Dutch hospital challenges big pharma by making own version of very pricey drug

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Amsterdam’s AMC teaching hospital is to start making its own version of a licenced drug to treat a rare metabolic disorder because the medicine is no longer covered by health insurance after the price shot up.

The drug, chenodeoxycholic acid or CDCA is produced by Italian pharmaceuticals company Leadiant. On April 1, the company ramped up the price by around 500% so it now costs some €200,000 per patient per year. The hospital can produce the drug for €25,000.

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.




Just 60 patients in the Netherlands suffer from the disease CTX which the drug is used to treat.

The drug has been available since the 1970s but Leadiant only registered it as an orphan medicine with the European medicines agency last year. Orphan status, given to drugs which are used to treat very specific and rare illnesses, means a drug cannot be copied for a 10-year period.

Prescription

There is a loophole, however:  a pharmacist can make the drug for their own patients. And even though the AMC only has two, ‘anyone can register at our pharmacy with a doctor’s prescription,’ AMC professor Carla Hollak told the NRC.

The measure is being supported by health insurance companies. Health minister Bruno Bruins told RTL news that he preferred the use of registered medicines because of the tough procedures they have gone through.

Nevertheless, he said, it is unacceptable that companies raise the price ‘to make fat profits’.

Blackmail

The Dutch healthcare institute Zorginstituut Nederland said in February insurers should stop paying for expensive drugs if pharmaceutical companies continue to refuse to say how they arrive at the price.

The institute, which assesses the efficacy of new drugs and advises the government on whether they should be included in the basic healthcare policy, says the drugs companies are effectively blackmailing officials by refusing to be transparent about their prices.

Leadiant Biosciences told DutchNews.nl in a statement: ‘We follow the discussion and the AMC initiative. Bringing medicines for rare diseases like CTX to patients and families in need requires a collaboration between industry and health systems, including governments, regulators, insurers, advocacy groups, and health professionals.

‘At the heart of the issue is ensuring the medicines we develop and deliver meet the appropriate standards of safety, efficacy and quality – and are accessible to the people who need them. We will continue to engage with the relevant stakeholders on solutions that address these needs.’

The company did not comment on the reason behind the price hike.


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