The National Institute for Health and Care Excellence (NICE) has today (2 June) recommended two treatments for NHS patients with diabetic macular oedema (DMO): Eylea and Ozurdex.
Eylea (aflibercept), manufactured by German pharma company Bayer, has already received recommendations for patients with wet age-related macular degeneration and macular oedema secondary to central retinal vein occlusion.
The latest draft Final Appraisal Determination now recommends the anti-VEGF treatment for patients with visual impairment due to DMO in England and Wales, with a retinal thickness of 400µm or more. The Scottish Medicines Consortium accepted Eylea for restricted use for the treatment of visual impairment due to DMO in November 2014.
The second treatment, Ozurdex, which is manufactured by Allergan, has also received a recommendation. The slow-release intravitreal implant is recommended for DMO patients with an intraocular lens, and whose condition does not respond to non-corticosteroid treatments, or where such treatment is unsuitable.
Director of the Health Technology Evaluation Centre at NICE, Professor Carole Longson, said: “NICE is pleased to give the green light to both dexamethasone intravitreal implant and aflibercept as treatment options for some people with diabetic macular oedema in final draft guidance. The condition affects around 189,000 people with diabetes in the UK, and can have a substantial negative impact on quality of life and daily activities. These decisions will therefore be welcome news to both patients and healthcare professionals.”
Commenting on the announcement, CEO of Bayer UK/Ireland, Dr Alexander Moscho, said: “We are pleased that NICE has recognised the difference that Eylea can bring to people with visual impairment due to DMO and to NHS eye services.”
Dr Moscho added: “The wealth of evidence from NHS clinical practice and ongoing clinical trials continue to cement this treatment as a valuable option for patients with serious retinal conditions and we hope that the real-life visual outcomes seen in other indications can now be replicated for people with DMO.”
The charity sector welcomed the announcement but raised concerns the latest recommendations fail to meet the “unmet need” for patients with DMO.
Dr Maria Dawson, part of the eye health campaigns team at Royal National Institute of Blind People, said: “The use of Eylea is only recommended as an option if the eye has a central retinal thickness of 400µm or more at the start of treatment. This means that those patients with early onset disease have no treatment options and as result may have to unnecessarily lose existing sight before they qualify for treatment.”
She added: “We feel it is unacceptable that a treatment proven to work is denied to many patients with early onset disease based on cost."
Dr Dawson also criticised the restrictions to the use of Ozurdex to patients with an artificial lens, highlighting the lack of treatment for patients with natural lens.
She commented: “Ultimately, there is still an unmet need for these patients with DMO which needs to be addressed. We are concerned that all these restrictions will result in patients needing to lose their sight as a pre-requisite for treatment, and that many will receive no treatment at all. We are calling on NICE to address the management of all patient groups, including those with early onset, when appraising treatments.”