Holanda: Consumers and Markets (ACM) multa a Leadiant 19.569.500 €

 

The Netherlands Authority for Consumers and Markets (ACM) has established that drug manufacturer Leadiant charged far too high a price for its prescription drug CDCA-Leadiant. 

As such, Leadiant abused its dominant position. ACM has therefore imposed a fine on Leadiant of 19,569,500 euros.

Martijn Snoep, Chairman of the Board of ACM, explains: 

‘Drugs manufacturers that introduce affordable, innovative prescription drugs make important contributions to society. And it’s okay to make money on such contributions. This situation however was something entirely different. After a small, low-risk investment, Leadiant implemented a huge price increase for a drug that had already existed for years. In this case, there was no innovation at all. We consider this to be a very serious violation. The price increase offers Leadiant a very high return, but it offers patients very few additional benefits, and it drives up the costs to society.’

What was the case about?

The drug chenodeoxycholic acid (CDCA)-Leadiant is used for the treatment of patients with the rare hereditary metabolic disorder cerebrotendineous xanthomatosis (CTX). In the Netherlands, approximately sixty patients suffer from this disease. These individuals need to use the drug for the rest of their lives.

For years, this drug had already been used for the treatment of CTX patients under various trade names and at much lower prices. In 2008, Leadiant acquired a CDCA-based drug from another manufacturer. 

At the time, the maximum price in the Netherlands was 46 euros for a package of 100 capsules. In late 2009, Leadiant changed the trade name of the drug to Xenbilox, and raised its price, as a result of which the selling price became 885 euros.

In 2014, Leadiant decided to apply for an orphan drug designation and marketing authorization for its CDCA-based drug for the treatment of CTX. In that context, Leadiant raised the price of Xenbilox, as a result of which the selling price went up from 885 euros to 3,103 euros. The orphan drug designation was granted in late 2014. When Leadiant in April 2017 was also granted the marketing authorization, the company was granted the exclusive right for ten years to supply a CDCA-based drug for the treatment of CTX to the European market. Shortly thereafter, in June 2017, Leadiant introduced CDCA-Leadiant on the Dutch market, and the company stopped selling Xenbilox. Although those two drugs do not differ in efficacy, safety, and form, and Leadiant had already recouped the application costs at that point, Leadiant increased the selling price to 14,000 euros. As a result, the drug costs approximately 153,000 euros per patient per year. This high price provoked a large public outcry, after which Amsterdam UMC made an attempt to manufacture the drug themselves (compounding). Leadiant charged this price of 14,000 euros in the Netherlands until Amsterdam UMC succeeded in manufacturing the drug in its own pharmacy in January 2020. Más