Praiseldy Langi Sasongko

112 Chapter 3 Figure 3.2 Relevant transformational factors that could increase (“up” arrows) or decrease (“down” arrows) demand Population-related: • Growing elderly population • Increasing age limits for therapies • Increasing weight • Increasing age of pregnant women • Growth of chronic disease population Physician-related: • Increasing awareness through varios tools (e.g. education) • Recommending Ig to colleagues Negative public perceptions Societal Demand • Consequences of various immunosuppressive treatments or alternatives, e.g. CAR-T, Rituxumab or Fc-Rn receptor blocker • Oncology protocols incorporating Ig suppletion • Algorithm to identify potential patients in medical records • Pediatric trial (IPAD) in the Netherlands on increased Ig dosage • Improved diagnostics for PID • Using steroids or Rituximab instead of Ig for neurological patients • Various alternative therapies FcRn and Fc receptor blockers, complement-inhibiting drugs, IdeS, or recombinant products • Gene-correcting therapies for certain PIDs Evidence: • RCTs disproving Ig’s efficacy or proving alternative therapies efficacy • Ongoing neurology trial to stop/taper patients off of IVIG • Mechanism studies of IVIG to create alternatives Technological / clinical • High cost of Ig • Emphasis on cost-effectiveness when choosing medicinal products Economical EMA Guideline revisions, 2019 • Strictness with off-label usage • Ethical stance not to harm plasma donors in any way Legal Dutch transfer Act, 2021 Political Figure 3.3 Miscellaneous transformational factors that impact demand Demand • Patient preferences: Having freedom of choice in choosing branding and application otpions (e.g. SCIg or fSCIg) • Ensuring the (positive) reputation of the organization and/or company Societal • Improved Ig treatments with optimized use of plasmaderived proteins that do not increase demand • Production factor: Technological changes to increase yield in the same pool of plasma Technological • Using SCIg could be substantially costsaving for multiple parties • Price-setting of Ig products • Specific governmental regulations regarding Ig • Varying reimbursements schemes per country and barriesf or patients, physicians, and insurance companies. Reiumbursement for on vs off-label prescription • Donor remuneration • Varying global markets for Ig (and products being diverted to the more lucrative markets) • Substantial power of pharmaceutical companies • Rate of off-label usage Economic/political/legal

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