Why Primary Care Docs Should Worry About the Aducanumab Approval

Hi, everyone. I'm Dr Kenny Lin. I am a family physician at Georgetown University Medical Center, and I blog at Common Sense Family Doctor.

Kenneth W. Lin, MD, MPH

Medscape recently polled 340 US physicians, including neurologists and primary care physicians, on their views of the FDA's controversial approval of aducanumab (Aduhelm) for treatment of Alzheimer's disease. Nearly 9 in 10 neurologists and a similar proportion of primary care physicians disagreed with the approval decision. Physicians cited insufficient evidence of the drug's benefits and harms or felt that the harms — which include brain swelling, headaches, and balance problems — outweigh the benefits. Although the majority do not plan to prescribe the drug, which is expected to cost about $56,000 annually, many are concerned that they will be pressured to do so by patients and their families.

In approving aducanumab, the FDA disregarded the failure of one of the drug's two phase 3 randomized trials to show a cognitive benefit and the overwhelmingly negative judgement of its advisory committee, which voted 8 to 1 that the data did not show effectiveness. An analysis by the Institute for Clinical and Economic Review concluded that even if aducanumab works as advertised, an appropriate price based on standard quality-adjusted life-year thresholds would have been $2500 to $8300 per year.

Why should primary care physicians care about an outrageously expensive and possibly ineffective drug that will likely be prescribed mostly by neurologists? I can think of at least three reasons. First, this misguided approval may accelerate the decline of public trust in the FDA, which has been criticized for past politically motivated decisions such as emergency use authorization for hydroxychloroquine to treat COVID-19 (which was later revoked when it became clear that the drug had no benefit). For my patients who are wary of other new drugs and vaccines, such as the COVID-19 vaccines, the FDA's assurances of safety and effectiveness no longer carry the weight they once did.

Another reason is that aducanumab could cause healthcare spending to skyrocket. At $6 billion to $29 billion per year, projected spending on this drug alone will likely be greater than the annual budget of the CDC ($8 billion) and could exceed the budget of NASA ($23 billion). Depending on how many older patients are prescribed aducanumab, total drug spending by Medicare and its beneficiaries may rise as much as 50%. Those extra billions of dollars will need to come from somewhere, and the resulting budget crunch could force substantial reductions in spending on physician services or increases in seniors' premiums and coinsurance payments, making it more difficult for family physicians to accept new Medicare patients and provide them with high-quality care.

Third, having a new drug for Alzheimer's disease will probably increase pressure on primary care physicians to screen older patients for mild cognitive impairment (MCI) during wellness visits or follow-ups for chronic conditions, even though in 2020 the US Preventive Services Task Force again found insufficient evidence to assess the balance of benefits and harms. Many screening tests are copyrighted and charge a fee for each use, and one copyright holder has already announced that it is "working with Biogen, and other major pharma, to not only test and validate treatment options — such as aducanumab — but to also facilitate rapid comprehensive screening of MCI and early-stage Alzheimer's among large populations." I agree with one of my colleagues, who predicted that lots of groups with financial conflicts of interest will soon be pushing family physicians to "jump on the 'screen everyone for possible dementia' bandwagon, then treat them [or refer to be treated] with a drug that an FDA advisory panel voted to reject."

The aducanumab saga has obscured the fact that primary care can already do quite a bit to prevent cognitive decline at a fraction of this drug's projected cost. Earlier this year, the American Heart Association published a scientific statement that identified several major, modifiable risk factors for cognitive decline: depression, midlife hypertension, midlife obesity, physical inactivity, diabetes, hyperlipidemia, and smoking. All of these conditions can be managed with lifestyle counseling, inexpensive generic medication, or both. Aducanumab and its copycats won't reduce the future burden of Alzheimer's disease nearly as much as practicing good family medicine already does.

Kenny Lin, MD, MPH, teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journal American Family Physician.

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