Approval of Alzheimer’s drug unlikely to alleviate coverage tensions

Medicare officials, Alzheimer’s patient groups, and lawmakers are embroiled in an ongoing dispute over coverage of a newly approved Alzheimer’s drug, despite the drug receiving the green light from federal health officials.

The Food and Drug Administration (FDA) granted full approval to the drug, Leqembi, based on clinical trial data that demonstrated a 27% reduction in cognitive decline compared to a placebo.

Developed by Eisai and Biogen, Leqembi is the first drug capable of slowing the progression of Alzheimer’s disease. It received fast-track approval in January, allowing for its launch based on preliminary evidence.

The FDA’s approval triggered expanded Medicare coverage for patients, but with a significant requirement.

Specifically, the Centers for Medicare and Medicaid Services (CMS) will mandate patients and clinicians to participate in a registry that collects real-world evidence on the drug’s effectiveness.

This registry requirement applies to all anti-amyloid drugs that may slow the progression of Alzheimer’s disease, distinguishing it from other FDA-approved medications.

Patient advocacy and industry groups, backed by bipartisan lawmakers, have vigorously lobbied for unrestricted coverage and criticize the decision, claiming it will hinder widespread access to treatment.

Leqembi is only the second drug in its class, with more on the horizon. Advocates aim to convince Medicare to revise its policy before other drugs receive approval.

“I cannot see how they would justify maintaining a policy based on outdated evidence given what we know today,” said Robert Egge, chief public policy officer and executive vice president of public affairs at the Alzheimer’s Association.

In response to the CMS decision, the Alzheimer’s Association acknowledged that CMS had made efforts to create a user-friendly registry but expressed disappointment that the requirement was not reconsidered entirely.

Congress has also been advocating for comprehensive Medicare coverage.

House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) stated that CMS should already be covering Alzheimer’s treatments approved through the FDA’s accelerated approval process.

Upon receiving traditional approval, McMorris Rodgers said, “there will be no excuses for CMS to effectively deny coverage to Americans in need.”

Rep. Anna Eshoo (D-Calif.), the ranking Democrat on the Energy and Commerce health subcommittee, emphasized the importance of Medicare providing broad coverage for Alzheimer’s treatments that receive traditional approval and pledged to monitor the situation closely.

Concerns about coverage are not hypothetical as Eli Lilly released promising results from a clinical trial for its new Alzheimer’s antibody treatment in May. The FDA may approve it by year end. 

Jason Karlawish, co-director of the University of Pennsylvania’s Penn Memory Center, argues that the U.S. health system is unprepared for these new drugs. He suggests that the focus should be on rational access to these drugs rather than widespread access, as the issue is complex and lands in an unready healthcare system.

However, some experts question the need for a registry requirement, especially for future drugs.

Dennis Selkoe, co-director of the Center for Neurologic Diseases at Brigham and Women’s Hospital, believes that having a registry requirement specifically for Alzheimer’s drugs could imply to patients that regulators doubt the drugs’ effectiveness.

“What was happening here? Why is this so sensitive that it needs a registry of all patients? Because the implication could be that we don’t believe this stuff really works. We’re worried that it might not be useful. And of course, that will give pause to patients,” Selkoe said.

Leqembi is an expensive drug, priced at $26,500 per year. If widely used, it could significantly increase Medicare premiums. As an infusion drug administered by physicians, it falls under Medicare Part B.

An estimated 6.7 million people in the United States are diagnosed with Alzheimer’s, with the number expected to rise as the population ages. Approximately 1.5 million people are in the early stages of the disease. 

Drugmaker Eisai anticipates that about 100,000 patients will use Leqembi in its first three years on the market.

Tricia Neuman, senior vice president of the health research group KFF and executive director of its Medicare policy program, calculated that if only 5% of Alzheimer’s patients take the drug, Medicare would face an additional annual spending of $9 billion. This figure is equivalent to the combined expenditure on the top three Part B drugs in 2021.

Some Medicare patients may also face out-of-pocket copay costs of over $5,000 per year for the drug.  

Additionally, safety concerns surround Leqembi and Eli Lilly’s drug, donanemab.

Requiring reporting of side effects to Medicare can contribute to the development and trials of future drugs.

Leqembi’s FDA approval included a black box warning on the label, alerting users to the drug’s potential to cause serious and life-threatening events, including fatal brain bleeding.

During the primary trial, three deaths occurred, and approximately 13% of participants experienced potentially serious brain bleeding and swelling associated with Leqembi.

Jeffrey Burns, a neurologist at the University of Kansas Medical Center, believes that given the controversies, costs, and side effects, it is reasonable to collect data through a registry requirement. He acknowledges that such a requirement may exacerbate access issues but believes it is necessary at present.

Denial of responsibility! VigourTimes is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.