The first drugs purported to slow the progression of Alzheimer’s disease enter the U.S. healthcare system several times a year, even though they remain out of reach for many of the low-income seniors who are most likely to suffer from dementia. It could cost billions of dollars.
Medicare and Medicaid patients will account for 92% of the lecanemab market, according to Eisai Co., which markets the drug under the brand name Lekembi. In addition to the $26,500 annual price tag for the drug, U.S. taxpayers will pay for genetic testing, frequent brain scans, safety monitoring, and other treatment costs per patient annually, according to clinical lab estimates. It can cost an average of $82,500. and Economic Review (ICER).of FDA has fully approved the drug July 6th. About one million Alzheimer’s patients in the United States may be eligible for it.
Patients with early Alzheimer’s disease taking lecanemab in large clinical trials Over the 18-month period, the decline was an average of five months slower than the other subjects, but many suffered brain swelling and bleeding. These side effects usually resolve without any obvious harm, but apparently she caused three deaths. The high cost of drugs and their treatments raises the question of how those costs will be paid for and who will benefit.
“Slowing the progression of dementia by a small amount is an important achievement in the history of science,” said John Muffy, a researcher and associate professor at the David Geffen School of Medicine at the University of California, Los Angeles. “But the real benefits for patients are very small, and there are real risks and real costs.”
To qualify for Rekembi, patients must undergo a PET scan that looks for amyloid plaques—the protein clumps that clog the brains of many Alzheimer’s patients. About one in five patients who took Lekembi in the drug’s lead clinical trial developed a cerebral hemorrhage or swelling. Because of this risk, people taking the drug must undergo frequent physical examinations and brain scans called MRIs.
In anticipation of additional costs from Lekembi’s drug class, the Centers for Medicare and Medicaid Services increased monthly premiums for Medicare patients by 15% in 2021. Insurance premiums may rise again 2024 onwards slight decrease this year.
Such an increase could be a heavy burden for many of the 62 million Medicare participants living on a fixed income. “Real people will be affected,” Mafi said. he contributed to a study Lecanemab and related treatments are estimated to cost Medicare $2 billion to $5 billion annually, making it one of the most expensive taxpayer-funded treatments.
In its analysis, ICER suggested that Lekembi could be cost-effective, with annual prices ranging from $8,900 to $21,500. ICER’s chief medical officer, David Lind, said in an interview that $10,000 to $15,000 a year is reasonable. “Beyond that, it doesn’t sound like a good place,” he said.
Handout via EISAI / Reuters
Whatever its price, the relative lack of specialists able to administer the drug may delay patient access to Rekumbi, requiring genetic testing and neurological testing to confirm patient eligibility. Psychological testing and even PET scans are required. A similar drug, Eli Lilly’s donamab, is likely to receive FDA approval this year.
Mafi noted that there was already a long wait for the tests required to assess dementia, with one patient with mild cognitive impairment having to wait eight months before being evaluated.
Such tests are not readily available due to the lack of effective treatments for Alzheimer’s disease, which poses a major challenge in geriatric care. A relatively unattractive specialty. The US has about one-third as many dementia specialists per population as Germany and about half as many as Italy.
Neuropsychological testing is “very time-critical,” said Mafi, and the drug is effective in treating the disease because once a patient’s cognitive abilities fall below a certain threshold, they are no longer eligible for treatment with the drug. It said only early-stage patients were tested.
Mafi’s study estimates that patients without additional Medicare insurance will have to pay about $6,600 out-of-pocket for treatment annually. This can be out of reach for many people. 1 in 7 people are “double qualified” Medicare beneficiaries whose income is low enough to qualify for state Medicaid programs at the same time. These programs cover about 20% of a doctor’s infusion costs, but not necessarily all.
Some health care providers, such as cancer centers, cover Medicaid losses by receiving higher premiums for privately insured patients. But nearly all patients with lecanemab are likely to have government insurance, so that “cross-subsidization” is a lesser option, said Soren Matke, director of the Center for Improved Treatment of Chronic Diseases at the University of Southern California.
“Dual-targets pose serious health equity issues as they are low-income patients with limited opportunities and education and at high risk for chronic diseases such as dementia,” Matke said in an interview. rice field. But many doctors may be reluctant to treat, he said. “The thought of denying access to this group is absolutely terrifying.”
Eisai spokeswoman Libby Holman said the company is working to educate specialists and primary care doctors about the drug and that reimbursement options are improving. Eisai plans to give the drug free to patients in need, and the company’s “Patient Navigator” will help secure insurance coverage, he said.
“Many clinicians are excited about this drug, and patients are hearing about it,” said David Moss, chief financial officer of Immune Bio, which is developing another Alzheimer’s drug. rice field. “This is a financial center for IV centers and MRI operators. It provides a reason for patients to come to the office and it’s for billing purposes.”
extraordinary Doubts about Lekhembi and related drugs Efforts to monitor patient experience are urgent. CMS requires Leqembi Patients should be enrolled in a registry that tracks their outcomes. The agency maintains a registry, but the Alzheimer’s Association, a leading advocacy group for people with dementia, Funds its own database Physician’s clinics will be offered $2,500 to participate, up to $300 per patient visit, to track people receiving treatment.
In a letter to CMS dated July 27, it said: CMS According to Policy Experts Group All Leqembi registries must ensure that detailed data is produced and shared so that researchers and FDA safety teams have a clear picture of the true profile of this drug.
ICER’s Lind says it has created a polarized environment in the medical community between those who believe anti-amyloid drugs like lecanemab are a dangerous waste of money and those who believe they are a great first step towards a cure. He said that he thought that lecanemab was not very effective. .
“People are as passionate about this issue as in almost everything I’ve seen in the medical community,” he says. “I don’t think it’s healthy.”
KFF Health NewsFormerly known as Kaiser Health News (KHN), it is a national news editorial office that produces in-depth journalism on health issues and is one of its core operating programs on health issues. KFFMore — An independent source for health policy research, polls and journalism.
