CurrentCentenePolicy CP.PHAR.187

Verteporfin (Visudyne)

Defines medical necessity criteria, initial and continued therapy coverage, dosing limits, approved indications (predominantly classic subfoveal CNV due to AMD, presumed ocular histoplasmosis, pathologic myopia), off-label central serous chorioretinopathy criteria, exclusions, required documentation, approval durations, and coding implications for Verteporfin (Visudyne) under Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyVerteporfin (Visudyne)

Policy CodePolicy CP.PHAR.187

Change TypeRevisions & Appendix updates

Effective Date03.01.16

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

1Q 2025 annual review: for CNV due to pathologic myopia, revised failure of Avastin or Lucentis to bevacizumab and ranibizumab; Appendix B additions and references updated.

1Q 2023 annual review: updated commercial length of benefit to '12 months or duration of request, whichever is less'.

Ad Hoc converted redirection language from 'must use' to 'Failure of bevacizumab intravitreal solution'.

Added HIM line of business and reference updates in 1Q2021 annual review.

3FDA-approved indications listed

1Off-label indication with criteria (CSC)

Coverage Summary & Scope

Coverage stance: covered_with_criteria. Scope summary: Visudyne (verteporfin) is covered for treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), presumed ocular histoplasmosis, or pathologic myopia, with dosing limited to a maximum of 6 mg/m2 body surface area. For AMD, coverage requires failure of bevacizumab intravitreal solution or disease progression after use of a VEGF as first-line treatment; for pathologic myopia, coverage requires failure of bevacizumab or ranibizumab unless contraindicated. Prescriptions must be by or in consultation with an ophthalmologist. Lines of business: Commercial, HIM, Medicaid. Effective date: 03.01.16; Last review date: 02.25.

Initial Therapy Criteria

Initial Approval Criteria

Visudyne is medically necessary when ALL of the following are met for the specified diagnosis:

Diagnosis of subfoveal CNV due to one of

Age-related macular degeneration (AMD)
Presumed ocular histoplasmosis
Pathologic myopia

Choroidal Neovascularization (must meet all)

Prescribed by or in consultation with an ophthalmologist
Age ≥ 18 years
Dose does not exceed 6 mg/m2 body surface area≤ 6 mg/m2
Maximum dose limit

AMD specific

Failure of bevacizumab intravitreal solution, unless contraindicated or clinically significant adverse effects are experienced
Prior authorization may be required for bevacizumab intravitreal solution
Disease has progressed after use of a vascular endothelial growth factor (VEGF) as first-line treatment (see Appendix B)

Pathologic myopia specific

For CNV due to pathologic myopia, failure of bevacizumab intravitreal solution or ranibizumab, unless clinically significant adverse effects are experienced or both are contraindicated

Therapeutic alternatives and coding

Refer to Appendix B for bevacizumab, ranibizumab, aflibercept and biosimilars dosing and alternatives

Initial Approval — Central Serous Chorioretinopathy (off-label)

Visudyne may be considered off-label when ALL of the following are met:

Central Serous Chorioretinopathy (off-label) (must meet all)

Prescribed by or in consultation with an ophthalmologist
Diagnosis of central serous chorioretinopathy confirmed by retinal scan
Chronicity / symptoms
- Persistent subretinal fluid for ≥ 3 months≥ 3 months
- Persistent subretinal fluid for < 3 months and prescriber attestation that member is symptomatic (e.g., blurry central vision)< 3 months

Other Indications / Off‑label Routing

Other diagnoses/indications

Coverage for other uses follows formulary/non-formulary or off-label use policies

Other diagnoses/indications (must meet 1 or 2)

If drug is on formulary/PDL: follow no coverage criteria policy CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid)
If drug NOT on formulary/PDL: follow non-formulary policy CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid)
If requested use not listed in section III and criterion 1 above does not apply: refer to off-label use policy CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Continuation / Re-authorization Criteria

Continued Therapy — Choroidal Neovascularization

Re-authorization when ALL of the following are met:

Choroidal Neovascularization (must meet all)

Eligibility to continue
- Member is currently receiving medication via Centene benefit
- Member has previously met initial approval criteria
Response criteria (one of)
- Detected neovascularization

Unproven / Not Authorized Uses

Diagnoses/Indications Not Authorized

Coverage not authorized when:

Diagnoses/Indications Not Authorized: Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation per off-label use policies is provided

Applicable Codes

HCPCS - Verteporfin injectionHCPCSCovered

J3396

Injection, verteporfin, 0.1 mg

Provider Actions & Billing Notes

Documentation Required

Submit supporting clinical documentation

Provider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria.

Prior Authorization

Prior authorization for Visudyne and alternatives

Prior authorization may be required for bevacizumab intravitreal solution and ranibizumab; requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved (per policy language).

IV formulations of Avastin, Mvasi, and Zirabev will not be approved per policy language.

Clinical Evidence & Trial Findings

ANCHOR: Lucentis vs Visudyne96.4% of Lucentis 0.5 mg patients lost <15 letters at 12 months vs 64.3% with Visudyne; higher intraocular inflammation with Lucentis (15% vs 2.8%).

RADIANCE: Ranibizumab vs vPDTRanibizumab superior to vPDT for myopic CNV on mean BCVA change through month 3 (group I +10.5/+10.6 vs group III +2.2 ETDRS letters; both p < 0.0001).

Anti-VEGF agents (for example, ranibizumab/Lucentis) demonstrated superior visual acuity outcomes compared with verteporfin photodynamic therapy: in the ANCHOR trial, Lucentis 0.5 mg resulted in 96.4% of patients losing fewer than 15 letters at 12 months versus 64.3% with Visudyne; and in the RADIANCE trial ranibizumab was superior to vPDT for myopic CNV based on mean best-corrected visual acuity change through month 3.

Background & Definitions

Verteporfin (Visudyne) is a light-activated drug used in photodynamic therapy. Visudyne is FDA-indicated for treatment of patients with predominantly classic subfoveal CNV due to age-related macular degeneration, presumed ocular histoplasmosis, or pathologic myopia; dosing is administered as an intravenous infusion with a maximum dose of 6 mg/m2 body surface area.

Term	Definition
AMD
age-related macular degeneration
CNV
choroidal neovascularization
mCNV
myopic choroidal neovascularization

Revision History

1Q2025 (P&T Approval Date = 02.25)materialLatest

1Q2025 annual review (material): For CNV due to pathologic myopia, revised failure language to require failure of bevacizumab and ranibizumab; Appendix B updated to add aflibercept and ranibizumab biosimilars; references reviewed and updated.

1Q2023 (P&T Approval Date = 02.23)material

1Q2023 annual review (material): Updated commercial length of benefit to "12 months or duration of request, whichever is less"; references reviewed and updated.

03.04.21 / 08.03.21material