NICE has recommended birch bark extract (also called Filsuvez and made by Amryt Pharmaceuticals) for treating skin wounds associated with dystrophic and junctional epidermolysis bullosa in final draft guidance published today (18 August 2023) as part of its highly specialised technologies programme.
This is the first time NICE has recommended a treatment for EB.
Epidermolysis bullosa (EB) is a general term for a group of rare inherited skin disorders that cause the skin to become very fragile. Any trauma or friction can cause the skin to blister and tear easily and substantial segments of skin may fall off. It can also cause constant itching, significant and prolonged pain and skin wounds that stay open for long periods of time, increasing the risk of infection.
As well as external blisters, EB can affect areas such as the eye, mouth or stomach. Other complications can include the development of aggressive skin cancers, dental problems, or nutritional problems linked to effects on the digestive system.
In the clinical trial birch bark extract led to quicker wound healing than a control gel in people with dystrophic and junctional EB. The results also suggest it may reduce the amount of skin affected.
Helen Knight, director of health technology assessment at NICE, said: “Today’s final draft guidance is yet another example of how NICE is able to drive innovation into the hands of health and care professionals and get the best care to people fast, striking a balance between effectiveness and the best use of public funding.
“EB can have significant negative effects on the quality of life of people with the condition and those who care for them. The committee heard from the patient experts that, with no disease modifying treatments available, there are substantial treatment requirements to manage symptoms. These include daily cleaning of wounds and dressing changes that can often total 37 hours a week and which themselves can cause substantial pain.
“Birch bark extract, by reducing the time taken for wounds to heal and therefore the time needed to clean and redress them and the pain associated with that, has the potential to improve the quality of life for people with EB and their carers and help free up time for other activities.
“We’re particularly grateful to the patient organisations, DEBRA and Genetic Alliance UK, and the patient experts for their powerful testimonies giving a valuable insight into the experiences of people with this debilitating and distressing condition.”
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