ITEM 2015 JBC APPROVED WORDING PROPOSED REVISIONS TO THE CRITERIA SPECIALIST WORKING GROUP RATIONALE FOR ADDITIONS/CLARIFICATIONS Solid organ transplantation (other than Solid organ transplantation (other than kidney) Unchanged Condition kidney) Name Specialty Transplantation Transplantation Unchanged Category Emerging therapeutic role Emerging therapeutic role Unchanged Heart Heart • Specific Unchanged Lung Lung • • Conditions Heart & Lung Heart & Lung • • Liver Liver • • Heart kidney Heart kidney • • Heart liver liver • • Liver kidney Liver kidney • • Pancreas Pancreas • • Small intestine Small intestine • • Level of Small case studies only; insufficient data Insufficient data (Category 4a) Unchanged Evidence (Category 4a) Justification Jordan et al (1998) combined data from Ig therapy plays an important immunomodulatory This section has been strengthened to include for Evidence seven renal transplant recipients and role in incompatible organ transplantation with supporting evidence for desensitisation and Category three heart transplant recipients with proven benefit (Level 1 evidence) for additional literature related to antibody steroid-resistant combined of highly sensitised patients mediated rejection. (AbMR) and cellular rejection. to improve transplant rates and clinical All patients in this series were outcomes (Jordan, 2004). For desensitisation, trials successfully treated with high-dose IVIg. have demonstrated improved outcomes when IVIg is used in association with Rituximab and/or other Findings from an International immunosuppressant agents. Consensus Conference in 2011 noted that IVIg has never been systematically
ITEM 2015 JBC APPROVED WORDING PROPOSED REVISIONS TO THE CRITERIA SPECIALIST WORKING GROUP RATIONALE FOR ADDITIONS/CLARIFICATIONS Condition Name Solid organ transplantation (other than kidney) Solid organ transplantation (other than kidney) Unchanged Specialty Transplantation Transplantation Unchanged Category Emerging therapeutic role Emerging therapeutic role Unchanged Specific Conditions • Heart • Lung • Heart & Lung • Liver • Heart kidney • Heart liver • Liver kidney • Pancreas • Small intestine Heart • Lung • Heart & Lung • Liver • Heart kidney • liver • Liver kidney • Pancreas • Small intestine Unchanged Level of Evidence Small case studies only; insufficient data (Category 4a) Insufficient data (Category 4a) Unchanged Justification for Evidence Category Jordan et al (1998) combined data from seven renal transplant recipients and three heart transplant recipients with steroid-resistant combined (AbMR) and cellular rejection. All patients in this series were successfully treated with high-dose IVIg. Findings from an International Consensus Conference in 2011 noted that IVIg has never been systematically Ig therapy plays an important immunomodulatory role in incompatible organ transplantation with proven benefit (Level 1 evidence) for of highly sensitised patients to improve transplant rates and clinical outcomes (Jordan, 2004). For desensitisation, trials have demonstrated improved outcomes when IVIg is used in association with Rituximab and/or other immunosuppressant agents. This section has been strengthened to include supporting evidence for desensitisation and additional literature related to antibody mediated rejection.
Solid-organ-transplantation-other-than-kidney2017.docx