WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR EYLEA HD?: CADTH recommends that Eylea HD should be reimbursed by public drug plans for the treatment of neovascular (wet) age-related macular degeneration (nAMD) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Eylea HD should only be reimbursed for adults who have not previously been treated with an anti–vascular endothelial growth factor (VEGF) drug for their nAMD, have a baseline best-corrected visual acuity score between 78 to 24 letters based on the Early Treatment Diabetic Retinopathy Study (ETDRS) scoring system, more than 50% of the newly formed abnormal blood vessels originate from the choroid layer of the eye, and imaging shows there is fluid buildup affecting the centre of the eye. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Eylea HD should only be reimbursed if it is prescribed by an ophthalmologist with experience managing nAMD, it is not used in combination with other anti-VEGF drugs, and the cost of Eylea HD is not more than the least costly anti-VEGF drug covered by the public drug plans for the treatment of nAMD. Eylea HD should only be authorized for reimbursement for 12 months the first time it is used. Eylea HD should not continue to be reimbursed if injections need to be given more frequently than every 12 weeks or if the patient’s vision worsens by at least 5 letters due to their nAMD persisting or worsening and their central retina thickens by greater than 25 μm, new abnormal blood vessels form, or there is bleeding in the part of the eye responsible for central vision. WHY DID CADTH MAKE THIS RECOMMENDATION? One randomized controlled trial demonstrated that Eylea HD is no worse (but no better) than Eylea in improving or maintaining clearness or sharpness of vision in patients with nAMD who had not previously been treated with another anti-VEGF drug. Patients expressed a need for new treatments for nAMD that require fewer injections. Eylea HD administered every 12 or 16 weeks was no worse (but not better) than Eylea administered every 8 weeks in treating nAMD. However, there is not enough evidence to prove that using Eylea HD results in fewer injections than Eylea in real-world clinical practice. Based on CADTH’s assessment of the health economic evidence, Eylea HD does not represent good value to the health care system at the public list price. The committee determined there is not enough evidence to justify a greater cost for Eylea HD compared with other anti-VEGF drugs covered by the public drug plans for patients with nAMD. Based on public list prices, Eylea HD may decrease costs for the public drug plans; however, the extent of any savings realized will depend on the frequency of injections.
WHAT IS NAMD? nAMD is an eye disease in which there is a leakage of blood and fluids from abnormal blood vessels formed under the central retina, which causes damage to the retina and irreversible loss of central vision. It is estimated that nAMD affects more than 150,000 people in Canada. UNMET NEEDS IN NAMD: Patients with nAMD expressed a need for new treatments for nAMD that are safe, effective, and require fewer injections. HOW MUCH DOES EYLEA HD COST? Treatment with Eylea HD is expected to cost between $6,250 to $10,000 per patient in the first year of use depending on how many injections are required (between 5 and 8 injections). In subsequent years, the annual cost per patient is expected to be between $5,000 to $8,750 (based on 4 to 7 injections per year).
