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ph-90659

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Vabysmo™ (faricimab-svoa)

Policy Number: PH-90659

Intravitreal

Last Review Date: 12/07/2023

Date of Origin: 03/01/2022

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

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.

  1. Length of Authorization

Coverage will be provided annually and may be renewed.

  1. Dosing Limits

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

  • 6 mg single-dose vial: 1 vial per eye every 28 days

B. 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)

  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:        

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 must have either an intolerance, a contraindication or inadequate response to an adequate trial of at least ONE bevacizumab product prior to initiating therapy with a non-preferred ophthalmic anti-VEGF agent. Patients who have been receiving a non-preferred agent may continue therapy with that product: AND
  • Patient is at least 18 years of age; AND

Universal Criteria 1-12

  • Patient is free of ocular and/or peri-ocular infections; AND
  • Patient does not have active intraocular inflammation; AND
  • Therapy will not be used with other ophthalmic VEGF inhibitors (.e.g., aflibercept, brolucizumab-dbll, 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

  1. 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 the baseline best corrected visual acuity (BCVA), etc.) and continued administration is necessary for the maintenance treatment of the condition
  1. 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.

  1. 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) solution for injection, overfilled single-dose vial: 50242-0096-xx
  1. References
  1. Vabysmo [package insert]. South San Francisco, CA; Genentech, Inc.; October 2023. Accessed November 2023.
  2. 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.
  3. 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).
  4. 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.
  5. 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).
  6. Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – July 2015. Accessed at https://www.rcophth.ac.uk/standards-publications-research/clinical-guidelines.
  7. 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.
  8. 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.
  9. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks-2022. December 2022.
  10. 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
  11. 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.
  12. 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.
  13. National Government Services, Inc. Local Coverage Article: Billing and Coding: Ranibizumab and biosimilars, Aflibercept, Brolucizumab-dbll and Faricimab-svoa (A52451). Centers for Medicare & Medicaid Services, Inc. Updated on 03/24/2023 with effective date of 04/01/2023. Accessed November 2023.

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)

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52451

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52451&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

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, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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

 

 

 

 

VABYSMO™ (faricimab-svoa) Prior Auth Criteria
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