What the Aduhelm manufacturers and others with agents in the pipeline can learn from early launch metrics
EXTON, Pa., October 7, 2021 /PRNewswire/ — At three months post-launch, the high expectations for Biogen/Eisai’s Aduhelm in Alzheimer’s disease have not quite materialized. Neurologist-reported patient share for the drug, as well as the percentage of neurologists who have ever prescribed it, remain low. Indeed, despite Aduhelm being the first disease-modifying therapy (DMT) approved for Alzheimer’s disease, neurologists generally have an unfavorable reaction to its risk/benefit profile – largely because of its lack of robust clinical efficacy coupled with meaningful safety risks (e.g., for ARIA [amyloid related imaging abnormalities]).
However, data captured in the first of six planned quarterly deep dive reports included in Spherix’s Launch Dynamix™: Aduhelm (Biogen) in Alzheimer’s Disease (US) service point to ways in which Biogen and Eisai could facilitate future use of the drug. This wave of research was informed by a quantitative survey conducted with 74 neurologists between September 2nd and 7th in addition to qualitative interviews done with eight of the survey respondents.
Four key factors that could drive future use of Aduhelm:
1. Biogen outreach and increased education
The company may have room to improve in terms of outreach and education, as roughly one-half of surveyed neurologists have never been detailed on Aduhelm by a Biogen sales representative and a similar percentage indicate that Biogen has not given them the necessary information to confidently initiate a patient on the new drug.
According to one interviewed neurologist, “I’m hesitant about [Aduhelm] at this point because I don’t have enough education on it.” Another neurologist mentioned, “[Biogen] should probably send more experienced clinicians in their pool who can talk about their experience with the drug – if they were part of the trials or at least had more than five patients in their pool – not send PhDs who know nothing about clinical treatment.”
2. Aduhelm onboarding and logistical support
Survey data suggest that neurologists have a clear idea as to who would be the most appropriate for Aduhelm: patients with mild cognitive impairment (MCI) or mild dementia stage of Alzheimer’s disease with confirmed beta amyloid plaques, consistent with the EMERGE and ENGAGE clinical trial populations. During qualitative interviews, neurologists reported using lumbar punctures and amyloid PET scans to determine this beta amyloid status. While Biogen is already assisting with such testing, the company should continue outreach to make these tests as accessible and easy to perform as possible for doctors and as affordable as possible for patients in order to build the pool of Aduhelm-ready patient candidates.
Several interviewed neurologists also reported that their centers are not offering Aduhelm infusions, necessitating patients to be referred out for administration and potentially creating a logistical barrier to prescribing.
While some interviewees were aware that Biogen has coordinated with infusion centers for Aduhelm administrations, others voiced the opposite assessment, “I don’t think that things are set up. If I had a patient today and called the infusion center, I’m sure they wouldn’t be ready to go on [Aduhelm].” The decision of certain large centers, such as the Cleveland Clinic, not to infuse Aduhelm has also made neurologists cautious about prescribing Aduhelm.
3. Access to peer-reviewed Aduhelm clinical trial data
While interviewed neurologists generally agree that Aduhelm is effective at clearing amyloid, they question its clinical efficacy – an arguably more important objective when treating patients. Indeed, its minimal perceived efficacy on slowing the progression of cognitive decline and its ambiguous clinical trial results are key barriers to its use, according to surveyed neurologists.
The availability of confirmatory Phase IV data showing clinical efficacy on cognition is anticipated to have a high positive impact on neurologists’ willingness to prescribe Aduhelm. However, given that these data and data from other post-marketing studies will likely not be available in the near-term, publication of full trial results from EMERGE and ENGAGE in a peer-reviewed journal would likely increase physicians’ comfort with the drug.
4. Improved Aduhelm reimbursement/decreased patient costs
Collectively, survey data suggest neurologists’ hesitancy to prescribe Aduhelm in the absence of a final decision from CMS (Centers for Medicare and Medicaid Services) allowing reimbursement of Aduhelm. This sentiment was echoed in qualitative interviews, with neurologists often mentioning uncertainty in relation to Aduhelm reimbursement by CMS as an obstacle to use.
For example, “If patients’ out of pocket cost is not an issue, then that reduces that part of the burden of treatment.” While Biogen can’t directly control the outcome of CMS’ decision, the company could further assist with costs associated with infusion administration and MRI and PET monitoring (which were pain points voiced by neurologists during interviews) to make the drug more affordable for patients.
With an FDA rolling submission for Eisai’s lecanemab initiated last week under the accelerated approval pathway and other pipeline agents, such as Eli Lilly’s donanemab, likely to follow in quick succession, the manufacturers of these drugs could take lessons from Aduhelm’s early launch to set their brands up for success. However, endorsement of these agents from leading Alzheimer’s disease medical institutes will likely be needed to overcome neurologists’ generally negative opinions of the FDA’s approval of purported Alzheimer’s DMTs based solely on biomarker data.
As mentioned by one interviewed neurologist, “Before Aduhelm’s approval, I had great confidence in the independence of the FDA and in their decisions and so did a lot of people. This totally undermines that.”
About Launch Dynamix™
Launch Dynamix™ is an independent service providing a monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into patient types initiated, brand perceptions, promotional activity, and drivers and barriers to uptake.
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