Understanding Reimbursement and Access Policies for Immunoglobulins and Other Plasma-Derived Medicinal Products Across Europe
Author(s)
Tomasz Kluszczynski, DPhil.1, Marek Kortus, M.A.2.
1ACESO Healthcare Consulting, Warsaw, Poland, 2PPTA Europe, Brussels, Belgium.
1ACESO Healthcare Consulting, Warsaw, Poland, 2PPTA Europe, Brussels, Belgium.
OBJECTIVES: Plasma-derived medicinal products (PDMPs), particularly immunoglobulins (IgGs), play a critical role in treating rare and chronic conditions. Most of these therapies are life-saving and depend on human plasma as a starting material, making them uniquely vulnerable to supply constraints. Against the backdrop of ongoing EU-level initiatives to improve the availability of critical medicines and strengthen supply chain resilience, this study aimed to map the landscape of reimbursement, cost-containment, and stockpiling policies across Europe to identify policy-driven access challenges and effective national practices.
METHODS: Data was collected through a structured survey focused on public policy frameworks relevant to PDMPs, distributed to private sector stakeholders operating in the European PDMP market. Responses were validated by independent third-party experts, via structured interviews, to ensure accuracy and comprehensiveness. The survey explored categories identified as particularly relevant to access for PDMPs: national cost-containment mechanisms (including external and internal reference pricing), stockpiling obligations, and reimbursement policies, assessed specifically for IgGs as a representative case study.
RESULTS: The analysis revealed a highly heterogeneous policy environment across Europe. While most countries apply supply-side cost-containment tools (e.g., clawbacks, statutory discounts, ERP-based price caps), some explicitly exempt PDMPs or subclasses such as IgGs due to their essential or critical medicines status. Reference pricing approaches vary widely, with only a few countries applying value-based pricing. Stockpiling requirements also differ substantially, from no obligations to mandates covering several months. Reimbursement frameworks for IgGs show broad variation in indication coverage, ranging from indication-specific funding to national tender systems and protocol-based hospital formularies.
CONCLUSIONS: National policies heterogeneity significantly affects equitable access to PDMPs in general and IgGs in particular across Europe. Countries that account for the unique characteristics of these products tend to ensure more stable supply and access. Improved coordination across national policies, with attention to the distinctive nature of PDMPs, could facilitate more equitable access.
METHODS: Data was collected through a structured survey focused on public policy frameworks relevant to PDMPs, distributed to private sector stakeholders operating in the European PDMP market. Responses were validated by independent third-party experts, via structured interviews, to ensure accuracy and comprehensiveness. The survey explored categories identified as particularly relevant to access for PDMPs: national cost-containment mechanisms (including external and internal reference pricing), stockpiling obligations, and reimbursement policies, assessed specifically for IgGs as a representative case study.
RESULTS: The analysis revealed a highly heterogeneous policy environment across Europe. While most countries apply supply-side cost-containment tools (e.g., clawbacks, statutory discounts, ERP-based price caps), some explicitly exempt PDMPs or subclasses such as IgGs due to their essential or critical medicines status. Reference pricing approaches vary widely, with only a few countries applying value-based pricing. Stockpiling requirements also differ substantially, from no obligations to mandates covering several months. Reimbursement frameworks for IgGs show broad variation in indication coverage, ranging from indication-specific funding to national tender systems and protocol-based hospital formularies.
CONCLUSIONS: National policies heterogeneity significantly affects equitable access to PDMPs in general and IgGs in particular across Europe. Countries that account for the unique characteristics of these products tend to ensure more stable supply and access. Improved coordination across national policies, with attention to the distinctive nature of PDMPs, could facilitate more equitable access.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR227
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Pricing Policy & Schemes, Procurement Systems, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
Neurological Disorders, Rare & Orphan Diseases, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)