Cost regulators for the National Health Service have rejected the use of Alimera's eye implant Iluvien to treat patients with chronic diabetic macular oedema (DMO), on grounds that it is too expensive.

Around three million people are currently living in the UK with diabetes, of which nearly 200,000 suffer from vision loss associated with DMO.

Iluvien (fluocinolone acetonide intravitreal implant) sits at the back of the eye delivering tiny levels of active substance for up to three years, its anti-vascular endothelial growth factor (anti-VEGF) properties decreasing the build up of fluid in the eye in patients with diabetes to limit visual loss and/or improve vision.

Its approval in Europe last year was based on clinical trial data showing that, after 30 months, 38% of patients with chronic DMO experienced a significant improvement in their visual acuity after receiving the product.

However, in final guidance published this week, the National Institute for Health and Clinical Excellence has stuck with its earlier stance that, while clinically effective, Iluvien does not offer the NHS value for money.

Its independent appraisal committee concluded that the most plausible incremental cost effectiveness ratio for Iluvien was likely to be at least £47,600 per QALY gained compared with standard care, making it too expensive for NHS use.

"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," Sir Andrew Dillon, Chief Executive of NICE, noted defending the decision. "In this case, the Committee concluded that the evidence and additional information submitted did not show that the benefits fluocinolone intravitreal implant provides to patients justify the price the NHS is being asked to pay.”

PAS in the wings

The cost of Iluvien is £5,500 (excluding VAT) per 190-microgram implant. Rather than appealing the Committee's findings, Alimera said it has chosen to pursue a simple patient access scheme (PAS) that is "intended to allow treatment decisions to be based on patient need, rather than cost". 

The PAS is currently under review by the Patient Access Schemes Liaison Unit (PASLU) at NICE and, if approved by the Department of Health, will be available to the Appraisal Committee for review and consideration.