Why Primary Care Physicians Should Worry About the Approval of Aducanumab

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 Reviewconcluded 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.