Ig therapy is required for eligibility Relapse in ANCA positive systemic necrotising vasculitis for further authorisation, should resistant following response to Ig therapy the patient relapse in the future. Current evidence of active vasculitis as assessed by increased reactivity in at least one of ESR, CRP, ANCA, BVAS or another indicator of active disease AND Unresponsive to previous Rituximab therapy OR Rituximab is contraindicated Relapse in ANCA positive systemic necrotising vasculitis resistant AND following response to Ig therapy A description of the relapse and current active vasculitis requiring treatment is provided Patient has previously AND demonstrated a clinical Clinical improvement in response to six months response following six months of Ig treatment was demonstrated previously as Ig therapy as measured by a measured by a reduction in at least one of reduction in at least one of Erythrocyte Sedimentation Rate (ESR), C-reactive Erythrocyte Sedimentation Rate protein (CRP) or ANCA level or Birmingham (ESR), C-reactive protein Vascular Activity Score (BVAS) version 3 (v3) or The criteria wording for the relapse (CRP) or ANCA level or another indicator of active disease compared to indication has been streamlined and Birmingham Vascular Activity pre-treatment levels simplified to more clearly explain the Score (BVAS) version 3 (v3) AND requirement for the patient to have already compared to the original A description of the patient’s clinical response to demonstrated a clinical response to the qualifying value. previous Ig therapy is provided initial Ig therapy, and confirm the patient’s AND non-responsiveness to Rituximab. A description of the patient’s previous response to therapy is provided AND
Ig therapy is required for eligibility for further authorisation, should the patient relapse in the future. Relapse in ANCA positive systemic necrotising vasculitis resistant following response to Ig therapy Patient has previously demonstrated a clinical response following six months Ig therapy as measured by a reduction in at least one of Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP) or ANCA level or Birmingham Vascular Activity Score (BVAS) version 3 (v3) compared to the original qualifying value. AND A description of the patient’s previous response to therapy is provided AND Relapse in ANCA positive systemic necrotising vasculitis resistant following response to Ig therapy Current evidence of active vasculitis as assessed by increased reactivity in at least one of ESR, CRP, ANCA, BVAS or another indicator of active disease AND Unresponsive to previous Rituximab therapy OR Rituximab is contraindicated AND A description of the relapse and current active vasculitis requiring treatment is provided AND Clinical improvement in response to six months of Ig treatment was demonstrated previously as measured by a reduction in at least one of Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP) or ANCA level or Birmingham Vascular Activity Score (BVAS) version 3 (v3) or another indicator of active disease compared to pre-treatment levels AND A description of the patient’s clinical response to previous Ig therapy is provided The criteria wording for the relapse indication has been streamlined and simplified to more clearly explain the requirement for the patient to have already demonstrated a clinical response to the initial Ig therapy, and confirm the patient’s non-responsiveness to Rituximab.
Immunology-Ch6-Anti-neutrophil-cytoplasmic-antibody-%28ANCA%29.DOCX