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Asset Publisher
Vabysmo™ (faricimab-svoa)
Policy Number: PH-0659
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
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- 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:
For PEEHIP Members Only |
Bevacizumab 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.
Lucentis or Eylea are the preferred products after bevacizumab products
|
For Commercial Members Only |
Bevacizumab 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 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:
Maintenance:
|
Diabetic macular edema (DME) |
|
Macular Edema following Retinal Vein Occlusion (RVO) |
|
*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 |