CurrentCareSourcePolicy N/A

Vabysmo Utilization Management Medical Policy

Defines prior authorization criteria, dosing requirements, approval durations, and prescriber requirements for medical-benefit coverage of Vabysmo for DME, macular edema following RVO, and neovascular (wet) AMD.

Policy Summary

PayerCareSource

PolicyVabysmo Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAdded indicationannual review

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approve only for requests meeting the specified indication, 6 mg per eye dosing, dosing interval not more frequent than every 4 weeks, prescriber supervision, and duration rules.

SourceLink

POLICY UPDATE CHANGES

Macular Edema Following Retinal Vein Occlusion condition and criteria for approval was added to the policy.

Annual revisions noted with review dates; 11/20/2024 review performed with no criteria changes noted in the most recent annual revision summary.

3Covered Indications

1RVO shorter approval (months)

Coverage Summary

Coverage stance: covered with criteria for Vabysmo (faricimab-svoa) intravitreal injection. Scope: prior authorization is required and coverage is recommended only when indication-specific criteria, dosing, prescriber supervision, and duration rules are met. Key policy requirements include prior authorization, that the medication be prescribed by or under the supervision of an ophthalmologist (or in consultation with a physician who specializes in the condition treated), and that requests for doses outside established dosing be reviewed case-by-case by a clinician.

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Authorization Criteria (Indication-specific)

FDA-Approved Indications (Authorization Criteria)

Coverage of Vabysmo is recommended in those who meet one of the following indication-specific criteria:

ANY of the following

Diabetic Macular Edema (DME)
- Indication: Diabetic Macular Edema
- Prescriber: Administered by or under the supervision of an ophthalmologist
- Dose: 6 mg administered by intravitreal injection for each eye treated6 mg per eye
  Requested dose must be 6 mg per eye
- Dosing interval: Not more frequent than once every 4 weeks for each eye treatedNot more frequent than once every 4 weeks
  Requested dosing interval must not be more frequent than every 4 weeks
- Approval duration: Approve for 1 year1 year
Macular Edema Following Retinal Vein Occlusion (RVO)
- Indication: Macular edema following retinal vein occlusion
- Prescriber: Administered by or under the supervision of an ophthalmologist
- Dose: 6 mg administered by intravitreal injection for each eye treated6 mg per eye
  Requested dose must be 6 mg per eye
- Dosing interval: Not more frequent than once every 4 weeks for each eye treatedNot more frequent than once every 4 weeks
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
- Indication: Neovascular (wet) age-related macular degeneration
- Prescriber: Administered by or under the supervision of an ophthalmologist
- Dose: 6 mg administered by intravitreal injection for each eye treated6 mg per eye
  Requested dose must be 6 mg per eye
- Dosing interval: Not more frequent than once every 4 weeks for each eye treatedNot more frequent than once every 4 weeks

General Approval and Exceptions

Additional authorization rules and exceptions

ALL of the following

Requests outside dosing limits: Requests for doses outside of the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist)
Extended approvals are allowed if the patient continues to meet the Criteria and Dosing
Prescriber specialty requirement: Vabysmo must be prescribed by or in consultation with a physician who specializes in the condition treated (e.g., ophthalmologist)
Because of specialized skills required

Not Recommended for Approval

Coverage exclusions

ALL of the following

Not recommended: Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria
Criteria will be updated as new published data are available

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Vabysmo; approval is recommended only for requests that meet the specified indication, dosing (6 mg per eye), dosing interval (not more frequent than once every 4 weeks), prescriber supervision, and the listed duration rules.

Diabetic Macular Edema (DME): Approve for 1 year; dose 6 mg per eye; interval not more frequent than every 4 weeks
Macular Edema Following Retinal Vein Occlusion (RVO): Approve for 6 months; dose 6 mg per eye; interval not more frequent than every 4 weeks
Neovascular (wet) Age-Related Macular Degeneration (nAMD): Approve for 1 year; dose 6 mg per eye; interval not more frequent than every 4 weeks

Documentation Required

Prescriber specialty requirement

Vabysmo must be prescribed by or in consultation with a physician who specializes in the condition treated (e.g., an ophthalmologist).

Billing Rule

Requests outside dosing limits

Requests for doses outside the established dosing in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Clinical Evidence & References

Prescribing information reference: Vabysmo intravitreal injection [prescribing information], Genentech; October 2023.

Dosing notes from the prescribing information (background/PI): the PI describes dosing regimens that include loading doses and variable maintenance intervals — for example, initial monthly dosing with extensions based on clinical evaluation allowing maintenance intervals up to 16 weeks for nAMD and variable regimens for DME.

Policy-specified authorization dosing and limits: for coverage the policy requires 6 mg per eye administered by intravitreal injection and a dosing interval not more frequent than once every 4 weeks. Requests outside the established dosing documented in the policy will be reviewed on a case-by-case basis by a clinician.

Background

Vabysmo (faricimab-svoa) is a dual VEGF and angiopoietin‑2 (Ang‑2) inhibitor indicated for DME, macular edema following retinal vein occlusion (RVO), and neovascular (wet) age‑related macular degeneration (nAMD).

The prescribing information describes dosing regimens that include loading doses (initial monthly injections) and maintenance intervals that may be extended based on clinical evaluation — for nAMD maintenance intervals can range from every 4 weeks to every 16 weeks. For DME the PI describes options including initial monthly dosing then interval modifications or every 8 weeks after initial dosing for some regimens.

The policy imposes specific authorization dosing and limits that constrain the PI regimens for coverage: the approved dose must be 6 mg intravitreal injection per eye and the dosing interval for authorization must be not more frequent than once every 4 weeks; approvals are granted for the durations noted by indication (DME and nAMD = 1 year, RVO = 6 months).

Definitions

Approval duration month1 month = 30 days

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