US group Alimera Sciences is looking to lower the price of Iluvien after cost regulators rejected its use on the National Health Service for the treatment of chronic diabetic macular oedema.
The National Institute for Health and Clinical Excellence has published final draft guidance which recognises that the drug is indeed clinically effective, but insists that its price is simply too high to be considered a cost effective use of resources.
NICE's Appraisal Committee concluded that the most plausible incremental cost-effectiveness ratio for Iluvien overall is likely to be at least £47,600 per QALY gained, thereby exceeding its threshold for what is normally considered value for money.
In response, Alimera said it is now working on a Patient Access Scheme to address these cost concerns, in the hope of determining an "appropriate pricing for Iluvien in order to ensure that treatment decisions are based on patient need, rather than cost".
Iluvien is an intravitreal implant - inserted in the back of the patient's eye - that delivers tiny levels of the active substance fluocinolone acetonide for up to three years, which was approved for use in the UK in May this year.
Via its anti-vascular endothelial growth factor (anti-VEGF) properties, the drug works by decreasing the build up of fluid in the eye in patients with diabetes, thereby limiting visual loss and/or improving vision.
Its approval was based on clinical trial data showing that, after 30 months, 38% of patients with chronic DME experienced a significant improvement in their visual acuity after receiving the drug.
In addition, at completion of the 36-month study, 34% achieved the same result, a “highly significant” difference compared to the control group, Alimera noted.
It is estimated that around three million people are currently living in the UK with diabetes, of which nearly 200,000 suffer from vision loss associated with DME, and Iluvien remains on track to be launched here in the Spring of next year.