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Zorginstituut Nederland, which advises the Minister on the reimbursement of drugs, believes that the price of CDCA delivered by Leadiant is also too high. The cost of treatment of an adult patient is 153 500 euros per year.
If the same patients are treated with the drug prepared at the hospital pharmacy, the cost is 20,000 to 25,000 per year. "We think the cost difference between CDCA-Leadiant and pharmacy preparation is unacceptable," the institute wrote last week in a letter to the minister.
Zorginstituut recommends that the Minister negotiate with the pharmaceutical manufacturer to reduce costs. The advisory body emphasizes in its letter to the Minister that Leadiant does not invoke anything that would justify a price increase.
Announcement
Leadiant filed a very detailed complaint against AMC at the IGJ. The Inspectorate has finally picked up only two of the points of this complaint: the impurities of the raw material used by the AMC and the violation of the rules regarding advertising.
This last point involves the ban on advertising for a drug that can be provided on prescription. The AMC had announced, by various means, that patients with CTX could report the drug to the AMC pharmacy.
The AMC had done so because, in the beginning, when she started to make CDCA, only two patients with CTX treated. Most people with this rare metabolic disease have visited the CWZ in Nijmegen, where it is the national center of expertise for the disease. But in Nijmegen, they do not have a pharmacy where the drug can be made
Privilege?
Leadiant's main objection was that the CMA allegedly violated the exclusive right of the Italian pharmaceutical company to manufacture CDCA. But the IGJ thinks this is not the case.
"The company asserted, writes the Inspectorate in a press release," that the AMC and other involved organizations had committed various violations. "The Inspectorate felt prepared on a small scale and delivered directly to patients, which is legally permitted. "
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