Asset Publisher

ph-90659

Vabysmo™ (faricimab-svoa)

Policy Number: PH-90659

(Intravitreal)

Last Review Date: 09/05/2024

Date of Origin: 03/01/2022

Dates Reviewed: 03/2022, 07/2022, 10/2022, 10/2023, 12/2023, 09/2024

Length of Authorization

Coverage will be provided annually and may be renewed.

Dosing Limits

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

6 mg single-dose vial: 1 vial per eye every 28 days
6 mg single-dose pre-filled syringe: 1 syringe per eye every 28 days

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

Diagnosis	MU for Initial Dosing	MU for Maintenance Dosing
Neovascular age-related macular degeneration (AMD)	120 billable units every 28 days x 4 doses	120 billable units every 28 days
Diabetic Macular Edema (DME)	120 billable units every 28 days x 6 doses	120 billable units every 28 days
Macular Edema following Retinal Vein Occlusion (RVO)	N/A	120 billable units every 28 days

(Max units are based on administration to both eyes)

Initial Approval Criteria ¹

Coverage is provided in the following conditions:

Bevacizumab (Avastin, Mvasi or Zirabev) is the preferred product for the following conditions: Neovascular (Wet) Age Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema, and Diabetic Retinopathy. Patient must have either an intolerance, a contraindication or inadequate response to an adequate trial of at least one (1) bevacizumab product prior to initiating therapy with a non-preferred agent (Beovu, Eylea, Lucentis, Macugen, Byooviz). Patients who have been receiving a non-preferred agent may continue therapy with that product.

Patient is at least 18 years of age; AND

Universal Criteria ^1-12

Patient is free of ocular and/or periocular infections; AND
Patient does not have active intraocular inflammation; AND
Therapy will not be used with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors (e.g., aflibercept, brolucizumab, ranibizumab, bevacizumab, etc.); AND
Patient’s best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment; AND
Patient has a definitive diagnosis of one of the following:

Neovascular (Wet) Age-Related Macular Degeneration (nAMD) †*

Diabetic Macular Edema (DME) †*

Macular Edema following Retinal Vein Occlusion (RVO) †

*Patients with an insufficient response during initial therapy administered every 4 weeks for at least 4 doses may continue with dosing every 4 weeks. Patients with loss of response to maintenance therapy administered at less frequent intervals may increase the dosing frequency in a step-wise manner until response is regained. (Refer to Section V).

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

Renewal Criteria ^1-12

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 and retinal detachments, increase in intraocular pressure, arterial thromboembolic events (ATE), retinal vasculitis and/or retinal vascular occlusion, etc.; AND
Patient has had a beneficial response to therapy (e.g., improvement in best corrected visual acuity (BCVA) from baseline, etc.) and continued administration is necessary for the maintenance treatment of the condition

Dosage/Administration ¹

Indication	Dose
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)	Initiation: Administer 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days, monthly) for the first four doses (16 weeks or 4 months) Maintenance: Follow the initial four doses with optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to ascertain whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: Weeks 28, 44, and every 16 weeks thereafter; or Weeks 24, 36, 48 and every 12 weeks thereafter; or Weeks 20, 28, 36, 44 and every 8 weeks thereafter*
Diabetic macular edema (DME)	Administer 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days, monthly) for at least four doses. If after at least 4 doses, resolution of edema based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography is achieved, then the interval of dosing may be modified by extensions of up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations; OR Administer 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days, monthly) for the first six doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks
Macular Edema following Retinal Vein Occlusion (RVO)	Administer 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days, monthly)
*Note: 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 four doses. Patients should be assessed regularly. Patients with loss of response to maintenance therapy administered at less frequent intervals may increase the dosing frequency in a step-wise manner until response is regained.

Billing Code/Availability Information

HCPCS Code:

J2777 – Injection, faricimab-svoa, 0.1 mg; 1 billable unit = 0.1 mg

NDC:

Vabysmo 6 mg/0.05 mL (concentration 120 mg/mL) single-dose vial: 50242-0096-xx
Vabysmo 6 mg/0.05 mL (concentration 120 mg/mL) single-dose prefilled syringe: 50242-0096-xx

References

Vabysmo [package insert]. South San Francisco, CA; Genentech, Inc.; July 2024. Accessed July 2024.
Solomon SD, Chew E, Duh EJ, et al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418.
American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Update 2019. Oct 2019. (Interim update March 2022).
American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Update 2019. Oct 2019.
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).
Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – July 2015. Accessed at https://www.rcophth.ac.uk/wp-content/uploads/2021/08/Retinal-Vein-Occlusion-RVO-Guidelines-July-2015.pdf.
Heier JS, Khanani AM, Quezada et al; TENAYA and LUCERNE Investigators. 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 Jan 21. Pii: S0140-6736(22)00010-1. Doi: 10.1016/S0140-6736(22)00010-1.
Wykoff CC, Abreu F, Adamis AP, 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 Jan 21. Pii: S0140-6736(22)00018-6. Doi: 10.1016/S0140-6736(22)00018-6.
American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks - 2023. December 2023.
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
Hattenbach LO, Abreu F, Arrisi P, et al. BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. Ophthalmol Sci. 2023 Mar 27;3(3):100302. doi: 10.1016/j.xops.2023.100302.
Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – 17 February 2022. Accessed at https://www.rcophth.ac.uk/wp-content/uploads/2015/07/Retinal-Vein-Occlusion-Guidelines-2022.pdf.
National Government Services, Inc. Local Coverage Article: Billing and Coding: Ranibizumab and biosimilars, Aflibercept, Aflibercept HD, Brolucizumab-dbll and Faricimab-svoa (A52451). Centers for Medicare & Medicaid Services, Inc. Updated on 03/20/2024 with effective date of 04/01/2024. Accessed July 2024.

Appendix 1 – Covered Diagnosis Codes

ICD-10	ICD-10 Description
E08.311	Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
E08.3211	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye
E08.3212	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, left eye
E08.3213	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E08.3219	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
E08.3311	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E08.3312	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E08.3313	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E08.3319	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E08.3411	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye
E08.3412	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye
E08.3413	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E08.3419	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
E08.3511	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye
E08.3512	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye
E08.3513	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral
E08.3519	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye
E09.311	Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema
E09.3211	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
E09.3212	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
E09.3213	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E09.3219	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
E09.3311	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E09.3312	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E09.3313	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E09.3319	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E09.3411	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
E09.3412	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
E09.3413	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E09.3419	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
E09.3511	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
E09.3512	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
E09.3513	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
E09.3519	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
E10.311	Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E10.3211	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
E10.3212	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
E10.3213	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E10.3219	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
E10.3311	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E10.3312	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E10.3313	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E10.3319	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E10.3411	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
E10.3412	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
E10.3413	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E10.3419	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
E10.3511	Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
E10.3512	Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
E10.3513	Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
E10.3519	Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
E11.311	Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E11.3211	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
E11.3212	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
E11.3213	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3219	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
E11.3311	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E11.3312	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E11.3313	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3319	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E11.3411	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
E11.3412	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
E11.3413	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3419	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
E11.3511	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
E11.3512	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
E11.3513	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
E11.3519	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
E13.311	Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema
E13.3211	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
E13.3212	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
E13.3213	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E13.3219	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
E13.3311	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E13.3312	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E13.3313	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E13.3319	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E13.3411	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
E13.3412	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
E13.3413	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E13.3419	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
E13.3511	Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
E13.3512	Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
E13.3513	Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
E13.3519	Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
H34.8110	Central retinal vein occlusion, right eye, with macular edema
H34.8120	Central retinal vein occlusion, left eye, with macular edema
H34.8130	Central retinal vein occlusion, bilateral, with macular edema
H34.8190	Central retinal vein occlusion, unspecified eye, with macular edema
H34.8310	Tributary (branch) retinal vein occlusion, right eye, with macular edema
H34.8320	Tributary (branch) retinal vein occlusion, left eye, with macular edema
H34.8330	Tributary (branch) retinal vein occlusion, bilateral, with macular edema
H34.8390	Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema
H35.3210	Exudative age-related macular degeneration, right eye, stage unspecified
H35.3211	Exudative age-related macular degeneration, right eye, with active choroidal neovascularization
H35.3212	Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization
H35.3213	Exudative age-related macular degeneration, right eye, with inactive scar
H35.3220	Exudative age-related macular degeneration, left eye, stage unspecified
H35.3221	Exudative age-related macular degeneration, left eye, with active choroidal neovascularization
H35.3222	Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization
H35.3223	Exudative age-related macular degeneration, left eye, with inactive scar
H35.3230	Exudative age-related macular degeneration, bilateral, stage unspecified
H35.3231	Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization
H35.3232	Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization
H35.3233	Exudative age-related macular degeneration, bilateral, with inactive scar
H35.3290	Exudative age-related macular degeneration, unspecified eye, stage unspecified
H35.3291	Exudative age-related macular degeneration, unspecified eye, with active choroidal neovascularization
H35.3292	Exudative age-related macular degeneration, unspecified eye, with inactive choroidal neovascularization
H35.3293	Exudative age-related macular degeneration, unspecified eye, with inactive scar

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
Jurisdiction	NCD/LCA/LCD Document (s)	Contractor
6, K	A52451	National Government Services, Inc.

Medicare Part B Administrative Contractor (MAC) Jurisdictions
Jurisdiction	Applicable State/US Territory	Contractor
E (1)	CA, HI, NV, AS, GU, CNMI	Noridian Healthcare Solutions, LLC
F (2 & 3)	AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ	Noridian Healthcare Solutions, LLC
5	KS, NE, IA, MO	Wisconsin Physicians Service Insurance Corp (WPS)
6	MN, WI, IL	National Government Services, Inc. (NGS)
H (4 & 7)	LA, AR, MS, TX, OK, CO, NM	Novitas Solutions, Inc.
8	MI, IN	Wisconsin Physicians Service Insurance Corp (WPS)
N (9)	FL, PR, VI	First Coast Service Options, Inc.
J (10)	TN, GA, AL	Palmetto GBA
M (11)	NC, SC, WV, VA (excluding below)	Palmetto GBA
L (12)	DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)	Novitas Solutions, Inc.
K (13 & 14)	NY, CT, MA, RI, VT, ME, NH	National Government Services, Inc. (NGS)
15	KY, OH	CGS Administrators, LLC

Medical Necessity Criteria

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