Exclusive: How much Medicare projects to pay for an Alzheimer's drug, what it takes to match chemo to patients, & how telehealth affects antibiotic prescribing

"This highlights the need for realistic expectations for what this medication is going to do." 

April 11, 2024 Check out STAT+

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By Elizabeth Cooney Reporter, Morning Rounds Writer

Good morning. It pays to read deep into actuaries' documents. STAT's Bob Herman and Rachel Cohrs Zhang discovered how much Medicare predicts it will pay for a new Alzheimer's drug, buried in a CMS document. Read their exclusive to learn why the figures are surprising.

exclusive Medicare projects spending $3.5 billion in 2025 on a new Alzheimer's drug Illustration: Alex Hogan/STAT; Photo: Eisai via AP Next year Medicare estimates it will spend $3.5 billion on the new Alzheimer's drug Leqembi, documents obtained by STAT show. That's way above what Wall Street or even its maker Eisai and marketer Biogen expect. This year's cost to Medicare is projected to be $550 million, so the higher forecast for 2025 would mean a big increase in who's taking the treatment. A Medicare spokesperson confirmed both numbers, found buried in a new CMS document. Meanwhile, Eisai estimates revenue that's just a third of what Medicare is estimating for next year alone.  While trials have shown that Leqembi slows the cognitive decline associated with Alzheimer's, its benefits are considered modest. There are also safety concerns about brain bleeding and swelling. "This highlights the need for realistic expectations for what this medication is going to do," said Ameet Sarpatwari of  Harvard Medical School. Read more from Bob Herman and Rachel Cohrs Zhang in their exclusive story. health tech Telehealth can fuel antibiotic resistance — or fight it Antibiotics have long been overprescribed, diminishing their power to vanquish infections when microbes develop resistance to them. Despite efforts to turn the tide, more than a quarter over of outpatient antibiotics are inappropriately prescribed. It's easy to imagine how telehealth could contribute to this problem. Research has shown that, on average, these online visits more often lead to antibiotic prescriptions than in-person visits.  There's also a distinction between antibiotic prescriptions written for respiratory symptoms during telehealth visits with a primary care provider (29%) and with a direct-to-consumer site (37%). Health organizations, from the CDC to the National Committee for Quality Assurance, are developing standards for better antibiotic stewardship.  "We want to have licensed medical professionals that are not just fulfilling the prescriptions that a patient asks for," said Kyle Zebley, head of public policy at the American Telemedicine Association. STAT's Katie Palmer has more. health care Synapticure will join new CMS program to support dementia caregivers Synapticure, a patient- and caregiver-founded organization that provides virtual care for several neurodegenerative disorders, announced yesterday that it will be part of a new CMS program, set to start on July 1, to support people living with dementia and their unpaid caregivers. An estimated 3 million individuals will be eligible for the program, and Synapticure is the only participating organization serving all 50 states.  The organization will receive a payment from CMS per member (between $60 and $400 per month) for patients and their caregivers to access a range of services, including a network of specialized providers, which can be especially helpful for people in rural areas. Notably, members will have access to up to $2,500 in respite care per year, which is currently not reimbursed by Medicare outside hospice contexts. "I think what this program will do is create a dialogue with patients and caregivers about what dementia is and what it means for families, and give people the resources to engage … with thing like behavioral health, speech language therapy, PT and OT — which sometimes they don't even know exist," said Joe Leinbach, a caregiver and the COO of Synapticure, which currently serves about 2,000 patients, of which around 20% are from underserved communities.

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closer look When precision medicine isn't enough, this is next Scott McIntyre for STAT  Logan Jenner (above) was diagnosed at age 3 with acute myeloid leukemia, with a mutation targeted by a precision therapy drug. Then, just as he was getting ready to undergo a bone marrow transplant, his younger sister was born in time to be the perfect matched donor. He relapsed a year and a half later. "Now what?" his father asked. Precision medicine wasn't enough for him, so doctors turned to the next thing: a new approach called functional precision medicine, powered by single-cell analytical techniques and lab automation.  Functional precision medicine trials done in Europe have begun yielding positive data in adults, and a new study in Nature Medicine today suggests the approach may help children, too. Five of six patients who received the guided approach had their cancers shrink while seven of eight patients who didn't saw their disease progress. The idea combines precision genomic medicine with a brute-force approach: take a sample of the patient's tumor, culture it in the lab, and test its sensitivity to every drug you can think of. STAT's Angus Chen has more on the process and how Logan fared. covid Sanders floats $10 billion long Covid 'moonshot'  You've heard of the Cancer Moonshot, launched when President Biden was vice president and then relaunched by his current administration Now Sen. Bernie Sanders (I-Vt.) wants a long Covid moonshot. His draft proposal, released this week, follows a January hearing that highlighted long Covid as a public health crisis. He's asking for a solid $10 billion over 10 years that would be in addition to funding for continuation of the RECOVER trial, often criticized for its glacial pace and questioned for its choice of trials. As we told you yesterday, about 1 in 10 people report persistent symptoms six months after their Covid infections. "I am heartened that Senator Sanders is treating long Covid as the urgent crisis it is and thrilled that he is directly responding to the community calls" for a moonshot, Lisa McCorkell, co-founder of the Patient-Led Research Collaborative, told STAT's Isabella Cueto in an email. Read more. health equity Report calls for including pregnant and lactating patients in research If researchers conducting clinical trials have been excluding pregnant or lactating participants for fear of legal liability, they're wrong, a new report  says, noting that a case law analysis found no claims of liability for injuries resulting from pregnant or lactating women participating in clinical trials since 1962. There have been lawsuits from people hurt by FDA-approved drugs during pregnancy, highlighting what the National Academies of Sciences, Engineering, and Medicine call an urgent need for including pregnant and lactating women in clinical trials, with appropriate safety measures. To address the dearth of high-quality data on drugs and vaccines that patients, their fetuses, or their children may be exposed to, the report calls on: The FDA to develop clearer guidance on including these populations in clinical trials  Congress to create incentives to encourage their inclusion The NIH to develop a plan to prioritize research with these populations across its institutes and centers.

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Thanks for reading! More tomorrow,

elizabeth.cooney@statnews.com

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