Category Archives: Alzheimer Drug

FDA advisers endorse experimental Alzheimer’s drug, Leqembi

Posted on by • Posted in Alzheimer Drug, Center for Medicare and Medicaid Services (CMS), Cognitive Decline, Food and Drug Administration (FDA), Health Insurance Coverage Adequacy, Health Policy, High Deductible Health Plans, High Drug Prices, Leqembi, Memory Care, Memory Treatment Center, Out of Pocket Expenses • Leave a comment

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This month, a panel of expert advisers recommended the Food and Drug Administration (FDA) grant full approval to Leqembi, a drug developed by Eisai and Biogen that targets amyloid plaques in the brain that are linked to the development of Alzheimer’s.

The drug was found to slow cognitive decline in patients by 27 percent over 18 months, though not without some serious side effects, including brain swelling and bleeding. While Leqembi received accelerated FDA approval in January 2023, it is now likely to become the first Alzheimer’s drug that slows the progression of the disease to secure full FDA approval. The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to cover this new class of Alzheimer’s drugs, as long as prescribing physicians participate in patient registries designed to continue collecting data about the drugs and their efficacy. The FDA is expected to make a final decision on Leqembi by early July. 

The Gist: In addition to risks of patient harm, much of the controversy around Leqembi surrounds its $27K list price. Payers, especially Medicare, are worried that it will balloon spending while exposing patients to unaffordable cost-sharing.

With the number of Americans diagnosed annually with Alzheimer’s and other dementias projected to double by 2050, Leqembi has the potential both to help millions and to drive unsustainable spending patterns, and it will be difficult to achieve the former without the latter.

But with full approval likely, a coming frenzy of investor activity to launch memory treatment centers for drug infusion services, capitalizing on the expected huge demand for the drug, seems inevitable.

Alzheimer’s drug presents Democrats’ new policy dilemma

Posted on by • Posted in Aduhelm, Alzheimer Drug, Controversy, Health Policy, High Drug Prices, Lobbyist, Medicare, Medicare 340B Drug Discount Program, Medicare Part D, Pharmaceutical Industry, Rationing Care, Value • Leave a comment
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New Alzheimer's drug could be 'devastating' for Medicare - POLITICO

With a $56,000-a-year price tag, Biogen’s newly approved Alzheimer’s drug Aduhelm is dovetailing into the debate on Capitol Hill over how to lower prescription drug prices.

Why it matters: Democrats may be positioning themselves to push policy measures that assign value to drugs and then price them accordingly — a huge potential blow to the pharmaceutical industry.

To truly address its launch price, policymakers have to grapple with big questions the U.S. system currently avoids: How should we determine the value of a drug, and who gets to make that decision?

  • President Biden proposed giving an independent review board the power to determine the Medicare rate for new drugs that don’t have any competition.
  • Democrats’ most prominent drug legislation is a House bill that gives Medicare the power to negotiate drug prices.
  • Sen. Ron Wyden, the chairman of the Senate Finance Committee, recently called out Aduhelm by name in a document outlining the principles that will guide the Senate’s drug pricing bill, a hint that the Senate’s legislation will take a different direction than the House’s.

The bottom line: “Any kind of process for valuing new drugs like Aduhelm take you immediately into the controversial quagmire of how to quantify improvements in quality of life for people,” said KFF’s Larry Levitt.