CurrentmhnPolicy CP.PHAR.187

Verteporfin (Visudyne) for photodynamic therapy

Defines medical necessity criteria, prior authorization, and coverage conditions for verteporfin (Visudyne) for choroidal neovascularization and select off-label use (central serous chorioretinopathy) for members covered by the payer.

Policy Summary

Payermhn

PolicyVerteporfin (Visudyne) for photodynamic therapy

Policy CodePolicy CP.PHAR.187

Change TypeNo material change

Effective DateMar 1, 2016

Next Review Date

Key ActionPrior authorization required; provider must demonstrate that the member meets the initial approval criteria and submit supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 mg/m2maximum dose every 3 months

Age ≥ 18minimum age for coverage

3 monthsstandard approval duration (HIM/Medicaid)

≤12 monthsstandard approval duration (Commercial)

J3396HCPCS code

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Coverage Criteria

Continued Therapy (CNV)

Re-authorization covered when ALL of the following are met

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

Indication and Dosing

Covered when ALL of the following are met

Indication and dosing: Use for predominantly classic subfoveal choroidal neovascularization (CNV) due to AMD, pathologic myopia, or presumed ocular histoplasmosis with dosing of 6 mg/m2 IV diluted with 5% dextrose to a final volume of 30 mL and infused over 10 minutes; maximum dose 6 mg/m2 every 3 months.

Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (for example, CP.CPA.09 for commercial products, HIM.PA.154 for marketplace, or CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Use of verteporfin (Visudyne) is contraindicated in patients with porphyria or with known hypersensitivity to verteporfin or any of its components. There are no boxed warnings listed for verteporfin in this policy.

Use of Visudyne for predominantly occult subfoveal CNV is considered not supported by the evidence: the FDA labeling states there is insufficient evidence to indicate Visudyne for this condition.

Coding

HCPCS CodesHCPCS

J3396

Injection, verteporfin, 0.1 mg

Visudyne dosing — Dose does not exceed 6 mg/m2 body surface area every 3 months

Dosage limitDose does not exceed 6 mg/m2 body surface area every 3 months.

Treatment intervalMaximum of one dose per 3-month period ( dosing interval applies to initial and continued therapy).

Applicable indicationsApplies to CNV indications (AMD, pathologic myopia, presumed ocular histoplasmosis) and to off‑label chronic/recurrent central serous chorioretinopathy when criteria met.

Provider requirementPrescribed by or in consultation with an ophthalmologist for covered indications.

Provider Actions and Requirements

Prior Authorization

Provider Actions and Requirements

Prior authorization is required. Provider must demonstrate that the member meets the Initial Approval Criteria and submit clinical documentation supporting the request. Failure to submit required documentation may result in denial.

Prior authorization required; provider must demonstrate criteria listed under Initial Approval Criteria.
Submit requests with diagnosis, indication, and planned dosing tied to coding guidance (see HCPCS J3396 for verteporfin).
For neovascular (wet) AMD and myopic choroidal neovascularization (mCNV), step therapy requires failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects exist. For CNV due to pathologic myopia, failure of bevacizumab or ranibizumab is required unless both are contraindicated or cause significant adverse effects.
For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395 (step therapy bypass).
Dose must not exceed 6 mg/m2 IV every 3 months (one dose every 3 months).
Provider must submit supporting documentation such as office chart notes, clinic records, laboratory results, imaging, and any prior treatment history demonstrating failure/intolerance to prior therapies.
Required documentation elements should explicitly support the indication and dosing (e.g., diagnosis of subfoveal CNV due to AMD, pathologic myopia, or presumed ocular histoplasmosis; age ≥ 18; prescribing ophthalmologist involvement; prior bevacizumab intravitreal solution use and reasons for failure or contraindication when applicable; planned dosing: 6 mg/m2 IV diluted to 30 mL infused over 10 minutes for predominantly classic subfoveal CNV as applicable).

Background

Verteporfin (Visudyne) is a light‑activated drug used in photodynamic therapy for treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to age‑related macular degeneration (AMD), pathologic myopia, or presumed ocular histoplasmosis. The FDA labeling notes that evidence is insufficient to support use for predominantly occult subfoveal CNV.

Definitions

AMD — age-related macular degeneration

DefinitionAMD = age-related macular degeneration.

Relevance to policyAMD is a covered etiology for subfoveal choroidal neovascularization eligible for verteporfin (Visudyne) under initial approval criteria.

Age requirementMember must be ≥ 18 years for coverage under CNV initial approval.

CNV — choroidal neovascularization

DefinitionCNV = choroidal neovascularization.

Clinical roleSubfoveal CNV due to AMD, pathologic myopia, or presumed ocular histoplasmosis is an FDA‑recognized indication for verteporfin (predominantly classic subfoveal CNV).

Policy Summary

Payermhn

PolicyVerteporfin (Visudyne) for photodynamic therapy

Policy CodePolicy CP.PHAR.187

Change TypeNo material change

Effective DateMar 1, 2016

Next Review Date

Key ActionPrior authorization required; provider must demonstrate that the member meets the initial approval criteria and submit supporting clinical documentation.

SourceLink

On This Page

Inclusion or exclusion of codes does not guarantee coverage. Providers should reference the most up-to-date professional coding guidance prior to claim submission.

Documentation Required

Clinical Documentation

Documentation requirements and coding guidance — submit clinical records that tie the requested service to the covered indication and planned dosing. Include prior treatment history and reason for failure or contraindication when step therapy applies.

Attach office chart notes, imaging reports, and prior medication records showing attempts and outcomes with bevacizumab intravitreal solution (and ranibizumab where applicable).
Specify diagnosis code(s) and link to the indication (e.g., subfoveal CNV due to AMD, pathologic myopia, presumed ocular histoplasmosis).
Document patient age (≥ 18) and that therapy is prescribed by or in consultation with an ophthalmologist.
Specify planned dosing regimen (6 mg/m2 IV diluted to 30 mL infused over 10 minutes for predominantly classic subfoveal CNV when applicable) and that dose will not exceed 6 mg/m2 every 3 months.

Step Therapy

Step Therapy for AMD and mCNV

Step therapy for AMD and mCNV — require trial and failure of bevacizumab intravitreal solution as first-line therapy unless contraindicated or clinically significant adverse effects occurred. For pathologic myopia CNV, require failure of bevacizumab or ranibizumab unless both are contraindicated.

Step therapy requirement: failure of bevacizumab intravitreal solution (Avastin) unless contraindicated or intolerant.
Prior authorization may be required for bevacizumab intravitreal solution; IV formulations of Avastin, Mvasi, and Zirabev will not be approved for intravitreal use.
Illinois HB 5395: for Illinois HIM requests, step therapy requirements do not apply — providers should indicate IL HIM status to bypass step therapy.
Document specific prior therapies, dates, doses, responses, and adverse effects to justify bypassing step therapy when applicable.

Billing Rule

Coding and Billing Caveats

Coding inclusion/exclusion caveat — codes listed in the policy are informational and do not guarantee coverage. Always reference current professional coding guidance before submitting claims.

HCPCS J3396 — Injection, verteporfin, 0.1 mg (informational only).
Inclusion/exclusion of codes does not ensure coverage; verify payer-specific billing rules and code edits prior to claim submission.

Diagnostic requirement

Diagnosis of subfoveal CNV must be documented to meet initial approval criteria.

Verteporfin dosing — Predominantly classic subfoveal CNV dosing

Standard dose per administration6 mg/m2 IV diluted with 5% dextrose to a final volume of 30 mL, infused over 10 minutes.

Product vialProduct supplied as a 15 mg vial for reconstitution (2 mg/mL after reconstitution).

Indications for this dosingDosing specified for predominantly classic subfoveal CNV due to AMD, pathologic myopia, or presumed ocular histoplasmosis.