CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vabysmo (faricimab-svoa) coverage

Defines prior authorization, medical necessity, and coverage criteria for Vabysmo (faricimab-svoa) for nAMD, DME, and RVO for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVabysmo (faricimab-svoa) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2022

Next Review DateMay 12, 2022

Key ActionObtain prior authorization; initial approvals issued for 6 months with continuation approvals available per criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA‑recognized indications covered

>=18Minimum age

6 moInitial auth duration

up to 12 moContinuation duration

J2777Billing code listed

Coverage Criteria for Vabysmo (faricimab-svoa)

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Initial Therapy

Covered when ALL of the following are met

Initial eligibility: Member is >= 18 years of age AND prescribed by or in consultation with a retina specialist

Diagnosis: Member has a diagnosis of neovascular (wet) age-related macular degeneration (AMD) OR diabetic macular edema (DME) OR macular edema due to retinal vein occlusion (RVO)

Baseline assessments: Best corrected visual acuity (BCVA) measured at baseline and periodically during treatment

Prior therapy requirements by indication: For neovascular AMD or RVO: inadequate response, intolerance, or contraindication to bevacizumab AND Byooviz (ranibizumab) or Lucentis (ranibizumab); For DME with baseline VA 20/50 or worse: inadequate response/intolerance/contraindication to bevacizumab OR Lucentis (ranibizumab); For DME with baseline VA better than 20/50: inadequate response/intolerance/contraindication to bevacizumab

Step therapy exceptions: members already on Vabysmo or Medicare members who received Vabysmo within the past 365 days are not subject to step therapy requirements

Safety exclusions: Member is free of ocular and periocular infection AND does not have active intraocular inflammation

No concurrent VEGF inhibitors: Therapy will not be used concurrently with other ophthalmic VEGF inhibitors (e.g., aflibercept, bevacizumab, brolucizumab, ranibizumab) unless documented that products are to be used in different eyes

RVO duration limit: Members requesting therapy for RVO cannot exceed 6 months of treatment

Continuation of Therapy

Covered when ALL of the following are met

Ongoing criteria: Member continues to meet all initial criteria

Tolerability: Member is tolerating treatment with absence of unacceptable toxicity (examples: endophthalmitis, retinal detachment, increased intraocular pressure, arterial thromboembolic events)

Clinical benefit: Member has had a beneficial response to therapy (e.g., improvement in BCVA) and continued administration is necessary for maintenance

RVO continuation: Members requesting therapy for RVO are not eligible for renewal

Dosage and Administration / Quantity Limits

Initiation dosing: 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 ± 7 days, monthly) for the first four doses (initiation phase, ~16 weeks)6 mg per injection

1 billable unit = 0.1 mg

Maintenance regimens: After the initial four doses, maintenance dosing may be at intervals of every 8, 12, or 16 weeks based on OCT and visual acuity; some patients may require every 4‑week (monthly) dosingintervals: 8, 12, 16 weeks (or monthly if needed)

Additional efficacy was not demonstrated in most patients when dosed every 4 weeks versus every 8 weeks during maintenance

RVO dosing and limit: For RVO: 6 mg intravitreally per affected eye once every 4 weeks for up to 6 months (RVO requests cannot exceed 6 months)6 months maximum for RVO

Therapies are considered investigational when used at a dose or for a condition other than those recognized as medically accepted indications per standard reference compendia. Accepted compendia include AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed published medical literature demonstrating sufficient evidence. Neighborhood does not provide coverage for drugs when used for investigational purposes.

Use of Vabysmo (faricimab‑svoa) for conditions or at doses that are not recognized as medically accepted indications in the cited compendia is not covered. Requests for coverage outside the recognized indications or dosing regimens will be treated as investigational and denied.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — initial approvals for 6 months for AMD, DME, and RVO. Coverage of Vabysmo (faricimab-svoa) will be reviewed prospectively via the prior authorization process. Use outside the listed guidelines may result in non-payment unless approved under an exception process.

Initial coverage: 6 months (AMD, DME, RVO)
Continuation coverage: AMD & DME — 12 months; RVO — cannot be renewed

Step Therapy

Step Therapy / Prior Agents

Step therapy is required. Members must have an inadequate response, intolerance, or contraindication to specified prior agents before Vabysmo is approved unless exempt (see exemptions for current or recent treatment and Medicare members).

For neovascular AMD or RVO: inadequate response/intolerance/contraindication to bevacizumab AND Byooviz (ranibizumab) or Lucentis (ranibizumab).
For DME with baseline VA 20/50 or worse: inadequate response/intolerance/contraindication to bevacizumab OR Lucentis (ranibizumab).
For DME with baseline VA better than 20/50: inadequate response/intolerance/contraindication to bevacizumab.
Medicare members who have received Vabysmo within the past 365 days are not subject to step therapy.

Documentation Required

Documentation Requirements

Documentation requirements: baseline and periodic measurements of best corrected visual acuity (BCVA) and optical coherence tomography (OCT) should be recorded. Visual acuity must be measured at baseline and periodically during treatment to support medical necessity.

Document baseline BCVA and periodic BCVA during treatment
Perform and document OCT assessments during initiation and maintenance as clinically indicated
Record visual documentation of response (e.g., central subfield thickness)

Note

Prescriber Requirement

Prescriber requirement — the medication must be prescribed by a Retina Specialist or with documented consultation from a Retina Specialist. Requests not meeting this requirement may be denied or require documentation of specialist involvement.

Prescribed by or in consultation with a Retina Specialist

Denial Risk

Concurrent Therapy Restriction

Concurrent therapy restriction — Vabysmo must not be used concurrently with other ophthalmic VEGF inhibitors (e.g., aflibercept, bevacizumab, brolucizumab, ranibizumab) unless documentation specifies that products are to be used in different eyes. Use without such documentation may lead to denial.

Concurrent use with other ophthalmic VEGF inhibitors is not allowed without documentation that products will be used in different eyes

Denial Risk

Coverage Enforcement

Coverage enforcement — use outside the listed guidelines may result in non-payment; coverage reviewed prospectively via prior authorization.

Use outside guidelines may result in non-payment unless approved under an exception process
Coverage decisions are made via prior authorization review

Background and Clinical Context

Vabysmo (faricimab‑svoa) is an intravitreal vascular endothelial growth factor (VEGF) inhibitor approved for neovascular age‑related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Phase 3 trials demonstrated noninferiority to aflibercept for visual acuity endpoints and supported extended dosing intervals for some patients. For RVO, trials evaluating shorter durations showed noninferiority at earlier time points.

The labeled dosing includes an initiation regimen of 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 ± 7 days) and indication‑specific guidance for continuing or limiting therapy (for example, RVO dosing limited to 6 months).

Definitions

inv-16: Vabysmo (faricimab-svoa) — intravitreal VEGF inhibitor indicated for nAMD, DME, and macular edema following RVO

Generic namefaricimab-svoa (Vabysmo)

Drug classIntravitreal vascular endothelial growth factor (VEGF) inhibitor

FDA‑recognized indicationsNeovascular (wet) age-related macular degeneration (nAMD); diabetic macular edema (DME); macular edema following retinal vein occlusion (RVO)

inv-17: BCVA — Best corrected visual acuity measured at baseline and periodically to assess response

DefinitionBest corrected visual acuity (BCVA): visual acuity measured with optimal correction to assess baseline vision and response to therapy

Use in policyBCVA must be measured at baseline and periodically during treatment to guide dosing intervals and assess clinical benefit

Role in dosing decisionsBCVA evaluations are used alongside OCT to determine maintenance dosing intervals (8, 12, or 16 weeks, or monthly if needed)

OpenPayer

Vabysmo (faricimab-svoa) coverage

Coverage Criteria for Vabysmo (faricimab-svoa)

Coding and Billing Information

Provider Actions and Requirements

Background and Clinical Context

Definitions