Since new Alzheimer’s disease treatments are available only to patients in the early stages of the disease, the potential impact on geriatricians, family doctors and other primary care physicians, who are responsible for approximately 85% of initial dementia diagnoses, cannot be overstated. In fact, when the proposed noncoverage policy from the National Institute for Health and Care Excellence (NICE) for the drug, called Leqembi, is finalized this fall, an estimated 70,000 patients living with early Alzheimer’s in the U.K. will be denied access to it.
Good thing that would never happen in the United States to treatments approved by the Food and Drug Administration (FDA) — except that it is, and it’s been going on here for more than a year.
Like in the U.K., the Medicare program and other public and private payers in the United States have set up rationing barriers to Leqembi and a second, newer FDA-approved drug in the same class, called Kisunla.
For more than two years, Medicare has barred coverage unless beneficiaries agree to participate in what the Centers for Medicare & Medicaid Services (CMS) calls coverage with evidence development (CED) for these early Alzheimer’s therapies. Under a CED, Medicare indiscriminately mandates that beneficiaries enroll in clinical studies for coverage of selected treatments, or else coverage will be denied. CMS also imposes strict eligibility criteria on the health professionals and hospitals that can qualify to collect data and run the studies. The net effect is only a small fraction of Medicare beneficiaries get access to FDA-approved treatments subject to CED, with communities of color far too often underrepresented in the required studies.
As my organization detailed in a February 2023 report, Medicare has applied CED over the last 20 years to procedures for severe hearing loss (cochlear implants), less-invasive heart valve replacement, and stem cell transplant for certain cancers and sickle cell disease. The report documents that the CED policy has largely been a failure in yielding meaningful evidence development or expanding timely access. Yet, ignoring the evidence, CMS in April 2022 applied the policy to Alzheimer’s disease medications — the first time Medicare applied CED to an on-label use of an FDA-approved drug. Updated CMS guidance policies released last month indicate it will not be the last.
Other public and private payers have followed CMS’ lead. Despite recent congressional pressure, TRICARE is denying beneficiary access to Leqembi, Kisunla and all future drugs in the same class. TRICARE is the uniformed services health care program for more than 9.5 million active duty and retired service members and their families. Coverage policies from the private insurer, Cigna, call Leqembi and Kisunla “experimental, investigational, or unproven” despite FDA approval and deny coverage for both medications. Several other private payers are using complex guidelines to deter utilization.
Most families contending with Alzheimer’s know that, just like most cancer drugs do not cure cancer, Leqembi and Kisunla do not cure early Alzheimer’s disease. However, like many cancer drugs, clinical trials of these Alzheimer’s therapies have shown effectiveness in delaying disease progression. A recently published study that modeled long-term scenarios found that starting the treatments during the early symptomatic stages of Alzheimer’s disease could delay severe dementia by four to seven months using conservative estimates, and potentially up to two to four years. This is particularly important for people living with early disease, as cognition, personality and ability to care for oneself slowly decline with each passing day.
The risk of side effects related to Leqembi is low, especially compared with almost any cancer drug. Yet, because Alzheimer’s is a deadly disease primarily affecting older adults, it is more likely to be underdiagnosed and undertreated.
Appallingly, we heard one senior CMS official recklessly refer to people living with early Alzheimer’s as “relatively healthy” following the decision to ration access to new treatments. We wonder — would they say the same about someone living with a small, malignant tumor? Probably not.
The annual list price for Leqembi, $26,500, has been slammed in the press. Piling on, CMS officials have wildly overblown cost projections as justification for raising Part B Medicare premiums and increasing Medicare Advantage (MA) provider payments due to the purported cost of Alzheimer’s treatments.
In a summary of its November 2023 call with MA plans, the CMS Office of the Actuary estimated Leqembi costs at $3.5 billion for 2025, jumping an improbable 536% from 2024 ($550 million). That would mean the number of patients receiving the drug would increase from a scant 2,000 beneficiaries at the beginning of 2024 to more than 125,000 patients next year. Yet, at the same time that Medicare has been heavily restricting access to new Alzheimer’s drugs, the program has expanded access to, and increased reimbursement for, $500,000 chimeric antigen receptor (CAR)-T therapies for advanced cancers. Both cancer and Alzheimer’s disease FDA-approved therapies should be equitably covered by Medicare, and neither patient group should be treated as second-class beneficiaries.
Ironically, while the CED process in effect drove manufacturers to lower their list price for the Alzheimer’s drugs, that too ends up hurting Alzheimer’s patients. Both the early Alzheimer’s medications and other complex medications like CAR-T treatments are paid for under Medicare Part B, which pays clinicians 6% of the list price to administer medications. Medicare’s broken payment policies compound the effects of its broken coverage policy, and since Medicare pays providers 6% of the cost of the drug to infuse it, it is more profitable for infusion centers to infuse more expensive drugs. Reports from the field indicate that the combined impact of Medicare’s CED policy and its Part B payment scheme is putting early Alzheimer’s disease patients on waiting lists behind much more lucrative cancer patients.
Ultimately, it is Medicare beneficiaries navigating early Alzheimer’s who will really pay the price, as treatments to delay progression of their disease are finally available but still out of reach due to Medicare’s CED policy. It is time for members of Congress to closely examine CMS’ abuse of CED and oppose any efforts to expand or codify it. This is especially important, considering the recent Supreme Court decision in the case of Loper Bright Enterprises v. Raimondo, which eliminated the deference to which CMS has been previously entitled in its interpretation of the Medicare law. As a result, a coordinated push is being made by others to codify a paradigm that not only isn’t working but is actively harming groups of Medicare beneficiaries.
Payers and cost-effectiveness regulators around the globe are increasingly encroaching on biomedical agency authority, at the expense of patient access. This must stop. If we don’t do something today, we will pay a much bigger societal price tomorrow.
