ACM extends its investigation into orphan drug CDCA-Leadiant

The Netherlands Authority for Consumers and Markets (ACM) extends its investigation into the orphan drug CDCA manufactured by Leadiant. The investigation focuses on the question whether the manufacturer abuses a dominant position in the pricing of the drug.

Background of the investigation

Following a complaint, among other reasons, ACM launched an investigation into the high prices of the drug chenodeoxycholic acid (CDCA) manufactured by Leadiant. ACM assesses whether the manufacturer abuses a dominant position by charging excessive prices. In order to answer this question, ACM carried out an extensive study into the market conditions, the price of the drug, the costs associated with the drug, as well as the price increases implemented by Leadiant. As part of this study, ACM requested information from the supplier of the raw material for CDCA and from the distributor of the drug in the Netherlands. In addition, ACM asked questions to various Dutch health care agencies, such as the National Health Care Institute (ZiN), the Medicines Evaluation Board (CBG-MEB), the Health and Youth Care Inspectorate (IGJ), and the European Medicines Agency (EMA). In the context of this investigation, ACM also works together with competition authorities in other countries. ACM expects to complete its factual investigation after the summer.

CDCA is prescribed for the treatment of the rare metabolic disease cerebrotendinous xanthomatosis (CTX). In the Netherlands, approximately sixty people suffer from CTX. CDCA has been sold for treatment of CTX in the Netherlands by Leadiant under the name CDCA-Leadiant since June 2017. Leadiant charges approximately 153,000 euros for the treatment of one patient for one year.

ACM’s oversight of prescription drug prices

Competition in the pharmaceutical industry helps foster innovation, and helps towards keeping prescription drugs affordable. ACM makes sure that drug manufacturers comply with competition rules. In 2018, ACM put ‘prescription drug prices’ on its agenda, because of the public debate about drug prices and the pressure on health care costs. In that context, ACM launched several investigations, including this investigation into Leadiant.