CurrentCountyCarePolicy RX.PA.055.CCH

Visudyne (verteporfin) Prior Authorization

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This policy governs prior authorization for verteporfin (Visudyne) used for specified forms of subfoveal choroidal neovascularization. It applies to CountyCare members whose providers request initial authorization or annual continuation of therapy.

Policy Summary

PayerCountyCare

PolicyVisudyne (verteporfin) Prior Authorization

Policy CodePolicy RX.PA.055.CCH

Change TypeNo material change

Effective DateNot specified

Next Review DateNot specified

Key ActionSubmit prior authorization documentation showing a qualifying diagnosis, eligible prescriber, member age, absence of porphyria, and inadequate response or intolerance to bevacizumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18 yearsMinimum member age

3Qualifying diagnoses

1 yearInitial authorization interval

J3396HCPCS code

Annual

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CurrentCountyCarePolicy RX.PA.055.CCH

Visudyne (verteporfin) Prior Authorization

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Policy Summary

PayerCountyCare

PolicyVisudyne (verteporfin) Prior Authorization

Policy CodePolicy RX.PA.055.CCH

Change TypeNo material change

Effective DateNot specified

Next Review DateNot specified

Key ActionSubmit prior authorization documentation showing a qualifying diagnosis, eligible prescriber, member age, absence of porphyria, and inadequate response or intolerance to bevacizumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18 yearsMinimum member age

3Qualifying diagnoses

1 yearInitial authorization interval

J3396HCPCS code

Annual

Coverage Criteria

Initial Authorization

Covered when ALL of the following are met:

Initial authorization requirements

Prescriber and age: Visudyne (verteporfin) is prescribed by a retinal specialist (ophthalmologist acceptable), and the member is 18 years of age or older.Age ≥18 years
ONE qualifying diagnosis
- Subfoveal choroidal neovascularization due to age-related macular degeneration.
- Subfoveal choroidal neovascularization due to pathologic myopia.
- Subfoveal choroidal neovascularization due to presumed ocular histoplasmosis.
Safety and preferred-product requirements: The member must not have porphyria and must have a documented inadequate response or intolerable adverse event with the preferred product bevacizumab (Avastin).

Reauthorization Criteria

Covered for continuation when annual review requirements are met:

Annual reauthorization

Documented clinical improvement: Authorization may be extended at 1-year intervals when chart documentation from the prescriber shows that the member's condition has improved based on the prescriber's assessment while on therapy.Authorization intervals up to 1 year
Continuation is based on documented improvement during therapy.

Members with porphyria are excluded from initial authorization for Visudyne (verteporfin).

Billing and Coding

HCPCS CodeHCPCS

J3396

VISUDYNE INJECTION, VERTEPORFIN, 0.1 MG

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Visudyne (verteporfin) requires prior authorization. The Health Plan reviews requests using FDA criteria to determine Medical Necessity, with prior authorization criteria approved by the Pharmacy & Therapeutics Committee under RX.002 and RX.003.

Prior authorization is required before Visudyne may be covered.

Step Therapy

Failure or Intolerance of Bevacizumab

Before Visudyne authorization, the member must have documented inadequate response or an intolerable adverse event with the preferred product, bevacizumab (Avastin).

Documentation must support either inadequate response or an intolerable adverse event with bevacizumab.
Bevacizumab is the preferred product and must be tried before Visudyne authorization, unless the documented exception is an intolerable adverse event.

Policy Background

Visudyne (verteporfin) is reviewed for the treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis. The policy requires that Visudyne be prescribed by a retinal specialist or ophthalmologist.

Documentation Required

Annual Continuation Documentation

All Visudyne renewals are reviewed annually for Medical Necessity. Submit chart documentation from the prescriber showing that the member’s condition has improved based on the prescriber’s assessment while on therapy; reauthorization is subject to the same established criteria as the initial authorization.

Annual continuation or reauthorization review is required.
Provide prescriber chart documentation of improvement while on Visudyne.
Reauthorization may be extended at 1-year intervals when criteria are met.
Reauthorization criteria are the same as the initial authorization criteria.

Denial Risk

Failure to Meet Authorization Criteria

Requests that do not meet the established Visudyne criteria may not be approved. If criteria are not met, the request is referred to a Medical Director for review when required by the plan and the level of the request.

Denial risk applies when any established requirement is not supported, including prescriber specialty, age, qualifying diagnosis, absence of porphyria, or documented inadequate response or intolerance to bevacizumab.
Initial authorization and reauthorization are limited to the established criteria; reauthorization is reviewed annually.
Medical Director review may be required when the established criteria are not met.