Jay Reinstein, a former assistant city manager in Fayetteville, N.C. who was diagnosed with Alzheimer’s disease in 2018, finally got some good news recently. His doctor told him he would be a good candidate for the newly approved drug lecanemab (Leqembi). He’s in the early stages of the neurodegenerative condition, which is when the drug appears to be the most effective. Studies show that for people like Reinstein, twice monthly infusions could slow cognitive decline by up to 27%. Perhaps more importantly, lecanemab also seems to help people continue their daily activities for a longer period of time compared to those not taking it. “The new drug approval gave me and my family hope,” Reinstein says.
The bad news is that at $26,500 a year, the treatment is financially out of reach for Reinstein—and so many others. Ivan Cheung, the president of Eisai, Inc., which developed lecanemab, speculates that patients may have to get the monthly infusions for at least two to three years before they can potentially shift to a less frequent maintenance dose. Medicare won’t cover it; the agency has grouped lecanemab into a class of drugs that it says requires additional evidence in order to qualify for coverage. It’s only the second medication approved by the U.S. Food and Drug Administration (FDA) to target amyloid, the protein that builds up in the brains of Alzheimer’s patients, and Medicare has decided that these first-in-class treatments are still too new to reimburse without additional evidence. Only patients who are enrolled in a designated registry that reports on patient outcomes will be reimbursed for their treatment.
But those registries haven’t even been set up, and once they are, they may not be widely accessible to the 6.5 million people living with Alzheimer’s, some of whom are in the early stages and who might benefit from the treatment. “I’m angry, because I feel we’ve been discriminated against,” Reinstein says.
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The frustration among patients like Reinstein is growing, and advocacy groups are calling out the Centers for Medicare and Medicaid Services (CMS), which oversees Medicare, for adding treatment coverage restrictions that weren’t put in place for other first-in-class therapies to treat diseases like HIV or cancer. Legislators proposed a bill last November that would prevent CMS from restricting access to entire classes of approved drugs without evaluating the merits of each individually.
“How can you continue to raise our hopes and then say, ‘We won’t pay for it’?” says Jim Taylor, who founded the patient advocacy group Voices of Alzheimer’s with his wife Geri (who was diagnosed with the disease about a decade ago). “It’s continued discrimination against people with the disease.”
No time to waste
The fact that lecanemab seems to be most effective during the earliest stages of the disease makes the policy even more of a gut-punch for patients and families. “I’m young enough and active enough that this would be the right time for me to start this drug,” says Reinstein. “So I’m feeling a sense of urgency; I want the progression of my disease to potentially be slowed down.” Each day, the Alzheimer’s Association estimates about 2,000 people move from the mild stage of disease to the moderate phase, at which point the drug becomes far less effective. The weeks or months it will take to set up the registries required by CMS mean that people who slip into more moderate and advanced disease will become ineligible for treatment.
“How can you defend that?” asks Taylor, who says that his group, Voices of Alzheimer’s, is prepared to convince CMS to reconsider its policy by any means possible. They are planning to publish a white paper on what it says is a legacy of discrimination against people with Alzheimer’s and dementia—and planning more disruptive tactics as well. “We might do a die-in in front of the Department of Health and Human Services building,” says Taylor, referring to a protest tactic in which activists lie on the ground mimicking corpses, “or a sit-in. We want to do everything we can to call attention to the untenable position CMS holds.”
A history of heartbreak
Alzheimer’s patients have been on a roller coaster of hope and frustration over the past several years. After decades of having only medications to treat Alzheimer’s symptoms, but not its root causes, the FDA approved the first disease-modifying therapy, aducanumab, in 2021. But the data supporting the approval, and the drug’s effectiveness, were controversial; one major study showed benefits to patients, while another did not. Based on that uncertainty, CMS placed aducanumab in a category called Coverage with Evidence Development (CED), a designation that only provides reimbursement if patients are enrolled in either a clinical trial to gather more information on the drug or a registry so the company and experts can continue to monitor for side effects and how well the patients do.
Because of how controversial the FDA’s approval was, CMS also decided to place any similar future drugs—monoclonal antibodies designed to find and bind to amyloid—under the same restrictions. That included lecanemab, which was approved in Jan. under an accelerated approval pathway. Even if lecanemab received traditional approval from the FDA, which is expected at some point this year, the requirement for reimbursement will remain the same: patients must be part of a registry in order to get covered.
For Alzheimer’s patients, that dampens any optimism that the approval of the drugs raised. “The FDA has approved other drugs for cancer, AIDS and other things, and CMS has approved them, so why is it dragging its feet on an Alzheimer’s drug?” says Reinstein, who serves on the board of directors for Voices of Alzheimer’s.
Taylor believes he knows why: “They’re trying to save money,” he says. “They don’t have the funds to pay for a drug for which millions will be eligible. Even if they are not supposed to consider cost, that’s the primary motivator to continue what we feel is a historic discrimination against people with Alzheimer’s and dementia.”
Susan Peschin, president and CEO of the Alliance for Aging Research, a nonprofit organization focused on supporting efforts toward healthy aging, agrees. “[CMS] is trying to control the flow of these services for Medicare to save money, under the guise of evidence collection,” she says.
In a written response to TIME, CMS said that the agency is “committed to making effective treatments available to people with Medicare,” noting that lecanemab is covered if patients meet the registry requirement for collecting additional information on the drug. A spokesperson said CMS “continues to actively engage with all interested stakeholders and is reviewing data that may answer these Coverage with Evidence Development (CED) questions” and “encourages any stakeholder to send relevant data to assist in a reconsideration of the current coverage.”
Maria Carrillo, chief science officer of the Alzheimer’s Association, says those requirements only delay getting the treatment to patients who need them the most. While the Association currently has a network of doctors and facilities, known as ALZ-NET, that collects information on patients treated with Alzheimer’s therapies and could be used a framework for gathering the data on lecanemab, Carrillo says setting up the required registries to meet CMS’s criteria would take months, if not years. “We really can’t afford to wait for the limited opportunity [to access] that CEDs create,” she says. “We expect, with the current accelerated approval, and with full approval, that there will be coverage [of lecanemab] immediately.”
With each day that passes, Reinstein feels his hope—and cognitive abilities—dissipating. He no longer drives, and his reading retention and short-term memory are starting to slip away. Giving up his driver’s license devastated him. “Now I’ve lost my independence; what’s next?” he says. “All I think about are my grandbabies, and spending time with them and my three kids. The new drug approval gave me and my family hope. Now it’s time to just get me the damn drug.”