Physician Views Preview: Will docs limit Aduhelm use to beta-amyloid Alzheimer's patients?
Half of the US neurologists and psychiatrists we snap-polled last week said they disagree with the FDA's controversial decision to approve Biogen's Aduhelm (aducanumab) for the treatment of Alzheimer's disease.
Many are still likely to use it, however, and surveyed physicians suggested on average that around 30% of all Alzheimer's disease patients could be potential recipients; a figure potentially enhanced by the considerable pressure that practitioners are likely to come under to prescribe the drug.
This aligns with the top-end of Biogen's projected commercial outlook for Aduhelm. The company estimates that there are up to 2 million patients in the US (from a total of approximately 6 million) that have been clinically diagnosed with mild cognitive impairment or mild dementia thought to result from Alzheimer's disease, and who would by amyloid beta-positive if tested.
Whilst this suggests Biogen will launch Aduhelm by targeting a specific cohort of patients (aligned to the criteria of those enrolled into its Phase III study programme), one of the bigger controversies surrounding US approval of Aduhelm is the very broad label granted by the FDA which appears to theoretically encompass all Alzheimer's disease patients. This plays out against a backdrop of continued debate about the clinical merits of Biogen's drug.
Whether or not practitioners intend to limit their use of Aduhelm to patients who test positive for beta-amyloid plaques is one of the questions we are asking in our follow-up snap-poll.
We are also keen to gauge to what extent testing for beta-amyloid and other logistical issues will act as a bottleneck to possibly delay patient access to Aduhelm, whether physicians have already seen an influx of requests about potential treatment from existing patients, and whether the controversial price of the drug is justified.
Survey results and analysis will be published later this week for FirstWord Pharma PLUS subscribers and can be purchased by non-FirstWord Pharma PLUS subscribers. To be notified when they become available, click here.
In the meantime, listen to FirstWord’s editors discuss the Aduhelm approval in the latest episode of The FirstTake podcast.