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),
Medtronic Australasia Pty Ltd Medtronic Inc Protecta XT CRT-D D354TRG 176435 Progressive Medical ELA Medical Ovatio CRT 6750 132650 Sorin Group Australia Sorin Biomedica Crm Srl Paradym CRT 8750 163470 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Atlas II HF Model V-365 136216 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Atlas II+ HF Model V-367 136218 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Promote RF Model 3213 149308 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Promote Accel RF Model CD3215 158920 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Promote Accel Model CD3215-36Q 170537 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Promote Quadra CD3237-40 181842 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Promote Quadra CD3237-40Q 181843 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Promote Quadra CD3239-40 184879 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Promote Quadra CD3239-40Q 184880 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Unify CRT-D CD3235-40Q 171540
Biotronik Australia Pty Ltd Biotronik SE & Co KG Siello S xx 170066 Biotronik Australia Pty Ltd Biotronik SE & Co KG Siello T xx 170067 Biotronik Australia Pty Ltd Biotronik SE & Co KG Siello JT xx 170068 Biotronik Australia Pty Ltd Biotronik SE & Co KG Safio S 188217 Biotronik Australia Pty Ltd Biotronik SE & Co KG Setrox S xx 129077 Boston Scientific Pty Ltd Cardiac Pacemakers Inc ACUITY Models 4554,4555,4556 126935 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Acuity Spiral Lead 155274 Boston Scientific Pty Ltd Cardiac Pacemakers Inc EASYTRAK IS-1 112809 Boston Scientific Pty Ltd Cardiac Pacemakers Inc EASYTRAK 3 114811 Boston Scientific Pty Ltd Cardiac Pacemakers Inc EASYTRAK 3 IS-1 119321 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Easytrak 2 99579 Boston Scientific Pty Ltd Cardiac Pacemakers Inc EASYTRAK 2 IS-1 112810 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance G Passive Fixation Leads model 0174-0177 116534 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance SG Passive Fixation Leads models 0170-0173 116535 Boston Scientific Pty Ltd Cardiac Pacemakers Inc ENDOTAK RELIANCE SG LEADS 119322 Boston Scientific Pty Ltd Cardiac Pacemakers Inc ENDOTAK RELIANCE G LEADS 119328 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance Leads models 0147,0148,0149 128708 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance S Passive Fixation Implantable Lead 165638 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance Active Fixation Implantable Lead 165639 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance S Active Fixation Implantable Lead 165640 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance G Passive Fixation Implantable Lead 165641 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance SG Passive Fixation Implantable Lead 165642 Boston Scientific Pty Ltd Cardiac Pacemakers Inc Endotak Reliance Passive Fixation Implantable Lead 165643
St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead Model 7121 159845 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead Model 7122 159846 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead Model 7131 159847 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead Model 7130 159848 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead Model 7170 159849 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead model 7120Q 170589 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead model 7121Q 170590 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead model 7122Q 170591 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead model 7170Q 170592 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead model 7171Q 170593 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Durata Lead model 7172Q 170594 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA IsoFlex S Lead Model 1636T 120363
St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA IsoFlex S Lead Model 1642T 120364 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA IsoFlex S Lead Model 1646T 120370 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA IsoFlex Lead Model 1944 159532 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA IsoFlex Lead Model 1948 159533 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Myodex Lead Model 1084T 145900 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA OptiSense Model 1699T Lead 143294 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA OptiSense Model 1699TC Lead 143296 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA OptiSense Lead Model 1999 159534 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA QuickFlex Lead Model 1258T 161391 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA QuickSite Lead Model 1056K 120366 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Quartet Model 1458Q Lead 171332 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Riata ST Optim Lead Model 7021 142966
St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Tendril ST Model 1882TC Lead 143300 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Tendril ST Model 1888TC Lead 143301 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Tendril STS Lead Model 1988TC 170585 St Jude Medical Australia Pty Ltd St Jude Medical Cardiac Rhythm Management Division USA Tendril STS Lead Model 2088TC 170587 Appendix 3 CRT-D devices on the Prosthesis list Sponsor Product name Description Min benefit ($) Max benefit ($) Biotronik Australia Pty Ltd Lumax 540 HF-T High Energy, Three Chamber ICD (Implantable Cardiac Defibrillator) with Advanced Patient Management Via unique Home Monitoring Technology incorporating Automatic RV/LV Threshold Monitoring and Extended Longevity. 47,840.00 Boston Scientific Australia Pty Ltd COGNIS 100 HE (DF-1/IS-1 & CRT-D high energy with RF 47,840.00 Boston Scientific Australia Pty Ltd COGNIS 100 HE CRT-D high energy with RF IS4 48,590.00 Boston Scientific Australia Pty Ltd ENERGEN CRT-D High energy CRT-D with DF-1 RV connector and IS-1 LV connector 47,840.00
Boston Scientific Australia Pty Ltd ENERGEN DF-4 CRT-D High energy CRT-D with DF-4 RV connector and IS-1 LV connector 48,590.00 Boston Scientific Australia Pty Ltd INCEPTA CRT-D High energy CRT-D with DF-1 RV connector & lS-1 (N163) or LV-1 (N165) LV connector 47,840.00 Boston Scientific Australia Pty Ltd INCEPTA DF-4 CRT-D High energy CRT-D with DF-4 RV connector and lS-1 LV connector 48,590.00 Boston Scientific Australia Pty Ltd LIVIAN CRT-D CRT-D with RF 45,760.00 Boston Scientific Australia Pty Ltd LIVIAN CRT-D HE CRT-D, high energy with RF 47,840.00 Guidant Australia Pty Ltd Contak Renewal 4 CRT-D Model H190, Model H195 CRT-D 45,760.00 Guidant Australia Pty Ltd Contak Renewal 4 HE CRT-D Model H197, Model H199 CRT-D high energy 47,840.00 Guidant Australia Pty Ltd Contak Renewal 4 AVT HE CRT - D - Model M177, M179 Implantable Cardioverter Defibrillator with cardiac resynchronisation Therapy 47,840.00 Guidant Australia Pty Ltd Contak Renewal 4 AVT CRT-D - Model M170 and M175 Implantable Cardioverter Defibrillator with Cardiac Resynchronisation Therapy 45,760.00
St Jude Medical Australia Pty Ltd Promote Accel CD3215-36Q Cardiac Resynchronisation Therapy Defibrillator with RF Telemetry and SJ4 connector 52,750.00 St Jude Medical Australia Pty Ltd Promote Accel CD3215-30 Cardiac Resynchronisation Therapy Defibrillator with RF Telemetry 49,760.00 St Jude Medical Australia Pty Ltd Promote Quadra CRT CD3239-40 Cardiac Resynchronisation Therapy Defibrillator with 40J delivered energy and VectSelect Quartet Programmable LV pulse configuration 52,000.00 St Jude Medical Australia Pty Ltd Promote Quadra CRT CD3237-40 Cardiac Resynchronisation Therapy Defibrillator with 40J delivered energy, VectSelect Quartet Programmable LV pulse configuration and Multisite Pacing 52,000.00 St Jude Medical Australia Pty Ltd Promote Quadra CRT CD3239-40Q Cardiac Resynchronisation Therapy Defibrillator with 40J delivered energy and VectSelect Quartet Programmable LV pulse configuration and SJ 4 connector 52,750.00 St Jude Medical Australia Pty Ltd Promote Quadra CD3237-40Q Cardiac Resynchronisation Therapy Defibrillator with 40J delivered energy and VectSelect Quartet Programmable LV pulse configuration plus Multisite Left Ventricular Pacing and SJ4 connector. 52,750.00 St Jude Medical Australia Pty Ltd Unify CRT Cardiac Resynchronisation Therapy Defibrillator with 40J delivered energy and SJ4 connector 52,750.00 St Jude Medical Australia Pty Ltd Unify Quadra CRT CD 3251-40 Cardiac Resynchronisation Therapy Defibrillator with 40J delivered plus Quadripolar pacing 52,000.00
Guidant Australia Pty Ltd ENDOTAK RELIANCE SG Active Active Single coil with GORE ePTFE covered coils 9,000.00 Medtronic Australasia Pty Ltd Medtronic Sprint Quattro Secure Lead Model 6947 58cm; Model 6947 65cm; Model 6947 75cm; Model 6947 100cm Leads, Defibrillator, Implantable, Silicone, polyurethane, platinised tantalum coils, steroid eluting tip 9,000.00 Medtronic Australasia Pty Ltd Sprint Quattro Secure S Model 6935, Active Fixation Single Coil Defibrillation Lead 9,000.00 Medtronic Australasia Pty Ltd Sprint Quattro Secure 6947M Lead Active fixation, true bipolar, dual coil defibrillation leads with silicone backfill and DF-4 connector 9,000.00 Sorin Group ISOLINE 2CR Active fixation, steroid eluting, integrated bipolar, dual coil defibrillation lead 9,000.00 St Jude Medical Australia Pty Ltd Durata 7120, 7121, 7122, 7130, 7131 Active fixation bipolar, coil Steroid-eluting Endocardial Defibrillation Leads 9,000.00 St Jude Medical Australia Pty Ltd Riata Transvenous tachyarrhythmia Leads Model 1582 Tri-polar Active - Fixation, Steroid Eluting, Single shock Coil Tachyarrhythmia; Lead 9,000.00 St Jude Medical Australia Pty Ltd Riata Transvenous Tachyarrhythmia Lead Model 1580, Model 1581 Quadripolar, dual-coil, steroid eluting, active fixation tachyarrhythmia leads 9,000.00 St Jude Medical Australia Pty Ltd Riata i Transvenous Tachyarrhythmia Leads Model 1590/1591 Active fixation leads, Steroid Eluting, Dual Shock Coil Defibrillation Lead 9,000.00 St Jude Medical Australia Pty Ltd Riata i Transvenous Tachyarrhythmia Lead Model 1592 Active Fixation, Steroid Eluting, Single Shock Coil Defibrillation Lead 9,000.00
Guidant Australia Pty Ltd Fineline II Sterox IROX Lead Bipolar passive fixation 1,248.00 Guidant Australia Pty Ltd Fineline II Sterox IROX Lead Bipolar passive fixation 1,248.00 Guidant Australia Pty Ltd Fineline II Sterox IROX Lead Bipolar, passive fixation 1,248.00 Medtronic Australasia Pty Ltd Medtronic Capsure Z Novus Model 5554 Pacing Lead Silicone; Contents: 1 x lead with anchoring sleeve, stylet & guide, 1 x vein lifter, 2 x fixation tools, extra stylets 1,248.00 Medtronic Australasia Pty Ltd Medtronic Capsure SP Novus Model 5092 Bipolar, steroid, pasive fixation pacing lead 1,248.00 Medtronic Australasia Pty Ltd Medtronic Capsure SP Novus Model 5594 Lead 30cm Bipolar, steroid, passive fixation pacing lead 1,248.00 Medtronic Australasia Pty Ltd Medtronic Capsure Z Novus Model 5054 Pacing Lead Silicone; Contents: 1 x lead with anchoring sleeve, stylet & guide, 1 x vein lifter, 2 x fixation tools, extra stylets 1,248.00 Medtronic Australasia Pty Ltd CapSure Sense pacemaker lead Models 4074 & 4574 Bipolar, steroid, passive fixation pacing lead 1,248.00 Sorin group Petite ER Series Steroid eluting passive fixation pacing lead. Permanent pacing lead, Petite ER series, is indicated for the pacing and sensing of the ventricle. This permanent pacing lead is used in conjunction with an IS-1 compatible implantable pulse generator (pacemaker). Permanent pacing lead, Petite ERJ series, is indicated for the pacing and sensing of the atrium. This permanent pacing lead is used in conjunction with an IS-1 compatible implantable pulse generator (pacemaker). 1,248.00
Sorin group Refino ER Series Steroid eluting passive fixation pacing lead. Permanent pacing lead, Model Refino ER, is indicated for the pacing and sensing of the ventricle. This permanent pacing lead is used in conjunction with an IS-1 compatible implantable pulse generator (pacemaker). Permanent pacing leads, Models Refino ERJ and ERJU are indicated for the pacing and sensing of the atrium. This permanent pacing lead is used in conjunction with and IS-1 compatible implantable pulse generator (pacemaker). 1,248.00 St Jude Medical Australia Pty Ltd Isoflex S, Models 1646T, 1642T and 1636T endocardial, Steroid Eluting, Silicone, Passive Fixation Pacing Leads with Fast-Pass Coating 1,248.00 St Jude Medical Australia Pty Ltd Isoflex P 1644T and 1648T Endocardial, Steroid Eluting, Polyurethane, Passive-Fixation Bipolar Pacing Leads with Fast-Pass Coating 1,248.00 St Jude Medical Australia Pty Ltd Isoflex 1944T & 1948T Passive-Fixation, Bipolar, Steroid Eluting, Endocardial Pacing Lead with Optim insulation 1,248.00 Guidant Australia Pty Ltd Guidant Aust Selute Picotip VDD Lead VDD bipolar, passive fixation 1,544.00 Medtronic Australasia Pty Ltd Medtronic Capsure VDD2 Model 5038 AV Pacing Lead Silicone; Contents: 1 x lead with anchoring sleeve, stylet & guide, 1 x vein lifter, 2 x fixation tools, extra stylets 1,544.00 Transvenous, bi-polar, active, steroid, right ventricular/atrial Biotronik Australia Pty Ltd Dextrus (marketed by Boston Scientific) Bipolar, silicone, active fixation, steroid eluting, pacing lead 1,248.00 Biotronik Australia Pty Ltd Selox SR Lead, pacemaker, implantable, endocardial 1,248.00 Biotronik Australia Pty Ltd Setrox S Bipolar active fixation lead with fractal coated and steroid eluting electrode 1,248.00
Biotronik Australia Pty Ltd Siello S Bipolar active fixation lead with fractal coated and steroid eluting electrode 1,248.00 Biotronik Australia Pty Ltd Safio S Steroid eluting active fixation pacemaker lead with an electrically active extendable/ retractable screw for fixating the lead in the myocardium. The lead body is insulated in Silicone. The entire lead is conditionally safe to be used in a MRI system. 1,248.00 Guidant Australia Pty Ltd Fineline II EZ Sterox IROX Lead Bipolar, active fixation 1,248.00 Guidant Australia Pty Ltd Fineline II EZ Sterox IROX Lead Bipolar, active fixation 1,248.00 Guidant Australia Pty Ltd Flextend Lead Models 4086, 4087 & 4088 Bipolar, active fixation 1,248.00 Medtronic Australasia Pty Ltd CapSureFix Novus Model 4076 Pacing Lead Active fixation pacemaker lead 1,248.00 Medtronic Australasia Pty Ltd CapSure Fix MRI Pacing Lead Model 5086, MRI Conditional 1,248.00 Medtronic Australasia Pty Ltd Medtronic Capsurefix Model 5568 Pacing Leads Bipolar, steroid, active fixation pacing lead 1,215.00 Medtronic Australasia Pty Ltd Medtronic Capsurefix Novus Model 5076 Pacing Lead Silicone; Contents: 1 x lead with anchoring sleeve, stylet & guide, 1 x vein lifter, 2 x fixation tools, extra stylets 1,248.00
Sorin Group Physique ER Series Steroid eluting active fixation pacing lead. Permanent pacing lead, Model Physique ER is indicated for the pacing and sensing of the ventricle or atrium. This permanent pacing lead is used in conjunction with a compatible implantable pulse generator. Permanent pacing lead, Model Physique ERJ is indicated for the pacing and sending of the atrium. This permanent pacing lead is used in conjunction with a compatible implantable pulse generator (pacemaker) IS-1 1,248.00 Sorin Group PY2-ER Series Steroid eluting active fixation pacing lead. Permanent pacing lead PY2-ER series, is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (Pacemaker) 1,248.00 St Jude Medical Australia Pty Ltd Tendril SDX Models 1688T and 1688TC Endocardial Steroid-Eluting Active Fixation Pacing Lead 1,248.00 St Jude Medical Australia Pty Ltd Tendril ST 1788T/TC and 1782TC Endocardial Bipolar Active Fixation Pacing Leads 1,248.00 St Jude Medical Australia Pty Ltd Tendril ST 1888TC and 1882TC Endocardial Bi-polar Active Fixation Pacing Leads 1,248.00 St Jude Medical Australia Pty Ltd Tendril STS 1988TC and 2088TC Endocardial Bi-polar Additive Fixation Pacing Leads 1,248.00 St Jude Medical Australia Pty Ltd Tendril MRI LPA 1200M The Tendril MRI™ lead, Model LPA1200M, is an MR Conditional, bipolar, active fixation implantable pacing lead with Optim™ insulation. 1,248.00 St Jude Medical Australia Pty Ltd OptiSense 1699T/1699TC Endocardial, Bi-polar Pacing Leads with Optim Insulation 1,248.00