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Tag: Leqembi

  • Who should take Leqembi, an Alzheimer’s drug?

    Who should take Leqembi, an Alzheimer’s drug?

    After years of review, the FDA approved Leqembi—lecanemab–for the treatment of Alzheimer’s. So, now, Medicare covers this drug. But, it’s not clear if any of the 6.5 million Americans with Alzheimer’s should take the drug, given that it can cause brain swelling and bleeding. Laurie McGinley reports for the Washington Post on the pros and cons of Leqembi.

    The clinical data indicate that, in some cases of individuals with early-stage dementia and a build-up of amyloid in their brains, Leqembi can slow cognitive decline for five months or so. But, Leqembi cannot stop the progression of Alzheimer’s disease, and it appears that it might not always be safe or effective.

    Medicare covers Leqembi under Medicare Part B for people with amyloid buildup in their brains. Patients who want the drug might have to pay out of pocket for a PET scan to demonstrate that building or get a spinal tap. They or their supplemental insurer is also responsible for the 20 percent coinsurance, more than $5,000.

    Medicare is requiring anyone administering the drug, which is injectable, to participate in a registry that documents Leqembi’s efficacy in the real world. And, people who take it will see a warning label that underscores the drug’s dangerous side effects, including brain bleeding and swelling.

    People on blood thinners are at extra risk of brain bleeds if they take Leqembi. So, the FDA has warned physicians to consider carefully whether to prescribe the drug to these people.

    To be clear, Leqembi does not improve memory or cognitive skills. It might help people be a little bit less forgetful. Patients who take Leqembi will need to undergo several brain scans and travel to receive the drug at an infusion center.

    Medicare’s registry will help scientists better understand the safety and efficacy of Leqembi. But, curiously, the Alzheimer’s Association is seemingly not interested and opposes the registry, claiming it will create a barrier to access.

    People with Alzheimer’s who are overweight or who smoke and people with hypertension or diabetes, could slow cognitive decline by losing weight, stopping smoking and/or treating their hypertension and diabetes.

    Leqembi comes with a price tag of $26,500 a year. The Medicare program is expected to spend $500 million on Leqembi this year and $3 billion on it next year. If so, Medicare Part B premiums will rise significantly because of this one drug over time, as will premiums for Medicare supplemental coverage.

    Here’s more from Just Care:

  • Beware experimental Alzheimer’s drug trials

    Beware experimental Alzheimer’s drug trials

    Melody Peterson reports for the LA TImes on how pharmaceutical companies enlist Californians with Medicare to participate in a clinical trial for experimental drugs intended to stave off Alzheimer’s. Ads promote drug trials for people who are losing their memories, as a way to keep their minds sharp. But, participating in an experimental Alzheimer’s drug trial carries serious risks.

    The pharmaceutical companies see Alzheimer’s drugs as a mega-opportunity to generate outsized profits. The six million-person market is huge and only growing. There’s little limit on what pharmaceutical companies can charge for these drugs. And, if FDA-approved, Medicare must cover them when medically reasonable and necessary.

    Already, the FDA has approved Aduhelm and Leqembi, which costs $26,000 a year, even though neither drug shows significant benefits and both can have serious side effects. Now, the race is on for pharmaceutical companies to market other drugs. But, the pharmaceutical companies need nearly 60,000 individuals to participate in the clinical trials of the 140 drugs being developed that are still experimental. 

    No question that if an Alzheimer’s drug works well, it could improve and extend the lives of people with Alzheimer’s and, arguably, save the health care system money as well. But, the clinical trials are not designed to treat people, only to test a drug’s efficacy. In fact, the trials can severely harm people.

    Some believe the Leqembi trials were responsible for the death of three people, though the drug’s manufacturer claims Leqembi was not likely the cause of their deaths. Four in ten participants in the Aduhelm trials experienced brain bleeding or swelling.

    Do trial participants understand that these experimental drugs come with a risk of brain swelling or bleeding? Is there a financial conflict of interest for the trial investigators who could make big money from the experimental drugs when they recruit trial participants? Do they overpromise?

    One recruiter offers older adults free meals and health tips. Pharmaceutical companies pay for the costs of recruitment activities. Then, their agents get people who are interested in participating in a clinical trial to sign a long consent form.

    But, how can you expect people who are struggling with memory issues to understand the consent form? They’re likely unaware of what they are signing. For that reason, federal regulations forbid people’s enrollment in a clinical trial if they lack the mental ability to understand a consent form, unless someone who has the legal authority to consent on their behalf does so.

    But, the clinical trial recruitment team is not required to have an independent monitor overseeing recruitment activities. And, it is not in their interest financially to ensure that the people they recruit have the ability to understand a consent form. The recruiters generally receive between $40,000 and $75,000 for every person they recruit to participate in a trial.

    What’s equally concerning is that the FDA can approve a drug like Leqembi, even when, based on the findings, experts question whether its benefits are meaningful. When a pharmaceutical company invests in a clinical trial, it does not need to release information on the results. To hide the results when they do not appear favorable, the pharmaceutical company can simply stop the trial.

    Here’s more from Just Care:

  • Bernie Sanders blasts drug manufacturers for the “unconscionable” price of Alzheimer’s drug

    Bernie Sanders blasts drug manufacturers for the “unconscionable” price of Alzheimer’s drug

    CNBC.com reports that Senate HELP committee chair, Bernie Sanders, is blasting drug manufacturers Eisai and Biogen for setting the price of its Alzheimer’s drug  at a level that will prevent people with Medicare from being able to get it. He wants the US Department of Health and Human Services to lower the price of Leqembi down from its “unconscionable” current price of $26,500 a year. 

    Like Aduhelm, Leqembi is a prescription drug administered by a physician and therefore covered under Medicare Part B. Medicare covers 80 percent of the cost, and individuals must pay 20 percent coinsurance. People’s annual out-of-pocket costs for Leqembi alone would be more than $5,000, unless they have Medicare supplemental coverage.

    Right now, the price of Leqembi will drive up Medicare spending significantly, along with Medicare Part B premiums. It will also contribute to the erosion of the Medicare Trust Fund. Medicare will be spending more than it spent on the three most costliest Part B drugs in 2021.  And, though the government has the right to negotiate drug prices for the Part B and D drugs it spends the most on, it will not be able to negotiate the price of Leqembi for 13 years, given restrictions on drug price negotiation in the Inflation Reduction Act.

    As I wrote earlier this year when the FDA approved Leqembi, “Keep in mind that after the FDA approved Aduhelm, the government adjusted the Medicare Part B premium up $11 a month! Its list price was $56,000 a year, and the government assumed hundreds of thousands of people would take it.” (Thankfully, Medicare did not end up covering Aduhelm because of health risks associated with taking it and only minor benefits at best.) “This year, the standard Part B monthly premium is down $5.20 because the government adjusted it to account for the fact that Medicare is not covering Aduhelm.”

    Sanders wants manufacturers to voluntarily reduce Leqembi’s price. If not, he wants the US Department of Health and Human Services to use its authority to break the drug’s patent in order to drive competition in the market. Sanders also suggests that the Centers for Medicare and Medicaid Services (CMS) has the authority to pay less for Leqembi. It is possible, though not likely, that a similar Eli Lilly drug, donanemab, that has not yet gone to market will help drive down Leqembi’s price.

    How many people with Medicare would get Leqembi? We don’t yet know how many people with Medicare will take Leqembi. Medicare is covering it for “patients with mild cognitive impairment or mild dementia with confirmed amyloid plaques,” which could be a large cohort of the 6.7 million people with Alzheimer’s disease. The Kaiser Family Foundation estimates that if one in 20 people with Medicare take it, it would cost the Medicare Part B Trust Fund $8.9 billion annually.

    About half of people with Medicare have an annual income under $30,000. They would be hard-pressed to afford coinsurance of more than $5,000. Even if they have Medicare supplemental coverage to pick up the coinsurance, the cost of their supplemental coverage is likely to rise significantly, given the cost of Leqembi and the number of people with Medicare who might take it.

    What is the fair price for Leqembi? The Institute for Clinical and Economic Review suggests that the fair price for Leqembi could be as low as $8,900 a year. Even at that price, it would mean nearly $1,800 a year in out-of-pocket costs for people taking it.

    Here’s more from Just Care:

  • FDA approves new Alzheimer’s drug

    FDA approves new Alzheimer’s drug

    Katherine Ellen Foley reports for Politico that the FDA just approved an Alzheimer’s disease drug that appears to show a small benefit to some people in the early stages of Alzheimer’s. That said, the drug, Leqembi, is expensive and comes with grave side effects for some people. For now, Medicare is not covering the drug, except for people in a Leqembi clinical trial.

    Keep in mind that after the FDA approved Aduhelm, the government adjusted the Medicare Part B premium up $11 a month! It’s list price was $56,000 a year, and the government assumed hundreds of thousands of people would take it. Thankfully, Medicare did not end up covering it. And, this year, the standard Part B monthly premium is down $5.20 because the government adjusted it to account for the fact that Medicare is not covering Aduhelm.

    Leqembi has now undergone three clinical trials to demonstrate clinical benefits, as required by the FDA for drugs approved through an accelerated process. The third trial shows modest clinical benefits and reduction of amyloid proteins in the brain. FDA approval is only for patients in the early stages of Alzheimer’s disease, with evidence of amyloid proteins in their brains.

    Leqembi has a launch price of $26,500 a year. It is infused into a patient’s body every two weeks.

    Eisai and Biogen manufacture the drug. These are the same companies that manufactured Aduhelm, which the FDA approved against the advice of its advisory committee. Medicare refused to cover Aduhelm, except in clinical trials, seemingly because of serious side effects and unremarkable clinical benefits.

    About one in seven people in the Leqembi trial suffer side effects, including swelling and bleeding of their brains. At the same time, about one in nine people who received a placebo in the trial also suffered from brain bleeding and swelling.

    Three people in the trial on Leqembi have died. It’s unclear whether Leqembi caused their deaths. Leqembi appears to reduce the rate of cognitive decline, though only by a modest amount. It also appears to keep Alzheimer’s-related proteins from gathering in the brain.

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