The systemic lupus erythematosus (SLE) therapy market in the United States is largely genericized and off-label. With the exception of GlaxoSmithKline’s Benlysta—which launched in 2011—the approvals of AstraZeneca’s Saphnelo and Aurinia’s Lupkynis in 2021 were the first for this indication in almost 60 years. Because Benlysta (IV and SC) is an expensive, branded biologic, access to it is typically restricted by payers. Several therapies are in late-phase development for SLE, including agents targeting a previously underserved subpopulation of SLE patients: active lupus nephritis (LN). This report examines the prescribing and reimbursement environment for key current therapies and emerging SLE agents in the United States, according to surveyed rheumatologists and MCO PDs / MDs. The content explores how physicians and payers perceive current and emerging SLE therapies and the reimbursement dynamics that will promote or restrict market access to the agents. therapies and the reimbursement dynamics that will promote or restrict market access to the agents.
What is the extent of MCO coverage of Benlysta, Saphnelo, Lupkynis, and off-label Rituxan, and how do the coverage policies affect rheumatologists' prescribing of these drugs? Where do the rituximab biosimilars fit in the SLE treatment algorithm?
Will the approval of Gazyva and Cosentyx for LN affect their coverage on commercial plans? How do rheumatologists perceive these agents for LN, and where in the treatment algorithm do physicians anticipate using them?
How do physicians anticipate using dapirolizumab pegol and BIIB059, which are in development for moderate to severe nonrenal SLE, and how do payers expect to cover these therapies on commercial plans?
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.
Ajay Puri, M.B.A., is an analyst on the Immune and Inflammatory Disorders team at Clarivate. He has developed expertise in ulcerative colitis, Crohn’s disease, and systemic lupus erythematosus. Previously, he worked as a knowledge management associate at ZS Associates, where he conducted competitive assessment, company and product profiling, and other projects. He holds a bachelor’s degree in pharmacy and an M.B.A. in marketing from the National Institute of Pharmaceutical Education and Research in Mohali, India.
Chris Lewis is a primary research manager at Clarivate. She is responsible for the coordination, content review, and content generation of U.S. Access & Reimbursement reports, including authoring select A&R reports on managed care trends. Before this position, Ms. Lewis was a senior analyst at HealthLeaders-InterStudy. She analyzed the managed care markets in California, New York, and Pennsylvania. She also launched and authored the Pharmacy Benefit Manager profile series. She received her bachelor’s degree from California State University in Sacramento.