Key takeaways:
- The FDA approved the amyloid-targeting antibody in July 2023.
- Investigating treatment earlier in Alzheimer’s disease course may provide answers on Leqembi’s efficacy.
The FDA’s approval of Leqembi in July 2023 triggered a wave of discussion in the medical community on how to prescribe and properly administer the amyloid-targeting antibody to treat those diagnosed with Alzheimer’s disease.
Leqembi (lecanemab, Eisai/Biogen), which works by clearing the telltale biomarker amyloid beta and removes amyloid plaques in the brain, was approved as a 100 mg/mL IV dose and indicated for those with mild cognitive impairment or the mild dementia stage of AD.
Despite FDA approval in July 2023, neurologists are still hesitant to take the plunge and give full confidence in prescribing Leqembi to treat the early stages of Alzheimer’s disease. Image: Adobe Stock
Unlike oral therapeutics that can be administered by the patient outside the clinical setting, IV administration of Leqembi requires intervention within the clinical space. According to the FDA, the process begins with dilution in sodium chloride, requires visual inspection prior to administration, then necessitates monitoring throughout administration for symptoms of infusion-related reactions.
Differing opinions on Leqembi efficacy
Questions early in 2024 lingered among neurology professionals regarding Leqembi’s practicality. Spherix Global Insights, a marketing research firm that focuses on health care, surveyed 79 providers in January to assess their prescription, administration and thoughts on Leqembi.
Its research showed patient requests are driving demand as well as some clinician optimism in Leqembi’s efficacy. Among the chief complaints, clinician confidence is low in Leqembi’s efficacy and a small percentage of AD patients and/or family members cannot cover out-of-pocket costs associated with treatment.
“Few surveyed neurologists considered Leqembi to be a significant medical advance over other historical Alzheimer’s treatments and satisfaction with Leqembi was low compared to Spherix neurology launch benchmarks,” Alissa Algarin, insights director of neurology at Spherix, told Healio.
Moreover, Algarin cited neurologists’ concerns over the logistical issues of genetic testing to find Apolipoprotein E 4, whose presence increases the risk of individuals to experience amyloid-related imaging abnormalities (ARIA), which 46% of respondents to Spherix inquiries cited as a chief deterrent in prescribing Leqembi.
And if that hurdle is cleared, concerns remain regarding testing to see whether ARIA is occurring, scheduling appointments for infusions and receiving the treatment via IV infusion every 2 weeks, she added.
Health care providers appear to be caught in a cycle of wait-and-see, unwilling to test the waters themselves until more information is reported from colleagues who have taken the plunge.
According to statistics cited in the Spherix report, when asked why they have not initiated a patient on Leqembi, 42% of neurologists are waiting for the body of academic knowledge on positive outcomes with Leqembi to increase; 40% cited a desire to learn more from colleagues and peers regarding beneficial outcomes; 16% acknowledged the drug is not yet available in their practice or medical center, and 14% stated they have already prescribed Leqembi but are waiting for confirmation of Medicare or other insurance to cover costs.
“The information from Spherix is very telling,” Rajesh R. Tampi MD, MS, DFAPA, professor and chairman of the department of psychiatry at Creighton University School of Medicine, wrote in an email to Healio.
“The public perception, both from patients and their families and from physicians regarding the efficacy and safety of the newer drugs (aducanumab and lecanemab) is that of skepticism.
Tampi also cited issues of equity, diversity and inclusivity involved with prescribing, not least of which are based in access as well as cost for underrepresented populations.
And still, Tampi pointed out, when access is granted, long-term safety must be considered for these populations, as many individuals from underrepresented groups do not have the means to continue following up at the required treatment intervals.
Meanwhile, business appears to be booming.
Global sales robust in first quarter
In late April, a subsequent Spherix release cited Biogen reporting $19 million in global sales during the first quarter of 2024, with Biogen and Eisai having increased by 2.5 times the number of patients prescribed Leqembi compared with the fourth quarter of 2023.
“Eisai and Biogen deployed specialized teams and materials to educate clinicians and care teams about the Leqembi journey with in-person resources, including neurology account specialists, clinical nurse educators, access and reimbursement specialists and medical liaisons,” Eisai spokesperson Libby Holman told Healio in an email regarding the companies’ efforts to boost education on Leqembi’s potential.
The Biogen/Eisai partnership focuses on providing information, such as patient case studies presented by clinicians with Leqembi experience, she said. Additionally, on a weekly basis, the partners have been distributing Leqembi to an increasing number of health care systems, community neurologists and infusion centers with established protocols and resources required to not only initiate but also to monitor treatment.
Rawan Tarawneh, MD, associate professor of neurology and cognitive neurologist at the University of New Mexico, posited that earlier intervention may be the key to definitive proof of Leqembi’s efficacy.
“As [Alzheimer’s disease] is a neuropathologically complex disease in which amyloid deposition has almost plateaued by the time the first signs of cognitive impairment appear, anti-amyloid agents may have a better chance of modifying disease progression if administered in earlier presymptomatic stages,” she told Healio.
Reference:
Launch Dynamix Leqembi in Alzheimer’s (US) Deep Dive Wave 2 January 2024.
Highlights of Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s000lbl.pdf. Published January, 2023. Accessed May 3, 2024.
Biogen plots 30% Leqembi field force bump, omnichannel campaigns as launch enters new phase. https://www.spherixglobalinsights.com/biogen-plots-30-leqembi-field-force-bump-omnichannel-campaigns-as-launch-enters-new-phase/. Published April 25, 2024. Accessed May 3, 2024.