Classification of an intervention for determination of economic Table 2: evaluation to be presented Comparative effectiveness versus comparator Superior Non-inferior Inferior Net clinical all Patients for who PBS CEA/CUA benefit listed oral anti-diabetic Neutral benefit CEA/CUA* have failed all medications Patients for who Net harms or are inappropriate and PBS listed oral as an alternative to medications have failed or are injectable therapies” inappropriate and as an DIAMOND™ system vs Superior alternative to injectable therapy injectable therapies. None^ CEA/CUA comparator DIAMOND™ system vs failed OAD medication DIAMOND™ system vs. versus CEA/CUA bariatric surgery CEA/CUA safety CEA/CUA CEA/CUA None^ Net Comparative clinical CEA/CUA benefit Inferior Neutral None^ None^ CEA/CUA* benefit Net None^ harms Abbreviations: CEA = cost-effectiveness analysis; CMA = cost-minimisation analysis; CUA = cost-utility analysis ^No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention Based on these claims, a cost-effective or cost-utility analysis is appropriate for both patient populations as outlined in Error! Reference source not found.. Fee for the proposed medical service Type of funding proposed for this service and details of the proposed fee. The proposed funding and MBS item descriptors are outlined in Table 3. Separate item descriptors and funding are suggested for the following: Insertion, removal or replacement of the IPG; Insertion, removal or replacement of the three (3) gastric leads; Interrogation of the Implantable Pulse Generator (IPG) device.
Table 2: Classification of an intervention for determination of economic evaluation to be presented Comparative effectiveness versus comparator Superior Non-inferior Inferior Comparative safety versus comparator Superior Patients for who all PBS listed oral medications have failed or are inappropriate and as an alternative to injectable therapies. DIAMOND™ system vs failed OAD medication CEA/CUA Patients for who all PBS listed oral anti-diabetic medications have failed or are inappropriate and as an alternative to injectable therapies” DIAMOND™ system vs injectable therapy CEA/CUA DIAMOND™ system vs. bariatric surgery CEA/CUA Net clinical benefit CEA/CUA Neutral benefit CEA/CUA* Net harms None^ CEA/CUA CEA/CUA None^ Inferior Net clinical benefit CEA/CUA None^ None^ Neutral benefit CEA/CUA* Net harms None^ Abbreviations: CEA = cost-effectiveness analysis; CMA = cost-minimisation analysis; CUA = cost-utility analysis ^No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention Based on these claims, a cost-effective or cost-utility analysis is appropriate for both patient populations as outlined in Error! Reference source not found.. Fee for the proposed medical service Type of funding proposed for this service and details of the proposed fee. The proposed funding and MBS item descriptors are outlined in Table 3. Separate item descriptors and funding are suggested for the following: Insertion, removal or replacement of the IPG; Insertion, removal or replacement of the three (3) gastric leads; Interrogation of the Implantable Pulse Generator (IPG) device.
1386-GastricContractilityModulation-PASCRatifiedProtocol-accessible.docx