Alzheimer’s Disease | Access & Reimbursement | US | 2022

Until recently, FDA-approved treatments for Alzheimer’s disease (AD) were limited to modestly effective symptomatic agents (e.g., donepezil, memantine), but in 2021, Biogen / Eisai’s Aduhelm (aducanumab) became the first potential disease-modifying therapy (DMT) approved for AD—an event marked by considerable controversy. Other DMTs (e.g., from Eisai / Biogen, Eli Lilly, Roche, Novo Nordisk) and symptomatic agents for treating AD-associated psychosis (Acadia’s Nuplazid) and agitation (Lundbeck / Otsuka’s Rexulti, Avanir / Otsuka’s AVP-786, Axsome’s AXS-05) are advancing through late-phase development with near-term launch potential; their approval could meaningfully alter the dynamics of this market, driven by clear need, strong market demand, and premium pricing—but only if these treatments are accessible. As the AD therapy market enters a new era, understanding neurologists’ preferences for and expectations from new therapeutics, counterpoised by payers’ receptivity to high-priced brands entering a highly underserved but heavily generic market, will be key for pharmaceutical companies developing new drugs or considering entering this wide-open arena.

QUESTIONS ANSWERED

• What impact does the cost of AD treatment have on prescribers and payers today? How will cost drive treatment choices in the future?
• What is the current state of coverage of key therapies used or approved for AD in the United States? What restrictions do payers impose, and how do market access dynamics influence surveyed neurologists’ prescribing?
• What coverage and uptake would be expected for future anti-Aβ monoclonal antibodies if their efficacy is confirmed in Phase III clinical trials? What clinical and nonclinical differentiators would drive preferential use and coverage terms?
• How receptive are payers to drugs in late-phase development for key neuropsychiatric symptoms? What coverage decisions do they anticipate? How do neurologists expect to prescribe the agents?
• What actions can developers take to optimize market access?

PRODUCT DESCRIPTION

U.S. Access & Reimbursement provides integrated brand- and disease-level insight on reimbursement dynamics and the impact of U.S. payer policy on physician prescribing behavior in the market access environment, including up-to-date analysis of drug coverage and restriction policies and payer and prescriber perspectives on key marketed drugs and receptivity to emerging therapies.

Markets covered: United States

Key drugs: AChEIs, memantine, Adlarity, Namzaric, Nuplazid, Rexulti, Aduhelm, lecanemab, donanemab, gantenerumab, semaglutide, AVP-786, AXS-05.

Key companies: Biogen, Eisai, Novartis, Novo Nordisk, AbbVie, Corium, Eli Lilly, Roche, Johnson & Johnson, Lundbeck / Otsuka, Acadia Pharmaceuticals.