WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR EYLEA HD?: CADTH recommends that aflibercept 8mg/0.07 mL (Eylea HD) be reimbursed by public drug plans for treating diabetic macular edema (DME) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Eylea HD should only be covered to treat adult patients with DME due to type 1 or 2 diabetes mellitus, with a central retinal thickness (CRT) of 300 µm or more (or 320 µm or more on the Spectralis scan) and a score of 78 to 24 letters in the eye with decreased vision primarily due to DME according to the early treatment diabetic retinopathy study (ETDRS) scoring system. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Eylea HD should only be reimbursed if it is prescribed by an ophthalmologist with experience managing DME, it is used in combination with other antivascular endothelial growth factor (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 DME. Eylea HD should only be authorized for reimbursement for 12 months the first time it is used. Eylea HD should no longer be reimbursed if injections need to be given more frequently than every 12 weeks or if the patient experiences > 10 letter loss in best-corrected visual acuity (BCVA) from week 12 in association with persistent or worsening DME and > 50 μm increase in CRT from week 12. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial (the PHOTON trial) demonstrated that in patients with DME, the clinical benefits of Eylea HD injections at intervals of either every 12 weeks or 16 weeks is no worse (but no better) than aflibercept 2 mg/ 0.05 mL (Eylea) administered every 8 weeks. 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 that there is not enough evidence to justify a greater cost for Eylea HD when compared with other anti-VEGF drugs covered by the public drug plans for patients with DME. Based on public list prices, Eylea HD may decrease costs for public drug plans; however, the extent of any savings realized will depend on the frequency of injection.
WHAT IS DME? DME is an eye disease that can occur in people living with diabetes. It is caused by blood vessels leaking fluid into a part of the eye called the macula, responsible for sharp central vision and fine detail. Untreated DME is a leading cause of visual loss, visual disability, and legal blindness in people with diabetes. It is estimated that 60,000 adults with DME in Canada experience vision impairment requiring treatment. UNMET NEEDS IN DME: Patients with DME expressed a need for new treatments that are effective, safe, and require fewer injections. HOW MUCH DOES DME COST? Treatment with Eylea HD is expected to cost between $6,250 and $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 and $8,750 (based on 4 to 7 injections per year).
