In June 2021, Biogen / Eisai’s anti-Aβ MAb aducanumab (Aduhelm) received accelerated approval from the FDA for the treatment of Alzheimer’s Disease (AD), rendering it the first potential DMT approved for this devastating disease. Although the drug’s approval has been met with considerable controversy, it nevertheless marks the dawn of a new era in drug development, disease management, and regulatory standards in this indication. Other products in the class are soon to follow (Eisai / Biogen’s lecanemab, Eli Lilly’s donanemab, Roche’s gantenerumab), while the broader AD pipeline features a very large and diverse range of DMT candidates with novel mechanisms of action / drug targets in various stages of development that, if successful, could expand the therapeutic options for AD and optimize future clinical outcomes. Meanwhile, the need for new symptomatic agents remains high, especially for key neuropsychiatric symptoms such as agitation. This space has seen a surge in development activity in recent years, as several novel adjuncts for treating AD-associated psychosis and agitation are advancing through the late-phase pipeline with near-term launch potential. As the AD therapy market enters this new era, understanding how prescribers perceive and plan to incorporate new brands in the AD treatment paradigm is critical. This report leverages quantitative primary research to assess evolving trends in a dynamic U.S. AD market by investigating physicians’ receptivity to, preparedness for, and anticipated use of newly launched (e.g., Aduhelm) and late-phase DMTs and anti-agitation compounds. Recognizing the critical role that cost and coverage will play in the access and uptake of new, premium-priced options, this report also provides additional perspective from U.S. payers.
QUESTIONS ANSWERED
How do physicians view the clinical profiles of Aduhelm, other DMTs, and emerging anti-agitation drugs? How do they plan to incorporate these agents in treatment, if approved?
What factors will drive the prescribing of new behavioral adjuncts for AD patients with agitation? How will these drugs compete and with off-label generic alternatives?
How do payers view the clinical profiles of pipeline therapies? What are the value drivers that will influence formulary decisions? What restrictions / requirements do payers envision?
PRODUCT DESCRIPTION
Clarivate’s Special Topics reports use quantitative and/or qualitative primary research to assess evolving trends and market effects in dynamic disease areas. Insights from this report will help developers gauge the competitiveness and sales potential of late-phase assets in the AD market.