Severe bacterial infections associated with HSCT is included under the other Hypogammaglobulinaemia secondary to Qualifying hypogammaglobulinaemia caused by a recognised secondary hypogammaglobulinaemia underlying disease or medical therapy Criteria disease process or B cell depletion therapy and/or given that all HSCT patients are managed immunosuppressant therapy. by haematologists. (including haemopoietic stem cell [Group1] Qualifying criteria have been defined transplantation [HCST]) with all the Serum IgG less than the lower limit of the including the assessment of baseline following: reference range measured on two separate serum IgM and IgA levels because if they occasions. Baseline serum IgA and IgM levels are normalising, this may suggest recovery should be provided to allow assessment of of the immune system. Serum IgG less than the lower limit immune recovery at review. Consistency with the other relevant of the reference range on two condition has been applied. (A) separate occasions; AND AND Underlying cause of hypogammaglobulinaemia cannot be reversed or underlying cause of hypogammaglobulinaemia is reversible but Underlying cause of reversal is contraindicated hypogammaglobulinaemia cannot be reversed or reversal is AND contraindicated; [Group 2] Patient has had one life-threatening bacterial AND infection in the previous 12 months At least one of the following: OR At least two serious infections in the last six One invasive or months requiring more than standard courses of antibiotics (eg. Hospitalisation, intravenous or bacterial prolonged antibiotic therapy). infection (e.g. pneumonia, meningitis, sepsis) in the OR Evidence of impaired antibody production in the previous year; or context of persistent infections affecting long term function such as persistent purulent
Qualifying Criteria Hypogammaglobulinaemia secondary to underlying disease or medical therapy (including haemopoietic stem cell transplantation [HCST]) with all the following: Serum IgG less than the lower limit of the reference range on two separate occasions; AND Underlying cause of hypogammaglobulinaemia cannot be reversed or reversal is contraindicated; AND At least one of the following: One invasive or bacterial infection (e.g. pneumonia, meningitis, sepsis) in the previous year; or Severe bacterial infections associated with hypogammaglobulinaemia caused by a recognised disease process or B cell depletion therapy and/or immunosuppressant therapy. [Group1] Serum IgG less than the lower limit of the reference range measured on two separate occasions. Baseline serum IgA and IgM levels should be provided to allow assessment of immune recovery at review. AND Underlying cause of hypogammaglobulinaemia cannot be reversed or underlying cause of hypogammaglobulinaemia is reversible but reversal is contraindicated AND [Group 2] Patient has had one life-threatening bacterial infection in the previous 12 months OR At least two serious infections in the last six months requiring more than standard courses of antibiotics (eg. Hospitalisation, intravenous or prolonged antibiotic therapy). OR Evidence of impaired antibody production in the context of persistent infections affecting long term function such as persistent purulent HSCT is included under the other secondary hypogammaglobulinaemia given that all HSCT patients are managed by haematologists. Qualifying criteria have been defined including the assessment of baseline serum IgM and IgA levels because if they are normalising, this may suggest recovery of the immune system. Consistency with the other relevant condition has been applied. (A)
secondary-hypogammaglobulinaemia-unrelated-to-haematological-malignancy-or-haemopoeitic-stem-cell-transplant-hsct_1.DOCX