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Dutch hospital makes own drug for rare condition after manufacturer hikes price to €170 000

BMJ 2018; 361 doi: (Published 10 May 2018) Cite this as: BMJ 2018;361:k2103
  1. Tony Sheldon
  1. Utrecht

A hospital in Amsterdam has begun producing its own cost price version of the orphan medicine Chenodeoxycholic acid Leadiant (CDCA), a primary bile acid used in treating a rare hereditary metabolic disorder, cerebrotendinous xanthomatosis (CTX), after the manufacturer hiked up the price more than fivefold.

This price increase came after the European Medicines Agency approved the drug’s market authorisation with an indication for CTX (EMA/241528/2017).

Last month Dutch health insurers stopped reimbursing the cost of the drug after Leadiant Biosciences decided to increase the price from €30 000 (£26 450; $35 800) per patient per year to around €170 000. Instead, the pharmacy at Amsterdam’s Academic Medical Center used raw materials imported from China to produce capsules of chenodeoxycholic acid as …

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