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www.fdanews.com/articles/170123-nice-gives-nod-to-two-diabetic-macular-edema-drugs

NICE Gives Nod to Two Diabetic Macular Edema Drugs

February 26, 2015

The UK’s National Institute for Health and Care Excellence gave a preliminary nod to two diabetic macular edema products, paving the way for their eventual inclusion in the government’s formulary.

Bayer’s Eylea (aflibercept) outperformed laser treatment in improving the vision of patients with a central retinal thickness of more than 400 micrometers, NICE’s draft guidance says. It was also more cost-effective than Genentech’s Lucentis (ranibizumab), at less than $46,000 per qualify-adjusted life year gained. NICE’s ceiling for cost-effectiveness is usually between $31,000 and $46,000.

Bayer also agreed to provide the drug at a discount, the cost watchdog agency says.

Nice also recommended Allergan’s dexamethasone intravitreal injection for patients who have an intraocular lens and have not responded to noncorticosteroid treatments.

At $1.8 million per QALY, the cost-effectiveness of Allergan’s drug is likely to be similar to comparator injections, such as Bausch & Lomb’s Reticert (fluocinolone acetonide) injection, in this patient group, the guidance says. NICE notes, however, that compared with Lucentis in Eylea’s patient population, dexamethasone is not cost-effective.

Comments on the Eylea draft guidance are due March 10 and on dexamethasone, March 12.  Read them at www.fdanews.com/02-20-15-guidance1.pdf and www.fdanews.com/02-20-15-guidance2.pdf, respectively. — Lena Freund