Thousands to get new treatment on NHS for wet age-related macular degeneration

Thousands of people in England will be able to get new treatment on the NHS for wet age-related macular degeneration or for diabetic macular oedema.

NICE (National Institute of Health and Care Excellence) has published its final draft guidance recommending the new drug faricimab (Vabysmo, Roche) after clinical evidence showed it is effective in improving vision or reducing vision loss and can be administered less frequently than other medicines currently available.

Faricimab is administered as an eye injection.

In the key clinical trials, aflibercept, another eye injection drug used to treat AMD (age-related macular degeneration) and DMO (diabetic macular oedema) was administered every 8 weeks, while faricimab dosing based on assessments of the disease activity allowed for an interval of up to 16 weeks between doses and was found to be equally effective.

Helen Knight, interim director for medicines evaluation at NICE, said: “I am delighted that we have been able to recommend this treatment to help tackle two leading causes of vision loss so close to its licence just last week.

“We are determined to drive innovations like these into the hands of clinicians to help patients as soon possible. We will continue to work closely with our colleagues in other healthcare organisations to ensure we deliver progressive treatments which balance the best care with value for money, delivering both for individuals and society as a whole.”

Up to 300,000 people in England with wet age-related macular degeneration (AMD) could be eligible to receive faricimab as part of their treatment alongside just over 28,000 people with diabetic macular oedema.

Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in the retina at the back of the eye, leaking blood or fluid which leads to scarring of the macula and rapid loss of central vision.

Diabetic macular oedema is the most common cause of sight loss in people with diabetes and affects the retina.

'This will make a real difference to the lives of many people'

Cathy Yelf, chief executive of leading sight loss charity the Macular Society, said in response to the recommendation: “Patients with wet age-related macular degeneration and diabetic macular oedema face the burden of regular hospital visits to receive the vital treatment they need to save their sight. However, we know these trips can be arduous and often rely on the support of friends and family, sometimes as often as every four weeks.

“We are delighted that a new treatment option, which has the potential to maintain vision and help minimise the number of hospital visits, will be made available to patients in England. This will make a real difference to the lives of many people living with this devastating condition.”

NICE’s final draft guidance is being published just a week after faricimab was announced as the first treatment to be licensed by the Medicines and Healthcare products Regulatory Agency’s (MHRA) through its participation in the Access Consortium ‘New Active Substance Work Sharing Initiative’.

The consortium is made up of regulatory authorities including the United Kingdom, Australia, Canada, Singapore, and Switzerland, which aims to give people faster access to high quality treatments.

Wet age-related macular degeneration and diabetic macular oedema are usually treated with injections of aflibercept or ranibizumab, or brolucizumab (AMD only), which are already recommended by NICE, and faricimab would be another treatment option which works in a similar way.

NICE found faricimab is likely to be cost saving or have a similar cost compared with aflibercept or ranibizumab and is likely to deliver similar health benefits. A patient access scheme has been agreed between NHS England and NHS Improvement and the company.

The final guidance is due to be published on 29 June.

Faricimab was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on 16 May and is recommended as an option for treating visual impairment due to diabetic macular oedema in adults, only if the eye has a central retinal thickness of 400 micrometres or more at the start of treatment.

Faricimab is also recommended as an option for treating wet age-related macular degeneration in adults, only if the eye has a best-corrected visual acuity between 6/12 and 6/96, there is no permanent structural damage to the central fovea of the eye, the lesion size is 12-disc areas or less in greatest linear dimension or there are signs the disease has progressed.