Italian company fined $31m for charging “exorbitantly high and unfair” drug price; 340 premises “sealed” in Nigerian crackdown; US pharmacist pleads guilty over multimillion-dollar healthcare fraud scheme
The Hague, The Netherlands: The Netherlands Authority for Consumers and Markets (ACM) has fined an Italian drug manufacturer AU$31.5 million for charging “far too high a price” for its prescription drug CDCA-Leadiant.
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 the disease and need to use the drug for the rest of their lives.
For years, the drug had already been used for the treatment of CTX patients under various trade names and at much lower prices.
In June 2017, Leadiant introduced CDCA-Leadiant on the Dutch market, and the company stopped selling another drug that was the same in efficacy, safety, and form. Prior to being acquired by Leadiant, this drug had originally cost a maximum of 46 euros (AU$74) for a package of 100 capsules in the Netherlands.
Leadiant increased the selling price of CDCA-Leadiant to 14,000 euros (AU$22,550). As a result, the drug costs approximately 153,000 euros (AU$246,441) per patient per year, according to the ACM.
“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,” said Martijn Snoep, Chairman of the Board of ACM.
According to ACM, “the price that Leadiant charged was exorbitantly high and unfair. It was exorbitantly high because the price in combination with the low costs and the low risks resulted in an exorbitant return for Leadiant. And it was unfair because the drug, under a different trade name, had already been on the market for years at a much lower price”.
Benin City, Nigeria: The Pharmacists Council of Nigeria (PCN) Enforcement team sealed 340 premises, including 84 pharmacies and 256 patent medicine vendor shops, during a week-long visit to the Local Government Areas of Edo State.
Director of Enforcement, pharmacist Stephen Esumobi, said the team also issued 22 Compliance Directives to premises for various offences, such as poor sanitary conditions, poor documentation and non-display of premises and pharmacist annual licences, reports the Nigerian Observer News.
Mr Esumobi said that those sanctioned were out of the 771 premises, comprising 431 patent and proprietary medicine vendor shops and 340 pharmacies, visited by the enforcement team.
During the visit, he said that the team observed that owners of many premises engaged in the sale of medicines with disregard to guidelines, while most of the patent medicine vendors were operating far beyond their approved scope.
The exercise was the first phase of activities by the PCN to improve the level of pharmaceutical service delivery to the people of Edo State.
Mississippi, United States: A Mississippi pharmacist has pleaded guilty for his role in a multimillion-dollar healthcare fraud scheme, reports the US Department of Justice.
The 42-year-old pharmacist and co-owner of various compounding pharmacies admitted that he participated in a scheme to defraud healthcare benefit programs by distributing medically unnecessary compounded medications.
He did this by adjusting prescription formulas to ensure the highest reimbursement without regard to efficacy, soliciting recruiters to procure prescriptions for high-margin compounded medications, and routinely waiving and reducing co-payments to be paid by beneficiaries and members.
The pharmacist pleaded guilty to conspiracy to defraud the United States and solicit, receive, offer and pay illegal kickbacks, and faces a maximum penalty of five years in prison. Sentencing has been scheduled for 30 November.