David Fogel says the Alzheimer's drug, Aduhelm, is a lifeline for him. His wife and caretaker, Alison, fears Medicare limitations on reimbursement may limit how many people have access to it. Credit: Courtesy of David and Alison Fogel

David Fogel used to be a charming jokester. But three years ago, he began forgetting words and becoming confused with GPS directions in the car.

Now, the 61-year-old York resident responds to other people’s questions, but rarely initiates conversation. His golf handicap has fallen from a solid 10 to a 20. He usually asks, “Now, what’s my distance?” three or four times before putting.

His Alzheimer’s diagnosis came in July 2020. The disease that causes progressive mental deterioration affects 29,000 Mainers aged 65 and older and is expected to affect 20 percent more in five years, according to the Alzheimer’s Association. Medicare already spends $212 million per year in care for Mainers with the condition.

New hope to stall the disease came last summer, when federal regulators approved Aduhelm, the first drug tackling the brain plaques that cause it. But a decision on Tuesday limited Medicare reimbursement for the $28,000-per-year drug to patients who participate in clinical trials to assess its effectiveness, which are not fully proven. That could severely restrict access to the drug and result in many patients only getting placebos.

Fogel started taking Aduhelm last July. After six treatments, he noticed an improvement and called the drug a “lifeline.” His wife of 23 years, Alison, said his disease has not worsened since then, a claim that is borne out by her observations and imaging tests. That positive result leads both to worry the drug will not be widely available.

“I couldn’t sleep when I heard that news,” Alison said. “Slowing the disease is important when you only have one or two years before someone can’t recognize you anymore.”

The Alzheimer’s Association said that the Medicare decision creates further health inequities and asks patients to participate in a clinical trial on a drug that the U.S. Food and Drug Administration already approved.

“There is no guarantee that those who do participate in the trials will receive the actual treatment. Some may receive placebo,” association spokesperson Mike Lynch said.

That risk isn’t worth it to David and Alison, who firmly support the drug. Although he is not 65, David could qualify for early Medicare this summer because he has been on disability for two years. They have been able to get the drug for free from Biogen, the company that makes it, although they must pay out of pocket for doctor’s visits.

The couple, who are retired now, but once ran their own staffing firm, urge Mainers to try to get the drug and to be persistent. Alison initially found no one in Maine who would administer the drug. Even the hospital where David was diagnosed in Boston refused to give it to him, saying benefits were not yet proven.

She kept calling Biogen, which entered her into a program to try the drug for free. She found a doctor in New Hampshire who would administer it. David has been getting one-hour infusions every 21 days for the past six months. He gets scans to make sure he doesn’t have brain bleeds — a side effect — and that plaques are decreasing, a result he got in December.

That is why Alison would be willing to pay for the drug herself rather than risk David being in a clinical trial and getting a placebo.

“I would not take the chance that he would not get it. Would you?” she said. “Once he’s been on it, are you gonna say, ‘OK, let’s do a 50-50 chance now?’”