113 Using a scenario approach to assess for the current and future demand of immunoglobulins Figure 3.4 Miscellaneous transformational factors that impact supply Supply Donor-related factors: • Obtaining sufficient healthy plasma donors and the marketing strategies herein • (Non)remuneration of donors 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 Manufacturing factors • Supply issues related to the dynamics of contract fractionation, access-issues, and self-sufficiency • Obtaining sufficient raw material (linked to societal factors) • Quality issues • Shipping/distribution disruptions Market forces • Varying global markets for Ig (and products being diverted to the more lucrative markets) • Competition within pharmaceutical industry and subsequent supply issues • Product discontinuation Legislation • Specific governmental regulations regarding Ig • Varying reimbursement schemes per country and barriers for patients, physicians, and insurance companies. Reimbursement for on vs off-label prescription • Donor remuneration policy • Substantial power of pharmaceutical companies Disruptive events, such as pandemics, wars, natural disasters, transmissable diseases or an infectious contamination Ecological Factors that remain to be seen on how it impacts demand Both the literature and interviews stated that evidence from more high-quality RCTs is needed30,38,44,49,51,73,74 and would impact demand in the direction of the results (i.e., if the evidence proved that Ig is truly efficacious and/or have increased dosage of the product, then it would potentially increase demand, but if the evidence proved otherwise, then it would decrease demand). Further, if studies could clearly elucidate IVIG’s mechanisms of action,75 then viable alternatives could be created. Additionally, some experts noted a trend in their patients regarding increased usage of SCIg or fSCIg. A study of Dutch neurologists stated that the effects of the PATH study30 could result in increased usage of SCIg amongst CIDP patients.76 Further, more studies are being done with fSCIG as the hyaluronidase allows for larger volumes at singular subcutaneous sites and thus, fewer doses.6,7,77 Literature states that SCIg is cost-saving31,78–81 with yet unknown consequence on demand. Miscellaneous but important factors As demand is linked with supply, relevant factors arose that affect both (Figure 3.3 and Figure 3.4). These include supply shortages due to the ‘system obstructions’, as coined by one expert, which reflect societal,82–84 economic/political/legal25,27,59,85–89 and ecological factors embedded and interrelated within the dynamics of contract plasma fractionation,1 such as market forces, manufacturing issues and infectious
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