Medicare angers patient groups with limits on Alzheimer’s drug coverage

alzassoc-300x200Although Medicare officials have slammed the door for now on paying for widespread use of a drug targeted for Alzheimer’s treatment, patient advocacy groups have thrown themselves into the battle over Aduhelm and whether taxpayers should pay its hefty price.

Aduhelm is the risky, costly prescription medication with sparse evidence of its purported benefits for those in early stages of cognitive decline.

The giant federal health insurer for seniors will cover Aduhelm only for patients participating in clinical trials that may yield more persuasive evidence about the drug’s safety and effectiveness, Medicare officials have decided. In doing so, they withstood a furious lobbying campaign from the nonprofits Alzheimer’s Association, a leading patient advocacy group reporting more than $400 million in 2021 revenue, and UsAgainstAlzheimer’s, which reported $9 million in 2020 revenue.

As the New York Times reported about the association’s lobbying of officials of the federal Centers for Medicare and Medicaid Services (CMS):

“[T]he Alzheimer’s Association and similar groups, along with Aduhelm’s manufacturer, Biogen, strongly object. They say that Aduhelm, a monoclonal antibody that is the first drug approved for Alzheimer’s in 18 years, should be covered for anyone with mild Alzheimer’s-related cognitive decline and that usage decisions should rest with patients and their doctors. The association’s campaign makes little mention of Aduhelm’s safety risks and uncertain benefit, arguing that restricting coverage of an FDA-approved drug is ‘shocking discrimination against everyone with Alzheimer’s disease’ …the group has organized tweets directed at President Bidenemails directed at Congress, and ads on social media and websites … It has orchestrated over 400 meetings in which people with Alzheimer’s, their family members or supporters have implored their members of Congress to press the Centers for Medicare and Medicaid Services to broadly cover the drug. In sessions prepping for those meetings, association officials suggested that people say versions of phrases like ‘I have a fatal disease and I want more time with my family’ and to discuss ‘how access to FDA-approved treatments will impact me and my family.’”

UsAgainstAlzheimer’s, the newspaper reported, “has run television ads featuring patients and has written in strident language to CMS that ‘the government would be consigning millions of Americans to inevitable decline and death, with no possibility of appeal’ [by rejecting coverage for wide use of Aduhelm.]”

Reporter Pam Belluck of the New York Times also noted that the association has raised eyebrows among its supporters and medical experts because of its financial ties with Biogen, Aduhelm’s maker:

“In fiscal year 2021, the Alzheimer’s Association received $1.6 million from manufacturers developing monoclonal antibodies, including $487,500 from Biogen.”

While the association denies that the funding affects its position on Aduhelm, Big Pharma’s handing big money to big patient advocacy groups has turned into a flashpoint before. As they have grown in ambition, size, activity, and influence, groups that advocate for patients, including those that provide them charitable support, have struggled to keep and build their own finances — and to ensure that their goals and missions don’t get corrupted by money.

The independent, nonpartisan Kaiser Health News Service has created a telling database that shows how slightly more than a dozen Big Pharma firms gave more than $100 million to influential, outspoken patient advocacy groups, raising questions as to whose interests such organizations most robustly represent. Concerns about outside funding apparently grew severe enough so that Otis Brawley, executive vice president and chief medical officer of the American Cancer Society, quit that organization after just under a dozen years.

With Aduhelm, the aggressive approach taken by advocacy groups has prompted objections patients and medical experts because the drug, even in the most favorable view, produces spare positive outcomes — and it carries high costs and hard-to-ignore risks, as the New York Times reported:

“The FDA itself acknowledged that it was unclear if the drug was beneficial when it approved Aduhelm last June …The clinical trial evidence reviewed by the FDA showed that patients in one trial of Aduhelm appeared to experience slight slowing of cognitive decline, while patients in a nearly identical trial didn’t appear to benefit at all. About 40% of patients on the dosage later approved experienced brain swelling or brain bleeding, often mild, but sometimes serious.

“Both a council of senior FDA officials and the agency’s independent advisory committee had said there wasn’t enough evidence for approval. Instead of giving the drug full approval, the FDA greenlighted it under a program called ‘accelerated approval,’ which allows authorization of drugs that have uncertain benefit if they are for serious diseases with few treatments and if the drug affects a biological mechanism in a way considered reasonably likely to help patients.”

Critics have ripped the FDA for letting the Biogen product on the market based on what experts in the field called contradictory and inconclusive data from clinical trials, which the company itself abandoned at one point when Aduhelm seemed a total flop. But the drug maker, working with FDA experts in what critics have questioned as too cozy a relationship, reinterpreted its trial information, leading the agency to expedite approval of Aduhelm.

Biogen hailed its drug as an important advance in dealing with a disease that has lacked safe and effective treatments. The company, again ignoring independent experts, put a sky-high price on the drug, potentially putting taxpayers on the hook for huge sums for Medicare coverage for an FDA-approved medication.

But medical specialists, hospitals, academic medical centers, and insurers — as well as the Department of Veterans Affairs — balked at the FDA action, criticizing the agency for approving Aduhelm and refusing to prescribe it.

Medicare officials, in a rare review, took their own look at a prescription drug approved by their FDA colleagues, whose views usually hold sway. Unlike their colleagues at FDA, Medicare officials had another reason to scrutinize Aduhelm — its budget-busting cost. Besides the expense of the drug itself, patients must take it as an infusion that can only be given in doctors’ offices, clinics, or hospitals, adding to this treatment’s expense. Because of the significant risk of side-effects, patients also were told they would need periodic, pricey scans to detect and safeguard themselves against brain swelling and bleeding. As the New York Times reported of Medicare’s quandary:

“Last year, Medicare’s actuarial division, acting without knowing what the coverage decision would be, imposed one of the biggest-ever increases in Medicare Part B premiums for 2022, partly driven by the possibility of coverage for Aduhelm, which at the time was priced by its manufacturer at $56,000 a year. Since then, Biogen, facing weak sales of the drug after many hospitals and doctors would not prescribe it, lowered the price to $28,800 a year, still much higher than many analysts have said is warranted. Xavier Becerra, secretary of health and human services, had said that he would consider lowering premiums after the final coverage decision for Aduhelm was made, adding that ‘We’re going to make sure that seniors don’t pay more than they have to.’”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous drugs, notably of the prescription variety.

The FDA allowance for Aduhelm, now under investigation by Congress, “was probably the worst drug approval decision in recent U.S. history,” according to Aaron Kesselheim, a Harvard Medical School professor, an independent agency advisor on drugs, and the holder of J.D., M.D., and M.P.H. degrees.

Medicare took the right step to require more testing of the drug and to keep taxpayers, especially seniors on fixed incomes, from getting fleeced for its use until rigorous trials show it is safe and effective — criteria that should be fundamental to approval by the FDA.

For the pro-business, pro-industry crowd who, in the name of innovation and getting products swiftly to markets, this case should be yet another rebuke of the meddling with the FDA that threatens to undermine its vital watchdog role for patients’ safety. The Aduhelm deliberations also may show doubters that Medicare — and taxpayers — could benefit if the giant health insurer for seniors had a real role in using its huge sway to advocate and negotiate for patients and against Big Pharma’s relentless pursuit of profits. Advocacy groups, of course, can play an important role in supporting sick people and pushing for needed advances — within reason. They should heed the experts and their own members, so they do not undercut their own credibility with extreme or unreasonable positions. We have much work to do to ensure patients have good access to affordable, safe, and effective drugs.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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