In June, the Food and Drug Administration's controversial approval of Biogen's aducanumab (marketed as Aduhelm) for Alzheimer's disease stirred up more questions than answers. The biologic was granted accelerated approval despite major questions about its unclear clinical efficacy, safety/risk profile, and the near-unanimous dissenting opinion of the FDA's own advisory committee. Congressional investigations examining the relationship between the FDA and Biogen—including an inquiry by the inspector general—are underway.
Meanwhile, healthcare leaders and broader society struggle to reconcile what this situation means. If the approval holds, aducanumab—priced at $56,000/patient per year—will be among the most expensive drugs in history, exceeding what the government annually spends on NASA and the Centers for Disease Control and Prevention combined. Add-on costs associated with imaging, safety monitoring, infusions, and provider time will further compound financial burden. Already, the Veterans Affairs Department, as well as the Cleveland Clinic, Mount Sinai, and Providence health systems, and Excellus Blue Cross and Blue Shield have all declined to offer the drug until results of the ongoing federal investigations are settled. A growing chorus of physicians have publicly stated that they will not prescribe the drug.
From a health economics perspective, it is not clear that either cost/benefit or cost-utility (quality of life) analyses would demonstrate individual or societal benefit. Expenditures would likely drive up premiums for Medicare Part B and Medicare supplemental policies and increase out-of-pocket expenses for Americans, unless a National Coverage Determination analysis underway precludes Medicare (and then likely private insurers) from payment.
There are opportunity costs as well. If CMS incurs drug spending at an unprecedented level, this will invariably crowd out other funding priorities including improving acute/chronic care for people with dementia. The Alzheimer's Association has claimed for years that such a drug would save the health system money and stimulate innovative research. Both are unlikely, based on planned "accelerated" submissions from Lilly and other similar drugs.
Our current predicament is emblematic of what we have come to call our "American dementia"—an undue faith in the capacity of biomedical science and markets to produce a "fix" for Alzheimer's. Despite hundreds of billions of dollars spent on anti-Alzheimer's drugs over the last several decades, there has been little positive impact on the millions of people and caregivers who still cope with those battling age-related cognitive challenges.
This pharmaceutical, market-oriented approach in pursuit of single-mechanism drugs has narrowed imaginative thinking about how to adapt to the challenges we face as an aging society. One of the more surprising research findings of the last decade is that dementia rates have been in decline in the U.S., Canada and Western Europe. This trend has little to do with biotechnology and ostensibly much to do with mid-20th century public policy that increased education (via the GI Bill and investment in state colleges and universities in the U.S.), expanded healthcare and improved treatment of risk factors that affect the brain (i.e., vascular disease, high cholesterol, hypertension), remarkably successful smoking cessation programs, de-leading gasoline, etc. Collectively, these state actions in service of public health are believed by most experts to have enhanced the brain resilience of those now in their graying years.
With contemporary uncertainties surrounding drug development foregrounded against the long-term impact of improved social determinants of health on brain aging, it is useful to think about how healthcare organizations might adapt in our current environment. Many institutions must undertake Community Health Needs Assessments, and, invariably, they will document dementia and other age-related chronic conditions as a prevalent issue and thus shoulder responsibility for improving the environments in which aging patients live. Current research suggests 40% of dementia risk may be amenable to prevention/delay, which means an organization's contributions can be significant. Minimizing diabetes, treating hypertension, preventing head injuries, lowering obesity, encouraging smoking cessation and avoidance of excessive alcohol, reducing exposure to air pollution, treating hearing impairment, and fostering opportunities for lifelong learning are all social determinants of brain health that hospitals can impact within their service areas, both clinically and via community outreach.
From a care perspective, helping seniors age in place may be of particular benefit. This could mean supporting family caregivers and investing in home-based care—specifically in approaches that bring teams (nurses, therapists, social workers) into homes. Given the toxic effects of loneliness on older adults, healthcare systems can support senior centers (or, better yet, "intergenerational centers") and connect patients with opportunities for socialization and meaningful community contributions. Increasingly, healthcare organizations are hosting farmers' markets, community gardens, mobile food markets, and other infrastructure that can integrate elders with their neighbors. Collaborating with national advocacy movements like Dementia Friendly America may be particularly useful for organizations seeking targeted improvements in transportation, nutrition and housing for elders in their service areas.
Ultimately, while the aducanumab drama plays out on the national (and international) stage, there's still much we can do in our communities—but we must think outside the reductive box of our current American dementia and beyond the false hope peddled by industry and advocacy organizations.
