There’s been a setback—or at least a pause—in the ongoing war on Alzheimer’s disease, the brain disorder that slowly destroys memory and thinking skills.
Medicare administrators proposed Tuesday to limit government payments for a medication—Aduhelm—because of concerns over its effectiveness.
Read: Biogen’s stock tumbles after the U.S. proposes restricting access to its Alzheimer’s disease drug
Developed by Biogen
BIIB,
Aduhelm was approved in June by the Food and Drug Administration. But the drug seemed troubled from the beginning: Three medical experts quit an FDA advisory panel in protest of Aduhelm’s approval, and in the seven months since, “almost no one is prescribing Aduhelm,” STAT+, a biopharma and health policy news service, reports. It cited at least 16 major health systems around the country who aren’t convinced that Aduhelm works.
Since peaking after the June FDA approval of Adulhelm, Biogen’s stock has lost nearly half its value.
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Tuesday’s announcement means that patients wanting Medicare to pay for the $28,000 a year drug will have to participate in clinical trials to determine its effectiveness in slowing the progression of early-stage dementia—as well as its safety.
Read: Government announces surprising hike in Medicare Part B premiums
In a statement Tuesday, Dr. Lee Fleisher, chief medical officer of the Centers for Medicare and Medicaid Services (CMS) acknowledged that while Aduhelm shows promise, it could also harm patients. “This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds.” He added: “We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision.”
That final decision is expected in mid-April, following further evaluation and public comment.
Biogen reacted harshly to the news, saying it “denies the daily burden of people living with Alzheimer’s disease” and “will exclude almost all patients who may benefit” from Aduhelm. It noted that clinical trials can take months, sometimes years, to evaluate. By then it warns, it may be too late for patients who are “progressing each day from mild to moderate disease stages, where treatment may no longer be an option.”
The Medicare announcement will certainly affect other drugmakers, including Eli Lilly
LLY,
and Roche Holding
RHHBY,
which are waiting on FDA approval for their own Alzheimer’s treatments.
The sheer cost of Aduhelm has also sparked criticism since June’s FDA approval. Biogen initially launched the drug at an average price per patient of $56,000 annually, before cutting that list price in half. Medicare typically pays for approved medicines unconditionally.
That initial $56,000 price is one reason Medicare enrollees saw a hike of nearly $22 in monthly “Part B” premiums for outpatient care for 2022. Medicare said about half of that was due to the anticipated cost of Aduhelm. Even after Biogen cut its list price, Medicare enrollees are still paying higher premiums; Health and Human Services Secretary Xavier Becerra has directed Medicare to reassess the increase.
