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Four UK charities have joined forces to urgently campaign for a potentially sight-saving drug to be made available for people with diabetic macular oedema (DMO) after the National Institute for Health and Clinical Excellence (NICE) turned down an appeal for it to be used on the NHS.

Diabetes UK, JDRF, the Macular Disease Society (MDS) and the Royal National Institute of Blind People (RNIB) are urging the manufacturer of Lucentis, Novartis, to rapidly agree a patient access scheme with the Department of Health and NICE. Such a scheme would reduce the cost of this treatment to the NHS and ensure the maximum number of people with DMO can benefit from the treatment without delay.

50,000 affected in UK

At least 50,000 people in the UK are affected by DMO, a serious eye condition which can lead to sight loss as a result of fluid leaking from the small blood vessels in the eye. Traditionally, laser treatment has been the standard treatment for DMO on the NHS, yet this only stops vision from deteriorating further. Lucentis, which is given in the form of an injection in the eye, is the first licensed treatment to improve vision in people with sight loss due to DMO.

Decision based on cost-effectiveness

NICE announced its original decision not to recommend Lucentis as a treatment for people with DMO on the NHS in July on the basis of cost-effectiveness. The charities appealed this decision, arguing that NICE failed to act fairly as key patient organisations and clinicians were not given the opportunity to comment on significant new evidence submitted by the drug manufacturer which may have led to incorrect conclusions being drawn in NICE’s final decision.

Patient access scheme

Now that the appeals have been rejected, the charities are calling on Novartis, the Department of Health and NICE to quickly agree a patient access scheme to ensure patients are able to access the treatment.

NICE has also made clear that people who are already receiving treatment on the NHS with Lucentis should have the option to continue treatment until they and their clinician consider it appropriate to stop.

"Human impact stretches far beyond financial costs"

Simon O’Neill, Director of Care, Information and Advocacy at Diabetes UK, said, "Naturally, we are disappointed that NICE has turned down our appeal, as we believe this treatment is vital to prevent people from needlessly losing their sight. Diabetic retinopathy is the leading causes of blindness in people of working age in the UK, and the human impact of this stretches far beyond the financial costs.

"It is now of upmost importance that the drug manufacturer works with the Department of Health and NICE to negotiate the costs of this treatment so people with diabetes are still able to access it without detracting from other vital NHS services, such as Diabetes Specialist Nurses and eye screening."

"A direct impact on thousands of people with Type 1 diabetes"

Sarah Johnson, Director of Policy and Communications at JDRF said, "Our concern is that NICE's decision to turn down our joint appeal will have a direct impact on thousands of people with Type 1 diabetes. People with the condition have a right to access safe and effective treatments to protect them from the serious complications of their condition, one of which is Diabetic Macular Oedema.

"We supported research into Lucentis during the early stages of the drug’s development, and were disappointed by NICE’s decision not to recommend the drug for use on the NHS. It is now vital that the Department of Health and NICE work together with the drug manufacturer to ensure the best outcome for people at risk of losing their sight."

"Not acceptable to deny access"

Helen Jackman, CEO the Macular Disease Society, said, "We are disappointed because this treatment makes such a difference to the lives of people with sight loss caused by diabetes. We do urge the manufacturer and the Department of Health to find a solution – it is not acceptable just to deny people access to a treatment that works."

"Wrong assumptions"

Steve Winyard, RNIB Head of Policy and Campaigns said: "As a patient organisation, we are deeply frustrated that a full review of all the available information has not been allowed. Patients at risk of losing their sight have a right to expect that clinical experts and patient organisations have a chance to review all the evidence on a treatment.

"We firmly believe that some of the assumptions made about the cost-effectiveness of the treatment were wrong. In particular, there is a very strong case for providing Lucentis to those patients with thicker retinas who are unable to benefit from existing laser treatments. A second consultation would have allowed this to be examined. However, we now hope that a patient access scheme can be agreed swiftly, so that patients with DMO are not left to needlessly lose their sight."

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