Dear Honorable Member of Congress:
It would be tragic if people with mild cognitive impairment died from complications from taking a medical treatment that was not proven to work. We write today as members of the Patient, Consumer, and Public Health Coalition to urge you to support the decision by the Centers for Medicare and Medicaid Services (CMS) to limit the coverage of newly approved Alzheimer’s drugs until the treatments have been shown to have a meaningful, clinical benefit that outweighs the risks for the Medicare population.
We want to start by thanking you for your efforts to reform the accelerated approval pathway through the FY2023 Omnibus spending package; clarifying and speeding up post-market study requirements and providing public updates of progress on those studies will improve evidence for Medicare coverage decisions. The viability of Medicare and Medicaid will be strengthened as a result. As you know, the FDA granted accelerated approval to two monoclonal antibodies for Alzheimer’s treatments, aducanemab (Aduhelm) and lecanemab (Leqembi) on the basis of an unproven biomarker, amyloid beta plaque on the brain. Although it has been shown that amyloid beta plaque tends to be associated with Alzheimer’s disease, decades of research has failed to demonstrate memory and cognitive function improvements when the plaque is reduced.1 Since both of these drugs can cause brain swelling that has been fatal for some patients, it is critically important for CMS to protect Medicare beneficiaries and the Medicare program overall from medical treatments where the health risks and financial costs may outweigh the benefits for patients with very mild impairment.
Our coalition of non-profit organizations understands the need for a safe and effective treatment for Alzheimer’s and would fully support Medicare coverage for a treatment that was proven to make a meaningful improvement in the lives of patients. We opposed the approval of Aduhelm as experts agreed there was no evidence that it provides a clinically meaningful benefit, there was evidence of potentially fatal risks, and because the studies submitted to the FDA provided limited information as they excluded 85% of the Medicare population with mild cognitive impairment. Our views were reinforced by the staff report of the Energy & Commerce Committee and House Oversight and Reform Committee, which provided clear evidence that the FDA decision was “rife with irregularities” and ignored their own policies when the agency approved Aduhelm.2
Despite the unprecedented public criticisms of the Aduhelm approval, the FDA subsequently approved Leqembi, again on the basis of its impact on amyloid plaque. Media coverage has been confusing, describing Leqembi as proven to improve memory and cognition based on a clinical trial that the FDA has not yet vetted and was not used for the Leqembi approval.3 In analyzing the data provided by the company that makes Leqembi, we agree with experts that the very slight reduction reported in the progression of cognitive impairment is not meaningful, in that the benefit would not be noticeable to patients or family members. In addition, three patients from the Leqembi trial died as a result of the drug. That’s why longer-term research is needed to determine whether or not this drug has meaningful benefits that outweigh the sometimes fatal risks. Medicare coverage of well-designed studies would provide that information, whereas broad coverage for all Medicare patients would not.
The costs of coverage for this class of drug would result in enormous increases in Medicare premiums, regardless of whether or not any Medicare patients would benefit. In an effort to protect Medicare patients and the Medicare program, our coalition sent a letter to CMS expressing our support for their Coverage with Evidence Development (CED) for FDA-approved monoclonal antibodies that are specifically targeting amyloid plaque for the treatment of Alzheimer’s disease. Our letter, featured in PoliticoPro, applauded the National Coverage Determination that made the wise decision to limit coverage of this class of drugs solely to patients participating in clinical trials following the approval of Aduhelm.4 We strongly agree with CMS’ February 22, 2023 announcement that they will maintain the current coverage policy, despite a formal request for reconsideration from the Alzheimer’s Association, explaining that the current scientific evidence does not meet CMS standards for coverage outside a clinical trial. We encourage you and your colleagues to support the CMS decision as well.
CMS protected the American public from paying for a controversial and ineffective drug and we are grateful for the oversight work conducted by Congressional leaders that supported that decision. It is unclear to what extent irregular practices influenced the approval of Leqembi, which is made by one of the same companies that sells Aduhelm (Biogen) and involved the same FDA official who has been accused of bias in his interactions with that company. To make matters worse, the FDA approval decision for Leqembi occurred behind closed doors and without a public FDA Advisory Committee meeting or even a press teleconference to answer reporters’ questions. We believe this lack of transparency strongly supports the key role of CMS as a gatekeeper that keeps Medicare beneficiaries safe by keeping the current CED in place.
We urge you to protect the financial security of the Medicare program by supporting the CMS limited coverage decision for Alzheimer’s treatments until, and unless, a treatment is proven to provide meaningful benefit for Medicare beneficiaries that outweigh the risks of fatal complications. In addition, we urge you to use the powers of Congressional oversight to investigate the process that led to the FDA’s approval of Leqembi and oppose the pressure on CMS to reverse their limited coverage decision for this class of drugs. Please contact Thomas Eagen at the National Center for Health Research (firstname.lastname@example.org) with any questions.
National Center for Health Research
American Medical Student Association (University of Wisconsin chapter)
Breast Cancer Action
Doctors for America
Jacobs Institute of Women’s Health
Mothers Against Medical Error
MRSA Survivors Network
National Women’s Health Network
Nile’s Project MRSA
Our Bodies Ourselves
Patient Safety Action Network
Patient Safety America
USA Patient Network
Washington Advocates for Patient Safety
1. Ackley, S., Zimmerman, S., Brenowitz, W. D., et al. (2021). Effect of reductions in amyloid levels on cognitive change in randomized trials: instrumental variable meta-analysis. BMJ (Clinical research ed.), 372, n156. https://doi.org/10.1136/bmj.n156
2. U.S. House of Representatives. (2022). The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans. https://democrats-energycommerce.house.gov/sites/democrats.energycommerce.house.gov
3. Sutter, S. (2023). Eisai’s Lecanemab: US FDA Showed Flexibility On Clinical Endpoint Results, Safety Database Size. Pink Sheet. https://pink.pharmaintelligence.informa.com/PS147551/Eisais-Lecanemab-US-FDA-Showed-Flexibility-On-Clinical-Endpoint-Results-Safety-Database-Size
4. Foley, K. (2023). Medicare, patient advocates at odds over coverage for an expensive new Alzheimer’s therapy. PoliticoPro. https://subscriber.politicopro.com/article/2023/01/medicare-patient-advocates-at-odds-over-coverage-for-an-expensive-new-alzheimers-therapy-00078221