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Medicare limits coverage of controversial Alzheimer's drug to those in clinical trials – CNN

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(CNN)Medicare will restrict coverage of the controversial and costly Alzheimer’s drug Aduhelm to those enrolled in qualifying clinical trials, the Centers for Medicare and Medicaid Services announced Thursday.

The final decision, which follows a proposed policy released in January, will have far-reaching consequences for millions of Alzheimer’s patients and tens of millions of Medicare enrollees. It’s the latest step in the drug’s contentious path to market.
It is expected to restrict the number of people who can receive the medication. The coverage policy would also apply to other drugs in this class — monoclonal antibodies that target amyloid, or plaque, for the treatment of Alzheimer’s disease — that the Food and Drug Administration may approve in the future.
The agency’s proposed policy to restrict coverage of Aduhelm was met with intense opposition from some patient groups and drug-makers. Congressional lawmakers from both parties also questioned CMS’ proposal to limit coverage of Aduhelm and similar drugs in the future.
The final policy allows a broader swath of patients participating in studies to receive Medicare coverage of future treatments that, unlike Aduhelm, receive traditional approval from the FDA. More than 6 million older Americans are believed to have Alzheimer’s disease, though Aduhelm has been approved to treat only those with milder stages of the disease.
Biogen, the maker of Aduhelm, called CMS’ decision unprecedented and said it effectively denies all Medicare enrollees access to the drug and may limit coverage for treatments approved in the future.
“When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeting therapies,” the company said in a statement, noting it is considering its options.
The decision sets a dangerous precedent, said Nicole Longo, a spokeswoman for PhRMA, a leading pharmaceutical industry group.
“CMS has further complicated matters by taking the unprecedented step of applying different standards for coverage of medicines depending on the FDA approval pathway taken, undermining the scientific assessment by experts at FDA,” she said.

More than 10,000 comments

The agency made this decision based on evidence and a thorough analysis of public feedback, CMS Administrator Chiquita Brooks-LaSure said in a statement. More than 10,000 comments on the proposed policy were submitted.
“CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population,” she said. “Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants.”
The agency weighed the potential for patient benefits against the significance of serious unknown factors that could result in harm, Dr. Lee Fleisher, CMS chief medical officer, said in a statement.
“There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” Fleisher said.
Medicare has never before required enrollees to participate in a clinical trial for a drug already approved by the FDA that’s being used for its intended purpose.
Patient advocates were quick to decry Medicare’s final policy.
“It’s unconscionable and reprehensible that CMS would force Alzheimer’s patients to play by a different set of rules than patients with other diseases like cancer and HIV,” UsAgainstAlzheimer’s co-founder George Vradenburg said in a statement.
Global Alzheimer’s Platform Foundation President John Dwyer likened the final decision to a “flat-out denial of coverage,” saying it will restrict access.
“This decision will affect the future of Alzheimer’s treatments for at least the next 10 years, representing a crushing blow for the more than 6 million Americans with Alzheimer’s who were depending on CMS to approve coverage to label for these treatment options,” he said in a statement.

Controversial from the start

The FDA’s approval of Aduhelm last June raised many questions and concerns about the process, the drug’s efficacy and its annual cost. Biogen initially priced it at about $56,000 a year.
The approval was also a driving force behind a massive increase in Medicare Part B premiums for 2022. The standard monthly payment soared to $170.10, up from $148.50 last year, for the more than 63 million enrollees.
About $10 of the premium spike is due to Aduhelm, a CMS official told CNN in November. The rest stems from a general increase in health care prices and usage, as well as from congressional action that limited the rise in Part B premiums for 2021 amid the coronavirus pandemic.
Even though Medicare had not yet decided at the time whether it would cover the medication, its actuaries had to make sure the program has sufficient funding in case it did.
Biogen later cut the price of the medication roughly in half to $28,200 a year. That prompted Health and Human Services Secretary Xavier Becerra to take the unusual step of instructing the agency to reassess a major increase in Medicare Part B premiums, which it is continuing to do.
Aside from the impact on Medicare, the drug’s approval process has spurred investigations by several congressional committees and the FDA’s inspector general.
It’s unclear how many patients will ultimately receive the medication. About a month after it initially approved Aduhelm, the FDA narrowed the group of patients who could receive it to those with mild cognitive impairment or milder states of the disease. Also, it’s unknown how many doctors will prescribe it because of questions surrounding its results.

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Transat AT reports $39.9M Q3 loss compared with $57.3M profit a year earlier

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September 12, 2024

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MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.

The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.

The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.

Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.

On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.

Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.

This report by The Canadian Press was first published Sept. 12, 2024.

Companies in this story: (TSX:TRZ)

The Canadian Press. All rights reserved.

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Dollarama keeping an eye on competitors as Loblaw launches new ultra-discount chain

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September 11, 2024

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Dollarama Inc.’s food aisles may have expanded far beyond sweet treats or piles of gum by the checkout counter in recent years, but its chief executive maintains his company is “not in the grocery business,” even if it’s keeping an eye on the sector.

“It’s just one small part of our store,” Neil Rossy told analysts on a Wednesday call, where he was questioned about the company’s food merchandise and rivals playing in the same space.

“We will keep an eye on all retailers — like all retailers keep an eye on us — to make sure that we’re competitive and we understand what’s out there.”

Over the last decade and as consumers have more recently sought deals, Dollarama’s food merchandise has expanded to include bread and pantry staples like cereal, rice and pasta sold at prices on par or below supermarkets.

However, the competition in the discount segment of the market Dollarama operates in intensified recently when the country’s biggest grocery chain began piloting a new ultra-discount store.

The No Name stores being tested by Loblaw Cos. Ltd. in Windsor, St. Catharines and Brockville, Ont., are billed as 20 per cent cheaper than discount retail competitors including No Frills. The grocery giant is able to offer such cost savings by relying on a smaller store footprint, fewer chilled products and a hearty range of No Name merchandise.

Though Rossy brushed off notions that his company is a supermarket challenger, grocers aren’t off his radar.

“All retailers in Canada are realistic about the fact that everyone is everyone’s competition on any given item or category,” he said.

Rossy declined to reveal how much of the chain’s sales would overlap with Loblaw or the food category, arguing the vast variety of items Dollarama sells is its strength rather than its grocery products alone.

“What makes Dollarama Dollarama is a very wide assortment of different departments that somewhat represent the old five-and-dime local convenience store,” he said.

The breadth of Dollarama’s offerings helped carry the company to a second-quarter profit of $285.9 million, up from $245.8 million in the same quarter last year as its sales rose 7.4 per cent.

The retailer said Wednesday the profit amounted to $1.02 per diluted share for the 13-week period ended July 28, up from 86 cents per diluted share a year earlier.

The period the quarter covers includes the start of summer, when Rossy said the weather was “terrible.”

“The weather got slightly better towards the end of the summer and our sales certainly increased, but not enough to make up for the season’s horrible start,” he said.

Sales totalled $1.56 billion for the quarter, up from $1.46 billion in the same quarter last year.

Comparable store sales, a key metric for retailers, increased 4.7 per cent, while the average transaction was down2.2 per cent and traffic was up seven per cent, RBC analyst Irene Nattel pointed out.

She told investors in a note that the numbers reflect “solid demand as cautious consumers focus on core consumables and everyday essentials.”

Analysts have attributed such behaviour to interest rates that have been slow to drop and high prices of key consumer goods, which are weighing on household budgets.

To cope, many Canadians have spent more time seeking deals, trading down to more affordable brands and forgoing small luxuries they would treat themselves to in better economic times.

“When people feel squeezed, they tend to shy away from discretionary, focus on the basics,” Rossy said. “When people are feeling good about their wallet, they tend to be more lax about the basics and more willing to spend on discretionary.”

The current economic situation has drawn in not just the average Canadian looking to save a buck or two, but also wealthier consumers.

“When the entire economy is feeling slightly squeezed, we get more consumers who might not have to or want to shop at a Dollarama generally or who enjoy shopping at a Dollarama but have the luxury of not having to worry about the price in some other store that they happen to be standing in that has those goods,” Rossy said.

“Well, when times are tougher, they’ll consider the extra five minutes to go to the store next door.”

This report by The Canadian Press was first published Sept. 11, 2024.

Companies in this story: (TSX:DOL)

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U.S. regulator fines TD Bank US$28M for faulty consumer reports

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September 11, 2024

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TORONTO – The U.S. Consumer Financial Protection Bureau has ordered TD Bank Group to pay US$28 million for repeatedly sharing inaccurate, negative information about its customers to consumer reporting companies.

The agency says TD has to pay US$7.76 million in total to tens of thousands of victims of its illegal actions, along with a US$20 million civil penalty.

It says TD shared information that contained systemic errors about credit card and bank deposit accounts to consumer reporting companies, which can include credit reports as well as screening reports for tenants and employees and other background checks.

CFPB director Rohit Chopra says in a statement that TD threatened the consumer reports of customers with fraudulent information then “barely lifted a finger to fix it,” and that regulators will need to “focus major attention” on TD Bank to change its course.

TD says in a statement it self-identified these issues and proactively worked to improve its practices, and that it is committed to delivering on its responsibilities to its customers.

The bank also faces scrutiny in the U.S. over its anti-money laundering program where it expects to pay more than US$3 billion in monetary penalties to resolve.

This report by The Canadian Press was first published Sept. 11, 2024.

Companies in this story: (TSX:TD)

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