VABYSMO (faricimab)

VABYSMO (faricimab)

Medical Administration – intravitreal injection

Diagnosis considered for coverage:

• Indicated for the treatment of patients with:
  • Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
  • Diabetic Macular Edema (DME)

Coverage Criteria:

For diagnosis of neovascular (Wet) Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME):

• Dose does not exceed FDA-approved dosing; AND
• Prescribed by or in consultation with an ophthalmologist; AND
• Diagnosis of one of the following:
  • Neovascular (Wet) Age-Related Degeneration (nAMD)
  • Diabetic Macular Edema (DME); AND
• Trial and positive response to at least 2 intravitreal injections of a VEGF inhibitor; AND
• A medically appropriate reason is provided why the patient cannot use the preferred vascular endothelial growth factor (VEGF) inhibitor agent(s) to treat their condition (e.g., ranibizumab [Lucentis], aflibercept [Eylea], brolucizumab-dbll [Beovu], bevacizumab [Avastin], etc.); AND
• Vabysmo will not be used in combination with another intravitreal VEGF inhibitor (i.e., aflibercept, brolucizumab, ranibizumab, pegaptanib, bevacizumab)

Reauthorization Criteria:

For diagnosis of neovascular (Wet) Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME):

• Dose does not exceed FDA-approved dosing; AND
• Documentation of a positive clinical response to therapy (e.g., Improvement in Best Corrected Visual Acuity [BVCA] compared to baseline, stable vision); AND
• Vabysmo will not be used in combination with another intravitreal VEGF inhibitor

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• QT prolongation
  • ECG monitoring is recommended
• Barhemsys should only be administered
• Your Health Maintenance Organization (HMO) may have preferred VEGF-inhibitor agents. HMO preferred agents may vary.  You will have to try their preferred agents, if any, prior to using Vabysmo.
• Dosing:
  • nAMD
    • Initiation: 6 mg (0.05 mL of 120 mg/mL solution) intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days, monthly) for the first four doses (16 weeks)
    • Maintenance:
      • Follow the initial four doses with optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to ascertain whether to give a 6 mg dose via intravitreal injection on one of the following three regimens:
        • Weeks 28 and 44 (every 16 weeks); or
        • Weeks 24, 36, and 48 (every 12 weeks); or
        • Weeks 20, 28, 36, and 44 (every 8 weeks)
  • DME
    • 1) 6 mg (0.05 mL of 120 mg/mL solution) intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days, monthly) for at least four doses. If after at least 4 doses, resolution of edema based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography is achieved, then the interval of dosing may be modified by extensions of up to 4-week interval increments or reductions of up to 8-week interval increments based on CST and visual acuity evaluations through week 52; OR
    • 2) 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days, monthly) for the first six doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months) over the next 28 weeks
• Administration:
  • For intravitreal injection.  Must be administered by a qualified physician
  • Each vial should only be used for the treatment of a single eye
• VEGF inhibitors: Aflibercept (Eylea), bevacizumab, brolucizumab (Beovu), ranibizumab (Lucentis, Susvimo), faricimab (Vabysmo)in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
• Use of Barhemsys is not recommended in patients with moderate or severe renal impairment (eGFR < 30 mL/min).

Policy Updates:

• 08/16/2022 – New policy approved by P&T.

References:

• Vabysmo Prescribing information. Genentech, Inc. South San Francisco, CA. January 2022.