NICE recommends Amryt’s Filsuvez for rare skin disorder

Around 670 people in England with epidermolysis bullosa will benefit from the treatment

The National Institute for Health and Care Excellence (NICE) has recommended Amryt Pharmaceuticals’ Filsuvez (birch bark extract) to treat skin wounds associated with dystrophic and junctional epidermolysis bullosa (EB).

Affecting around 500,000 people worldwide, EB is a general term for a group of rare inherited skin disorders that cause the skin to become very fragile, causing blisters, tears and the loss of skin segments.

As well as external blisters, the condition can cause complications including the development of aggressive skin cancers, dental problems, or nutritional problems linked to effects on the digestive system.

NICE’s final draft guidance marks the first time the institute has recommended a treatment for EB, with around 670 patients in England expected to benefit from Filsuvez.

Helen Knight, director of health technology assessment at NICE, said: “There are substantial treatment requirements to manage [EB] 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.”

The recommendation is supported by positive results from the late-stage birch bark extract clinical trial, EASE, which found that the treatment led to quicker wound healing in patients with dystrophic and junctional EB and had the potential to reduce the amount of skin affected.

Knight added: “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.”

In June 2022, the European Commission approved Filsuvez in the EU for patients aged six months and older for partial-thickness wounds associated with dystrophic and junctional EB.