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NICE in U-turn on Novartis’ Lucentis in diabetic macular oedema

Patient access scheme influences draft recommendation

National Institute for Health and Clinical Excellence (NICE)

Novartis' Lucentis could be available for mainstream use in the NHS to treat visual impairment due to diabetic macular oedema (VI-DMO) after the National Institute for Health and Clinical Excellence (NICE) issued a draft recommendation overturning a previous negative decision made last year.

The revised guidance, which only applies to patients who have a central retinal thickness of 400 micrometres or more, is due to a patient access scheme implemented by Novartis.

This means the pharma company would cover part of the drug's cost of £742.17 per monthly injection when used to treat the condition, although exactly how much was not disclosed.

In addition, NICE's draft recommendation was also influenced by further data provided by Novartis about the drug's benefits in the specific group of patients it is now provisionally recommended for.

“The manufacturer included updated analyses showing that ranibizumab could be expected to have a superior relative effect among people with central retinal thickness greater than 400 micrometres,” said Professor Carole Longson, Health Technology Evaluation Centre Director at NICE.

In a statement, Novartis said it was “pleased” with NICE's latest guidance, although expressed disappointment it didn't apply to patients with retinal thickness less than 400 micrometres.

The company said: “Novartis however remains concerned that limiting ranibizumab to those with a retinal thickness of 400 micrometres or more will result in patients with high unmet need, who do not meet the criteria, not gaining access.”

Lucentis is currently the only licensed anti-vascular endothelial growth factor (VEGF) treatment for VI-DMO.

If made available on the NHS, it would provide an alternative to laser treatment for patients with VI-DMO is laser treatment, which is unsuitable for certain patients and is not generally associated with improvements in vision.

There now follows a consultation period, with final guidance is expected in February 2013.

5th October 2012

From: Sales

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