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NICE backs oedema drug after change of mind

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A new drug option has been provisionally approved for treating visual impairment caused by macular oedema after branch retinal vein occlusion (BRVO).

The National Institute for Health and Care Excellence has today published a final appraisal determination (FAD) on the anti-VEGF injection aflibercept (Eylea) for treating visual impairment in adults caused by macular oedema after BRVO.

“It is great news that patients will have access to an anti-VEGF treatment at the start of the treatment journey”

Cathy Yelf

In an alteration from earlier guideline drafts, it has now recommended that aflibercept be made available under a patient access scheme discount agreed with drug company Bayer.

The move represents a change from draft guidance in June when it was recommended only if laser photocoagulation had not been beneficial or was not suitable due to the extent of the haemorrhage.

At the time, Bayer argued that the draft decision was not in line with Royal College of Ophthalmologists guidelines, which last year recommended prompt first-line treatment with anti-VEGF agents.

The FAD noted that NICE’s guideline committee had subsequently concluded that aflibercept was more clinically effective than laser photocoagulation for untreated visual impairment – caused by macular oedema after BRVO.

It added that “clinical experience” also suggested that aflibercept was more clinically effective when given before, rather than after, laser photocoagulation.

In addition, NICE said it had been informed that aflibercept was considered more effective or equivalent to existing drug treatment options approved for the condition – dexamethasone and ranibizumab.

NICE approved dexamethasone in 2011 and ranibizumab in 2013 to treat visual impairment caused by macular oedema secondary to either central or branch retinal vein occlusion.

Aflibercept injections are already approved by NICE for macular oedema after central branch vein occlusion (CRVO).

Aflibercept costs £816 for a 4mg vial (excluding VAT). The discount provided to the NHS is “commercial in confidence”, noted NICE.

The decision to approve the drug following BRVO will be under consultation until 8 September, with final guidance expected soon after in October.

If it goes ahead, aflibercept will then become the only medicinal product currently approved by NICE as a first-line treatment option for visual impairment due to macular oedema secondary to BRVO.

There are approximately 15,000 cases of macular oedema secondary to BRVO in England and Wales each year, according to NICE.

Aflibercept solution for injection is made up of two human proteins fused together to interfere with two growth factors, vascular endothelial growth factor – A (VEGF-A) and placental growth factor (PlGF).

The growth factors affect the blood vessels beneath the macula by increasing inflammation and fluid leakage, and promoting the growth of abnormal and fragile blood vessels.

By interfering with these growth factors, aflibercept blocks their effect on blood vessels beneath the macula, preventing further damage to sight.

Macular Society

NICE backs oedema drug after change of mind

Cathy Yelf

Cathy Yelf, chief executive of the Macular Society, said: “It is great news that patients will have access to an anti-VEGF treatment at the start of the treatment journey.

“It will mean that they will not have to go through the pain and discomfort that can often be associated with laser treatment and will have the opportunity to preserve their eye sight as much as possible so they are able maintain their independence and the quality of life,” she said.

Alflibercept was licensed by the European Medicines Agency for visual impairment due to macular oedema secondary to BRVO in February 2015.

The Scottish Medicines Consortium also accepted the drug for the treatment of wet age-related macular degeneration in April 2013 and visual impairment due to macular oedema secondary to CRVO in April 2014.

In addition, the SMC accepted it for restricted use for the treatment of visual impairment due to diabetic macular oedema in November 2014.

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