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Novartis Drug for Macular Oedema Denied

NICE, the UK Regulator denies Novartis Eye DMO Drug yet again

July 2011

The National Institute for Health and Clinical Excellence, NICE, have stated that compared to the standard laser therapy, Novartis drug therapy for patients suffering from diabetic macular oedema "substantially" exceeds the range" which the cost regulator deems reasonable.

"Although it has been shown in clinical trials to be an effective treatment, the appraisal committee was unable to recommend the drug as a cost-effective use of resources compared to laser [therapy] for this condition," said NICE chief executive Andrew Dillon.

The Swiss drug maker reacted with disappointment and said it would appeal the UK decision, which is provisional at present.

NICE, which is reimbursing Lucentis for the treatment of wet age-related macular degeneration, said Novartis underestimated the costs, especially for patients who need to treat both eyes.

Lucentis, which is administered via an injection into the eye, where it blocks the production of a protein that can lead to vision loss, can cost up to £1000 per injection.

Its high price has also been under pressure in the U.S. from doctors and regulators.

Novartis claimed that Lucentis has shown to provide superior and sustained vision gains compared to laser therapy.

The Swiss drug maker said it has "an excellent track record of working with health authorities and reimbursement agencies across the world to secure access to medicines for patients" and would appeal the verdict.

Chief executive Joe Jimenez has repeatedly said that Novartis was looking for fair solutions with regulators. As part of its efforts to win reimbursement for the drug in the U.K., Novartis is offering to pay for the injections in patients, who need more than 12 injections.

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