Development of a prioritisation protocol for the use of immunoglobulins in view of the global supply problem

ABSTRACT

Background and importanceHighly purified immunoglobulins (95%) are obtained from the purification of human plasma extracted from healthy donors. The mechanism of action consists of an antigen-specific activity, exerting immunomodulatory functions in addition to those of the natural immunoglobulins. The increase in demand, the dependence exclusively on plasma donations, and the pandemic situation have reduced the supply of immunoglobulins worldwide.Aim and objectivesTo elaborate a protocol at regional level (seven hospitals) to prioritise, rationalise and reduce the use of immunoglobulins in view of the worldwide supply problem.Material and methodsA multidisciplinary work team was created comprising professionals involved in the use of these therapies (immunologists, haematologists, internists, neurologists, paediatricians and pharmacists). The main pathologies involved were specified.Subsequently, the indications depicted in the technical data sheet and the available scientific evidence were reviewed, to define three priority groupsPriority 1 Necessary treatment, there is no other therapeutic alternative.Priority 2 Pathologies or clinical situations where the use of immunoglobulins is recommended.Priority 3 Clinical situations without sufficient scientific evidence.Finally, the indications and dose regimen of all patients under active treatment were reviewed.ResultsThe work team defined Priority 1 as followsChronic treatments primary and secondary immunodeficiencies, CAR–T hypogammaglobulinaemia in paediatrics, pure motor chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy.Acute treatments Kawasaki disease, primary immune thrombocytopenia (PIT) before undergoing urgent surgery or PIT with severe thrombopenia/large bleeding diathesis.Priority 2 included Guillain-Barré syndrome, myasthenia gravis, PIT with high risk of bleeding, CIDP (excluding pure motor), severe neonatal sepsis, alloimmune haemolytic disease in neonates, alloimmune neonatal thrombocytopenia, haemophagocytic syndrome and paediatric multisystem inflammatory syndrome due to SARS-CoV-2.Pathologies not mentioned above were considered Priority 3, being evaluated by a multidisciplinary Experts Committee.After reviewing the active treatments, 21% of them were temporarily suspended. Since the protocol approval, eight new cases have been assessed as Priority 3, with only one of them being denied.Conclusion and relevanceThe creation of the protocol has made it possible to rationalise the use of immunoglobulins, reducing their consumption and promoting the use of therapeutic alternatives. Thus, completely necessary treatments are guaranteed through equitable and equal access throughout the region.References and/or acknowledgementsConflict of interestNo conflict of interest