Beovu

For the treatment of patients with mild-to-moderate 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) or aflibercept (Eylea) are not eligible for reimbursement.

Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 3 months.

The interval between two doses should not be shorter than eight weeks.

Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy and should be discontinued if any of the following occurs:

1. reduction in best corrected visual acuity (BCVA) in the treated eye to less than 15 letters (absolute) on two consecutive visits attributed to AMD in the absence of other pathology
2. reduction of BCVA of 30 letters or more compared to baseline and/or best recorded level since baseline as this may indicate either poor treatment effect or adverse event or both
3. evidence of deterioration of the lesion morphology despite treatment over three consecutive visits.

For clarity, coverage will be provided for patients responding to therapy with Lucentis or Eylea who switch to Beovu. Coverage will NOT be provided for patients who have failed to respond to Lucentis or Eylea

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.

Treatment should be initiated with an intravitreal injection every 6 weeks for the first 5 consecutive doses, followed by one injection every 8 to 12 weeks. An interval of 8 weeks may be considered for those with disease activity, whereas an interval of up to 12 weeks may be considered for those without disease activity.

After the first 5 initiation doses, the interval between two doses should not be shorter than 8 weeks.

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 Beovu. Coverage will NOT be provided for patients who have failed to respond to another anti-VEGF agent.