| The Alzheimer’s market is expanding as earlier diagnosis, newly approved drugs and a growing pipeline of therapies create new opportunities for health industry players. But there are still questions about Medicare coverage and provider capacity that could determine how quickly those advances reach patients. It’s a pressing topic as 13 million Americans are expected to have Alzheimer’s disease by 2050 — almost double the current number — and it’s the subject of the latest report from WP Intelligence Lead Health Care Analyst Rebecca Adams. Let’s get into it. The disease already costs the U.S. health care system an estimated $263 billion per year, with nearly 85 percent going toward late-stage institutional and hospice care, according to the House Ways and Means Committee. Now, drugmakers and diagnostic companies are betting that treating the disease earlier can change that equation. “We have a beachhead in the war against Alzheimer’s,” Jason Karlawish, a professor at the University of Pennsylvania Perelman School of Medicine specializing in geriatric care, told Rebecca. “We’ve made substantive progress that’s opened up an avenue of therapeutics.” Why it matters: Analysts are projecting that the Alzheimer’s therapy market across eight major countries — including the United States, China and Germany — will grow from $2.4 billion in 2023 to $19.3 billion in 2033. - The FDA has approved two drugs in the past three years — lecanemab, known by its brand name Leqembi, and donanemab, or Kisunla — that can slow the progression of early Alzheimer’s.
- The treatments have created a promising opportunity for industry and patients, but the success can hinge on finding the disease early enough to treat it. That is driving interest in new blood-based tests that can identify Alzheimer’s-related changes before significant cognitive decline.
WHAT TO WATCH Last week, the House Ways and Means Committee unanimously advanced legislation that would provide transitional Medicare coverage for FDA-approved blood tests beginning in 2028, while federal officials consider broader coverage. It’s secured 219 co-sponsors in the House, enough for passage if brought to the floor. A companion bill in the Senate has 50 co-sponsors. Rep. Vern Buchanan (R-Florida), the leader of the House Ways and Means health subcommittee and the bill’s primary sponsor, told Rebecca that he’s “working closely with House leadership to help drive this crucial bill to the finish line.” For diagnostic companies, Medicare coverage could substantially expand the addressable market. It could also have spillover effects across the insurance industry, as Medicare coverage decisions often influence commercial plans. The legislation could also help drugmakers by expanding the pool of patients who can be identified as candidates for treatment. Both current drugs require patients to be in the early stages of disease and carry risks including brain swelling and bleeding — making it critical to both effectively diagnose and monitor patients’ progress. → This comes as the pharmaceutical industry is trying to expand the number of treatments on the market. - There were 158 experimental Alzheimer’s therapies in 192 clinical trials — including 120 drugs in mid- or late-stage trials — at the beginning of this year, according to an analysis published in the journal of the Alzheimer’s Association in May.
- And the Alzheimer’s pipeline extends well beyond the current class of drugs that target amyloid plaques thought to contribute to the disease. Roche is testing trontinemab, which is designed to improve delivery of treatment into the brain, including potentially for people who do not yet have symptoms. Other researchers are pursuing tau-targeting drugs and treatments aimed at neuroinflammation.
“For the first time ever, when it comes to Alzheimer’s disease, there is hope,” Erika Sward, the chief advocacy officer for disease advocacy group UsAgainstAlzheimer’s, told Rebecca. In addition to the bill paving the way for payment of Alzheimer’s diagnostics, there’s also a legislative effort to support providers caring for Alzheimer’s patients. A bipartisan bill that would expand virtual training for clinicians treating dementia, particularly in underserved areas, passed the House in July. Patient and disease group advocates hope both measures could move during the post-election lame-duck session, likely tucked into a larger legislative vehicle. For your calendar: The Senate Health, Education, Labor, and Pensions Committee is set to vote next week on three Trump administration health nominees: Nicole Saphier for surgeon general, Timothy Westlake for assistant secretary for mental health and substance use, and Mary Lazare for assistant secretary for aging. The vote is scheduled for Wednesday at 9:45 a.m., after being postponed from this week. Heidi Overton, President Donald Trump’s pick to lead the Food and Drug Administration, isn’t on the agenda — which will push her confirmation vote until after the midterm elections, as the Senate will leave Washington at the end of next week to go campaign. The fight over compounding pharmacies producing copycat weight-loss drugs could be ramping up, as the FDA slapped Empower Pharmacy with a warning letter tied to its production of compounded GLP-1s. - In the letter, the FDA acknowledged high demand for compounded GLP-1s, but it raised questions about the volume that Empower is producing, saying that it “suggests that differences between products you are compounding and the FDA-approved products are pretextual.”
Compounding pharmacies make custom medications for patients who need minor modifications to their prescriptions, such as making it in liquid form for those unable to take pills. Empower, based in Texas, is one of the largest compounding pharmacies in the country. The FDA cited Empower’s compounded products that combine tirzepatide, the active ingredient in Zepbound, with niacinamide, and semaglutide, the active ingredient in Wegovy, with a synthetic form of vitamin B12. - As part of its warning, FDA also flagged that Empower’s records did not consistently show that prescribers had determined the combinations would make a significant difference for individual patients.
- Other prescriptions, however, used the same language repeatedly — which Clint Narver, the director of the FDA’s Office of Compounding Quality and Compliance, said in the letter raises questions about whether the scripts were “pre-generated” instead of doctors’ making individualized decisions for their patients. The letter also cited problems with sterile production and quality-control procedures.
An Empower spokesperson tells me that the company has “already remediated many of the issues” from the warning letter and is “working with the FDA to address the remaining matters expeditiously and comprehensively to the agency’s satisfaction.” “Empower has been registered with the FDA for more than a decade,” the spokesperson said. “We view regulatory oversight as essential to safe compounding.” The Alliance for Pharmacy Compounding, an industry group, defended the infractions as an issue with proper documentation — not how much GLP-1s the pharmacy had been producing. “Volume itself is not the violation,” the group wrote in a statement. “Federal law does not impose a numerical limit on how much a 503A pharmacy may compound when that volume is supported by valid prescriptions for individually identified patients.” Zoom out: As more people want to try GLP-1 weight-loss drugs, a cottage industry of copycat products has popped up — sold at a fraction of the list price of the brand-name medications. That includes products from telehealth platforms and compounding pharmacies, offering customized dosages or combination products to patients. Novo and Eli Lilly, the primary companies that make Wegovy and Zepbound, respectively, have been pressing regulators to crack down on these companies, arguing that a shortage of the medications that had given compounders the green light to produce them has long ended. The companies also filed suit against some telehealth platforms, compounding pharmacies and medspas offering copycat versions of GLP-1s. Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines, called the letter “welcome and overdue.” The group, whose members include the largest pharmaceutical industry group by revenue, called for additional action from FDA, including “seizures and injunctions where warranted.” “EU Parliament president calls on Germany to reach a deal with Trump on drug pricing,” Politico’s Stefanie Bolzen reports. “Trump Officials May Undo Nursing Home Mandates for Reporting Covid,” report Christopher Rowland and Carolyn Y. Johnson at the New York Times. This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from The Washington Post newsroom. Learn more about WP Intelligence. | 
