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Tag: Aduhelm

  • 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.

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  • Biden administration says Part B premiums will drop in 2023

    Biden administration says Part B premiums will drop in 2023

    People with Medicare are paying about $11 a month in extra Part B premiums this year but, next year, everyone with Medicare should see lower Part B premiums according to HealthCareFinanceNews. After factoring the cost of covering Aduhelm, a new exceedingly costly Alzheimer’s drug, into this year’s Part B premium, the Biden administration determined that Medicare would not cover the drug, except in limited circumstances. Still it is not giving people a refund or adjusting the Part B premium until next year.

    Medicare’s projected spending on Aduhelm is responsible for $11 in Part B premiums this year based on the manufacturer’s $56,000 a year launch price and an assumption that Medicare would cover it. Since the Part B premium was calculated, however, Biogen, the manufacturer cut the launch price in half, and Medicare said it would only cover the drug for people in clinical trials.

    The Biden Administration claims it cannot lower the Part B premium this year because of administrative and legal obstacles. Secretary of Health and Human Services, Xavier Becerra said that “After receiving CMS’s report reevaluating the 2022 Medicare Part B premiums, we have determined that we can put cost-savings directly back into the pockets of people enrolled in Medicare in 2023.” “We had hoped to achieve this sooner, but CMS explains that the options to accomplish this would not be feasible.”

    Fierce Healthcare reports that a CMS report goes further: CMS  “does not have sufficient authority to send premium refunds directly to beneficiaries unless there is excess payment relative to the established premium.” If CMS had not considered the cost of Aduhelm in its Part B premium calculation this year, the premium would have been $160.40.

    Because the Centers for Medicare and Medicaid Services factored the cost of Aduhelm into the Part B premium, the 2022 Part B premium is $21.60 higher than it was last year, a 14.5 percent increase.

    Aduhelm has been found to have serious and sometimes even deadly side effects and no clear benefits. The manufacturers of Aduhelm ended two clinical trials because the drug was not helping people. At any price, the drug is likely ill-advised based on the clinical evidence to date. At $27,000, it’s insane.

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  • Medicare won’t cover Alzheimer’s drug, except in clinical trials

    Medicare won’t cover Alzheimer’s drug, except in clinical trials

    Once in a while, the government prevails against drugmakers. Last Thursday, the Centers for Medicare and Medicaid Services (CMS) decided it would not cover the controversial Alzheimer’s drug, Aduhelm, except in clinical trials, despite the FDA’s approval of the drug. In an opinion piece for Stat News, John N. Mafi and Catherine Sarkisian, professors of medicine at UCLA, explain why it is appropriate that Medicare will only cover the drug for people participating in clinical trials.

    Physicians and scientists have applauded CMS’ decision. Aduhelm has unclear benefits and presents huge risks. But, not surprisingly, Wall Street went ballistic on hearing the decision. Biogen threatened to sue CMS. While the cost of the drug is astronomical and reason enough to question whether it should be covered, the danger to people’s health and well-being from taking the drug are real and serious.

    No one can argue that Aduhelm is either safe or effective, based on the evidence. More than four in ten people who took the drug ended up with bleeding or swelling in the brain. On top of that, one in fifty people lost their vision permanently. Other dangerous side effects are not yet known.

    In addition, clinical trials at best show a possible benefit from the drug and many trials show no improved memory. The possible benefit was determined only in retrospective analysis, where there is a high likelihood of false positives. Moreover, the clinical trials were not conducted on an ethnically or racially diverse population.

    Medicare is not allowed to factor in the cost of a drug when deciding whether to cover it. But, it should not pay for a drug that has no proven value and proven risks. The Medicare trust fund is predicted to be insolvent by 2026. At its initial launch price of $56,000, the drug would drive up costs for a Medicare population already struggling to afford needed care. It added $11 to the monthly Part B premium this year. People taking Aduhelm would spend about $6,800 a year, more than a quarter of their typical income, out of pocket.

    Those arguing for Medicare’s coverage of the drug falsely claim that it will keep other drugs from being developed. There’s too much money in drug development, and drugmakers know that CMS’ decision is the exception, not the rule. Moreover, CMS has previously opted not to cover an FDA-approved drug.

    Thank goodness CMS did not agree to cover Aduhelm at this time. That should lead to a lower Part B premium in the not too distant future.

    Here’s more from Just Care:

  • One billionaire’s influence over lowering drug prices

    One billionaire’s influence over lowering drug prices

    Rose Adams writes for The American Prospect about one billionaire’s influence over lowering drug prices. John Arnold, a former senior executive at Enron–remember Enron, the company that effectively blew itself up?–has been dedicating a significant amount of his wealth towards initiatives that lower drug prices. The sad reality is that the hundred million he has invested over the last decade has barely moved the needle.

    Pharma and the pharmaceutical companies have been investing a hundred million dollars a year or more to make sure Congress does not lower drug prices. Some of that money goes to members of Congress, like Kyrsten Sinema, to stand firm against any legislation that would bring down drug prices. Some of that money goes to advertisements designed to mislead Americans about the consequences of lower drug prices.

    Lower drug prices could easily mean smarter research and innovation, rather than many invested to create new versions of the same old drugs–me-too drugs–so that pharmaceutical companies can charge more for them.

    Some Pharma money goes to patient advocacy groups to serve as Pharma shills and to disease groups to remain silent on the issue of drug price affordability. Disease groups rarely if ever advocate on behalf of their members who struggle to afford or, worse still, forgo life-saving drugs because of their cost. Biogen, for example, has managed to ensure that the Alzheimer’s Association is mum on the issue of Aduhelm’s $56,000 a year pricetag and its potentially serious side effects.

    What’s so troubling is that Pharma continues to have the upper hand in the debate over drug prices, even though lowering drug prices is Americans’ number one policy priority and citizens of every other deeloped country typically pay less than half of what Americans do for their drugs. Without fair drug prices, tens of thousands of Americans will continue to die each year because they cannot afford their life-saving medications.

    Arnold and his foundation, Arnold Ventures, fund many groups to fight the good fight. Yet, if we’re lucky, at best we will see in the Build Back Better Act lower drug prices for 60 drugs over the next several years. That’s what’s in the legislation the House just passed. And, it’s not clear yet whether only people with Medicare would benefit from these lower prices or working people would also benefit. For sure, the uninsured will not benefit.

    Looking on the bright side, negotiated drug prices for 60 drugs, even if only for some of the population–if the Senate passes this provision in Build Back Better–is a foot in the door to lower drug prices on all drugs for everyone. Looking on the dark side, everyone thought that Medicare’s enactment 56 years ago was a foot in the door to guaranteed health care for all.

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  • New Alzheimer’s drug drives up Part B premiums

    New Alzheimer’s drug drives up Part B premiums

    As with all health care costs, Medicare out-of-pocket costs are rising rapidly. In 2022, Medicare Part B premiums, which everyone with Medicare must pay–except for people with Medicaid–will be 14.5 percent higher. The reason in large part is Aduhelm, the new Alzheimer’s drug, which Medicare is likely to begin covering under Part B and which costs a hefty $56,000 a year.

    About half of the Medicare Part B increase–$15 a month or $180 a year–can be attributed to an expected Centers for Medicare and Medicaid Services’ final determination that Medicare should cover 80 percent of the cost of Aduhelm. It is unacceptably tragic that Medicare would cover this extraordinarily costly drug, which has yet to show any benefits in clinical trials, yet does not cover long-term nursing home care and home care, or vision, hearing and dental care, which we know would benefit everyone.

    Part B premiums for almost everyone with Medicare will be $170.10 a month in 2022, up $21.60 from this year. For people with annual incomes over $91,000, these premiums will be even larger. While Social Security benefits are increasing an average of $90 a month, this Medicare Part B premium increase will eat into more than 20 percent of that benefit increase.

    Right now, few insurers are willing to pay for Aduhelm. And, for good reason. There is no evidence that it slows the progression of dementia and provides benefits worth anything close to its $56,000 a year price tag. But, it has been approved by the Food and Drug Administration. And, the Centers for Medicare and Medicaid Services historically has covered all drugs that are FDA approved, though it is not obligated to do so.

    The non-profit Institute for Clinical and Economic Review has ascribed a value of around $5,000 a year to Aduhelm, based on the little known about its benefits. That’s about ten percent of what Biogen, its manufacturer, is charging for it.

    Nothing in the Build Back Better legislation currently being finalized in Congress would bring down the price of Aduhelm. At best, the bill would bring down the cost of 60 drugs that Medicare covers, beginning with the 10 that are the most expensive for the program, so long as they have been on the market for nine years or more and 12 years or more for biologics.

    If approved, Aduhelm will be covered under Medicare Part B, because it must be administered by a physician and cannot be bought at the pharmacy. In addition to bearing the expense of higher Part B premiums, people in traditional Medicare will likely see significantly higher premiums for supplemental insurance. And, people in Medicare Advantage plans will likely see far higher out-of-pocket costs.

    Here’s more from Just Care:

  • Medicare to decide when new Alzheimer’s drug is covered

    Medicare to decide when new Alzheimer’s drug is covered

    As a rule, Medicare covers all federally approved treatments and medicines. But, there are always exceptions. Rachel Cohrs and Ed Silverman report for Stat that coverage for Aduhelm, the ridiculously expensive new Alzheimer’s drug, which is not at all guaranteed to be effective, will be one of them. In this case, Medicare is doing the right thing.

    The Food and Drug Administration (FDA) should never have approved Aduhelm as broadly as it did, if at all. In fact, it approved the drug against the advice of its advisors. After a large outcry, it narrowed its approval to people with mild cognitive impairments, the condition studied in the clinical trial.

    Whether the drug is clinically effective is still questionable, and it appears it can cause serious side effects, such as brain swelling and bleeding. Interestingly, two large hospital systems have just announced that they will not administer Aduhelm, Mount Sinai Health System in New York and the Cleveland Clinic in Ohio.

    The FDA does not approve drugs based on their cost. But, in this case, approving Aduhelm, which costs $56,000 a year, opens the door to driving up Medicare, spending and depleting the Medicare Trust Fund, at a rapid rate, as well as increasing the cost of Medicare supplemental coverage.

    It’s therefore good news that Medicare is making a national coverage determination with regard to Aduhelm. Medicare will determine who qualifies for Medicare coverage of Aduhelm and when.

    There’s some evidence that people with mild Alzheimer’s symptoms could benefit from the drug. If Medicare approved the drug for this cohort, it could cover as many as 1-2 million people. But, should it? To understand how this would impact Medicare spending, it would cost $29 billion to pay for the drug for 500,000 people.

    Since Medicare does not provide full drug coverage for any drug and copays can be significant, it’s not clear how many people with Medicare could even afford the drug.

    Stakeholders will be able to weigh in on Medicare’s decision. So, it will likely take nine months.

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  • New Alzheimer’s drug has questionable benefits and costs a small fortune

    New Alzheimer’s drug has questionable benefits and costs a small fortune

    In the “not so surprising” department, Axios reports that the FDA has just approved a new drug to treat Alzheimer’s disease that has questionable benefits and costs a small fortune. Unless Congress reins in drug prices asap, drug costs are likely to drive up Medicare spending to new heights in the coming years. Aduhelm, the Alzheimer’s drug, is projected to cost as much each year as the costliest eight Medicare drugs combined.

    Experts say that Aduhelm is far from sure to help any of the 6,000,000 people with Alzheimer’s disease. But, that won’t stop Biogen, its manufacturer, from promoting it wildly and broadly. It will do what it can to get as many doctors as it can to prescribe it. And, Medicare will be stuck paying a huge bill, even if the drug does not work.

    Still, the FDA approved the drug against the advice of its scientific advisory committee, reports The Atlantic. There is little clinical evidence that Aduhelm benefits people with Alzheimer’s. And, it has some serious side effects, including brain swelling and bleeding, which could undermine any of its benefits.

    Because the US does not regulate drug prices and because doctors can prescribe pretty much whatever drugs they please, drug manufacturers can drive up drug spending on drugs that offer very little, if any, value.

    Biogen says it will charge $56,000 a year for monthly infusions of Aduhelm. And, people will typically take the drug for three to 11 years, their usual lifespan after an Alzheimer’s diagnosis.

    Incredibly, the FDA approval of Aduhelm covers everyone with Alzheimer’s, even though the drug was only tested on a small subpopulation of Alzheimer’s patients. That would mean that it alone could cost Medicare around $112 billion a year if one-third of all people with an Alzheimer’s diagnosis are prescribed the drug. In 2020, Medicare spent $90 billion on all Part D drugs combined.

    People with Medicare and taxpayers would bear way more of the cost than you might think. The drug is administered by a doctor and covered under Part B. So, people will have 20 percent coinsurance. If they have supplemental coverage that picks up that cost, the premium for that coverage is likely to rise significantly.

    Senator Ron Wyden of Oregon, who heads the Senate Finance Committee, believes that Medicare should have the ability to negotiate a fair price for this drug, which it currently cannot do. He is leading the Senate Democrats on legislation that would give Medicare that power. Let’s see whether he can succeed.

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