Byooviz

For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a verteporfin PDT (Visudyne)-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 with another anti-VEGF agent are not eligible for reimbursement.

Treatment should be initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase.

During the maintenance phase, patients should be monitored for best corrected visual acuity or continued disease activity. If there is clinical or diagnostic evidence of disease activity such as a loss of greater than 5 letters in visual acuity (Early Treatment Diabetic Retinopathy Score (ETDRS) chart or one Snellen line equivalent), Byooviz may be administered.

The interval between two doses should not be shorter than one month.

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 Byooviz. 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 11 percent.

Treatment to be given monthly and continued until maximum visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on Byooviz treatment. Thereafter patients should be monitored monthly for visual acuity.

Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to DME and continued until stable visual acuity is reached again for three consecutive monthly assessments.

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 Byooviz. 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 macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Treatment to be given monthly and continued until maximum visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on Byooviz treatment. Thereafter patients should be monitored monthly for visual acuity.

Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to macular edema secondary to retinal vein occlusion and continued until stable visual acuity is reached again for three consecutive monthly assessments.

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 Byooviz. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.

For the treatment of patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia.

Treatment is initiated with a single intravitreal injection. Monitoring is recommended monthly for the first 2 months and at least every 3 months thereafter during the first year. If monitoring reveals signs of disease activity (e.g. reduced visual acuity and/or signs of lesion activity), further treatment is recommended at a frequency of 1 injection per month until no disease activity is seen.