Paul Sancia/Associated Press
Although very rare, very high lead levels can cause seizures, coma, and brain swelling, which can be life-threatening.
CNN
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Rising Pharmaceuticals, which makes a key drug for the most severe cases of lead poisoning, is helping uninsured and underinsured patients afford a drug that costs more than $32,000 for one course of treatment. He said that he plans to launch a support program to help.
The company announced it would introduce the program “immediately” following CNN's report. report On Wednesday, the company announced it had priced its drug, which was approved by the U.S. Food and Drug Administration in August, at nearly 10 times the price of the French import.
Sen. Amy Klobuchar (D-Minnesota) letter Rising CEO on Thursday. It wants answers about how the company arrived at that price and how it impacts patient care.
Pediatric toxicologists say the high price of the drug, called calcium disodium EDTA, can make it difficult for hospitals to stock it, potentially delaying treatment by days for children with the most severe cases of lead poisoning. He said there is. Although very rare, very high lead levels can cause seizures, coma, and brain swelling, which can be life-threatening.
Rising said in a statement Friday that it is “ensuring that we stock our products in all of our wholesale stores nationally and regionally for quick delivery to hospitals and clinics with patients in need.” We can deliver on the same day or overnight.” Same-day or next-day administration. ”
The company said it also has a “free exchange program,” noting that because the drug is rarely used, “a significant portion of the products manufactured and launched each year are returned for replacement or disposal.”
Rising noted that “previous U.S. companies discontinued production and exited the market for this product due to low production volumes and continued availability being economically unsustainable.”
The wholesale price of the French version of EDTA in the United States was $3,500, according to manufacturer BTG Pharmaceuticals, a SERB company. The FDA approved imports last year after the drug was in short supply in the U.S. in 2021. The former manufacturer, Valeant Pharmaceuticals, which has since changed its name to Bausch Health, raised the price to about $27,000 per course before discontinuing the product 10 years ago.Continue backlash.
Rising said it developed the version for reintroduction more than a decade ago, and in a statement said it had “developed a U.S.-approved, U.S.-compliant product to support the needs of physicians and patients for the foreseeable future.” We will do our best to maintain this in the market.”
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Patient assistance programs can provide a way for drug companies to cover a portion of a patient's costs when insurance does not fully cover the price of the drug. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said these are “a common way for drug companies to try to allay concerns about prices being too high.”
Kesselheim, who also directs the Regulatory, Therapeutic, and Legal Program in the Department of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, said such programs can be helpful for some patients; He said studies often have restrictions on who is eligible, and they may be underutilized because patients either don't know about them or don't want to give sensitive information to drug companies. .
He also noted that while some plans only cover patients' out-of-pocket costs, insurance companies still have to pay for the majority of drug costs, “which increases the cost of health care for everyone.” .
“Patient assistance programs are therefore not a sustainable and reliable solution to this problem,” Kesselheim said.
