Birch bark extract is recommended, within its marketing authorisation, as an option for treating partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa in people aged 6 months and over. It is only recommended if the company provides it according to the commercial arrangement.
Why the committee made these recommendations
Dystrophic and junctional epidermolysis bullosa have a substantial impact on quality of life, and there are no licensed treatments. Usual treatment includes wound management, pain management and repeated surgery.
In a clinical trial, birch bark extract led to quicker wound healing than a control gel. The results also suggest that it may lead to a reduced amount of affected skin.
The results of the trial were used to estimate the numbers of people with different disease severities in the economic model. But some people did not finish the trial, and a higher proportion of people with severe epidermolysis bullosa dropped out than those with less severe epidermolysis bullosa. This means there was uncertainty around cost-effectiveness estimates.
Taking into account the evidence and the uncertainties, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, birch bark extract is recommended.