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Vedrop®
- Question
- Hello,
I would like to know the latest status concering the prescription of Vedrop® in patients with cystic fibrosis.
Our CF center informed me that the company withdrew the approval for individuals with CF and that therefore they do not prescribe the drug anymore since the health insurance does not pay for it anymore [the original question was asked in German; question and answer refer to the German health care system].
This can also be found here:
http://www.akdae.de/Arzneimitteltherapie/NA/Archiv/2009008-Vedrop.pdf
[German link; a link that is not an exact translation but contains similar information is:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000920/WC500047920.pdf ; see also
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000920/WC500047919.pdf ]
I know, however, from other parents of children with CF that their CF centers do still prescribe Vedrop®.
Could you maybe clarify what the facts are?
Many thanks and best regards
- Answer
- Dear questioner,
Vedrop® is a vitamin E preparation (each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU of tocopherol). The drug is listed on the "Roten Liste" [German data sheet compendium for all drugs approved in Germany including EU approvals] for the following therapeutic indications:
Vedrop® is indicated in 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.
This indications could also include cystic fibrosis if generously considered. However, the drug has no specific approval for CF. The indication for using it in CF patients has to be discussed in every single case with the attending physician.
Generally speaking, vitamin E is not paid by the health insurance for CF patients. Vitamin E is a vitamin that does not have to be reimbursed by the insurances (this also applies for children under 12). Usually pediatricians prescribe it for children up to 12 and in most cases the health insurances cover the costs; they are not obliged to do so, though.
Best regards,
Dr. Christina Smaczny - 15.05.2012
