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LLY 1Y mountain Shares of Eli Lilly over the past 12 months. The FDA granted accelerated approval to an anti-amyloid drug — developed by Japanese pharmaceutical firm Eisai and U.S.-based partner Biogen (BIIB) — in early January. For Eli Lilly, specifically, Seigerman said the donanemab data appears to be a "home run." Eli Lilly said two participants in the Phase 3 trial died due to ARIA side effects, while a third patient did after a serious ARIA incident. The Eli Lilly logo is shown on one of the company's offices in San Diego, California, September 17, 2020.
The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Democratic and Republican attorneys general in nearly half of U.S. states are calling on Medicare to provide unrestricted coverage of antibody treatments for Alzheimer's disease, according to a letter released Monday. "We ask that CMS provide unrestricted Medicare coverage for FDA-approved Alzheimer's treatments, consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries," the attorneys general, led by Oklahoma's Gentner Drummond, told CMS Administrator Chiquita Brooks-LaSure and Health Secretary Xavier Becerra. More than 70 House lawmakers and 18 senators called on Medicare to provide unrestricted coverage of Alzheimer's treatments in February. The push by members of Congress and state attorneys general comes after Medicare rejected a request by the Alzheimer's Association to cover Leqembi without any conditions.
WASHINGTON, May 1 (Reuters) - The United States will end its COVID-19 vaccination requirements for federal employees and contractors, and international air travelers on May 11, when the coronavirus public health emergency ends, the White House said on Monday. "Additionally, HHS and DHS announced today that they will start the process to end their vaccination requirements for Head Start educators, CMS-certified healthcare facilities, and certain noncitizens at the land border. In the coming days, further details related to ending these requirements will be provided," the White House said. Reporting by Jasper Ward; Editing by Eric BeechOur Standards: The Thomson Reuters Trust Principles.
Medicare will cover the new Alzheimer's treatment Leqembi for all patients eligible under the medication's label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare's controversial coverage policy for new Alzheimer's treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the majority of costs for Leqembi for patients participating in federally approved clinical trials. "When FDA approves the drug, whichever populations they say it is appropriate for, that will be the basis of which people will get the drug," she said.
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Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."
LLY 1Y mountain Shares of Eli Lilly over the past 12 months. Still, a commercially successful Alzheimer's drug would be material for Eli Lilly and strengthen its long-term position. Mounjaro is the heart of our Eli Lilly investment case. Another catalyst looming for Eli Lilly shares is results from a study conducted by its competitor in the weight-loss category Novo Nordisk . Eli Lilly Pharmaceutical company logo SOPA Images | LightRocket | Getty Images
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Piper Sandler said several positive catalysts are in sight for Biogen over the next several quarters. The firm named the foremost catalyst for Biogen as Alzheimer's treatment Leqembi , which it co-developed with Japanese pharmaceutical company Eisai. Specifically, while share today is minimal (0.7% of patients), docs project this share to almost quadruple within 6 months," Raymond wrote in a Monday note. Aduhelm is the controversial Alzheimer's treatment developed by Biogen and Eisai, whose sales fell below Wall Street's expectations as its efficacy was called into question. "For our part, we think Leqembi has set a high bar – especially with regard to safety," said Raymond.
European Big Tech employees have better labor protections"There are regulations in Europe that apply to collective situations, based on European law: the so-called Mass Dismissal Directive," said Dr. Jordan. But in January, Twitter employees were reported to have been paid just one month's severance, according to CNN. Twitter employees in other European hubs such as Germany, Spain, Ireland, and the UK are also pushing back, with the help of the countries' labor laws and unions. Twitter employees in Germany have also worked with the Verdi union to push Twitter into making a better severance offer, Fortune reported. The process could take months instead of weeks, Brittin added — another testament to Europe's stronger labor protections for its employees.
Every weekday the CNBC Investing Club with Jim Cramer holds a "Morning Meeting" livestream at 10:20 a.m. Stocks fall, as oil soars Stocks started the second quarter of the year largely under pressure Monday morning. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB.
WASHINGTON, March 31 (Reuters) - The U.S. government announced on Friday a lower than expected 1.1% average cut of 2024 reimbursement rates for health insurers that offer coverage through the Medicare Advantage program, boosting shares of the market's largest players. Health insurers who operate Medicare Advantage plans have come under pressure after the government last month proposed new rules for an audit program to avoid overpaying them. The companies are among the largest players in the Medicare Advantage market in which private insurers are paid a set rate by the government to manage member healthcare. Medicare Advantage covers nearly half of the 65 million people enrolled in the government's Medicare program for people aged 65 and older or disabled. The agency pegged the spending increase in the traditional Medicare program, which in previous years was the main factor determining how much the agency pays Medicare Advantage insurers, at 2.3%, up from 2.1% in its initial proposal.
The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.
Big Tech layoffs at Meta, Twitter, Amazon and Snap have laid off thousands of workers globally. Until recently, tech employees haven't had to think too seriously about mass layoffs. European Big Tech employees have better labor protections"There are regulations in Europe that apply to collective situations, based on European law: the so-called Mass Dismissal Directive," said Dr. Jordan. But in January, Twitter employees were reported to have been paid just one month's severance, according to CNN. Twitter employees in Germany have also worked with the Verdi union to push Twitter into making a better severance offer, Fortune reported.
[1/3] A pharmacist holds a bottle of the drug Eliquis, made by Bristol Myers Squibb and Pfizer, at a pharmacy in Provo, Utah, U.S. January 9, 2020. The government will launch the negotiation process in September by naming the first drugs it plans to target. "We couldn't have the other parts of the IRA without this Medicare negotiation," said Sean Dickson, director of the West Health Policy Center, a non-partisan healthcare think tank. Eliquis, which Bristol Myers (BMY.N) shares with Pfizer (PFE.N), Ibrance, and Imbruvica, sold by AbbVie and Johnson & Johnson (JNJ.N), appear on every list. Pfizer, Novo Nordisk and J&J declined to comment on the likelihood their drugs would be included in the first round of negotiations.
March 11 (Reuters) - The cost of expanding U.S. Medicare prescription drug coverage to pay for expensive, new obesity medications could be catastrophic, health economists warned in a report published on Saturday. Big-selling diabetes drugs have been repurposed as obesity treatments after demonstrating weight loss of more than 20% in clinical trials. While they are far more effective than older drugs, lifetime use might be required to keep lost weight off. But should the bipartisan The Treat and Reduce Obesity Act get reintroduced and passed by Congress, Medicare will be compelled to cover drugs for weight loss. The Medicare health program covers more than 60 million Americans, most over age 65.
A deeper look at the company's billing practices revealed what appeared to be Medicare fraud, Pérez Aybar said. Fraud flourishesThat's just one of thousands of examples of how Medicare fraud is flourishing — not only in south Florida, but across the country. Taxpayers are losing more than $100 billion a year to Medicare and Medicaid fraud, according to estimates from the National Health Care Anti-Fraud Association. This convicted felon says Medicare and Medicaid fraud is "very easy" to get away with. The same pills could be sold and resold multiple times with different phony patients, billing Medicare each time.
The Food and Drug Administration will make a decision on whether to fully approve Eisai and Biogen 's Alzheimer's treatment Leqembi by July 6, the companies announced Monday. It is administered intravenously twice a month and slowed the progression of early Alzheimer's disease by 27% in clinical trials. Although the FDA approved Leqembi on an expedited basis in January, access to the treatment is virtually nonexistent right now. Learn more and register today: http://bit.ly/3DUNbRoThe Alzheimer's Association called on CMS in December to provide unrestricted coverage of treatments like Leqembi. "As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary," the agency said in its statement.
No Country for Alzheimer’s Patients
  + stars: | 2023-03-03 | by ( The Editorial Board | ) www.wsj.com   time to read: 1 min
The Centers for Medicare and Medicaid Services office in Woodlawn, Md. President Biden says his Administration is leading the fight against Alzheimer’s disease, but at the same time it is restricting access to breakthrough treatments. The Centers for Medicare and Medicaid Services (CMS) took the unprecedented step last year of limiting coverage of novel Alzheimer’s drugs. Normally if the Food and Drug Administration approves a drug, Medicare pays for it. But CMS said it wasn’t convinced that a new class of Alzheimer’s drugs is “reasonable and necessary” for seniors.
The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Due to the drug's high price and Medicare's coverage restrictions, seniors are unable to access the treatment. The letter the Alzheimer's Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Medicare adopted the coverage restrictions after controversy over the Alzheimer's antibody treatment Aduhelm, which was also developed by Eisai and Biogen.
Posting to social media sounded like an easy work-from-home gig, so he applied. This post from the Prigozhin-backed Social CMS network in Mexico referred to America as "we." He verified his account by providing chat transcripts, screenshots, contracts, and internal company documents. But just because Social CMS didn't yield an immediate, large-scale impact doesn't mean it should be ignored. "I didn't know who are you," wrote the person who is listed in the corporate directory as Prigozhin's media liaison.
U.S. senators on Friday called for Medicare to offer broad coverage of Alzheimer's treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. The 20 senators told CMS that Alzheimer's will cost the nation $1 trillion by 2050 if the U.S. does not take decisive action. As a consequence, Medicare coverage for the expensive drug is basically nonexistent. The Alzheimer's Association wrote CMS in December calling for the agency to provide unrestricted Medicare coverage for Leqembi. "We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria."
Here are the biggest calls on Wall Street on Friday: Compass Point upgrades Coinbase to buy from neutral Compass said the "long-term opportunities outweigh near-term risks." Goldman Sachs reiterates Tesla as buy Goldman said it's bullish heading into the company's investor day on March 1. KeyBanc reiterates Nvidia as overweight KeyBanc raised its price target on the stock to $280 per share from $220. Daiwa reiterates Disney as buy Daiwa said it sees international growth for Disney which will further drive parks outperformance. Evercore ISI adds a positive tactical call on Walmart Evercore said it's bullish on Walmart heading into earnings next week.
Early Alzheimer's typically hits people ages 65 and older, causing cognitive impairment and other issues. Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. Drug rollout will take yearsIf everything goes according to Eisai's expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer's patients will be eligible by year three of the drug's rollout. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said.
The Centers for Medicare and Medicaid (CMS) said it would test the models in the Medicare health program for people age 65 or over and the disabled and the Medicaid program for the poor. The agency also said it would work on developing a mandatory model for payment methods for drugs approved by the U.S. Food and Drug Administration (FDA) under its Accelerated Approval Program (APP). CMS will announce the first model's start date "as soon as operationally feasible", it said. Development on the Medicaid gene and cell therapy model will start in 2023 and launch for testing in 2026. The agency will start working with the FDA on the accelerated approval model in 2023 but has no planned launched date yet.
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