Document ID: chunk:federal_register_of_legislation:F2024C01228:front:0:p11
Version: federal_register_of_legislation:F2024C01228
Segment Type: other
Provision Reference: 
Character Range: 25885–30054

provided to a person who is at least 18 years of age and is considered at increased risk of herpes zoster in any of the following circumstances, noting that more than one circumstance may be applicable:
 (a) has an underlying condition, including any of the following:

            (i) acute haematological malignancies such as acute leukaemia or aggressive lymphomas;
            (ii) chronic haematological malignancies, such as:
                    (A) myelodysplastic syndromes;
                    (B) chronic myeloproliferative disorders;
                    (C) lymphoproliferative malignancies;
                    (D) plasma cell dyscrasias which includes myeloproliferative neoplasms, chronic lymphocytic leukaemia, indolent non‑Hodgkin lymphoma or multiple myeloma;

            (iii) human immunodeficiency virus infection with CD4+ cell count < 200/µL;
            (iv) inborn errors of immunity with ongoing functional deficits including:
                    (A) humoral e.g., X‑linked agammaglobulinemia;
                    (B) combined defects, including severe combined immunodeficiency;
                    (C) phagocytic disorders, including chronic granulomatous disease; or
                    (D) other inborn errors of immunity except complement disorders, hereditary angioedema and IgA deficiency;

            (v) stage 5 kidney disease or on dialysis;
 (b) malignancy, autoimmune or inflammatory conditions receiving immunomodulatory or immunosuppressive treatments, including any of the following:

            (i) cellular therapies, whether received currently or within the previous 24 months, including:
                    (A) autologous haematopoietic stem cell transplant;
                    (B) allogeneic haematopoietic stem cell transplant, including ongoing graft vs host disease with immunosuppressive therapy, where a person is considered high risk beyond a 24 month period; or
                    (C) chimeric antigen receptor T‑cell therapy;

            (ii) B and T‑cell targeted monoclonal antibody therapies, whether received currently or within the last 6 months, including any of the following:
                    (A) anti‑CD20;
                    (B) anti B‑cell activating factor;
                    (C) anti‑CD52;
                    (D) anti‑thymocyte globulin;

            (iii) conventional chemotherapy for:
                    (A) treatment of haematological malignancy; or
                    (B) solid organ tumours, currently or within the last 6 months;

            (iv) immunosuppressive therapy to prevent organ rejection prior to or following solid organ transplantation, currently or within the last 6 months;
            (v) conventional immunosuppressive agents, currently or within the last 6 months, including any of the following:
                    (A) high dose methotrexate ≥20mg per week (oral and subcutaneous);
                    (B) azathioprine ≥3.0mg/kg/day;
                    (C) 6‑mercaptopurine ≥1.5mg/kg/day;
                    (D) mycophenolate ≥1g/day;
                    (E) cyclophosphamide;
                    (F) systemic calcineurin inhibitors such as tacrolimus or cyclosporin;
                    (G) mTOR inhibitors;
                    (H) purine analogues such as cladribine;

            (vi) biologic therapies, currently being received or that have been received in the last 6 months, not including lower risk biologics such as anti‑integrins including natalizumab and vedolizumab, anti‑IgE antibodies, anti‑complement antibodies and lower risk interleukin (IL) inhibitors anti‑IL17 antibodies, anti‑IL 12/23 antibodies, anti‑IL23 antibodies, and anti‑IL31 antibodies, but including any of the following:
                    (A) tumour necrosis factor inhibitors;
                    (B) T‑cell co‑stimulation modulators such as Abatacept);
                    (C) soluble TNF receptors;
                    (D) type I interferon receptor inhibitors;
                    (E) proteasome inhibitors;
                    (F) IL inhibitors currently or within the last 6 months, including anti‑IL1 antibodies, anti‑IL4/13 antibodies, anti‑IL5 antibodies, anti‑IL6