Thus, in not approving aducanumab, PBM and VHA leadership acted on the core bioethical principles of beneficence and nonmaleficence to prevent harms that proportionally outweighed benefits. Another ethical consideration for the VHA was that of distributive justice given the expense of the medication and the VHA obligation to be responsible stewards of public resources. At the time of the VHA decision, a year’s worth of aducanumab cost about $56,000: In December 2021, the manufacturer announced a dramatic decrease in the drug’s price.12 Although it may seem that fairness requires the VHA to provide any possible treatment for veterans whose cognitive impairment is in part an adverse effect of their time in uniform, a stronger counter argument is that the same high safety and scientific standard should be used for the approval of medications for patients with dementia as for any other disorder.
Among VHA HCPs and their patients with new and early diagnosed mild cognitive impairment or mild dementia, what is lacking in PBM’s clinical ethics analysis is the important principle of autonomy. PBM did carve out a space for the use of the drug in “highly selected patients by experts and centers that have the necessary diagnostic and management expertise.”5 The series of safety standards that must be met along with monitoring for the drug to be prescribed is PBM’s effort to obtain an equilibrium between preventing harm while respecting professional judgment and patient choice. PBM and VHA will reconsider its criteria if research shows improved effectiveness and safety. As with most debated decisions, for some patients and HCPs that balancing act may not have gone far enough, yet many believe that VHA for now is on the right side of the controversy.