UK’s NICE says yes to Alimera’s Iluvien

In final guidance published this morning by UK drugs watch dog the National Institute for Health and Care Excellence (NICE), USA-based ophthalmic biopharma specialist Alimera Sciences’ (Nasdaq: ALIM) fluocinolone acetonide intravitreal implant Iluvien is recommended as an option for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies only if the implant is to be used in an eye with an intraocular (pseudophakic) lens.

Fluocinolone acetonide intravitreal implant is recommended as an option for treating chronic diabetic macular edema that is insufficiently responsive to available therapies only if:

• the implant is to be used in an eye with an intraocular (pseudophakiciv) lens; and
• the manufacturer makes it available to the National Health Service under the terms agreed with the Department of Health as part of a patient access scheme.

Reverses earlier decision due to patient access scheme

NICE’s original guidance, published in January 2013, did not recommend fluocinolone. NICE conducted a rapid review of this guidance because the manufacturer submitted a patient access scheme, which is a scheme proposed by a pharmaceutical company and agreed between the company and the Department of Health. It provides a discount to the list price of fluocinolone to the National Health Service and aims to improve its cost-effectiveness.

Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “NICE is pleased to be able to recommend fluocinolone for some people with diabetic macular edema. The condition affects around 14% of people with diabetes in the UK, and can cause blurred or double vision, so this will be welcome news to both patients and health care professionals alike.”