Intensive research is carried out by several pharmaceutical companies in order to develop a disease modifying drug for Alzheimer’s disease (AD). The development of drug candidates which reduce Aß and tau in the brain seems particularly promising. These drugs and the characteristics of AD raise a number of ethical challenges. In this report we analyze these challenges in relation to priority setting and the diagnostic measures associated with these drugs. The former analysis draws primarily on the Swedish ethical platform for health care priority setting, whereas the latter draws on the guidelines for screening developed by the National Board of Health and Welfare.
Although the effect of the new drugs is likely to have an impact on relatives of people with AD, it is our interpretation that the Swedish ethical platform leaves no room for such considerations.
In relation to the effect of the drugs there is also reason to pay special attention to the extent to which the surrogate measures used in the clinical studies are of clinical relevance.
When it comes to aggregating benefits across individuals, it is our interpretation that the platform does not allow aggregation of patient benefits in such a way. This means that the fact that people with AD constitute a large group of patients does not in itself constitute a reason for giving this group a higher priority. The ethical platform rather seems to prescribe that the effect must be assessed with regard to how it accrues to each individual. In a scenario where the budgetary impact becomes so great that decision makers need to prioritize within the group, it seems that there are no relevant criteria for these priorities.
AD is a condition with a very high degree of severity. However, as the new drugs are targeting the preclinical or Mild Cognitive Impairment (MCI) phase, the severity of the condition should be decreased with respect to the likelihood of actually developing AD. The severity of the condition thus becomes different for drugs that aim at the preclinical phase, those that aim at the MCI phase and those that aim at clinical stages of AD.
Solidarity considerations in the platform prescribes that people with AD may be less able than other patient groups to communicate their needs, they should therefore be given special consideration. However, this does not mean a higher priority but to stress that people with AD have the same right to health care as other groups with similar needs.
Population screening for AD is associated with several problems. There are general problems with screening from, for example, an autonomy point of view. But there are also problems related to the fact that current methods of risk stratification are so unreliable, which in turn results in false negatives (with risk of undertreatment) and false positives (with risk of overtreatment).
Screening in the MCI phase has (in addition to the problems that come with population screening) problems with inequality and arbitrariness. When the clinical phase begins, there is no longer any point with screening: the later the identification, the less potential treatment benefits compared to standard diagnostics.
It is our overall assessment that the new drugs must generate large health benefits for people at risk of developing AD in order to be eligible for general funding and to justify the ethical costs that come with current diagnostic methods.