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NICE backs Novartis' Jetrea in rare eye condition

Recommends drug be available for NHS use to treat vitreomacular traction

Novartis building

Novartis has won backing from the UK's National Institute for Health and Care Excellence (NICE) for Jetrea in the treatment of the rare eye condition vitreomacular traction.

The cost-effectiveness watchdog's final draft guidance recommends the drug be available for regular use on the NHS in England and Wales and halts a series of negative NICE decisions for Novartis, including rejections for blood cancer drug Jakavi (ruxolitinib) and Afinitor (everolimus) for advanced breast cancer.

NICE's decision means Jetrea (ocriplasmin) is on course to become the first non-surgical treatment recommended for NHS use to treat vitreomacular traction, which involves the vitreous – the gel-like substance in the eye – pulling on the retina to distort vision and create a hole in the macular area of the eye.

As per its initial recommendation in June 2013, NICE's final draft guidance limits the drug's use to patients with a macular hole greater than 400 micrometres in diameter and who have severe symptoms and do not have the related eye complication epiretinal membrane.

This differs from its licence from the European Medicines Agency (EMA), which in March 2013 approved the use of Jetrea in any adult with the condition.

Despite these limitations, Novartis said it was “pleased” with NICE's recommendation, and expects final positive guidance in autumn this year.

Once launched, Jetrea will be marketed by Novartis' eye division Alcon, which purchased non-US rights to the drug from Belgian pharma company ThromboGenics in March 2012. ThromboGenics retains the rights to commercialise the drug in the US, where it was approved by the Food and Drug Administration (FDA) in October 2012.

Tim Jackson, consultant retinal surgeon at King's College Hospital, explained the benefits the recommendation brings to the estimated 45,000 vitreomacular traction patients in the UK whose only previous option was a period of 'watchful waiting', involving a stage of observation before becoming eligible for eye surgery.

“For suitable patients, the injection offers a treatment that may avoid the need for eye surgery, and means those unsuited to surgery can now be treated, often before their condition deteriorates,” said Jackson.

“Today's decision is an important step forward in increasing the treatment options for patients and eye doctors."

Article by
Thomas Meek

30th August 2013

From: Sales, Healthcare



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