Photo: DutchNews.nl |
Amsterdam’s AMC teaching hospital can make its own
version of a licenced drug to treat a rare metabolic disorder but must adapt
its production methods, health ministry inspectors said on Wednesday.
The
inspectors were responding to a complaint by by Italian pharmaceuticals company
Leadiant, which produces the drug henodeoxycholic acid or CDCA, used to treat a
rare metabolic disorder.
The hospital began making its own version of the drug
in April because it was no longer covered by health insurance after the price
shot up. That month Leadiant ramped up the price by around 500% so it now costs
some €200,000 per patient per year.
The hospital said at the time it could
produce the drug for €25,000.
In August the hospital was ordered to recall the
drug by health inspectors because of fears the raw materials might contain
impurities, a worry which turned out to be true.
However, rather than ban the
hospital from picking up production again, the inspectorate has said it can
continue, if it changes the production process. It must also stop ‘advertising’
the drug – by promoting it to other patients via the media, a second complaint
submitted by Leadiant.
Hospital pharmacies make their own medicines more often
but this case is unusual because of the financial considerations. The hospital
is offering ‘a social and economically-responsible alternative to a registered
medicine which is so expensive that it is inaccessible to patients,’ the AMC
said in April.
Just 60 patients in the Netherlands suffer from the disease CTX
which the drug is used to treat.
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