Immunoglobulin A Nephropathy – Access & Reimbursement – Access & Reimbursement – IgA Nephropathy (US)

The U.S. IgA nephropathy (IgAN) therapy market predominantly comprises supportive treatments such as RAAS inhibitors, SGLT-2 inhibitors, immunosuppressants, and/or diuretics. The FDA’s acceptance of the surrogate clinical trial endpoint “reduction in proteinuria” has enabled early approval of therapeutic agents labeled for IgAN: Calliditas Therapeutics’ Tarpeyo (DR-budesonide), Travere Therapeutics’ Filspari (sparsentan), and Novartis’s Fabhalta (iptacopan). Because all approved targeted therapies are expensive, payers usually restrict their access to high-risk patients. Several therapies are also in late-phase development for IgAN. This report examines the prescribing and reimbursement environment for key current and emerging IgAN agents in the United States according to surveyed nephrologists and MCO PDs / MDs. It explores how physicians and payers perceive current and emerging IgAN therapies and the reimbursement dynamics that will promote or restrict market access to the agents.

Questions answered

• What is the state of coverage of Tarpeyo, Filspari, and Fabhalta? What restrictions do payers impose, and how do market access dynamics influence surveyed nephrologists’ prescribing?
• What is the state of coverage for IgAN diagnostics (e.g., kidney biopsy, blood-based biomarkers such as eGFR and UPCR), and how are physicians using them? What factors will drive preferential use and coverage?
• How receptive are payers to emerging drugs (e.g., Vera Therapeutics’ APRIL/BAFF inhibitor atacicept, Novartis’s endothelin receptor antagonist atrasentan)? What points of differentiation are / will be most compelling to nephrologists and payers of new therapies for IgAN?

Content highlights

Geography: United States

Primary research: Survey of 100 U.S. nephrologists; survey of 30 U.S. managed care organization (MCO) pharmacy and medical directors (PDs/MDs)

Key drugs covered: Tarpeyo, Filspari, Fabhalta, RAAS inhibitors, SGLT-2 inhibitors, iptacopan, sibeprenlimab, zigakibart, atacicept, povetacicept, atrasentan

Production description

Leveraging Clarivate’s proprietary data sources and surveys with physicians and payers, Access & Reimbursement provides integrated brand- and disease-level insight on reimbursement dynamics and the impact of payer policy on physician prescribing behavior in the United States. Through detailed analyses of drug coverage, restriction policies, and contracting, as well as payer and prescriber perspectives on key marketed drugs and their receptivity to emerging therapies, this report enables you to:

• Identify and learn how to overcome roadblocks to market access to best position your brand.
• Identify key stakeholders and reimbursement drivers and assess the impact that reimbursement decisions have on treatment selection.