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11 September 2018 / news

Life Sciences Bit: Minister of Health, Welfare and Sport condemns price increase of CDCA drug

Minister Bruins (Medical Care and Sport) of the Ministry of Health, Welfare and Sport (VWS) condemns the decision of pharmaceutical company Leadiant to significantly increase the price of the drug CDCA.

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He wrote this in a letter to the House of Representatives last week.

CDCA (chenodeoxycholic acid) is used as a drug for treatment of the rare genetic metabolic disease CTX (cerebrotendinous xanthomatosis). Over the past years, the price of CDCA have increased from € 300 to € 500 per person a year to € 40,000 per person a year. Last year, Leadiant (the marketing-authorisation holder for CDCA) sharply raised the price of CDCA again to € 153,000 or even € 163,000 per person a year.

The Minister of VWS describes Leadiant’s behavior of more than quadrupling the price of CDCA as "unacceptable to the general public". He said that he could not avoid the impression that Leadiant is abusing its decade-long monopoly on this orphan drug and charges exorbitant prices only to get higher profits. Minister Bruins therefore strongly disapproves Leadiant's conduct.

The Amsterdam University Medical Center (Amsterdam UMC) started preparing its own version of the drug as a result of the gigantic increase in the price of CDCA, but was forced to stop after investigators on behalf of the Health and Youth Care Inspectorate (IGJ) identified some impurities in the used drug substance. The impurity level was higher than permitted according to the IGJ. The IGJ conducts its investigation at the request of Leadiant. The investigation by the IGJ has not yet been completed. Our Life Sciences Team will keep a close eye on any developments in this respect.

Pharmaceutical compounding is rarely permitted and pharmacists engaged in compounding are expected to follow strict legal quality standards and regulations. The IGJ discovered that the active substance used by Amsterdam UMC in the preparation of CDCA did not meet such high quality standards. The minister suspects that Leadiant also controls the supply of the active ingredient of CDCA, as a result of which Amsterdam UMC had to turn to another (less reliable) supplier. Amsterdam UMC immediately stopped the pharmaceutical preparation of CDCA after the finding of impurities and withdrew the already distributed medicines. Amsterdam UMC is, however, researching whether it can prepare a medicine that does meet all legal quality standards in the near future.

The minister is of the opinion that the pharmaceutical preparation of CDCA by Amsterdam UMC should be continued, provided that Amsterdam UMC complies with all quality and safety standards and regulations. According to Minister Bruins, such standards and regulations determine in each individual case whether pharmaceutical compounding is allowed. For the sake of completeness, he notes that this legal framework is unrelated to the costs of pharmaceutically compounded medicines and whether such costs are being covered by a basic health insurance.

 

Should you have any questions regarding the legal standards and regulations in respect of pharmaceutical compounding, please do not hesitate to contact Dieuwertje van Dijk or your permanent Loyens & Loeff advisor.

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