Vabysmo

For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye.

Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections.

Patients receiving concurrent administration of verteporfin PDT (Visudyne), ranibizumab (Lucentis), aflibercept (Eylea) or brolucizumab (Beovu) are not eligible for reimbursement.

Treatment should be initiated with an intravitreal injection every 4 weeks for the first 4 doses, followed by one injection every 8 to 16 weeks based upon disease activity.

Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For

For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Vabysmo. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.

For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and who have a hemoglobin A1c of less than 12 percent.

Vabysmo is to be administered using one of the following dosing regimens:

Treatment should be initiated with an intravitreal injection every 4 weeks for the first 6 doses, followed by an intravitreal injection at a dosing interval of every 8 weeks.

OR

Treatment should be initiated with an intravitreal injection every 4 weeks for the first 4 doses or until macular edema is resolved. Thereafter, the dosing interval may be extended up to every 16 weeks (4 months) in up to 4-week increments. If anatomic and/or visual outcomes deteriorate, then the treatment interval should be shortened accordingly.

Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy.

For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Vabysmo. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.