109 Using a scenario approach to assess for the current and future demand of immunoglobulins Nine of the 15 experts gave suggestions on new areas of medical need, although only a few (3/9) could provide specifics: in dermatology, soft tissue infections; in neurology, small fiber neuropathy or myositis; in infectious diseases, Ebola or dengue (with convalescent plasma). The other experts provided generalized ideas for new indications’ in the realms of aging-related, autoimmune, and/or immune-modulating diseases, and other SIDs. Table 3.2 Description of European Medicines Agency Guideline revisions and the specialties affected Indication type Definition Specialties affected I) Replacement therapy in adults, and children and adolescents age 0–18 years For replacement therapy, IVIG should be initiated in A. Primary immunodeficiency syndromes (PID) with impaired antibody production and B. Secondary immunodeficiencies (SID) in patients who have proven either specific antibody failure (PSAF) or serum IgG level of <4 g/L and suffer from severe or recurrent infections, ineffective antimicrobial treatment** Immunology, oncology, hematology, hemato- oncology, pediatrics II) Immunomodulation in adults, and children and adolescents age 0– 18 years. For immunomodulation, IVIG is indicated in five specific diseases in which they need maintenance dosages for longer periods of time due to the chronic nature of the diseases. 1. Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count (including ITP in pregnancy29)` 2. Guillain Barré syndrome (GBS)` 3. Kawasaki disease (in conjunction with acetylsalicylic acid) 4. Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)30–33 a 5. Multifocal motor neuropathy (MMN)33,34 a Hematology, neurology, pediatrics aNewly-added indications as part of the 2019 revisions.
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