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Doctors face dilemma on whether to recommend new Alzheimer’s treatment

This month, the Food and Drug Administration approved a new treatment for Alzheimer’s disease — the first in nearly 20 years. But the decision was not without controversy, with doctors split on how they feel about the treatment.

Since the approval, doctors have faced questions from patients and families desperate for good news, but they are conflicted on whether to recommend and prescribe the new drug, developed by Biogen.

“The news is out, and patients and families are calling with their hopes up,” said Dr. Ipsit Vahia, a geriatric psychiatrist and researcher and the medical director of the Geriatric Psychiatry Outpatient Services at McLean Hospital.

“I think many people, including myself, find themselves conflicted between a strong urge to do something to help, using a tool that we couldn’t just offer previously, and balancing of course, first doing no harm and also not knowing for sure that it works for everyone,” Vahia said.

“So if you ask, would I recommend Aduhelm? It’s complicated.”

The FDA granted a broad approval for Aduhelm, the so-called “drug label” open to any patient with Alzheimer’s disease. But the clinical trials studying the drug only looked at a narrow group of patients: those recently diagnosed and those early in the progression of their disease.

In the resulting uncertainty, neurologists, psychiatrists and hospital systems are coming together to establish guidelines on how to safely prescribe the drug.

“The bar to get the medication is still very high, and appropriately so,” said Dr. Brent Forester, a geriatric psychiatrist and chief of the Center of Excellence in Geriatric Psychiatry at McLean Hospital. “Despite the FDA label, I would limit using Aduhelm to only the patients within the study population, in addition to all exclusion criteria within the trial.”

On Tuesday, the FDA’s Center for Drug Evaluation and Research Director Patrizia Cavazzoni acknowledged the controversy and released new documents on the FDA Adulhem website stating “in the presence of such complexity, it is not surprising that our deliberations were lengthy and at times difficult.” The FDA website notes that the approval was given “an expectation of clinical benefit despite some uncertainty about the clinical benefit.”

Biogen, the company that makes the drug, said in a statement that the company is encouraged by the approval of “a new treatment option to address a defining pathology of the disease” and that they “continue to hear from many physicians who are supportive of the data.”

Aduhelm is estimated to cost more than $50,000 per person per year before discounts and rebates. The drug is likely to be covered by Medicare Part B, though insurance companies may limit who can receive the drug.

In a press release, Biogen and its partner Eisai announced payment assistance programs that are available, saying the companies feel a “great sense of purpose and responsibility” and are “committed to providing access to Aduhelm for patients across a spectrum of financial situations.”

Forester and Vahia said the cost is not just about the drug itself. Finding the right patient also involves screening tests, imaging considerations, risk management and resources that would be needed to get patients the monthly infusions.

“So much would need to be in place first — protocols, resources, etc. And then you run into enormous issues of cost and equity,” Vahia said.

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