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.
The patient has evidence of active vasculitis as assessed by increased reactivity in at least one of ESR, CRP, ANCA or BVAS compared to level after Ig therapy. AND A description of the relapse and active vasculitis requiring treatment is provided Review Criteria ANCA positive systemic necrotising vasculitis failing to respond to corticosteroids and cytotoxic immunosuppression Six-month’s treatment is authorised for patients in the first instance, and no review is required. The reporting of clinical outcome data is encouraged as demonstrated clinical response to Ig therapy is required for eligibility for further authorisation, should the patient relapse in the future. Outcome measures Evidence of clinical benefit and response to treatment is assessed ANCA positive systemic necrotising vasculitis failing to respond to corticosteroids and cytotoxic immunosuppression Six-month’s treatment is authorised for patients in the first instance. The reporting of clinical outcome data is encouraged as demonstrated clinical response to Ig therapy is required for eligibility for further authorisation, should the patient relapse in the future. Clinical effectiveness of Ig therapy may be demonstrated by: Reduction in at least one indicator of Erythrocyte Sedimentation Rate(ESR) C-reactive protein (CRP) level, ANCA Level or Birmingham Vasculitis Activity Score (BVAS) (<50%) or other indicator of active disease compared to the qualifying value The review criteria have been simplified and streamlined but content is largely unchanged. Patients will still only receive six month’s treatment initially, and will then be required to requalify under the relapse indication if more treatment is required.
Vasculitis Activity (BVAS) Score compared to the original qualifying value. On review of a continuing authorisation period Once the patient has been in clinical remission for two years, a trial off therapy should be considered. Patients demonstrate evidence of clinical benefit and response to Ig treatment as assessed by stabilisation of at least one indicator of Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP) level, ANCA level or Birmingham Vasculitis Activity (BVAS) Score compared to the previous review score AND A trial off Ig therapy is planned unless a valid reason is provided. protein (CRP) level, ANCA level or Birmingham Vasculitis Activity (BVAS) Score or other indicator of active disease compared to the previous review score AND A trial off Ig therapy is planned following two years in remission unless a valid reason is provided