More than six million Americans are living with Alzheimer’s Disease. It is a devastating disease that typically affects middle-age adults with symptoms of dementia before their elderly years. President Biden says his Administration is leading the fight against the disease, but at the same time it is restricting access to breakthrough treatments. Members of Congress in both parties and Alzheimer’s experts are calling out this contradiction.
The Wall Street Journal editorial board tells us 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.
Since we know CMS doesn’t do anything without the approval of the White House, one has to wonder why the Biden Administration is opposing progress for this devastating disease. WSJ calls this “back-door government medical rationing.” Since we know progressives favor socialized medicine, it would seem this is another indication of their intent to implement that form of healthcare without Congressional approval.
Medicare’s coverage restrictions of these new drugs were a political response to the FDA’s controversial approval of Biogen’s Aduhelm, a monoclonal antibody that removes amyloid plaque in the brain. The cause of Alzheimer’s isn’t known, but amyloid is a feature of the disease.
Neurologists posit that removing amyloid could slow progression, A high-dose of Aduhelm removed 71% of plaque buildup. Patients in one trial who received the highest dose also showed 25% to 28% less decline in memory and problem-solving. A second trial showed unclear benefits in part because patients were on the highest dose for less time. FDA, to its credit, showed regulatory flexibility and approved the drug through its accelerated approval pathway based on amyloid clearance. This prompted progressive howls. “It’s unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective,” Oregon Sen. Ron Wyden tweeted. (I wonder how he feels about taxpayers paying off loans for student borrowers?)
Biogen later slashed Aduhelm’s price by half, but CMS ensured that Medicare patients couldn’t get it – or other similar future FDA-approved treatments. Medicare said it would only pay for anti-amyloid monoclonal antibodies that win accelerated approval if patients enroll in randomized controlled trials. The CMS decision limits Alzheimer’s treatments to a small number of patients who live near large medical centers capable of conducting trials. Some patients would also receive a placebo. Even treatments that receive regular FDA approval would be available only through CMS-approved studies that would still restrict access.
To justify its restrictions, CMS claimed that no large randomized controlled trial on anti-amyloid treatments had shown a “clear (non-conflicting) improved health outcome” and that it could reconsider its position if one does. Well, now one has – and yet CMS still refuses to budge.
The FDA in January approved an anti-amyloid treatment (Leqembi) by Biogen and Eisai that slowed progression by 5.3 months over an 18-month trial. Even some neurologists who were skeptical of Aduhelm say Leqembi could be a game-changer. The Alzheimer’s Association and more than 200 researchers have asked CMS to revise its restrictions. In addition, 20 Senators, including Democrats Gary Peters and Amy Klobuchar, plus 74 House Members including 38 Democrats have joined the fight. The House Members said in a letter to CMS that “access to disease-modifying therapy for Alzheimer’s disease will be extremely limited, nearly nonexistent,” resulting in “irreversible disease progression” and “added burdens for patient caregivers.”
CMS is unmoved. The agency told the Alzheimer’s Association that it hasn’t received “new evidence that meets the required criteria” for reconsideration, and it wants to study how the anti-amyloid treatments work in the “real world.” CMS Administrator Chiquita Brooks-LaSure told reporters the agency wants to “learn what these products are going to do.”
CMS has apparently forgotten that evaluating the safety and efficacy of drugs is the job of the FDA, not Medicare. For unknown reasons, CMS is discriminating against Alzheimer’s patients by rearranging the deck chairs and assuming a role they don’t have. This seems to be a classic case of government being more interested in saving money than saving lives. This is one of the hallmarks of socialized medicine systems.
Those who understand how new drugs are developed realize the Biden Administration is talking out of both sides of their mouths. WSJ editors say, “In his State of the Union address, President Biden touted a new government research agency “to drive breakthroughs in the fights against cancer, Alzheimer’s, diabetes, and so much more.” Yet it makes no sense to fund treatments while restricting patient access to them and discouraging private investment. We’re glad to see Congress and disease experts pushing back.”
