MHN verteporfin (Visudyne) Coverage

Coverage Criteria

Initial Therapy (Choroidal Neovascularization)

Covered when ALL of the following are met for Initial Approval — Choroidal Neovascularization:

Initial CNV approval: 1. Diagnosis of subfoveal choroidal neovascularization (CNV) due to one of the following: (a) age-related macular degeneration (AMD), (b) pathologic myopia, or (c) presumed ocular histoplasmosis; 2. Prescribed by or in consultation with an ophthalmologist; 3. Age ≥ 18 years; 4. For AMD, either (a) failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced (prior authorization for bevacizumab may be required), or (b) disease progression after use of a vascular endothelial growth factor (VEGF) agent as first-line treatment; 5. For CNV due to pathologic myopia, failure of bevacizumab intravitreal solution or ranibizumab unless clinically significant adverse effects are experienced or both are contraindicated; 6. Dose does not exceed 6 mg/m2 body surface area; note: requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved for systemic IV use as a substitute.

Initial Therapy (Central Serous Chorioretinopathy)

Covered when ALL of the following are met for Initial Approval — Central Serous Chorioretinopathy (off‑label):

Initial CSC approval: 1. Diagnosis of central serous chorioretinopathy confirmed by retinal scan; 2. Prescribed by or in consultation with an ophthalmologist; 3. Disease is chronic or recurrent as evidenced by (a) persistent subretinal fluid for ≥ 3 months, or (b) persistent subretinal fluid < 3 months with prescriber attestation that the member is symptomatic (e.g., blurry central vision); 4. Either (a) member is not taking medications from the following classes: corticosteroids, stimulants, decongestants, or erectile dysfunction medications, or (b) documentation that the prescriber has evaluated these medications as risk factors if the member is taking them; 5. Dose does not exceed 6 mg/m2 body surface area.

Continuation Therapy (Choroidal Neovascularization)

Covered when ALL of the following are met for Continuation/Re‑authorization — Choroidal Neovascularization:

Reauthorization CNV: 1. Member currently receiving medication via the plan benefit or has previously met the initial approval criteria, or member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by one of the following: (a) detained neovascularization, (b) improvement in visual acuity, (c) maintenance of corrected visual acuity from prior treatment, or (d) supportive findings on optical coherence tomography or fluorescein angiography; 3. Recent fluorescein angiography performed at least 3 months after the last treatment shows recurrent or persistent CNV leakage; 4. If a dose increase is requested, the new dose does not exceed 6 mg/m2 body surface area.

Continuation Therapy (Central Serous Chorioretinopathy)

Reauthorization stance for Central Serous Chorioretinopathy:

CSC reauthorization: Re-authorization is not permitted. Members must meet the initial approval criteria for treatment.

Other Indications / Label Changes

Other uses or recent label changes:

Other diagnoses/indications: 1. If the drug has had a recent label change not yet reflected in this policy (e.g., new indication, age expansion, or dosing), follow the applicable formulary/no-coverage/non-formulary policy for the relevant line of business; 2. If the requested use (diagnosis, age, dosing) is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid).

Dosing, Contraindications, and Coding-related Criteria

Key clinical and administrative criteria referenced in this section (partial document):

Dosing for covered indications: Administer verteporfin (Visudyne) 6 mg/m2 IV diluted with 5% dextrose to a final volume of 30 mL and infused over 10 minutes for predominantly classic subfoveal CNV due to AMD, pathologic myopia, or presumed ocular histoplasmosis.6 mg/m2; 30 mL; 10 minutes

Maximum dose 6 mg/m2; vial for reconstitution 15 mg.

Contraindications: Do not use in patients with porphyria or known hypersensitivity to verteporfin or its excipients.N/A

No boxed warnings reported.

Coding and prior therapy considerations: Use HCPCS code J3396 for billing (verteporfin 0.1 mg). Policy history includes step therapy/redirection involving bevacizumab and other anti-VEGF agents for CNV indications; check plan-specific criteria for required prior anti-VEGF failure or step edits.

Requests for use of verteporfin (Visudyne) for non‑FDA approved indications that are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation demonstrating efficacy and safety. Such requests should follow the applicable off‑label use policy for the member’s line of business (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Verteporfin (Visudyne) must not be used in patients with documented porphyria or a known hypersensitivity to verteporfin or its excipients. These contraindications are listed in the product appendices and preclude coverage for treatment in affected members.

Visudyne (vPDT) is not supported for treatment of predominantly occult subfoveal CNV. The FDA‑approved indication and the policy limitations specify that evidence is insufficient to support use in predominantly occult lesions.

Randomized comparative trials cited in the policy demonstrate that intravitreal anti‑VEGF therapy produced superior visual acuity outcomes compared with verteporfin photodynamic therapy in certain CNV populations. For example, the ANCHOR trial reported substantially better preservation of letters with ranibizumab (Lucentis) versus Visudyne at 12 months, and the RADIANCE trial showed ranibizumab superiority on mean BCVA change versus vPDT for myopic CNV. These findings support preference for anti‑VEGF agents in many CNV settings and inform plan‑level step‑therapy and coverage considerations.

Coding

Covered HCPCS CodesHCPCSCovered

J3396

Verteporfin injection, 1 mg

Referenced Therapeutic Alternatives (no claim codes intended)mixed

Bevacizumab (Avastin) - dosing listed	Intravitreal bevacizumab dosing regimens and dose limits are provided as therapeutic alternatives
Ranibizumab (Lucentis) - dosing listed	Intravitreal ranibizumab dosing regimens and dose limits provided
Aflibercept (Eylea) - dosing listed	Intravitreal aflibercept dosing regimens and dose limits provided

Referenced HCPCS CodesHCPCS

J3396

Injection, verteporfin, 0.1 mg

Maximum verteporfin dose

Maximum dose≤ 6 mg/m2 body surface area

Context in initial CNV criteriaDose does not exceed 6 mg/m2 for initial choroidal neovascularization approval

Context in continuation criteriaIf request is for a dose increase, new dose must not exceed 6 mg/m2

Infusion volume/time

Final infusion volumeFinal volume 30 mL (diluted with 5% dextrose)

Infusion timeInfused over 10 minutes

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must demonstrate that the member meets the listed initial or reauthorization criteria in the policy.

Prior authorization may be required for bevacizumab intravitreal solution and ranibizumab when referenced as step therapy options.
Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved.

Documentation Required

Providers must submit supporting clinical documentation (e.g., office chart notes, lab results, imaging reports) with the request. Failure to provide adequate documentation may result in denial of the request.

Examples: recent optical coherence tomography, fluorescein angiography, visual acuity measurements, medication history showing failure/intolerance to prior anti-VEGF therapy.

Background

Verteporfin (Visudyne) is a light‑activated photosensitizing agent used in photodynamic therapy (vPDT) for the treatment of subfoveal choroidal neovascularization due to AMD, pathologic myopia, or presumed ocular histoplasmosis. The therapeutic approach involves intravenous administration of verteporfin followed by activation with a targeted laser to produce local photochemical damage to neovascular tissue, thereby reducing leakage and neovascular growth. Product preparation and administration details referenced in the policy include reconstitution from a 15 mg vial and dosing guidance relevant to covered indications.

Definitions

CNV

AbbreviationCNV

DefinitionChoroidal neovascularization

Context in policyUsed throughout for indications such as subfoveal CNV due to AMD, pathologic myopia, or presumed ocular histoplasmosis

AMD

AbbreviationAMD

DefinitionAge-related macular degeneration

RelevanceAMD is a listed etiology for subfoveal CNV in initial approval criteria

OpenPayer

Clinical Policy: Verteporfin (Visudyne)

Coverage Criteria

Coding

Provider Actions and Requirements

Background

Definitions