Faricimab-svoa (Vabysmo) Form

Faricimab-svoa (Vabysmo®) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor.
FDA Approved Indication(s) Vabysmo is indicated for the treatment of patients with: • Neovascular (wet) age-related macular degeneration (nAMD) • Diabetic macular edema (DME) • Macular edema following retinal vein occlusion (RVO) 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 Vabysmo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Ophthalmic Disease (must meet all):

1. Diagnosis of one of the following (a, b, or c): a. nAMD; b. DME; c. Macular edema following RVO;
2. Prescribed by or in consultation with an ophthalmologist;
   
   3. Age ≥ 18 years;
   4. 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

3. Dose does not exceed (a, b, or c):
   a. nAMD: 6 mg (1 vial) every 4 weeks for the first 4 doses; b. DME: one of the following (i or ii):
   i. Fixed dosing regimen: 6 mg (1 vial) every 4 weeks for the first 6 doses, then 6 mg every 8 weeks thereafter; ii. Variable dosing regimen: 6 mg (1 vial) every 4 weeks for at least 4 doses and until a central subfield thickness (CST) of < 325 µM is achieved, then one of the following (1 or 2): Page 1 of 8

   CLINICAL POLICY Faricimab-svoa 1) 6 mg (1 vial) every 8 to 16 weeks; 2) 6 mg (1 vial) every 4 weeks, and one of the following (a or b): a) Member has had an inadequate response to every 8-week dosing, defined as one of the following (i or ii): i) CST has increased between > 10% and ≤ 20% with an associated ≥ 5- to < 10-letter best-corrected visual acuity (BCVA) decrease from the reference values (see Appendix D); ii) CST has increased by > 20% without an associated ≥ 10-letter BCVA decrease from the reference values (see Appendix D); b) Member has had an inadequate response to every 12-week dosing, defined as > 10% increase in CST and ≥ 10-letter BCVA decrease from the reference value (see Appendix D); c. RVO: 6 mg (1 vial) every 4 weeks for 6 months. Approval duration:
   nAMD – 4 months (first 4 doses)
   DME – 6 months (up to 6 doses)
   RVO – 6 months (up to 6 doses) B. Other diagnoses/indications (must meet 1 or 2):

4. 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
5. 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.
   II. Continued Therapy A. Macular Edema Following Retinal Vein Occlusion (must meet all):
6. Re-authorization is not permitted. Approval duration: Not applicable B. All Other Indications (must meet all):

7. Currently meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; Page 2 of 8

   CLINICAL POLICY Faricimab-svoa 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. If request is for a dose increase, new dose does not exceed (a or b): a. nAMD: one of the following (i, ii, or iii):
   i. 6 mg (1 vial) every 16 weeks; ii. 6 mg (1 vial) every 12 weeks if member has documented active disease (see Appendix D) at week 24;
   iii. 6 mg (1 vial) every 8 weeks if member has documented active disease (see Appendix D) at week 20;
   b. DME: one of the following (i or ii):
   i. Fixed dosing regimen: 6 mg (1 vial) every 8 weeks; ii. Variable dosing regimen: 6 mg (1 vial) every 4 weeks until a CST of < 325 µM is achieved, then one of the following (1 or 2):
   1) 6 mg (1 vial) every 8 to 16 weeks;
   2) 6 mg (1 vial) every 4 weeks, and one of the following (a or b): a) Member has had an inadequate response to every 8-week dosing, defined as one of the following (i or ii): i) CST has increased between > 10% and ≤ 20% with an associated ≥ 5- to < 10-letter BCVA decrease from the reference values (see Appendix D); ii) CST has increased by > 20% without an associated ≥ 10-letter BCVA decrease from the reference values (see Appendix D); b) Member has had an inadequate response to every 12-week dosing, defined as > 10% increase in CST and ≥ 10-letter BCVA decrease from the reference value (see Appendix D). Approval duration: 6 months
   B. Other diagnoses/indications (must meet 1 or 2):

10. 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: Page 3 of 8

    CLINICAL POLICY Faricimab-svoa CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

11. 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. 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 Ang-2: angiopoietin-2 BCVA: best-corrected visual acuity CST: central subfield thickness
    DME: diabetic macular edema FDA: Food and Drug Administration nAMD: neovascular age-related macular degeneration OCT: optical coherence tomography RVO: retinal vein occlusion VEGF: vascular endothelial growth factor 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 for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen bevacizumab (Avastin) nAMD: 1.25 to 2.5 mg administered by intravitreal injection every 4 weeks. DME: 1.25 mg administered by intravitreal injection every 6 weeks
    Macular edema secondary to RVO: 1 mg to 2.5 mg administered by intravitreal injection every 4 weeks Dose Limit/ Maximum Dose 2.5 mg/month 1.25 mg/6 weeks
    2.5 mg/month 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): ocular or periocular infection, active intraocular inflammation, hypersensitivity • Boxed warning(s): none reported
    Page 4 of 8

    CLINICAL POLICY Faricimab-svoa Appendix D: General Information
    • For the indication of nAMD, active disease is defined as any of the following:
    o Optical coherence tomography (OCT) (a or b): a. Increase in CST > 50 µM compared to average CST over previous 2 visits; b. Increase in CST ≥ 75 µM compared with lowest CST recorded at either of previous 2 visit;
    o Visual acuity (a or b): a. Decrease of ≥ 5 letters of BCVA compared with average BCVA over previous 2 visits, due to nAMD; b. Decrease of ≥ 10 letters of BCVA compared with highest BCVA recorded over previous 2 visits, due to nAMD;
    o Presence of new macular hemorrhage. • For the indication of nAMD, clinical criteria for every 4-week dosing following the initial every 4-week dosing was not defined nor evaluated in the clinical studies.
    • Reference CST is defined as the CST value when the initial CST threshold (< 325 µM) is met. Reference CST is adjusted if CST decreases by > 10% from the previous reference CST for two consecutive drug dosing visits and the values obtained are within 30 µM. The CST value obtained at the latter visit will serve as the new reference CST starting immediately at that visit.
    • Reference BCVA is defined as the mean of the three best BCVA scores obtained at any time prior to study drug dosing visit. • For the indication of DME, CST and BCVA should be examined at each dosing interval to determine subsequent dosing frequency for variable dosing regimens. V. Dosage and Administration
    Indication Dosing Regimen nAMD 6 mg (1 vial) administered by intravitreal injection every 4 weeks for the first 4 doses, followed by OCT and visual acuity evaluation 8 and 12 weeks later to inform whether to give 6 mg dose on one of the following regimens outlined below:
    1) Weeks 28 and 44 2) Weeks 24, 36 and 48 or
    3) Weeks 20, 28, 36, and 44 Maximum Dose 6 mg every 4 weeks* DME Although Vabysmo may be dosed as frequently as every 4 weeks, additional efficacy was not demonstrated in most patients when Vabysmo was dosed every 4 weeks compared to 8 weeks. Some patients may need every 4- week dosing after the first 4 doses.
    Administered using one of the following dosing regimens:
    1) 6 mg (1 vial) administered by intravitreal injection every 4 weeks for 4 doses. If after the first 4 doses, resolution of edema based on CST of the macula as 6 mg every 4 weeks Page 5 of 8

    CLINICAL POLICY Faricimab-svoa Indication Dosing Regimen Maximum Dose measured by OCT is achieved, then the interval dosing may be modified by extension of up to 4- week increments or reduction of up to 8-week increments based on CST and visual acuity evaluation through Week 52 2) 6 mg (1 vial) administer by intravitreal injection every 4 weeks for the first 6 doses, followed by 6 mg every 8 weeks over the next 28 weeks.
    Although Vabysmo may be dosed as frequently as every 4 weeks, additional efficacy was not demonstrated in most patients when Vabysmo was dosed every 4 weeks compared to 8 weeks. Some patients may need every 4- week dosing after the first 4 doses. 6 mg (1 vial) administered by intravitreal injection every 4 weeks for 6 months RVO 6 mg every 4 weeks *This dosing regimen has not been evaluated in clinical studies beyond the initial doses. VI. Product Availability
    Solution in single-dose vial: 6 mg/0.05 mL (120 mg/mL) VII.