Raphael Stevens

Medicare is now covering Leqembi, the only Alzheimer’s treatment on the market that slowed cognitive decline in early stages of the disease in a clinical trial.
Although Medicare will pick up a majority of the bill, patients could still pay more than $5,000 in out-of-pocket costs.
Those out-of-pocket costs could prove unaffordable for many people, particularly Black and Hispanic patients who are at higher risk of Alzheimer’s disease.

The Alzheimer’s drug Leqembi is seen in this undated handout image obtained by Reuters on January 20, 2023.
Eisai | via Reuters

Medicare has agreed to pay for the Alzheimer’s treatment Leqembi, a major turning point for patients who are diagnosed with the early stages of the disease.
Leqembi is the only drug on the market right now that has demonstrated the ability to slow the progression of early stages of Alzheimer’s disease in a clinical trial. The monoclonal antibody, administered twice monthly through intravenous means, slowed cognitive decline by 27% over 18 months in the trial.

Leqembi is made by Japanese drugmaker Eisai and its partner Biogen, which is based in Cambridge, Massachusetts.
Medicare’s decision to cover Leqembi, which came moments after the Food and Drug Administration fully approved the drug Thursday, promises to make the treatment more accessible to patients.
Medicare coverage is crucial for most patients to have any hope of being able to afford Leqembi. Eisai has priced Leqembi at $26,500 per year before insurance coverage, which is extraordinarily expensive for Medicare patients, who have a median income of about $30,000.
Medicare is picking up the majority of the bill, though many patients will still face several thousand dollars in out-of-pocket costs.
Patients with traditional Medicare will pay 20% of the bill for Leqembi, according to the federal Centers for Medicare and Medicaid Services. That means these patients could see an annual bill of more than $5,000, according to an estimate from KFF, a nonprofit group that researches health-care issues.

People with Medicare Advantage plans also typically pay 20% for drugs such as Leqembi, up to their out-of-pocket maximum, which was about $5,000 on average for in-network services, according to KFF.
Patients with supplemental insurance such as Medigap or Medicaid might pay less, according to KFF.
People of modest means might not be able to afford the out-of-pocket costs for Leqembi even with Medicare coverage, said Tricia Neuman, an expert on Medicare at KFF.
This is particularly concerning because Black and Hispanic people are at higher risk of Alzheimer’s disease but are also more likely to have lower incomes, Neuman said.
If demand for Leqembi is high, there are also concerns that patients might face long wait times to see specialists and receive infusions.

What are the coverage conditions?

Medicare has imposed certain conditions that must be fulfilled for patients to become eligible to have Leqembi covered.

Leqembi coverage requirements

You must be enrolled in Medicare.
You must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease with evidence of amyloid plaque on the brain.
You must have a doctor who is participating in a registry that collects information on the tests you’ve taken as part of your diagnosis, notes whether you are on blood thinners and documents whether you have had side effects from Leqembi.

To get diagnosed with Alzheimer’s or a mild cognitive impairment, patients must undergo a cognitive evaluation and have a PET scan or spinal tap to detect the amyloid protein associated with the disease. PET scans are the most common method to detect amyloid because they are less invasive.
Medicare currently covers a single PET scan per lifetime to detect amyloid. CMS is reconsidering this policy and plans to issue a proposed rule soon, an agency spokesperson said.
The requirement that doctors enter information on the patient into a registry system is controversial. The Alzheimer’s Association and some members of Congress are worried the data-collection requirement creates unnecessary red tape for patients to get treated.
The federal Centers for Medicare and Medicaid Services has set up a nationwide portal that is supposed to make it easy for doctors to enter the required information about their patients. CMS has released a video that shows doctors how to navigate the system:

Doctors can access the free-to-use registry at this website.
Dr. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said the registry is minimalist and unlikely to be burdensome to patients and physicians.

What are the benefits and risks?

Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether the benefits of Leqembi outweigh the risks, according to CMS.
Although Leqembi modestly slowed cognitive decline in the clinical trial, the treatment also carries serious risks of brain swelling and bleeding. In the trial, 13% of patients who received Leqembi had swelling and 14% had bleeding.
The swelling and bleeding were typically mild, without obvious symptoms, but these episodes can be fatal, according to the Food and Drug Administration’s independent review of the clinical trial data. When symptoms do present, they include headache, confusion, dizziness, vision changes and nausea. 
People with two copies of a gene mutation called APOE4 are at higher risk of swelling and bleeding and patients should be tested to confirm whether they have the mutation before taking Leqembi, according to the FDA. Medicare covers testing for the APOE4 mutation, a CMS spokesperson said.
And patients on anticoagulants also appear to have a higher risk of brain bleeding, according to the FDA.
Three patients who received Leqembi in the trial died, although the FDA was unable to conclude whether these deaths were related to the treatment.
Knopman said appropriately diagnosed and informed patients should be able to decide for themselves whether they want to take Leqembi after weighing the benefits of treatment against the risks of potential serious side effects. More

Bed Bath & Beyond canceled an auction for Buy Buy Baby, but the chain could still end up being saved.
Buyers had backed out of the auction because the chain’s value had deteriorated, but there are still parties interested in its assets.
Dream on Me Industries, a former supplier to Buy Buy Baby, has agreed to purchase the chain’s intellectual property for $15.5 million if no better bids arise.

“Store Closing” signs at a Buy Buy Baby store in the Brooklyn borough of New York, on Monday, Feb. 6, 2023.
Stephanie Keith | Bloomberg | Getty Images

Bed Bath & Beyond canceled a Friday auction for its Buy Buy Baby chain because it failed to secure a buyer willing to keep its stores running – but it’s not quite over for the baby retailer just yet, CNBC has learned.
Bidders backed out of the auction after they determined the chain was no longer worth buying because its value had deteriorated so much, but there are parties still interested in its assets, according to two people close to the matter who weren’t authorized to discuss it publicly.

While it would be unusual, Bed Bath & Beyond could still accept a bid for Buy Buy Baby early next week. The chain’s fate won’t be definitively determined until Tuesday, when a court hearing is scheduled to approve the sale of Buy Buy Baby’s intellectual property to Dream on Me Industries. The company, a little known New Jersey-based retailer and one of Buy Buy Baby’s former suppliers, agreed to buy its trademark and digital assets for $15.5 million if no higher bids arise.
Once considered the crown jewel of Bed Bath & Beyond’s now-failed empire, the baby chain has been in the midst of liquidation sales at its 120 stores since its parent company filed for bankruptcy protection April 23. 
As the auction process dragged on and Buy Buy Baby’s inventory dwindled, so did its value. Nearly three months into close out sales, there’s little left to bid on besides the brand’s intellectual property, one of the people said.
“Most of the value was in the IP,  especially at this point in the process. One can imagine that three months ago, when they were fully functioning stores operating and running, that might not be the case,” said the person.
For the past several weeks, Bed Bath & Beyond has repeatedly pushed back and split up the bankruptcy-run auction process for Buy Buy Baby so it could secure higher bids and find a firm that was willing to keep stores running. 

It scheduled an auction solely for Buy Buy Baby’s intellectual property last week and announced Dream on Me as the winner. 
Bed Bath & Beyond scheduled a separate auction for Friday in which buyers could bid on the chain as a going concern and noted Dream on Me’s bid could be superseded if they received a higher sale price. 
However, it canceled the auction late Thursday when those bids failed to materialize, a spokesperson said in a statement. 
Go Global Retail, a brand investment firm that’s represented by Ankura Capital Advisors, had been interested in keeping about 75% of Buy Buy Baby’s stores running and had earlier sought an additional $50 million in capital to shore up its bid, CNBC previously reported. The firm is already in the baby business and currently owns children’s apparel company Janie and Jack. It declined to comment when reached by CNBC.
If the auction had been held, bids likely would not have been much higher than the $15.5 million Dream on Me offered for the chain’s intellectual property because the only other assets leftover were its employees, empty stores, leases and whatever inventory was left, said the source. 
Any firm that’s willing to take over will likely have to shut the stores down for a couple of months so they can restock and get them back up and running.
Last month, Overstock.com won the auction for Bed Bath & Beyond’s intellectual property and digital assets with a bid price of $21.5 million. It decided to change its eponymous website name to Bedbathandbeyond.com.
It is not clear what Dream on Me plans to do with Buy Buy Baby if it ends up the ultimate victor. The company didn’t return requests for more information from CNBC. More

Outplacement firm Challenger Gray projected teens will gain 1.1 million jobs in 2023, down slightly from last year’s numbers and the lowest forecast since 2011.
The unemployment rate for teens aged 16 to 19 crept up slightly in June, while the labor participation rate fell year on year.
For teens who want to work this summer, pay is competitive and some jobs are offering flexibility.

As the summer hiring market heats up, small and seasonal businesses may find they’re missing a key demographic to fill roles – teen workers.
Outplacement firm Challenger Gray projected teens will gain 1.1 million jobs in 2023, down slightly from last year’s numbers and the lowest forecast since 2011. The group said this spring that teens are once again working at pre-pandemic levels, but cautioned many teens who are willing to take on jobs are likely already in the workforce.

The unemployment rate for teens aged 16 to 19 crept up slightly in June to 11% from the previous month, according to Friday’s June jobs report from the Bureau of Labor Statistics. Meanwhile the labor participation rate fell year on year, to 36.3% from 42.9% in June 2022.
That could mean fewer available workers for businesses like Grotto Pizza that rely heavily on teens, according to hiring manager Glenn Byrum.
Across Grotto’s 20 locations in Delaware and Maryland, teens make up a little less than a third of the company’s 1,100 workers. They’re always hiring, but staffed well for this summer, he said.
“They are a critical piece of our success,” Byrum said, adding both younger workers and J-1 visa employees help to staff seasonal locations at the beach. 
“Teen hiring is always a process,” he said. “They seem to be much more cognizant of the flexibility in their jobs, how much they’re going to get paid, the work environment itself.”

Byrum described what he saw as a common mentality among young workers, born out of a wealth of job opportunities during the summer.
“If they don’t like something that employers ask them to do, even though it’s part of the job, they can easily go down the street and work somewhere else and find an alternate employment with the same wages or maybe even better,” he said. “So it just keeps us on our toes as far as making sure that we’re providing the best work environment we can.”
Grotto often starts teen workers above minimum wage, Byrum said, and provides incentives for some to move between locations as seasonal demand fluctuates.
Lexi Mathis, 16, was given a pay raise to work at a Grotto beach location for the summer months. She said the company is flexible with her schedule and the extra pay helps her to cover commuting costs as inflation has remained somewhat stubborn.
“I moved down here to try and make a little bit more money tips. And that was one of the best decisions ever because it’s been a big increase and subsequently they gave me a little bit of a pay raise,” Mathis said.
Hiring and labor availability has been an ongoing headache for small business owners in particular.
The dynamics of worker availability and needs have shifted in the wake of the pandemic, and owners often struggle to find skilled and unskilled workers to fill positions.
The restaurant sector is among those that has felt the sting of a lack of labor. The National Restaurant Association has said it projects restaurants will add another 500,000 jobs by the end of the year, but have seen just one job seeker for every two open jobs, enhancing competition for workers.
Makiah Grindstaff has worked at Famous Toastery in Davidson, North Carolina, for more than two years, during both the school year and summers. The high school senior has been saving up for several goals, and said pay can reach $25 an hour depending on the role she’s filling in the restaurant and what day of the week it is.
She and her friends take pride in having cash on hand to shop, dine and drive, Grindstaff said.
“I started driving and gas is expensive, and I wanted to start saving for college,” she said. “And I just want to be able to have my own money.” More

Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said.
Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Biogen and Eisai’s Leqembi.
It’s the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. 

Jay Reinstein, who suffers from Alzheimer’s, receives an injection so he can have a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023.
Michael Robinson Chávez | The Washington Post | Getty Images

Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. 
Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure. 

Leqembi, from drugmakers Eisai and Biogen, is the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. 
Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions.
Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially weigh on sales of the drug – at least in the near term.
“While logistic hurdles make accessibility to the drug challenging for the incoming 6-12 months, we do expect to start seeing sales ticking up starting in mid-2024,” Guggenheim analyst Yatin Suneja wrote in a note Thursday. 
Medicare will pay for Leqembi as long as patients find health-care providers participating in a registry or a database that tracks the drug’s benefits and risks. 

The initial process of building out a registry is one logistical hurdle that “will take time and could be somewhat burdensome early on,” Jefferies analyst Michael Yee said in a research note Thursday. 
Yee added that the firm’s channel checks suggest doctors see the registry requirement “as a potential real-world challenge – at least in the initial phase.” But he noted that it could ease as the drug’s launch progresses. 
Another hurdle could be related to a testing requirement on the drug’s prescribing label. 
The FDA recommends doctors test patients for a genetic mutation known as ApoE4 before starting treatment. Those with that mutation are at greater risk of swelling and brain bleeds if they take Leqembi. About 15% of people with Alzheimer’s have ApoE4, according to the National Institute on Aging. 
The testing requirement makes the drug “even more difficult to prescribe,” Stifel analyst Paul Matteis wrote Thursday. 
“The strong suggestion to test, for most clinicians, is going to add another hurdle” on top of other “substantial infrastructure requirements,” he wrote. 
That includes navigating Medicare’s registry requirement and coordinating PET scans and MRIs to screen for dangerous side effects of the drug. 
Jefferies’ Yee also highlighted MRI monitoring – a requirement on the drug’s prescribing label – as another logistical challenge in the near term. 
The label says patients should get multiple MRIs during the first year of treatment to check for signs of ARIA, a side effect that causes brain swelling or bleeding and can be fatal in rare cases. 
Yee said scheduling MRI scheduling and reimbursements take time and noted that there is a fixed capacity for MRI equipment and scans. 
The prescription label requirements won’t impact the uptake of Leqembi overall because “physicians were already planning to treat patients accordingly anyway,” SVB Securities analyst Marc Goodman wrote Thursday.
But Goodman, like other analysts, also noted that “we continue to expect a slow ramp in 2023 and acceleration moving into 2024.” More

U.S. public health officials say the risk of locally transmitted malaria in the country remains low as new cases in Florida and Texas raise questions. 
The Florida Department of Health said two cases of locally acquired malaria have been reported in Sarasota County, bringing the nationwide total to seven.
The CDC and other health experts say the new locally acquired cases shouldn’t warrant panic about widespread malaria transmission in the country.
It’s important for the public to remain vigilant at a time when climate change and a rebound in international travel increasingly contribute to the spread of mosquito-borne diseases like malaria. 

Barrington Sanders, a Miami-Dade Mosquito Control Inspector, sprays a pesticide to kill adult mosquitos on June 29, 2023 in Miami, Florida. 
Joe Raedle | Getty Images

U.S. public health officials say the risk of locally transmitted malaria in the country remains low as seven new cases in Florida and Texas raise questions. 
The Florida Department of Health on Friday said two cases of locally acquired malaria have been reported in Sarasota County, bringing the total in the state to six.

Last week, the Centers for Disease Control and Prevention issued a nationwide advisory over the four initial Florida cases and one in Texas to alert health-care providers, local health departments and the public about the possibility of local malaria transmission.
Those five patients “have received treatment and are improving,” according to the CDC. “Despite these cases, the risk of locally acquired malaria remains extremely low in the United States,” the agency added.
The seven are the first known cases of “locally acquired” malaria in the country since 2003. That means the new infections were not linked to foreign travel and appear to have been spread by U.S. mosquitoes carrying the parasite that causes the disease.
Malaria is a serious and potentially fatal disease typically transmitted through the bite of an infective female anopheline mosquito, according to the CDC. It was once endemic in the U.S., meaning it occurred regularly and required broad public health interventions.
The risk of the disease is higher in areas where warmer climate conditions allow those mosquitoes to survive during most of the year, the agency said.

The U.S. records roughly 2,000 malaria cases each year, nearly all of them in people who acquired the disease abroad, not within the country. 
Health experts say the new locally acquired cases shouldn’t warrant panic about widespread malaria transmission in the U.S.
But they also note that it’s important for the public to remain vigilant at a time when climate change and a rebound in international travel increasingly contribute to the spread of insect-borne diseases. 
U.S. public health authorities and health-care providers should also be prepared to ramp up their surveillance of malaria, experts added. 
Here’s what you need to know about the locally acquired malaria cases in the U.S. – and why the risk of transmission remains low right now.

The cause of the cases remains unclear 

Investigations by health departments in Texas and Florida confirmed that none of the five cases were directly linked to international travel, a CDC spokesperson told CNBC.
But it’s still unclear how mosquitoes in the U.S. came to carry malaria.
One possible explanation has to do with the nature of the malaria species identified in both states: P. vivax, the most common form of the disease. 

Barrington Sanders, a Miami-Dade Mosquito Control Inspector, sprays a pesticide to kill adult mosquitos on June 29, 2023 in Miami, Florida. 
Joe Raedle | Getty Images

P. vivax isn’t the deadliest kind of malaria, but it’s more difficult to treat than other forms, according to Daniel Parker, associate professor of population health and disease prevention with the UC Irvine program in public health.
The P. vivax parasite can cause symptoms – which range from fever to difficulty breathing – soon after infection, like other forms of malaria. 
But the parasite can also lie dormant in the liver for days, months or years before popping up in the bloodstream again and causing symptoms to reappear, Parker said. During that dormant period, P. vivax causes no symptoms and remains undetectable in blood tests.  
It’s possible a Florida or Texas resident was infected with P. vivax abroad and returned to the U.S. without realizing they had malaria due to a lack of symptoms, according to Sadie Ryan, a medical geography professor at the University of Florida and director of the Florida Climate Institute.
Local mosquitoes could have picked up malaria from an unknowing traveler after P. vivax became active in their bloodstream again, and those mosquitoes could have spread it to other people in the area.
“It might be that one malaria case came to the U.S. from somewhere else. Then local mosquitoes here picked it up and bit people locally,” Ryan said.
But without more details on the cases, experts say it’s difficult to offer definitive explanations. 

U.S. is mostly equipped to contain local transmission

Experts told CNBC that it’s possible for locally acquired malaria cases to spread to other parts of Florida, Texas or potentially other states, but the probability is low.
That’s largely because public health authorities responded to the cases quickly and are mostly equipped to contain local malaria transmission, especially in areas known to be more suitable for mosquito-borne illnesses. 
Ryan said health authorities did a “really good job” alerting the public and health-care providers about the cases quickly.
The CDC and state-level warnings in Florida and Texas were also timely since they were issued ahead of the Fourth of July holiday, when more people typically expose themselves to mosquitoes outdoors, Ryan added.
“They got the message out and said, ‘Beware this is here. Here are the things you can do to protect yourselves from it,'” she told CNBC.
Local health authorities in Florida and Texas have also carried out aggressive “vector control” efforts in areas where the cases emerged, she added. That involves spraying insecticide from the ground or from a helicopter to kill off mosquitoes capable of carrying malaria. 

Health officials at Sarasota County Mosquito Management Services study specimens of anopheles mosquitoes that cause malaria, in Sarasota, Florida on June 30, 2023.
Chandan Khanna | AFP | Getty Images

UC Irvine’s Parker also said the U.S.’s case-tracking protocols make the country more prepared to contain the spread.  
Health-care providers are required to report all cases of laboratory-confirmed malaria to their local or state health department, making it easier to track the potential spread of the disease, according to the CDC.
Parker added that public health authorities also investigate cases after they’re identified to better understand their origins, which is in some ways “similar to contact tracing efforts that we’re now more used to because of Covid-19.”
“The CDC was partially born out of our malaria elimination efforts. While I would argue that we’ve neglected some of our public health infrastructure, there are systems in place…that can quickly be put into action when cases are identified,” Parker said, referring to the CDC’s inception in 1946.
The agency played a critical role in declaring the disease’s elimination in the U.S. in 1951.
But the U.S.’s toolkit for fighting local malaria transmission isn’t perfect. Not all areas of the country have the local public health infrastructure in place to track and combat the disease, putting them a step behind if locally acquired cases spread.

Overall threat of malaria is still rising

Several factors are also making the country increasingly vulnerable to malaria overall, regardless of whether they are local or imported infections. 
Climate change is causing a shift in weather patterns that can worsen malaria conditions, according to Dr. Rajiv Chowdhury, a global health expert from Florida International University. He said global warming could lead to “higher mosquito migration and abundance” in areas of the country that were previously uninhabitable by anopheles mosquitoes.
Existing evidence suggests warmer temperatures can increase the growth rate and transmissibility of the parasites responsible for malaria, Chowdhury added.
He also said climate change can lead to excess rainfall and sea level rise in the U.S., creating more open spaces with standing water that serve as “effective breeding grounds” for mosquitoes.
It’s unclear whether the new local cases in Texas and Florida are connected to rising temperatures. Ryan of the Florida Climate Institute noted those states were already warm enough for the disease to spread in the first place. 
Chowdhury agreed: “It’s really difficult to pinpoint causation for particular cases to the broader environmental changes that have been occurring. We need a bit more research to make that connection in the U.S.”
A CDC spokesperson told CNBC that “it is not clear that the recently reported cases are due to changes in climate,” even though shifting weather conditions do influence the distribution of diseases like malaria. 
But the agency said a rebound in foreign travel levels this year could also increase the number of imported cases of malaria in the country. The agency last week highlighted its “concern for a potential rise” in those cases associated with increased international summer travel that could return to pre-Covid levels.
Parker said increased international travel could potentially lead to more imported and local infections.
“It is possible that we’ll have more imported cases and since we already have the mosquitoes locally, it’s possible that they’ll get some and there could be more local transmission,” he said.
But he added: “I wouldn’t say I’m not too worried about it. As long as we remain vigilant.”

There are ways to manage the risk

Experts noted there is more work that public health authorities, health-care providers and people can do to manage the nation’s rising risk of malaria. 
U.S. public health authorities should consider which areas of the country are becoming more suitable for malaria transmission and how those places can build or bolster the infrastructure needed to deal with the disease, according to Ryan. 
“That’s the sort of realm in which we need to be concerned – to think about where people should be anticipating this and what they can do to build that capacity needed to manage the disease with vector control, public health messaging and other pieces of the puzzle,” she said. 

Stephane de Sakutin | AFP | Getty Images

Clinicians can also strengthen their surveillance of the disease by considering malaria diagnoses in any person with a fever of unknown origin, regardless of their travel history, according to the CDC.
“It’s possible for someone to come back with malaria and for their physician to have never seen a malaria case before. So they aren’t used to dealing with the disease,” Parker said. “But public health agencies are putting out reports on local cases, so physicians should have malaria on their radar.” 
There is no malaria vaccine available to the U.S. public yet, but travelers can prevent malaria infections during international travel using anti-malarial medicines. Those drugs appear to be underused: Only a quarter of travelers reported taking so-called malaria prophylaxis in 2018. 
It’s easy for people to mistake malaria for a common viral infection since the disease often causes flu-like symptoms. But the CDC says the “most important step” people can take is to see a doctor if they are sick and are presently – or have recently been – in an area with malaria. 
Getting a diagnosis early on can ensure that a malaria infection is treated before it becomes serious and life-threatening, the agency said. 
“Right now, we should not panic,” Chowdhury said. “But we definitely need to keep an eye on malaria and take those preparatory measures.” More