual acuity gains compared to aflibercept, with the potential for extended dosing intervals (up to 16 weeks) in a subset of patients.
4. DME (YOSEMITE and RHINE Trials): Faricimab-svoa demonstrated noninferiority to aflibercept in improving visual acuity and reducing central subfield thickness (CST), with many patients achieving extended dosing intervals (up to 16 weeks). PROFESSIONAL GUIDELINES
   American Academy of Ophthalmology (AAO): • Supports the use of anti-VEGF agents, including faricimab-svoa, for the treatment of nAMD and DME. • Recommends individualized treatment plans based on patient response and disease activity. REFERENCES Government Agency Centers for Medicare and Medicaid Services (CMS). Medicare coverage database (no National Coverage Determination identified; no applicable LCD identified). Available from CMS. Prescribing Information Vabysmo (faricimab) [prescribing information]. South San Francisco, CA: Genentech Inc; January 2023. Peer-reviewed Literature, Guidelines, and Consensus 1. Heier JS, Khanani AM, Quezada Ruiz C, Basu K, et al.; TENAYA and LUCERNE Investigators.

Page 6 of 7 AHP- Vabysmo (faricimab-svoa) Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age- related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. 2. Petri AS, Boysen K, Cehofski LJ, et al. Intravitreal injections with vascular endothelial growth factor inhibitors: a practical approach. OphthalmolTher. 2020;9(1):191-203. doi:10.1007/s40123-020- 00230-4. 3. Wykoff CC, Abreu F, Adamis AP, Basu K, et al. YOSEMITE and RHINE Investigators Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. 4. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology;

2019. Available at: https://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp. 5. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern Guidelines. Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/preferred-practice-pattern/age-related- macular-degeneration-ppp. 6. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern Guidelines. Retinal Vein Occlusions. San Francisco, CA: American Academy of Ophthalmology;
2020. Available at: https://www.aao.org/preferred-practice-pattern/retinal-vein-occlusions-ppp. IMPORTANT REMINDER This Medicare Part B Step Therapy Medical Necessity Guideline is for informational purposes only and does not constitute or replace professional medical advice. Physicians, hospitals, and other providers are responsible for administering and using drugs/biologicals in the most effective and clinically appropriate manner and are solely responsible for all medical care decisions. This guideline is not a substitute for clinical judgment or individualized patient care. Coverage determinations are based on the member's Evidence of Coverage (EOC), which contains specific coverage provisions, limitations, and exclusions. In the event of a conflict between this guideline and the member's EOC, the EOC will govern. Aspire Health Plan (AHP) adheres to applicable Medicare guidelines, including National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and other relevant Medicare manuals published by the Centers for Medicare & Medicaid Services (CMS). Compliance with these guidelines is required where applicable. For the most current Medicare policies and coverage information, please refer to the CMS website at cms.gov and search the Medicare Coverage Database. All LCDs are the same for each state within a Jurisdiction. The Medicare Administrative Contractor (MAC) for California (Jurisdiction E) is Noridian. Active LCDs for JE Part B can be found on the Noridian Medicare website (noridianmedicare.com). In the event of a discrepancy between this guideline and a Medicare NCD or LCD, the NCD/LCD will govern. This guideline is used by AHP to determine coverage in the absence of applicable CMS Medicare guidelines. The Medicare source materials used to develop this guideline are referenced below. This document does not replace the official Medicare source materials, which provide detailed information on Medicare coverage requirements. In the event of a conflict between this document and Medicare source materials, the Medicare source materials will prevail. The inclusion of a code in this guideline does not guarantee coverage or reimbursement. Benefit coverage is determined by the member's specific plan document, applicable state and federal laws, and CMS guidelines. Other policies and standards may also apply. Providers are expected to maintain documentation to support coverage decisions and make it available upon request.

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AHP- Vabysmo (faricimab-svoa) POLICY HISTORY Version Date Summary of Changes 1 09/27/2023 New Policy 2 02/25/2025 Annual Review (effective May 15, 2025). References updated. Policy was reformatted throughout to enhance clarity. Policy revisions with annual review include: 1) Added the most recent FDA-approved indication for the treatment of macular edema following retinal vein occlusion (RVO). 2) Added two points to the ‘Exclusion’ criteria: • Known hypersensitivity to Vabysmo or any of its components. • Other ocular conditions that, in the opinion of the treating physician, would preclude Vabysmo treatment or confound assessment of its effectiveness. 3) Revised monotherapy criteria. Removed the monotherapy requirement: • From: Vabysmo (faricimab-svoa) is being prescribed as monotherapy: Member is not on additional ophthalmic vascular endothelial growth factor (VEGF) inhibitors (i.e., aflibercept, ranibizumab, pegaptanib, bevacizumab). • To: Member is not on additional ophthalmic vascular endothelial growth factor (VEGF) inhibitors (i.e., aflibercept, ranibizumab, pegaptanib, bevacizumab). 4) Revised the ‘Reauthorization/Continuation of Therapy’ criteria for clarity: • From: Positive response to therapy (e.g., improvement or maintenance in best corrected visual acuity or visual field, or a reduction in the rate of vision decline or the risk of more severe vision loss) and continued administration is necessary for the maintenance treatment of the condition • To: Positive response to therapy documented by ONE or more of the following:  Improvement in best corrected visual acuity (BCVA)  Stabilization of BCVA (i.e., no significant decline)  Reduction in central retinal thickness (as measured by OCT)  Other objective measures of disease activity as determined by the treating physician. 5) Revised the ‘Reauthorization/Continuation of Therapy’ to include documentation of dose. • From: Documentation of administration records showing dates and eye(s) administered, along with documentation of member compliance with treatment plan. • To: Documentation of the following:  Administration records with dates, eye(s) administered, and dose.  Adherence to treatment plan.