Major Insurers Weigh in on “Medical Necessity” of Biogen’s Aduhelm

Biogen_John Tlumacki/The Boston Globe via Getty

John Tlumacki/The Boston Globe via Getty

As reported during Biogen’s third-quarter report in October, its controversial Alzheimer’s drug Aduhelm (aducanumab) is struggling to get traction in the marketplace. Some of it is physicians’ reluctance to prescribe it because of questionable efficacy and potentially serious side effects. One patient may have died as a result of those side effects, although that is still being investigated. In addition, insurers are reluctant to pay for the drug, which has a price tag of $56,000 per patient per year. Medicare is still evaluating the drug to make its reimbursement recommendation, but a final decision isn’t expected until March or April 2022.

There are new reports that insurers are balking at paying for the drug. In a Bloomberg News survey of 25 large insurers, none described the drug as “medically necessary,” and said Aduhelm was still experimental — despite FDA approval — while some are still evaluating it.

Dr. Paul Schulz, a physician with the McGovern Medical School at UTHealth Houston and Memorial Hermann-Texas Medical Center, noted that for each person who is considered eligible for the drug, staffers can spend five hours working to get insurance approval, which is rarely granted.

“It’s very difficult to spend that much time getting something approved on a case-by-case basis,” Schulz said.

A representative for Health Care Services Corp., which has almost 17 million members in Blue Cross Blue Shield plans in five states, including Texas, said Aduhelm isn’t medically necessary for Alzheimer’s treatment “as a clinical benefit has not been established.”

Kaiser Permanente, a California-based health maintenance organization, pays for Aduhelm when a member’s doctor determines it is medically necessary.

Humana, another insurer, said it hasn’t made a final decision on who to cover and expressed concerns over conflicting data. It did say that Medicare’s decision will influence its final policy.

Cigna Corp. in June was quoted by Biogen as saying it was “working to ensure that the patients who will benefit most from this new treatment have a clear path to access it.”

But Cigna has since also called the drug “unproven” and won’t cover it. The company cited “emerging concerns regarding its safety and efficacy.”

Other patients who haven’t received approval from their payers have received the drug for free from Biogen, at least temporarily. However, there are concerns about delays, because the drug appears to be most effective when given early in the disease.

Dr. Jeffrey Gelblum of First Choice Neurology, a group of south Florida clinics that has about 80 patients receiving Aduhelm, said, “I don’t want to waste time. You’ve got a two-year window of intervention here, and if a patient comes in saying, ‘Look I’ve had this problem for a year,’ well, now I know I’m already a year into the problem.”

And deciding on eligibility not only includes standard Alzheimer’s cognitive tests, but a PET scan of the brain looking for amyloid plaques. The procedure runs about $5000 and isn’t covered by insurers. Another option is a spinal tap.

“There are many bottlenecks,” said Dr. Marwan Sabbagh, a physician at the Barrow Neurological Institute in Phoenix. “It’s not exclusive to our healthcare system.”

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