NICE has not recommended the use of Alimera Sciences’ implant Iluvien (fluocinolone acetonide intravitreal) for the treatment of chronic diabetic macular oedema (DMO).

The Institute’s Appraisal Committee analysed data supplied by Alimera but raised concerns over a number of uncertainties.

Sir Andrew Dillon, NICE Chief Executive, said the information supplied did not show the benefits to patients to “justify the price the NHS is being asked to pay.”

Alimera Sciences submitted additional information following draft guidance, which was published by NICE in August.

But the updated data failed to impress NICE’s Appraisal Committee who questioned the implant’s clinical effectiveness, its negative side effects and how Alimera had judged Iluvien’s use in current clinical practice.

“When NICE recommends any drug or treatment, we have to be sure that it is both clinically and cost effective, because money has to be diverted from elsewhere in the health service to pay for it,” said Sir Andrew Dillon.

Alimera Sciences’ Iluvien (fluocinolone acetonide intravitreal) has not been recommended within its marketing authorisation for the treatment of chronic diabetic macular oedema (DMO) in final draft guidance.

NICE again raised concerns over the economic model supplied by the manufacturer and concluded that the data did not accurately reflect current clinical practice.

Sir Andrew Dillon (pictured), Chief Executive of NICE, said “the evidence provided did not show that the benefits fluocinolone intravitreal implant provides to patients justify the price the NHS is being asked to pay.”

Iluvien was not recommended in draft guidance published in early August 2012 after NICE questioned the economic model submitted by Alimera and the evidence it supplied during the appraisal.

In response Alimera submitted an updated economic model. However, NICE says this model underestimated the incremental cost-effectiveness ratio (ICER) for Iluvien compared to optimised standard of care.

The independent Appraisal Committee concluded that the most plausible ICER well exceeded the range that NICE usually considers an effective use of NHS resources. The updated cost model also failed to take into account any possible negative effects.

Alimera also proposed a pseudophakic subgroup (with an implanted synthetic optical lens) in its modelling. NICE accepted this subgroup was reasonable, but the small numbers of patients in the evidence submitted led to uncertainties in the estimates of clinical effectiveness and economic modelling in this group.

“Unfortunately, in this case, despite additional information on a pseudophakic subgroup and updated economic modelling from the manufacturer, the Committee concluded that the evidence provided did not show that the benefits fluocinolone intravitreal implant provides to patients justify the price the NHS is being asked to pay,” said Sir Andrew Dillon.

NICE has failed to recommend Alimera’s Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of chronic diabetic macular oedema (DMO) in draft guidance.

Its independent Appraisal Committee raised concerns over the economic model submitted by Alimera and the evidence it supplied during the appraisal.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the Committee “agreed” that the evidence supplied “could not support a positive recommendation”.

Around 336,000 in the UK with diabetes have DMO. Prevalence increases to nearly a third (29%) of people with diabetes who have used insulin for more than 20 years.

DMO occurs as a result of changes in retinal blood vessels. Iluvien is a corticosteroid which has anti-inflammatory and anti-vascular endothelial growth factor (anti-VEGF) properties. By inhabiting VEGT, the implant can decrease the oedema and improve vision.

But NICE concluded economic models “underestimated” the incremental cost-effectiveness ratio for the treatment and that data supplied did not “accurately reflect” current clinical practice.

The draft recommendation is now open to consultation.