NICE OKs aflibercept for DME with qualifications

The National Institute for Health and Clinical Excellence (NICE), an independent UK health agency, has recommended aflibercept (Eylea) for diabetic macular edema (DME), but not for patients with early-stage disease.

In its preliminary draft guidance, NICE recommends aflibercept only in patients where:

• the eye has a central retinal thickness of 400 micrometres or more at the start of treatment, and
• the manufacturer  provides aflibercept with the discount agreed in the patient access scheme.

Bayer issued a press release in response, expressing its disappointment with the draft guidance. “Bayer is disappointed that a core group of patients diagnosed with early stage [diabetic macular edema] (central retinal thickness < 400 µm) would be denied treatment until their disease has progressed to a stage where permanent damage to the eye has already begun.”

Eylea is approved in the European Union for DME and in the United States for wet AMD, macular edema following retinal vein occlusion, and DME.

The phase 3 VISTA-DME and VIVID-DME studies found that BCVA significantly improved in patients with DME given Eylea 2 mg monthly or every 2 months after 5 initial monthly injections compared with patients who underwent macular laser photocoagulation at baseline and then as needed.

A final decision from NICE is expected in June.