Thousands of people in England could benefit after NICE today (Tuesday, 24 May) published final draft guidance recommending a new drug to help treat two leading causes of sight loss and visual impairment.
Clinical evidence shows faricimab (Vabysmo, Roche) 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 and is being recommended as an option for treating some adults with wet age-related macular degeneration (AMD) or with diabetic macular oedema (DMO).
In the key clinical trials, aflibercept, another eye injection drug used to treat AMD and DMO, 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.
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.
Our final draft guidance is being published just a week after faricimab was announced as the first treatment to be licensed by the Medicines and Healthcare products Regulatory Agency’s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.
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.”
Cathy Yelf, chief executive of leading sight loss charity the Macular Society, said: “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.”
Health and Social Care Secretary Sajid Javid said: “It’s excellent news that Faricimab will be rolled out across England to help thousands of patients suffering from sight loss and visual impairment.
“Now we have left the EU, the UK is free to team up with other world-leading experts to support initiatives and research, speed up the approval process for medicines, and maintain the highest safety standards.
“This is a great example of UK patients getting quicker access to ground-breaking treatments and I’m grateful to NICE for playing its part in making this possible.”
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.
Our committee found that 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 confidential price discount, or patient access scheme, has been agreed between NHS England and NHS Improvement and the company.
The final appraisal documents (FAD) on faricimab to treat wet age-related macular degeneration and diabetic macular oedema are open to appeal and are available to view in full on the NICE website.
The final guidance is due to be published on June 29.
