Resources Ambulance transport, if Re-dosing with C1-INH, if Ambulance transport, if provided in required required required association Re-dosing with C1-INH in Emergency Department visit Emergency Department visit with Emergency Department, if for breakthrough attack for breakthrough attacks proposed required (non-admitted) Hospital admission for two-day Hospital admission for two-day intervention Hospital admission for two-day observation following a severe observation following a severe observation following a severe attack attack attack Intubation and ventilation Intubation and ventilation Intubation and ventilation Tracheotomy Tracheotomy Tracheotomy Other rescue medication to Other rescue medication to Other rescue medication to achieve relief from achieve relief from achieve relief breakthrough attack breakthrough attack Resources Specialist/GP visit for Specialist/GP visit for provided to prescription prescription deliver the Cost of icatibant per Cost of oral danazol per comparator administration administration Emergency department visit for administration of icatibant if not ‘on hand’ No administration cost for patients who are eligible for IRT; however, a proportion of patients will need assistance with SC administration from a healthcare provider (e.g. community nurse, GP). Resources Ambulance transport, if Re-dosing with danazol, if Ambulance transport, if provided in required required required association Re-dosing with icatibant in Emergency Department visit Emergency Department visit with Emergency Department for breakthrough attack for breakthrough attack comparator Hospital admission for two-day Hospital admission for two-day Hospital admission for two-day observation following a severe observation following a severe observation following a severe attack attack attack Intubation and ventilation Intubation and ventilation Intubation and ventilation Tracheotomy Tracheotomy Tracheotomy Other rescue medication to Other rescue medication to Other rescue medication to achieve relief achieve relief from achieve relief from breakthrough attack breakthrough attack Abbreviations: C1-INH, C1 esterase inhibitor concentrate; GP, general practitioner; IRT, individual replacement therapy; SC, subcutaneous There are a number of published animal and clinical studies of C1-INH concentrate for indications other than HAE (Singer et al, 2011). In particular, the use of C1-INH concentrate in patients with septic shock has been explored. Being the largest potential alternative population for this intervention, such potential use of C1-INH concentrate will be examined in financial impact sensitivity analyses.
Resources provided in association with proposed intervention Ambulance transport, if required Re-dosing with C1-INH in Emergency Department, if required (non-admitted) Hospital admission for two-day observation following a severe attack Intubation and ventilation Tracheotomy Other rescue medication to achieve relief Re-dosing with C1-INH, if required Emergency Department visit for breakthrough attack Hospital admission for two-day observation following a severe attack Intubation and ventilation Tracheotomy Other rescue medication to achieve relief from breakthrough attack Ambulance transport, if required Emergency Department visit for breakthrough attacks Hospital admission for two-day observation following a severe attack Intubation and ventilation Tracheotomy Other rescue medication to achieve relief from breakthrough attack Resources provided to deliver the comparator Specialist/GP visit for prescription Cost of icatibant per administration Emergency department visit for administration of icatibant if not ‘on hand’ No administration cost for patients who are eligible for IRT; however, a proportion of patients will need assistance with SC administration from a healthcare provider (e.g. community nurse, GP). Specialist/GP visit for prescription Cost of oral danazol per administration Resources provided in association with comparator Ambulance transport, if required Re-dosing with icatibant in Emergency Department Hospital admission for two-day observation following a severe attack Intubation and ventilation Tracheotomy Other rescue medication to achieve relief Re-dosing with danazol, if required Emergency Department visit for breakthrough attack Hospital admission for two-day observation following a severe attack Intubation and ventilation Tracheotomy Other rescue medication to achieve relief from breakthrough attack Ambulance transport, if required Emergency Department visit for breakthrough attack Hospital admission for two-day observation following a severe attack Intubation and ventilation Tracheotomy Other rescue medication to achieve relief from breakthrough attack Abbreviations: C1-INH, C1 esterase inhibitor concentrate; GP, general practitioner; IRT, individual replacement therapy; SC, subcutaneous There are a number of published animal and clinical studies of C1-INH concentrate for indications other than HAE (Singer et al, 2011). In particular, the use of C1-INH concentrate in patients with septic shock has been explored. Being the largest potential alternative population for this intervention, such potential use of C1-INH concentrate will be examined in financial impact sensitivity analyses.
1394%20-%20C1%20esterase%20inhibitor%20-%20DRAFT%20PROTOCOL%20-%20web%20accessible%207Oct14-accessible.docx