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NICE set to approve Novartis eye drug Lucentis

Final draft guidance says treatment is cost-effective in diabetic macular oedema

Novartis Lucentis

Patients in England will soon have access to Novartis' Lucentis after it was finally deemed a cost-effective use of NHS resources as a treatment for the eye condition diabetic macular oedema.

The final draft guidance from the National Institute for Health and Clinical Excellence (NICE) comes almost two years after Novartis first submitted the drug for recommendation, with Lucentis (ranibizumab) originally turned down in November 2011 when it was deemed too expensive.

However, Novartis has since agreed a patient access scheme with NICE to cover part of the drug's cost, with NICE also insisting the drug only be available for a limited group of patients who have a central retinal thickness of 400 micrometres or more - over twice that seen in a normal eye.

“In November 2011, NICE published guidance which did not recommend the drug as an effective use of NHS resources,” said Professor Carole Longson, Health Technology Evaluation Centre director at NICE.

“However, following the submission of a revised patient access scheme, we have conducted a rapid review of the original guidance. The manufacturer also 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.”

Novartis had previously raised concerns about the limited nature of the recommendation, and said the drug should be available to a wider patient population when NICE posted previous draft guidance in October, 2012, but the cost-effectiveness body has stuck to its decision, ruling that the quality-adjusted life year (QALY) cost for patients with thinner retinas would likely otherwise exceed NICE's threshold of £25,000 per QALY.

Commenting on the latest recommendation, Novartis said: “An estimated 25,000 people with the condition could now soon be eligible for treatment with ranibizumab, which has more likelihood to not only preserve but improve vision compared with laser therapy, the current standard of care.”

Final guidance for Lucentis' use in the treatment of diabetic macular oedema, which involves the build-up of excess fluid in the eye, is now expected in February 2013 and the new final draft guidance puts Lucentis on course for a second NICE recommendation, having already been deemed a cost-effective treatment for age-related macular degeneration (AMD).

4th January 2013

From: Sales

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