What has SMC said?
Birch bark extract was assessed by the Scottish Medicines Consortium (SMC) and meets the definition of an ultra-orphan medicine, which is a medicine to treat an extremely rare condition.
This document summarises the initial SMC assessment of birch bark extract for treating partial thickness wounds (where the upper layers of skin have been damaged) due to dystrophic and junctional epidermolysis bullosa (EB, also known as Butterfly skin). It is used in patients who are 6 months old or older.
You can find more detailed information by looking at the SMC ultra-orphan initial assessment (SMC2651).
What does SMC's assessment mean for patients?
The Scottish Government will confirm when birch bark extract is available for prescribing on the NHS in Scotland as part of the ultra-orphan pathway.
Your healthcare professional can discuss with you if it is the right treatment for you or your child.
You can find more information about making decisions about your or your child’s treatment in this booklet called: Medicines in Scotland: What’s the right treatment for me?
What has SMC said in this assessment?
The clinical trial showed that birch bark extract gel led to quicker wound healing than a control gel (a dummy treatment). However, the effect of birch bark extract on other symptoms (for example pain and itching) in patients with EB is unclear.
There is uncertainty about whether the beneficial effects of birch bark extract gel seen in patients with recessive dystrophic EB (most patients in the trial) will also be seen in patients with the other subtypes of EB.
Despite the confidential discount offered by the company, the cost in relation to the health benefits of birch bark extract gel remains high.
How does SMC assess ultra-orphan medicines?
SMC uses a broad assessment framework for ultra-orphan medicines. This is part of the ultra-orphan pathway in NHSScotland.
You can find out more about how SMC assesses medicines in the ultra-orphan pathway here: https://www.scottishmedicines.org.uk/how-we-decide/ultra-orphan-medicines-for-extremely-rare-conditions
More information and support
The organisation below can provide more information and support for people with EB and their families. SMC is not responsible for the content of any information provided by external organisations.
DEBRA UK
https://www.debra.org.uk
01344 771961
You can find out more about birch bark extract (Filsuvez®) in the Patient Leaflet by searching for the medicine name on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
https://products.mhra.gov.uk/