Clinical Policy: Faricimab-svoa (Vabysmo)

Reference Number: CP.PHAR.581
Effective Date: 06.01.22
Last Review Date: 02.26
Line of Business: Commercial, HIM, Medicaid

[Coding Implications](Coding Implications)
[Revision Log](Revision Log)

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Faricimab-svoa (Vabysmo®) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor.

FDA Approved Indication(s)

Vabysmo is indicated for the treatment of patients with:

• Neovascular (wet) age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)
• Macular edema following retinal vein occlusion (RVO)

Policy/Criteria

a. nAMD;
b. DME;
c. Macular edema following RVO;

2. Prescribed by or in consultation with an ophthalmologist;
3. Age ≥ 18 years;
4. Failure of bevacizumab intravitreal solution^, unless contraindicated or clinically significant adverse effects are experienced;Prior authorization may be required for bevacizumab intravitreal solution. Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved
   *For Illinois HIM requests, the step therapy requirements above do not apply per IL HB 5395
5. Dose does not exceed (a, b, or c):
   a. nAMD: 6 mg (1 vial/syringe) every 4 weeks for the first 4 doses;
   b. DME: 6 mg (1 vial/syringe) every 4 weeks for the first 6 doses;
   c. RVO: 6 mg (1 vial/syringe) every 4 weeks for 6 doses.

Approval duration:
nAMD – 4 months
DME, RVO – 6 months

Clinical Policy

Faricimab-svoa

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

II. Continued Therapy

A. Ophthalmic Disease (must meet all):

1. Currently meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);

   a. nAMD: one of the following (i, ii, or iii):
   i. 6 mg (1 vial/syringe) every 16 weeks;
   ii. 6 mg (1 vial/syringe) every 12 weeks if member has documented active disease (see Appendix D) at week 24;
   iii. 6 mg (1 vial/syringe) every 8 weeks if member has documented active disease (see Appendix D) at week 20;
   b. DME or RVO: 6 mg (1 vial/syringe) every 4 weeks.

Approval duration: 12 months

Clinical Policy

Faricimab-svoa

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

III.Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.

IV.Appendices/General Information

Appendix A: Abbreviation/Acronym Key

Appendix B: Therapeutic Alternatives

This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. <br>†Off-label

Clinical Policy

Faricimab-svoa

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): ocular or periocular infection, active intraocular inflammation, hypersensitivity
• Boxed warning(s): none reported

Appendix D: General Information

• For the indication of nAMD, clinical criteria for every 4-week dosing following the initial every 4-week dosing was not defined nor evaluated in the clinical studies.
• For the indication DME, although additional efficacy was not demonstrated in most patients when Vabysmo was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4-week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.

V. Dosage and Administration

*This dosing regimen has not been evaluated in clinical studies beyond the initial doses.

VI. Product Availability

• Single-dose vial: 6 mg/0.05 mL (120 mg/mL)

• Single-dose prefilled syringe: 6 mg/0.05 mL (120 mg/mL)

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Clinical Policy

Faricimab-svoa

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical

Clinical Policy

Faricimab-svoa

practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.