NICE Endorses Two Diabetic Macular Edema Drugs

June 8, 2015

The UK’s National Institute for Health and Care Excellence confirmed its recommendations for Bayer’s Eylea and Allergan’s Ozurdex for some patients with diabetic macular edema in separate final draft guidances.

NICE proposes reimbursing for Eylea (aflibercept) in DME patients with central retinal thickness of 400 micrometers or more at the start of treatment, and as long as Bayer provides the drug at a discount.

In clinical studies, patients in this group had improved vision with Eylea compared with laser treatment, the guidance says. And at $32,673 per quality of life year gained, it rings in far below the institute’s upper limit of $45,714.

The second drug, intravitreal implant Ozurdex (dexamethasone) should be paid for only when used in patients with pseudophakic lenses whose DME doesn’t respond to noncorticosteroid treatment or for whom this treatment is unsuitable, NICE says.

NICE’s appraisal committee determined that Ozurdex is not particularly cost-effective compared with Genentech’s Lucentis (ranibizumab) or Roche’s Avastin (bevacizumab), or with laser photocoagulation in Eylea’s patient population. On the other hand, Ozurdex’s cost is likely similar to Bausch & Lomb’s Reticert (fluocinolone acetonide) injection.

Both initial draft guidances were released in February. NICE spokesman Shalu Kanal says final guidance on each drug is expected in July.

Read the final draft guidances at www.fdanews.com/06-02-15-Eylea.pdf and www.fdanews.com/06-02-15-Ozurdex.pdf. — Lena Freund