Verteporfin Form

Verteporfin (Visudyne®) is a light activated drug used in photodynamic therapy. FDA Approved Indication(s) Visudyne is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to: • Age-related macular degeneration (AMD) • Pathologic myopia • Presumed ocular histoplasmosis Limitation(s) of use: There is insufficient evidence to indicate Visudyne for the treatment of predominantly occult subfoveal CNV. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Visudyne is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Choroidal Neovascularization (must meet all):

1. Diagnosis of subfoveal CNV due to one of the following (a, b, or c): a. AMD; b. Pathologic myopia; c. Presumed ocular histoplasmosis;

2. Prescribed by or in consultation with an ophthalmologist;

   3. Age ≥ 18 years;
   4. For AMD, member meets one of the following (a or b): a. Failure of bevacizumab intravitreal solution, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization may be required for bevacizumab intravitreal solution. Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved b. Disease has progressed after use of a vascular endothelial growth factor (VEGF) as first-line treatment (see Appendix B); Page 1 of 8

   CLINICAL POLICY Verteporfin

3. For CNV due to pathologic myopia, failure of intravitreal Avastin® or Lucentis®, unless clinically significant adverse effects are experienced or both are contraindicated; *Prior authorization may be required for Avastin and Lucentis
4. Dose does not exceed 6 mg/m2 body surface area. Approval duration: HIM/Medicaid – 3 months (1 dose) Commercial – 12 months or duration of request, whichever is less B. Central Serous Chorioretinopathy (off-label) (must meet all):
5. Diagnosis of central serous chorioretinopathy confirmed by retinal scan;
   2. Prescribed by or in consultation with an ophthalmologist;
   3. Disease is characterized as chronic or recurrent as evidenced by one of the following (a or b): a. Persistent subretinal fluid for ≥ 3 months; b. Persistent subretinal fluid for < 3 months and prescriber attestation that member is symptomatic (e.g., blurry central vision);
   4. Member meets one of the following (a or b): a. Member is not taking medications from any of the following classes: corticosteroids, stimulants, decongestants, or erectile dysfunction medications; b. Documentation that prescriber has evaluated medications as risk factors if they are from any of the following classes: corticosteroids, stimulants, decongestants, or erectile dysfunction medications;
   5. Dose does not exceed 6 mg/m2 body surface area. Approval duration: HIM/Medicaid – 3 months (1 dose) Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
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   CLINICAL POLICY Verteporfin II. Continued Therapy A. Choroidal Neovascularization (must meet all):

   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
8. Member is responding positively to therapy as evidenced by one of the following (a, b, c, or d): a. Detained neovascularization; b. Improvement in visual acuity; c. Maintenance of corrected visual acuity from prior treatment; d. Supportive findings from optical coherence tomography or fluorescein angiography;
9. Recent fluorescein angiography, conducted at least 3 months after the last treatment, shows recurrent or persistent choroidal neovascular leakage;
10. If request is for a dose increase, new dose does not exceed 6 mg/m2 body surface area. Approval duration: HIM/Medicaid – 3 months (1 dose) Commercial – 12 months or duration of request, whichever is less B. Central Serous Chorioretinopathy (off-label):
11. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable C. Other diagnoses/indications (must meet 1 or 2):
12. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

13. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
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    CLINICAL POLICY Verteporfin III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AMD: age-related macular degeneration CNV: choroidal neovascularization
    mCNV: myopic choroidal neovascularization FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose 2.5 mg/month 0.5 mL/month 6 mg (1 vial) every 2 months after loading period Eylea: 2 mg/month Eylea HD: 0.8 mg/dose 0.5 mg/month bevacizumab (Avastin) Beovu® (brolucizumab) Eylea®, Eylea® HD (aflibercept) Lucentis® (ranibizumab) Neovascular (wet) AMD: 1.25 to 2.5 mg administered by intravitreal injection every 4 weeks mCNV: 0.05 mL initial intravitreal injection, followed by monthly evaluation for additional injections as needed Neovascular (wet) AMD: 6 mg (1 via) administered by intravitreal injection every 4 weeks for the first 3 months, then every 8 or 12 weeks thereafter Neovascular (wet) AMD: Eylea: 2 mg (0.05 mL) administered by intravitreal injection once a month for 3 months then 2mg every 2 months. Eylea HD: 8 mg administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg via intravitreal injection once every 8 to 16 weeks, +/- 1 week Neovascular (wet) AMD: 0.5 mg (0.05 mL) administered by intravitreal injection once a month. Alternative dosing: Once monthly injections for three months followed by 4-5 doses dispersed among the following 9 months Page 4 of 8

    CLINICAL POLICY Verteporfin Drug Name Dosing Regimen Or Treatment may be reduced to one injection every 3 months after the first four injections if monthly injections are not feasible. Myopic CNV: 0.5 mg (0.05 mL) administered by intravitreal injection once a month for up to 3 months. Patients may be retreated if needed. Neovascular (wet) AMD: 0.3 mg (0.09 mL) administered by intravitreal injection every 6 weeks Macugen® (pegaptanib) Dose Limit/ Maximum Dose 0.5 mg/month 0.3 mg/6 weeks Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
    o Porphyria
    o Hypersensitivity
    • Boxed warning(s): none reported Appendix D: General Information • • In the ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularisation in AMD (ANCHOR) trial, the number of patients that lost fewer than 15 letters at 12 months was achieved by 96.4% of patients treated with Lucentis 0.5 mg compared to 64.3% of patients treated with Visudyne (p < 0.001). Rate of intraocular inflammation was higher for patients treated with Lucentis 0.5 mg at 15% compared to Visudyne at 2.8%. In the RADIANCE, a Phase III, 12-month, multicenter, randomized, double-masked, active-controlled trial, Lucentis was compared to vPDT (Visudyne and photodynamic therapy) for the treatment of mCNV. Lucentis treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 (group I: +10.5, group II: +10.6 vs. group III: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both p < 0.0001). Lucentis treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month 1 through month 6 (group II: +11.7 vs. group I: +11.9 ETDRS letters; p < 0.00001). Mean BCVA change from baseline to month 12 was +13.8 (group I), +14.4 (group II), and +9.3 ETDRS letters (group III). At month 12, 63.8% to 65.7% of patients showed resolution of myopic CNV leakage. Patients received a median of 4.0 (group I) and 2.0 (groups II and III) ranibizumab injections over 12 months. No deaths or cases of endophthalmitis and myocardial infarction occurred.
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    CLINICAL POLICY Verteporfin V. Dosage and Administration
    Indication Predominantly classic subfoveal CNV due to AMD, pathologic myopia or presumed ocular histoplasmosis
    Dosing Regimen 6 mg/m2 IV diluted with 5% dextrose to a final volume of 30 mL infused over 10 minutes Maximum Dose 6 mg/m2 IV VI. Product Availability
    Vial for reconstitution: 15 mg (2 mg/mL after reconstitution) VII.