Table 6 Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Outcomes to be assessed Healthcare resources to be considered Patient must meet all of the following criteria: (a) Symptomatic heart failure due to systolic left ventricular dysfunction despite failed Optimal Medical Therapy; (b) NYHA Class III (c) ≥ 18 years; (d) Normal QRS duration (<120ms); (e) LVEF ≥25% ≤45% Cardiac contractility modulation therapy + OMT Failed optimal medical therapy (OMT) Peak VO2 Improvement in quality of life (MLWHF) Improvement in NYHA classification; and LVEF Mean change in 6 minute hall walk test All-cause mortality and all-cause hospitalisations. Death or hospitalisation due to HF Device and side effects Serious adverse events Incremental cost per life year saved Incremental cost per QALY gain Insertion, removal or replacement of CCM IPG device Insertion, removal or replacement of the bipolar leads CCM IPG device Device related costs Bipolar leads Anaesthesia Cardiologist Cardiac monitoring Hospital stay Ongoing interrogation of device Prophylactic antibiotics Cardiologist visit GP visits Outpatient visits Heart Failure medications Management of adverse events/complications Outpatient visits Emergency service Outcomes for the economic model may include: Primary Efficacy Outcomes QALY Overall survival Safety Outcomes Adverse Events Lead Failure An example of a decision analytic model is provided below. There are no published cost effectiveness models available for CCM although published economic evaluations exist for CHF. A model will be prepared for the MSAC application. Figure 7: Indicative decision diagram for cost effectiveness model
Table 7 List of resources to be considered in the economic analysis Provider of resource Setting in which resource is provided Proportion of patients receiving resource Number of units of resource per relevant time horizon per patient Disaggregated unit cost MBS Safety nets* Other govt budget Private health insurer Patient Total cost Resources provided to identify eligible population None over and above current standard practice Resources provided to deliver proposed intervention Insertion, removal or replacement of IPG device Surgeon/ specialist Private/public hospital 100% TBD $255.45 TBD TBD Insertion, removal or replacement of the bipolar leads Surgeon/ specialist Private/public hospital 100% TBD $1,224.60 TBD TBD IPG device Manufacturers Private/public hospital 100% TBD TBD TBD TBD Bipolar leads Manufacturers Private/public hospital 100% TBD TBD TBD TBD Anaesthesia Specialist Private/public hospital 100% TBD TBD TBD Cardiologist Surgeon/ specialist Private/public hospital 100% TBD TBD TBD TBD Cardiac monitoring Hospital Private/public hospital 100% TBD TBD TBD Hospital stay Hospital Private/public hospital 100% TBD TBD TBD TBD Ongoing interrogation of device Hospital Private/public hospital 100% TBD $69.75 TBD Prophylactic antibiotics Hospital/PBS Private/public hospital 100% TBD TBD TBD TBD Resources associated with the outcomes of therapy Cardiologist visit Specialist Private/public hospital 100% TBD TBD TBD TBD GP visits GP Community TBD TBD TBD TBD TBD Outpatient visits Specialist Private/public hospital TBD TBD TBD TBD Hospital stay Private hospital Private/public hospital TBD TBD TBD TBD
Provider of resource Setting in which resource is provided Proportion of patients receiving resource Number of units of resource per relevant time horizon per patient Disaggregated unit cost MBS Safety nets* Other govt budget Private health insurer Patient Total cost Emergency service Hospital Private/public hospital TBD TBD TBD TBD Inpatient nights Surgeon/specialist Private/public hospital TBD TBD TBD TBD TBD Heart Failure medications PBS Community TBD TBD TBD TBD TBD Resources provided in association with comparator Cardiologist visit Specialist Private/public hospital 100% TBD TBD TBD TBD GP visits GP Community TBD TBD TBD TBD TBD Outpatient visits Hospital Private/public hospital TBD TBD TBD TBD Hospital stay Hospital Private/public hospital TBD TBD TBD TBD Emergency service Hospital Private/public hospital TBD TBD TBD TBD Inpatient nights Hospital Private/public hospital TBD TBD TBD TBD TBD Heart Failure medications PBS Community TBD TBD TBD TBD TBD Resources used to manage patients successfully and unsuccessfully treated with the proposed intervention Ongoing heart failure management, including GP and specialists consultations, A&E visits, hospitalisations as required (likely to vary according to outcomes achieved) Resources used to manage patients successfully and unsuccessfully treated with the proposed comparator Ongoing heart failure management, including GP and specialists consultations, A&E visits, hospitalisations as required (likely to vary according to outcomes achieved)