Advice
following a resubmission:
tocofersolan oral solution (Vedrop®) is not recommended for use within NHS Scotland.
Indication under review: vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
In an open-label, single-arm study, 96% of patients had an improved or stable neurological score after 2.5 years of treatment with tocofersolan.
The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
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Medicine details
- Medicine name:
- tocofersolan (Vedrop)
- SMC ID:
- 696/11
- Indication:
- vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
- Pharmaceutical company
- Orphan Europe (UK) Ltd
- BNF chapter
- Nutrition and blood
- Submission type
- Resubmission
- Status
- Not recommended
- Date advice published
- 08 October 2012