Purpose of this document This document is intended to provide a draft decision analytic protocol that will be used to guide the assessment of an intervention for a particular population of patients. The draft protocol that will be finalised after inviting relevant stakeholders to provide input to the protocol. The final protocol will provide the basis for the assessment of the intervention. The protocol guiding the assessment of the health intervention has been developed using the widely accepted “PICO” approach. The PICO approach involves a clear articulation of the following aspects of the research question that the assessment is intended to answer: Patients – specification of the characteristics of the patients in whom the intervention is to be considered for use; Intervention – specification of the proposed intervention Comparator – specification of the therapy most likely to be replaced by the proposed intervention Outcomes – specification of the health outcomes and the healthcare resources likely to be affected by the introduction of the proposed intervention Purpose of application A proposal for an application requesting Medical Benefits Schedule (MBS) listing of insertion, replacement, or removal of a cardiac resynchronisation therapy device capable of defibrillation (CRT-D) for mild chronic heart failure (New York Heart Association (NYHA) class II) was received from OptumInsight (working with Biotronik, Boston Scientific, Medtronic Australasia and St Jude Medical) by the Department of Health and Ageing in May 2012. This intervention is already listed on the MBS for patients with moderate to severe chronic heart failure (NYHA class III or IV) (item numbers 38371, 38368, 38654),
Purpose of this document This document is intended to provide a draft decision analytic protocol that will be used to guide the assessment of an intervention for a particular population of patients. The draft protocol that will be finalised after inviting relevant stakeholders to provide input to the protocol. The final protocol will provide the basis for the assessment of the intervention. The protocol guiding the assessment of the health intervention has been developed using the widely accepted “PICO” approach. The PICO approach involves a clear articulation of the following aspects of the research question that the assessment is intended to answer: Patients – specification of the characteristics of the patients in whom the intervention is to be considered for use; Intervention – specification of the proposed intervention Comparator – specification of the therapy most likely to be replaced by the proposed intervention Outcomes – specification of the health outcomes and the healthcare resources likely to be affected by the introduction of the proposed intervention Purpose of application A proposal for an application requesting Medical Benefits Schedule (MBS) listing of insertion, replacement, or removal of a cardiac resynchronisation therapy device capable of defibrillation (CRT-D) for mild chronic heart failure (New York Heart Association (NYHA) class II) was received from OptumInsight (working with Biotronik, Boston Scientific, Medtronic Australasia and St Jude Medical) by the Department of Health and Ageing in May 2012. This intervention is already listed on the MBS for patients with moderate to severe chronic heart failure (NYHA class III or IV) (item numbers 38371, 38368, 38654),
1223-Final-Protocol.docx