110 Chapter 3 III. Key transformational factors that could impact immunoglobulin demand and its subsequent effect When literature was searched and experts were asked regarding transformational factors that could impact Ig demand and to what effect, three groups emerged: factors that could increase Ig demand, factors that could decrease Ig demand, and factors that remain to be seen how it impacts demand. (Supplementary Tables 2–4 list these factors in-depth and by which method they were found - scoping review or interview). Factors that could increase demand Both the literature review and interviews revealed social, technological, economic, political, and legal factors that could increase demand (shown in the ‘up’ arrows in Figure 3.2). With regards to social factors, both methods described demographic factors, such as age (the growing elderly patient population,6,40,51,54 the older age of women becoming pregnant52 and heightened age limits for various therapies) and increasing weight (as treatment is weight-based).51,54 From a communication perspective, experts shared that increasing physician awareness (through education, diagnostic tools) and interactions (word-of-mouth) may also contribute to increasing demand.51 Two clinician-researchers cautioned that while these factors may increase demand, this may not be entirely applicable to pediatrics due to the small number of pediatric patients with PIDs, whereas another clinician-researcher stated that as more adults are being diagnosed with PIDs, there would be heightened demand due to the chronic and weight-based natures of treatment. Linking both social and technological/clinical factors, experts stated that as increasing age is no longer a limiting factor for treatments, and as new cellular and immunosuppressant therapies and drugs are developed, patients endure a prolonged immunosuppressive state that possibly warrant Ig as secondary support.6,51,55–59 Lastly, one expert familiar with the EMA Guideline revisions stated it could justify increased Ig demand in Europe, particularly for SIDs. Factors that could decrease demand Both the literature review and interviews revealed technological/clinical, and economic-political factors that could decrease demand (shown in the ‘down’ arrows in Figure 3.2). With regards to technological/clinical factors, alternative therapies were found that overlap with Ig’s mechanisms of action, such as the neonatal receptor (FcRn)60 and other Fc receptor blockers,61 complement-inhibiting drugs,62,63 and reduction of antibody production.64 A clinical expert spoke of the value of trials seeking to taper/stop neurology patients off of Ig or switching to Rituximab instead (which
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