CurrentCareSourcePolicy N/A

Visudyne (verteporfin) Pharmacy Policy Statement

Defines prior authorization criteria, dosing/quantity limits, initial and reauthorization clinical requirements, and coverage exclusions for Visudyne (verteporfin) when used for photodynamic therapy to treat choroidal neovascularization (CNV). Applies to medical benefit (Visudyne = Medical) under Arkansas PASSE benefit.

Policy Summary

PayerCareSource

PolicyVisudyne (verteporfin) Pharmacy Policy Statement

Policy CodePolicy N/A

Change TypeCreated; Revised (references)

Effective DateApr 1, 2024

Next Review Date

Key ActionObtain prior authorization: initial approval for 3 months (1 dose per eye) when criteria met; reauthorization for an additional 3 months (1 dose per eye) when reauthorization criteria met.

SourceLink

POLICY UPDATE CHANGES

Policy created 10/19/2021

Revised 10/04/2023 to add references

3Covered etiologies

1 dose/eye/3moApproval duration/quantity

6 mg/m2Dose per administration

Coverage Summary

Coverage stance: covered_with_criteria for Visudyne (verteporfin) photodynamic therapy for choroidal neovascularization (CNV). Effective date: 2024-04-01. Scope: defines prior authorization criteria, dosing/quantity limits, initial and reauthorization clinical requirements, and coverage exclusions for Visudyne when used for PDT to treat CNV; applies to the medical benefit (Visudyne = Medical) under the Arkansas PASSE benefit. Approval duration/quantity: 1 dose per eye per 3 months for initial approval (and for each reauthorization when criteria met). Dose per administration: 6 mg/m2 body surface area IV.

Initial Authorization - Choroidal Neovascularization (CNV)

Covered when ALL of the following are met:

ALL of the following

Member is at least 18 years of age>= 18 years
ALL of the following
- Etiology (ONE of)
  - "Wet" age-related macular degeneration (AMD)
  - Presumed ocular histoplasmosis
  - Pathologic myopia
Medication must be prescribed by or in consultation with an ophthalmologist
Member has tried and failed bevacizumab
Member does NOT have predominantly occult subfoveal CNV
Dosage allowed/Quantity limit: 6 mg/m2 body surface area IV6 mg/m2

Reauthorization

Covered when ALL of the following are met:

ALL of the following

Choroidal neovascular leakage has recurred as detected on fluorescein angiography (FA) or optical coherence tomography (OCT)
Chart notes must document positive clinical response (e.g;, slowed progression of vision loss) following prior photodynamic treatment

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Visudyne (verteporfin) requires prior authorization. When initial criteria are met the medication is approved for 3 months (one dose per eye); if reauthorization criteria are met it may be approved for an additional 3 months (one dose per eye).

Documentation Required

Diagnosis and specialist involvement

The medication must be prescribed by or in consultation with an ophthalmologist. Documentation must include a diagnosis of predominantly classic subfoveal choroidal neovascularization (CNV) and the etiology ("wet" AMD, presumed ocular histoplasmosis, or pathologic myopia).

Documentation Required

Prior therapy requirement

Chart documentation must show a prior trial and failure of bevacizumab before initial approval will be granted.

Documentation Required

Recurrent leakage documentation

For reauthorization, chart documentation must show recurrent choroidal neovascular leakage demonstrated on fluorescein angiography (FA) or optical coherence tomography (OCT) and chart notes must document a positive clinical response to prior photodynamic treatment (e.g., slowed progression of vision loss).

Billing Rule

Quantity limit per approval

Approval is for one dose per eye for each 3-month approval period. The permitted dosage per administration is limited to 6 mg/m2 body surface area IV.

Documentation Required

Post-procedure patient counseling

Patients must avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days following the procedure; this counseling should be documented in the chart.

Clinical Evidence & Definitions

Supporting evidence: Prescribing information — Visudyne [prescribing information], Bausch & Lomb; 2023; and a Cochrane review — Photodynamic therapy for neovascular age-related macular degeneration, Cochrane Database Syst Rev. 2007. These references are listed as the supporting references in the policy.

CNV (Choroidal neovascularization): creation of new blood vessels in the choroid layer of the eye that can lead to vision loss.

Predominantly classic subfoveal CNV: a subtype of CNV characterized by predominantly classic lesions located under the fovea (as specified in the policy clinical criteria).

Background

Background: Visudyne (verteporfin) is a light-activated drug used in photodynamic therapy (PDT) to treat certain cases of choroidal neovascularization (CNV). Treatment is a two-step process: intravenous administration of Visudyne followed by activation with light from a nonthermal diode laser. Patients must avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days following the procedure. This policy and scope apply to the medical benefit (Visudyne = Medical) under the Arkansas PASSE benefit.

Quick thresholds/details

AgeAge: >= 18 years

Approval duration/quantity1 dose per eye per 3 months

Dose per administration6 mg/m2 body surface area IV

Policy Summary

PayerCareSource

PolicyVisudyne (verteporfin) Pharmacy Policy Statement

Policy CodePolicy N/A

Change TypeCreated; Revised (references)

Effective DateApr 1, 2024

Next Review Date

Key ActionObtain prior authorization: initial approval for 3 months (1 dose per eye) when criteria met; reauthorization for an additional 3 months (1 dose per eye) when reauthorization criteria met.

SourceLink

On This Page

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Visudyne (verteporfin) Pharmacy Policy Statement

Coverage Summary

Provider Actions & Prior Authorization

Applicable Codes and Dosing

Clinical Evidence & Definitions

Background

Revision History