Vascular Endothelial Growth Factor (VEGF) Inhibitors for Ophthalmic Use
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Policy governs medical necessity and prior authorization requirements for intravitreal VEGF inhibitor drugs used to treat choroidal and retinal vascular disorders for Blue Cross Blue Shield - Iowa members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Coverage for preferred products
Preferred products are considered medically necessary for the following diagnoses without prior authorization when benefit exists:
Applies to Lucentis, Byooviz, Eylea, Eylea HD, Vabysmo; bevacizumab also considered medically necessary without prior authorization.
Initial approval criteria for non-preferred products
Non-preferred products may be approved when applicable Preferred Drug Plan Design criteria are met (at least ONE required):
Required for initial approval of non-preferred products (Beovu, Cimerli, Pavblu, Susvimo) and per Preferred Drug Plan Design the member must meet plan design and criteria for initial approval.
Required for continuation or transition to ongoing therapy with non-preferred agents.
Susvimo (implant) criteria
Susvimo (ranibizumab ocular implant) specific criteria for medical necessity:
Applies to Susvimo only; member must meet Preferred Drug Plan Design where applicable.
Targeted product indications
Targeted products may be considered medically necessary for specific indications when criteria are met:
Cimerli is a biosimilar to Lucentis.
Beovu is listed as targeted/non-preferred.
Pavblu is a targeted/non-preferred aflibercept product; use with Susvimo ocular implant as required by Preferred Drug Plan Design where specified.
Initial Therapy Indications (Pavblu series)
A series of intravitreal injections with Pavblu (aflibercept-ayyh) may be considered medically necessary for the following:
Use must follow Preferred Drug Plan Design; when specified, Pavblu series must be used in conjunction with the Susvimo ocular implant.
Continuation Therapy
Continuation of therapy
Positive clinical response examples include improvement or maintenance in best corrected visual acuity (BCVA) or visual field, or reduction in rate of vision decline; authorization of 12 months may be granted.
This policy governs medical necessity and prior authorization requirements for intravitreal vascular endothelial growth factor (VEGF) inhibitor drugs used to treat choroidal and retinal vascular disorders for Blue Cross Blue Shield - Iowa members. Benefit determinations are based on the applicable contract language in effect when services were rendered; exclusions, limitations, or exceptions may apply and individual member benefits must be verified. The policy notes that it may not apply to FEP (Federal Employee Program); benefits for FEP members are determined by the Federal Employee Program and are subject to that program's contract language and rules.
Some HCPCS/alpha-numeric codes listed in the policy are no longer current for billing. Examples called out in the procedures and billing codes section include C9161 (Injection, aflibercept hd, 1 mg — cancelled 3-31-2024) and C9097 (Injection, faricimab-svoa, 0.1 mg — deleted 10-1-2022). Providers should use the active J- and Q-codes listed in the coding table for claim submission where applicable.
When benefit exists, the policy distinguishes preferred and non-preferred (targeted) VEGF agents and specifies coverage and prior authorization workflows accordingly. Preferred products (for example, bevacizumab, Lucentis, Byooviz, Eylea, Eylea HD, Vabysmo) are considered medically necessary for listed retinal and choroidal vascular diagnoses without prior authorization. Non-preferred products (Beovu, Cimerli, Pavblu, Susvimo) require prior authorization under the Preferred Drug Plan Design; initial approval generally requires documentation of inadequate response or intolerable adverse event to a preferred product or evidence the member is already receiving and benefiting from the non-preferred agent. Initial authorizations are approved for 6 months, and continuation may be authorized for up to 12 months when documentation demonstrates a positive clinical response (for example, improvement or maintenance in best corrected visual acuity or visual field or reduced rate of vision decline). Providers must supply chart notes and supporting documentation as specified in the policy. Refer to the full procedures and billing codes section for current HCPCS/J/Q code guidance.
Prior Authorization, Documentation, and Billing Actions
Prior authorization required for non-preferred products
Non-preferred VEGF products (Beovu, Cimerli, Pavblu, Susvimo) require prior authorization; preferred agents — bevacizumab, Lucentis, Byooviz, Eylea, Eylea HD, and Vabysmo — do not require prior authorization when benefit exists.
- Affected products requiring prior authorization: Beovu, Cimerli, Pavblu, Susvimo
- Preferred products not requiring prior authorization: Bevacizumab; Lucentis; Byooviz; Eylea; Eylea HD; Vabysmo
Prior authorization duration
Initial prior authorization approvals are granted for 6 months. If the member demonstrates a positive clinical response, continuation authorization of up to 12 months may be granted.
- Initial approval duration: 6 months
- Continuation authorization (if documented positive response): up to 12 months
Preferred Drug Plan Design requirements
Members must meet both the Preferred Drug Plan Design and the applicable Criteria for Initial Approval or Continuation of Therapy; initial approval for non-preferred products requires at least one qualifying criterion under the Preferred Drug Plan Design.
- Member must meet BOTH the Preferred Drug Plan Design and the Criteria for Initial Approval/Continuation of Therapy
- Initial approval for non-preferred products applies only when at least ONE Preferred Drug Plan criterion is met (e.g., documented inadequate response or intolerable adverse event to a preferred product, or currently receiving a non-preferred product with positive therapeutic outcome)
Pavblu must be used with Susvimo under Preferred Drug Plan
When the Preferred Drug Plan Design is applicable, a Pavblu (aflibercept-ayyh) series must be used in conjunction with the Susvimo ocular implant per the plan constraint.
- Pavblu series use must be in conjunction with the Susvimo ocular implant
Required documentation to request prior authorization for non-preferred products
To initiate prior authorization for non-preferred products (Beovu, Cimerli, Pavblu, Susvimo), submit chart notes documenting inadequate response to or intolerable adverse events from preferred products (Byooviz, Lucentis, Eylea, Eylea HD, Vabysmo) for the same FDA‑approved or compendial indication.
- Required: chart notes documenting inadequate response or intolerable adverse event to a preferred product for the relevant indication
Documentation of positive clinical response required for continuation
Continuation (renewal) authorization for non-preferred therapy requires documentation showing the member has demonstrated a positive clinical response to therapy (examples: improvement or maintenance in BCVA or visual field, or reduced rate of vision decline).
- Documentation must show positive clinical response (e.g., BCVA or visual field improvement/maintenance or reduced rate of vision decline)
- Positive-response documentation is required to support a 12‑month continuation authorization
Susvimo concomitant use requirement for Pavblu
When Pavblu is used with Susvimo, the treatment must be used in conjunction with the Susvimo ocular implant as specified in the Preferred Drug Plan Design.
- Pavblu use condition: must be used in conjunction with Susvimo ocular implant
Documentation-based denials for non-preferred products
Failure to submit the required chart notes documenting inadequate response or intolerable adverse event to preferred products when requesting prior authorization for non-preferred products may result in denial of the request.
- Omissions of required chart notes may trigger denial for Beovu, Cimerli, Pavblu, Susvimo prior authorization requests
Continuation authorization requires documented positive response
Continuation (renewal) authorizations will be denied or not extended to 12 months if the provider does not document a positive clinical response (e.g., improvement/maintenance in BCVA or visual field, or reduction in rate of vision decline).
- Continuation authorization of 12 months requires documented positive clinical response; lack of such documentation risks denial or shorter approval
Billing Codes and Status
| C9161 | Injection, aflibercept hd, 1 mg (cancelled 3-31-2024) |
| C9097 | Injection, faricimab-svoa, 0.1 mg (deleted 10-1-2022) |
| C9399 | Unclassified drugs or biologicals |
| J0177 | Injection, aflibercept hd, 1 mg (effective 4-1-2024) |
| J0178 | Injection, aflibercept, 1 mg |
| J0179 | Injection, brolucizumab, 1 mg |
| J2777 | Injection, faricimab-svoa, 0.1 mg (effective 10-1-2022) |
| J2778 | Injection, ranibizumab, 0.1 mg |
| J2779 | Injection, ranibizumab, via sustained release intravitreal implant (susvimo), 0.1 mg (effective 7/1/2022) |
| J3490 | Unclassified drugs |
Key Terms and Product Designations
Clinical Background
VEGF inhibitors are used to treat neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and other choroidal neovascular conditions. The policy lists FDA-approved indications by agent and separates agents into preferred and targeted/non-preferred categories to guide coverage and prior authorization. Bevacizumab, while not FDA-approved for ophthalmic use, is supported by peer-reviewed literature and is considered a medically necessary, lower-cost option in the preferred group. Targeted/non-preferred agents (including Beovu, Cimerli, Susvimo, and Pavblu) have specific initiation and continuation criteria; for example, Susvimo requires prior responsive intravitreal therapy (at least 2 prior responding injections within the past 6 months) and use in conjunction with the Susvimo ocular implant, and Pavblu series use is subject to the Preferred Drug Plan Design constraints described in the policy.
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