Maker of $32,000 lead poisoning antidote pledges to create assistance program to help uninsured patients afford drug

By CNN Newsource

Published December 8, 2023 12:56 PM

By Meg Tirrell, CNN

(CNN) — Rising Pharmaceuticals, maker of a crucial drug for the most severe cases of lead poisoning, said it plans to start an assistance program to help uninsured and underinsured patients afford the medicine, which costs more than $32,000 for one course of treatment.

The company said it will introduce the program “soon,” after CNN reported Wednesday that it had priced its drug – approved by the US Food and Drug Administration in August – almost 10 times higher than an imported version from France.

Sen. Amy Klobuchar, D-Minnesota, sent a letter to Rising’s CEO on Thursday, seeking answers about how the company reached the price and what effects it has on patient care.

Pediatric toxicologists said the cost of the medicine, called calcium disodium EDTA, can make it difficult for hospitals to stock, leading to potential delays of a few days in treating children with the most severe cases of lead poisoning. Although it’s very rare, when lead levels get extremely high, they can cause seizures, coma and brain swelling and can be life-threatening.

Rising said in a statement Friday that it “ensures the product is stocked at all national and regional wholesale outlets for rapid distribution to any hospital or clinic that has a patient in need” and said it “can be delivered the same day or overnight for same day or next day administration.”

The company said it also has a “free replacement program,” noting that because the drug is so rarely used, “a sizable portion of product manufactured and released each year will be returned for replacement and/or destroyed.”

Rising pointed out that “prior US companies stopped manufacturing and exited this product market due to the low volume and unsustainable economics of keeping it available.”

The French version of EDTA had a wholesale acquisition cost of $3,500 in the US, according to its maker, SERB’s BTG Pharmaceuticals. The FDA allowed importation last year after the drug went into shortage in the US in 2021. Its previous maker, Valeant Pharmaceuticals, which subsequently changed its name to Bausch Health, had raised the price to almost $27,000 a course a decade ago before discontinuing the product following backlash.

Rising said it developed its version for reintroduction more than 10 years ago and said in its statement that it’s “committed to maintaining a US approved, US compliant product on the market to support practitioner and patient needs for the foreseeable future.”

Patient assistance programs can provide ways for drugmakers to cover some costs for patients when insurance doesn’t cover enough of the price of a medicine. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said they “are a common way that pharmaceutical manufacturers have tried to quell concerns about their excessively high prices.”

Kesselheim, who also directs the Program on Regulations, Therapeutics and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, noted that such programs can be helpful for some patients but said studies show that they often have restrictions about who qualifies and that they may be underused because patients don’t know about them or don’t want to provide sensitive information to drug companies.

He also pointed out that some programs cover only the patient’s out-of-pocket costs, while insurers still must pay for the majority of the drug’s cost, “which raises health care spending for everyone.”

“So patient assistance programs are not a sustainable, reliable solution to the issue,” Kesselheim said.