Prognosis in patients who underwent hematopoietic stem-cell transplantation (HSCT) has improved over the years due to better disease control and decreased complications related to HSCT. Without evidence in HSCT, it would be reasonable to follow the guidelines for other diseases with hypogammaglobulinemia. Other challenges are heterogeneous patient characteristics, or immunoglobulin formulation, dosage, schedule, route and duration of IgRT. One crucial issue is that no studies exist for patients with only hypogammaglobulinemia after HSCT. Most of the available data derives from matched-related HSCT using myeloablative regimen, and the impact in haploidentical and cord blood transplantation, or reduced-intensity HSCT remains unknown. Consequently, a meta-analysis did not show the benefit of IgRT in HSCT. Although an early randomized trial demonstrated that IgRT decreased infection risk and transplant-related mortality after HSCT, subsequent clinical trials could not validate the benefit. The utility in hematopoietic stem-cell transplantation (HSCT) remains unknown. Clinical guidelines for CLL describe immunoglobulin administration in patients with a low IgG who have experienced a severe/repeated bacterial infection. Clinical development of anti-B cell therapies including a monoclonal antibody, bispecific antibody, or chimeric antigen receptor T-cell therapy which could result in severe hypogammaglobulinemia accelerates the argument of prophylactic use of IgRT. Potentially, the results of trials may provide sufficient evidence of clinical utility that a future NCD on this topic will provide coverage for such testing for all Medicare beneficiaries.The efficacy of immunoglobulin replacement therapy (IgRT) has been demonstrated for primary immune deficiency diseases and hematological malignancies such as chronic lymphocytic leukemia (CLL) or multiple myeloma with hypogammaglobulinemia.
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