Precertification required

Precertification is required for listed intravitreal VEGF inhibitors for all Aetna participating providers and members in applicable plan designs; call (866) 752-7021 or fax (888) 267-3277 and submit Statement of Medical Necessity (SMN) forms via Specialty Pharmacy Precertification.

• Precertification applies to listed products including aflibercept (Eylea, biosimilars), brolucizumab (Beovu), faricimab (Vabysmo), ranibizumab (Lucentis, Susvimo, biosimilars).

Susvimo prior-response requirement

For Susvimo (ranibizumab intravitreal injection/implant), the member must have previously responded to at least two intravitreal injections of a VEGF inhibitor (e.g., Avastin, Eylea) within the past 6 months before Susvimo is considered medically necessary.

Dosing limits and Susvimo implant

Approvals may be subject to dosing limits consistent with FDA labeling, accepted compendia, and Aetna specialty medication quantity limits; the Susvimo implant is considered medically necessary only when criteria for intravitreal ranibizumab injection are met.

• Dosing limits referenced to Medical Specialty Medication Quantity Limits.
• Susvimo implant use tied to meeting intravitreal ranibizumab (Susvimo) criteria.

Use manufacturer dosing schedules for authorization

When requesting authorization, reference the manufacturer's FDA-approved dosing schedules for the specific product (for example, aflibercept 2 mg schedules, brolucizumab 6 mg schedules) as the rationale for the requested regimen.

• Aflibercept: typical 2 mg loading then q8w maintenance (product-specific variations in chunks 55–66).
• Brolucizumab: 6 mg loading then q8–12w maintenance (chunks 71–72).

Coverage tied to listed CPT/HCPCS/ICD-10 codes

Coverage and billing should be linked to the CPT/HCPCS/ICD-10 codes listed in the policy; these procedure and drug codes are covered when the policy selection criteria are met (examples include CPT 67028 and listed J/Q HCPCS codes and the covered ICD-10 diagnosis ranges).

• Example procedure code: 67028 (intravitreal injection).
• Example HCPCS/J/Q codes listed for agents (see policy code tables).
• Covered ICD-10 ranges tied to indications (e.g., H35.3210–H35.3293 for exudative AMD; E08–E13 series for diabetic retinopathy/DME).

PA required when billing listed injectable codes

Prior authorization is required when billing the listed HCPCS/J/Q codes for intravitreal VEGF inhibitors and biosimilars; coverage is contingent on meeting selection criteria and appropriate ICD-10 diagnosis linkage.

• Examples of injectable codes requiring PA include J0177, J0178, J2777 and multiple Q-codes and J-codes listed in the code tables.
• Ensure submitted diagnosis codes correspond to the covered ICD-10 ranges in the policy.

Document indication and dosing for PA

Prior authorization requests must document the specific ocular indication and the dosing regimen intended (e.g., 2 mg q4w or q8w for aflibercept, or HD dosing per PULSAR) to support approval.

• Indicate indication (DME, nAMD, RVO, etc.) and specific dosing schedule per product label.
• Include whether loading then maintenance schedule is planned (product-specific).

PA background (no new PA codes specified)

(Background note) This background section provides clinical context and does not itself specify additional prior authorization codes or requirements beyond the policy's PA statements and code tables.

Document prior therapy and OCT/VA when switching for RVO‑CME

When switching therapy for persistent CME after prior ranibizumab/bevacizumab, prior authorization should document prior anti‑VEGF treatment history and objective measures such as central foveal thickness (CFT ≥300 μm) and visual acuity at time of switch.

• Document duration and number/dates of prior injections and baseline CFT (≥300 μm used in the reported switch study).
• Provide rationale for switch to aflibercept with supporting OCT/VA data.

Support PA with diagnosis, BCVA, OCT, prior injections

Prior authorization requests should be supported by documented diagnosis, baseline and follow‑up best-corrected visual acuity (BCVA) and OCT measurements, and the number and dates of prior intravitreal injections to demonstrate medical necessity.

• Include BCVA/ETDRS scores and OCT-measured retinal thickness (CFT/CST) at baseline and follow-up.
• List prior treatment history (agent, dose, dates, number of injections).

CATT evidence may support bevacizumab PA decisions

Clinical evidence from randomized trials (for example, CATT) supports bevacizumab use for neovascular AMD with visual outcomes comparable to ranibizumab; prior authorization should consider such trial-based indications and weigh safety signals noted in trials.

• CATT showed equivalence in VA at 1 year between bevacizumab and ranibizumab; monitor for higher serious systemic adverse events with bevacizumab reported in CATT.

PA background (clinical evidence only)

(Background only) This section provides clinical background and evidence summaries and does not specify additional prior authorization requirements in this excerpt.

Specify drug and regimen in PA request

Include the specific drug and regimen in the prior authorization request (for example, brolucizumab 6 mg with planned q8/q12‑week maintenance after loading; faricimab 6 mg up to q16w or PTI schedules) and provide clinical justification.

• State intended maintenance interval (e.g., q12w, q16w) and disease-activity assessment schedule used to justify extended intervals.
• If requesting HD or non-standard dosing reference the supporting trial (e.g., PULSAR).

PA for labeled indications: document diagnosis, prior therapy, findings

For FDA‑approved labeled indications, prior authorization typically requires documentation of diagnosis, prior treatments as applicable, and clinical findings demonstrating ongoing need aligned with labeled use.

• Confirm the request is for an FDA‑approved ocular indication (nAMD, DME, RVO‑associated macular edema, DR, ROP for specified agents).
• Provide dosing regimen consistent with product labeling and trial‑based schedules.

Brand selection / step therapy may apply

Aetna commercial plans may require trial of a lower‑cost preferred medication within the same therapeutic class before approving a higher‑cost drug; refer to the Aetna Commercial Clinical Program Summary for preferred drug lists.

• Check plan-level preferred drug requirements prior to requesting higher-cost agents.
• Document trial of preferred agent and response when applicable.

Susvimo prior‑response summary for PA

Summary: Susvimo implant is only covered after demonstration of prior response to at least two intravitreal injections of a VEGF inhibitor within the past 6 months; document prior response and that implant will be used as required.

• Ensure Susvimo PA includes dates and agents of the two prior responsive intravitreal injections.
• Confirm implant will be used in conjunction with intravitreal ranibizumab injection per labeling.

Include loading to maintenance dosing in authorization plan

When authorizing initial courses, note loading followed by maintenance intervals per product labeling (for example, monthly loading doses then transition to q8w or individualized intervals) and document planned schedule in the request.

• Aflibercept typical loading: monthly x3 (or x5 for DME) then every 8 weeks maintenance per product.
• Beovu and Vabysmo have specified loading/maintenance schedules—include these in PA rationale.

Concurrent VEGF inhibitors in same eye not accepted

Concurrent use of more than one VEGF inhibitor in the same eye is considered experimental, investigational, or unproven and is not an accepted therapy sequence; do not request simultaneous agents for the same eye.

• If considering multiple agents, document rationale and acknowledge policy states combinational use in same eye is experimental/unproven.

Use comparative trial context in PA rationale

Clinical trials comparing aflibercept with ranibizumab or laser (and other comparative studies) may be used to justify choices in PA requests and support sequencing decisions when prior therapies were tried.

• Reference relevant trial data (e.g., VIEW, VISTA/VIVID) when justifying use of aflibercept over alternatives.

Document prior therapy trials when requesting switches

Consider documenting prior trials of alternative anti‑VEGF agents or PDT when requesting a switch to another agent for refractory disease; prior therapeutic trials reported in literature may inform approval decisions.

• For refractory PCV or CNV, include prior therapy history and imaging (ICGA/OCT) demonstrating lesion characteristics and prior response.

Provide prior treatment history to justify therapeutic sequencing

Therapeutic sequencing (e.g., switching from ranibizumab to aflibercept after failure or combining with PDT) is described in the literature; when used to justify a non-standard sequence, provide prior treatment history and objective measures.

Step therapy may consider laser alternatives

When step‑therapy considerations involve laser photocoagulation as an alternative, document why anti‑VEGF is preferred and reference comparative trials versus macular laser where applicable.

• If electing anti‑VEGF instead of laser, include OCT/VA evidence and rationale referencing trial results showing benefit over delayed or no anti‑VEGF.

CATT comparative data may inform step therapy

Comparative effectiveness data such as CATT showing similar efficacy between bevacizumab and ranibizumab may be cited in step‑therapy decisions between agents.

Step therapy: no explicit sequencing mandated in excerpt

(Informational) CATT and other comparative trials are discussed in the background but no explicit step therapy sequencing is mandated in the policy excerpt.

How to precertify (phone/fax and SMN forms)

Precertification can be obtained by phone at 866-752-7021 or by fax at 888-267-3277; Statement of Medical Necessity (SMN) precertification forms are available through Specialty Pharmacy Precertification.

Document positive clinical response (BCVA/OCT) for continuation

Document clinical evidence of positive response for continuation or reauthorization requests, including BCVA (ETDRS or Snellen) and OCT measures showing decreased retinal thickness or stable/improved vision.

• Include comparative BCVA measures (baseline and follow-up) and OCT central subfield thickness or CFT trends to support continuation.
• State whether response represents improvement or maintenance of vision per policy continuation criteria.

Document Susvimo implant use and dosing per label

For Susvimo implant requests, document that use is accompanied by ranibizumab intravitreal injection and that dosing aligns with FDA labeling and referenced prescribing information; note refill intervals and any supplemental injections planned.

• State Susvimo refill plan (refill-exchange every 24 weeks for nAMD/DME or every 36 weeks for DR) and any anticipated supplemental 0.5 mg intravitreal injections.
• Confirm strict aseptic conditions for implantation and refill procedures.

Cite manufacturer/trial sources for nonstandard dosing

When using nonstandard regimens or supporting alternative dosing, cite manufacturer prescribing information or the referenced pivotal trials as justification in the prior authorization submission.

• Provide manufacturer source and year (e.g., Celltrion USA 2025 for Eydenzelt; Novartis 2023 for Beovu) when requesting deviations from standard schedules.

Susvimo procedures require strict aseptic technique

Initial implantation, refill‑exchange, and implant removal procedures for Susvimo require strict aseptic technique; document that procedures will be performed under such conditions.

Link ICD-10 diagnosis codes to documented clinical findings

Required diagnostic documentation must link the billed ICD-10 diagnosis to the documented clinical findings (for example, diabetes with retinopathy codes for DME or H34.8110–H34.8192 for CRVO with macular edema).

• Ensure submitted ICD-10 codes correspond to the covered ranges in the policy and include supporting clinical evidence (OCT/VA).

Include supporting trial identifiers and regimens in PA

When requesting authorization, list the pivotal trials and their dosing regimens that support the indication (examples: BUTTERFLEYE, FIREFLEYE, PULSAR for aflibercept; TENAYA/LUCERNE for faricimab) as applicable to the clinical rationale.

• Reference trial endpoints (BCVA changes at specified timepoints) and how the requested regimen aligns with trial protocols.

Provide prior treatment history and objective measures for switches

For switches or continuation, include prior treatment history and objective outcome measures (BCVA and OCT) as recommended clinical documentation to justify ongoing or altered therapy.

• For RVO‑CME switch cases include prior anti‑VEGF duration/number of injections and baseline CFT (≥300 μm where study criteria applied).
• For PCV or POHS CNV include ICGA/OCT lesion characterization and prior response to therapy.

Required clinical outcome documentation for PA

Document required clinical outcomes to support authorization such as BCVA/ETDRS scores, OCT-measured retinal thickness (CFT/CST), and treatment history (number and dates of prior intravitreal injections).

• Provide baseline and follow-up BCVA and OCT/CFT measurements; list prior injection dates and agents.

Document FDA indication, regimen, and disease‑activity evidence

Required clinical documentation for authorization should include the FDA‑approved indication, the dosing regimen used (including loading and maintenance intervals), and evidence of disease activity guiding the chosen interval.

• Specify whether extended intervals (e.g., faricimab up to q16w) are based on protocol-defined disease‑activity assessments and provide those assessment results.

Use trial efficacy endpoints to support authorization

Use trial efficacy endpoints (e.g., change in BCVA at 6 or 24 months) and diagnosis‑specific trial results when providing efficacy documentation to support authorization for long‑term or high‑cost regimens.

Failure to precertify may risk noncoverage

Failure to obtain precertification for listed VEGF inhibitors may result in noncoverage or denial of payment.

Off‑label indications may be denied

Use of agents for indications other than those listed (for example, faricimab beyond DME, nAMD, and RVO) is considered not medically necessary and may be denied if requested for unlisted indications.

Non‑listed Susvimo/ranibizumab uses considered NMN

Use of ranibizumab products or the Susvimo implant for indications not listed in the policy is considered not medically necessary/experimental and may be denied.

Dosing limits and frequency deviations may affect approval

Approvals may be subject to dosing limits in accordance with FDA labeling, accepted compendia, and evidence‑based practice guidelines; requests for more frequent dosing than recommended may not be supported.

• Deviations to more frequent dosing should include efficacy justification and supporting trial or manufacturer evidence.

More‑frequent‑than‑label dosing may not be supported

Dosing more frequently than recommended (for example, more frequent than manufacturer‑specified intervals) may not be supported by efficacy data and could risk non‑approval.

Ocular infection/endophthalmitis is denial trigger

VEGF inhibitors are contraindicated and would be denied for persons with endophthalmitis or ocular/periocular infection; document absence of these contraindications.

• Contraindications per label also include active intraocular inflammation and hypersensitivity—these would likely lead to denial.

Diagnosis‑code linkage required for coverage

Use of specific ICD‑10 codes is required for coverage of certain drugs; absence of a covered diagnosis code (for example, diabetes with retinopathy codes for DME or H34.8110–H34.8192 for CRVO) may trigger denial.

• Ensure billed ICD‑10 codes match the covered ranges listed in the policy code tables to avoid denial.

Label contraindications may lead to denial

Contraindications per product labels include ocular or periocular infection, active intraocular inflammation, and hypersensitivity; use in these conditions would likely be denied.

Procedural/coverage denial triggers not specified here

(Placeholder) Specific procedural or other coverage denial triggers are not detailed in the excerpted background and trial sections.

Limited CSC evidence may affect authorization

Because evidence for many interventions in central serous chorioretinopathy (CSC) is low quality and inconsistent, lack of strong RCT evidence may lead to denial or requests for additional justification for aflibercept use in CSC.

Safety evidence gaps may affect authorization

Potential systemic safety evidence gaps (for example, arterial thromboembolic events) in diabetic patients and other safety concerns may affect authorization decisions if safety data are inadequate for a given patient.

• Document comorbidities and risk factors when requesting therapy for high‑risk patients.

Require documentation of active CNV for rare indications

Use for rare causes of choroidal neovascularization should be limited to patients with visual loss due to active CNV documented by fluorescein angiography or OCT; absence of such documentation may risk denial.

• Provide FA or OCT evidence of active CNV when requesting bevacizumab for rare CNV indications.

Background — no explicit PA triggers here

(Placeholder) No specific PA/denial triggers are stated in these background excerpts for this block.

ROP safety/ documentation may affect authorization

Use of anti‑VEGF agents in premature infants requires judicious consideration because systemic VEGF suppression and long‑term effects are uncertain; insufficient documentation of indication/severity for type I ROP could risk denial.

• When treating ROP, document severity (Type I, zone, plus disease), rationale for anti‑VEGF vs laser, and plans for extended follow‑up.

Serious adverse events/contraindications affect authorization

Contraindications, serious adverse events (ocular/periocular infection, hypersensitivity, endophthalmitis) and documented safety concerns are important safety‑related authorization risks and may lead to denial.