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Dr. Jason Westin, director of the Lymphoma Clinical Research Program at MD Anderson Cancer Center in Houston, regularly witnesses the life-saving power of cancer drugs. But he says he and his patients are in a terrible position because generic cancer drugs are often in short supply in the United States.
“The absence of affordable generic drugs like fludarabine can literally mean the difference between life and death,” Westin told members. US Senate Committee on Finance at a public hearing Tuesday.
The committee is investigating record drug shortages, which studies have found are endemic to the United States and have been going on for decades.
Several senators said they have heard from constituents who are getting sick or suffering from these shortages. Sen. Marsha Blackburn noted that Vanderbilt Medical Center in Nashville had to dedicate more than 100 staff members to managing and mitigating the disruption caused by staffing shortages.
“This is something that has become all too common among our providers,” the Tennessee Republican said Tuesday.
The majority (84%) of the roughly 200 ongoing shortages involve generic drugs that have been on the market for decades, rather than new or new drugs, he said. Sen. Mike Crapo, Republican, Idaho. With generic drugs accounting for 9 out of 10 prescriptions in the United States, shortages have a major impact on the nation's health.
“These shortages could cause serious harm to large numbers of Americans,” Crapo said. “The average shortage affects at least 500,000 consumers, who are forced to scramble for viable alternatives or otherwise abandon treatment altogether.”
Many of these generic drugs treat cancer.Fludarabine, a reliable drug used as part of CAR T cells I'm in therapy shortage Now, according to US Food and Drug Administration. Like many generic drugs used to treat cancer, this drug has been on and off the list over the years.
For Westin and his colleagues, patients with aggressive, rapidly progressing blood cancers don't have time to wait for drugs to come back in stock. There is a limited period of time when a person can be healthy enough to potentially save a life. CAR T cells This is a treatment that only works with fludarabine. Westin told the committee there was no alternative.
“My colleagues are faced with impossible choices, including choosing which patients receive priority access to potentially curative treatments,” he said.
“We know how to treat cancer, but scarcity forces us to make impossible choices,” he added. “We have shortages of life-saving and life-threatening medicines.”
A big part of the problem with generic drugs is that companies often aren't interested in manufacturing them because the margins are so thin and the profits are almost non-existent. Crapo said the number of companies exiting the market to produce these drugs exceeds the rate of companies entering the market by more than 40%.
Much of the manufacturing of generic drugs is outsourced to other countries such as China and India, which can pose not only quality control issues but also geopolitical issues, said Dr. Inmaculada Hernandez, professor in the Department of Clinical Pharmacy at the Skaggs School of Pharmacy. . at the University of California, San Diego.
“Our pharmaceutical supply chain is heavily dependent on overseas manufacturing. This is a national public health risk,” Hernandez told the committee.
One solution is for governments to use value-based payments to encourage large purchasers of generic drugs, such as pharmacies and hospital systems, to buy drugs from manufacturers with more reliable supply chains. He said:
Generic drug manufacturers are not required to share information about their supply chain, so buyers currently choose based solely on price.
To truly end the shortage, the Centers for Medicare and Medicaid Services, the nation's largest purchaser of drugs, must be able to buy based on manufacturing quality and reliability, not just price, said the economist and economist. said Dr. Marta E. Wosinska. Senior Fellow at the Brookings Institution.
“If you start rewarding reliability, manufacturers will actually be able to maintain a higher price point because they're being rewarded for that reliability. Then there will be an incentive down the road.” Wosinska testified Tuesday.
In other words, more companies will enter the generic drug business.
Another problem the government must overcome is consolidating generic drug purchases into “a small group of very powerful medical intermediaries,” experts testified in Oregon. said Democratic Sen. Ron Wyden. While there is money to be made on generic drugs, it goes to intermediaries such as drug wholesalers and pharmacy benefit managers (PBMs), not to manufacturers.
“There are many companies producing generic drugs, but they have to compete for the attention of highly integrated intermediaries,” Wyden said. According to him, three drug wholesalers control 90% of the domestic drug market.
“Generic drug makers who get contracts from intermediaries do so by offering dollar-for-dollar prices,” Wyden said.
With prices so low, companies are not making enough money to invest in the production capacity and equipment that is key to producing reliable, high-quality medicines.
“This effectively creates a race to the bottom for generic drugs, leading to quality control issues and factory closures,” Wyden said.
These “intermediaries” also criticism To raise drug prices.In published research In Tuesday's JAMA magazine, Hernandez and his co-authors found that PBMs often pay pharmacies “unreasonably excessive amounts, as much as 10 times the acquisition cost, for generic drugs,” and that the PBM then closes them rather than passing them on to customers. It states that it will be collected through bags.
Hernandez told the Senate committee that of the top 50 generic drugs paid for by Medicare Part D, 16 had price increases of more than 1,000 percent. For aripiprazole, an antipsychotic, the pharmacy paid him an average of 17 cents per pill.Rite Aid's Pharmacy benefits managers paid $11.70 per tablet, a 7,000% markup.
“So instead of the manufacturer actually paying for the drug, you end up paying a lot more than the pharmacy actually paid,” Hernandez said.
Hernandez said he recommends increased oversight of PBMs. law The Senate is currently voting before PBMs can outlaw “spread pricing,” in which companies charge payers or health plans more for prescription drugs than they reimburse pharmacies, and PBMs cover the difference. .
Wosinska and other experts agreed to continue the policy until some legislation is enacted to address drug shortages.
“The trouble with these shortages is that most of them are avoidable,” Woshinska said.
