For decades, treatments for Alzheimer’s have focused mostly on managing symptoms. But now, for the first time, FDA-approved treatments can modify the course of the disease. Restrictive policies, however, prevent most patients – particularly those covered by Medicare – from benefiting.
New Treatments Are Approved to Slow Alzheimer’s.
Two novel, disease-modifying treatments, lecanemab and aducanumab, have been approved through the FDA’s accelerated approval pathway for people in the early stages of Alzheimer’s disease. These medications have been shown to slow cognitive decline by targeting amyloid plaques, offering hope to a community that previously had no disease-modifying treatments.
Now FDA has also approved lecanemab via the traditional approval pathway, an important step forward for the Alzheimer’s community.
Despite FDA approval, significant barriers limit who can access these medications.
Coverage Policies Can Stand in Patients’ Way.
Barriers are especially significant for Medicare patients.
Last year, the Centers for Medicare and Medicaid Services declared that the Medicare program would not cover any drugs in this class that had been approved through the FDA’s accelerated approval process until more evidence supported their efficacy – despite the FDA having already deemed the medications safe and effective.
This process, called coverage with evidence development, means that the breakthrough Alzheimer’s drugs are covered only for patients participating in a clinical trial that have been approved by the Centers for Medicare and Medicaid Services. As a result, few patients have access.
To access medications in this class that have been approved through the FDA’s traditional approval process, as lecanemab now has been, patients are not required to participate in a clinical trial. They do, however, face other access barriers.
For example, patients must join a patient registry. The requirement constitutes an added step for patients who need timely treatment and yet another administrative burden for time-strapped health care providers. Registry requirement is unprecedented; no other FDA-approved medication is subject to this type of restriction from the Centers for Medicare and Medicaid Services.
Access to brain imaging is another pain point for Alzheimer’s patients. PET scans allow clinicians to diagnose Alzheimer’s and to determine whether a particular Alzheimer’s treatment is likely to work for a patient. Yet Medicare limits coverage for amyloid PET scans to just one scan per lifetime, administered as part of a clinical trial. In positive news, CMS in July announced they are revisiting this requirement, which could remove one of the many barriers for patients who may be eligible for an FDA-approved Alzheimer’s medication.
Alzheimer’s disease can devastate both patients and their loved ones. Promising treatments could revolutionize Alzheimer’s treatment, but only with policy changes that ensure fair access for patients.