115 Using a scenario approach to assess for the current and future demand of immunoglobulins the latter could be hampered if there was standardization of dosing based on ideal or adjusted body weight but wide variations in practice still persist.96–98 Arguably, Ig need not be the first line of treatment options,4,99 but the broadened EMA definition for SIDs28 provides allowance for it to be. Furthermore, we found four transformational factors that impact both immune deficiencies and immunomodulation. First is the EMA 2019 guideline revisions, which gives prescribing justification for reimbursement agencies, physicians, and other stakeholders in Europe. Its inclusion of CIDP and MMN into its approved indications reflect current practice and justifies its continual (and possibly, increased) use. This latter point is reflected in CSL Behring’s growth of IVIG and SCIg sales in early 2020 due to the inclusion of CIDP in its product labeling.100 However, the impact for possible increase within Europe will vary depending upon country-specific reimbursement policies. Secondly, the rise of possible alternative therapies, particularly, FcRn receptor blocker61,101 and complement inhibiting drugs,63 could curb demand significantly if it were successful. Whatever replacement or alternative products or therapies are produced must be proven to be safe and (cost) effective in order to be truly viable options. One example of such is eltrombopag, found to be a noninferior but more cost-effective option than IVIG as bridging therapy for ITP.102 The evidence from trials of these alternatives or basal studies of Ig’s mechanisms will contribute to a body of evidence (the third element) that will be tale-telling to the direction of demand. Lastly, the rising popularity of SCIg103 and fSCIg7,77 have a questionable impact on demand, although studies show its economic beenfit.7,31,78–80 Pharmacokinetic and clinical studies suggest that switching from IVIG to SCIg requires a higher dosage,104,105 which would result in increased demand,104 whereas others found that a 1:1 dosage is comparable and/or equally effective 30,79,106 and the FDA recommends a conversion rate of 1.4. Further RCTs are needed to determine the most beneficial or personalized dosing strategy. Hence, future demand for the Netherlands and other high-income countries is likely to increase given strong demand patterns,9,13 and the aforementioned factors that could increase demand. However, the growth of the demand will also be abated by the individual and cumulative effects of the transformational factors noted above. Thus, for clinicians and policy makers, it is necessary to monitor both aspects in making decisions regarding Ig sufficiency. For the Netherlands, one way would be to create a centralized monitoring system, such as the UK’s National Immunoglobulin Database.27 Such a system could also monitor the factors mentioned here, include changes to guidelines or in prescribing practices, for the sake of assessing effect and making more accurate predictions for the country’s future demand. Furthermore, measures to steward its use are necessary, and a first step would be to conduct
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