A cost-effectiveness evaluation is performed comparing TAVI versus medical management. The economic evaluation should model the medical management treatment arm with and without balloon valvuloplasty, as these will have different weights and costs. The health benefits associated with TAVI over medical management +/- balloon valvuloplasty are likely to be improved quality of life and improved life expectancy. The decision analytic model will be structured as follows: Figure 2: Decision analytical model TAVI: transcatheter aortic valve implantation; SAVR: standard aortic valve replacement; TF: transfemoral; Proposed MBS item and fee The proposed medical service is likely to substitute standard aortic valve replacement in patients considered eligible by the heart team. Standard aortic valve replacement is already publicly funded under the following MBS items: 38488 and 38489. The proposed fee for the intervention is based on item 38488 ‘valve replacement with bioprosthesis or mechanical prosthesis’ with a fee of $1,909.60 (as of 20 February 2014).
Table 9 Summary of PICO to define research question Population Intervention Comparator Outcomes to be assessed Health care resources to be considered Patients at high risk for operative mortality & percutaneous peripheral access is available TAVI – transfemoral Standard AVR Improvement in overall survival. Impact on quality of life Cost of intervention and comparator. Cost of management of adverse events. Cost of follow-up management. Patients who are non-operable but do not have a short life expectancy & percutaneous peripheral access is available TAVI – transaortic / transapical / sub-clavian Medical management ± balloon valvuloplasty Improvement in overall survival. Impact on quality of life Cost of intervention and comparator. Cost of management of adverse events. Cost of follow-up management. Patients at high risk for operative mortality & percutaneous peripheral access is NOT available TAVI - transfemoral Standard AVR Improvement in overall survival. Impact on quality of life Cost of intervention and comparator. Cost of management of adverse events. Cost of management. Patients who are non-operable but do not have a short life expectancy & percutaneous peripheral access is NOT available TAVI - transaortic / transapical / sub-clavian Medical management ± balloon valvuloplasty Improvement in overall survival. Impact on quality of life Cost of intervention and comparator. Cost of management of adverse events. Cost of management. up
Table 10 List of resources to be considered in the economic analysis Provider of resource Setting in which resource is provided Number of units of resource per relevant time horizon per patient receiving resource Disaggregated unit cost MBS a (item number in brackets) Safety nets* Other government budget Private health insurer Patient Total cost b Resources provided to identify eligible population Electrocardiography Echocardiographer Outpatient $26.60 (11700) $0.00 $0.00 $4.65 $31.25 Chest x-ray Radiologist Outpatient $40.10 (58503) $0.00 $0.00 $7.15 $47.15 Transthoracic echo Radiologist Outpatient $196.10 (55113, 55114, 55115) $0.00 $0.00 $34.55 $230.65 Resources provided to deliver TAVI (transfemoral or minimally invasive surgery) CT Scan Radiologist Outpatient $399.50 (57341, 57345) $70.50 $470.00 Prosthesis (device and delivery system) Interventional cardiologist Delivery TAVI procedure Interventional cardiologist Delivery Surgical assistant (MBS 51303) Interventional cardiologist Delivery Transeosophageal electrocardiography Echocardiographer Delivery $144.50 (55130) $0.00 $0.00 $25.50 $170.00 Catheterisation / hybrid lab Hospital Delivery
Fluoroscopy Technician Delivery $220.10 (61109, 61110) $0.00 $0.00 $38.80 $258.90 Resources provided in association with TAVI (transfemoral or minimally invasive surgery) Intensive care unit management Hospital $271.60 c (13870) $0.00 $0.00 $90.50 $362.10 Coronary care unit Hospital General care Hospital Ward nursing Hospital Pharmacy Hospital Transthoracic echocardiography Cardiologist $196.10 (55113, 55114, 55115) $0.00 $0.00 $34.55 $230.65 Resources provided to deliver SAVR (surgical aortic valve replacement) Prosthesis (device and delivery system) Surgeon/ cardiologist Delivery Surgical procedure Surgeon / cardiologist Delivery Anaesthesiology Anaesthesiologist Delivery Perfusion Perfusionist Delivery
Resources used to manage patients successfully treated with SAVR (surgical aortic valve replacement) Pharmacy Hospital Specialist visit Cardiologist Echocardiography Echocardiographer 1 x 30-day follow-up; 1 x 6-month follow-up; 1 x 12-month follow-up; 1 x yearly follow-up $26.60 (11700) $0.00 $0.00 $4.65 $31.25 Resources used to manage patients who are unsuccessfully treated with SAVR (surgical aortic valve replacement) Pharmacy Hospital Specialist visit Cardiologist Transthoracic echocardiography Cardiologist 1 x 30-day follow-up; 1 x 6-month follow-up; 1 x 12-month follow-up; 1 x yearly follow-up $196.10 (55113, 55114, 55115) $0.00 $0.00 $34.55 $230.65 Echocardiography Echocardiographer 1 x 30-day follow-up; 1 x 6-month follow-up; 1 x 12-month follow-up; 1 x yearly follow-up $26.60 (11700) $0.00 $0.00 $4.65 $31.25 * Include costs relating to both the standard and extended safety net. a applying a 85% benefit to the relevant MBS item fee. b Actual MBS item fee as of 25th February 2014. c applying a 75% benefit to the relevant MBS item fee.
12. Miller DC, et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012; 143(4):832-843.e13. 13. Reynolds MR, et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011; 124(18):1964-72. 14. Smith CR, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23):2187-98. 15. Leon MB, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363(17):1597-607. APPENDIX 3 ANZ TAVI Platforms Summary Product Name Company First in Man Completed CE Mark Approval FDA Approval TGA Approval Valve Design SAPIEN – TF EL April 2002 Sept 2007 Nov 2011 Sept 2013 Balloon Expanded Stainless Steel Frame CoreValve - TF Med July 2004 May 2007 Jan 2014 - Self- Expanding Nitinol SAPIEN – TA EL Nov 2005 Sept 2007 Oct 2012 Sept 2013 Balloon Expanded Stainless Steel Frame SAPIEN XT – TF EL 2008 March 2010 June 2014 - Balloon Expanded Cobalt Chromium Frame SAPIEN XT – TA / Tao EL 2008 March 2010 June 2014 - Balloon Expanded Cobalt Chromium Frame SAPIEN 3 – TF EL 2009 Jan 2014 - - Balloon Expanded Cobalt Chromium Frame SAPIEN 3 – TA / Tao EL 2009 Jan 2014 - - Balloon Expanded Cobalt Chromium Frame Lotus BS 2010 Oct 2013 - - Self- Expanding Nitinol PORTICO – TF StJ June 2011 Nov 2012 - - Self- Expanding Nitinol PORTICO – TA StJ Nov 2012 - - - Self- Expanding Nitinol Corevalve Evolut R Med Sept 2013 - - - Self- Expanding Nitinol
Edwards - SAPIEN 3 TF Overview Description Next-generation balloon-expandable transcatheter heart valve delivered through a 14 Fr expandable eSheath; features a paravalvular leak solution and improved distal flexing History Edwards first discussed publicly its work on this project during its analyst day on Dec. 10, 2009. Edwards said during its Dec. 10, 2009 analyst day that it is working on enhanced transcatheter heart valve designs below 18 Fr. In a clinicaltrials.gov posting for the company’s CE Mark trial dated March 7, 2013, Edwards indicated that Edwards SAPIEN 3 is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement. On Jan. 13, 2014, Edwards announced completion of enrollment of its U.S. clinical trial studying the SAPIEN 3 valve in the treatment of high-risk or inoperable patients. On Jan. 27, 2014, Edwards announced that it has received CE Mark approval of the SAPIEN 3 valve and has initiated its launch. During its Q4 2013 earnings call on Feb. 4, 2014, Edwards said that it has commenced “an aggressive” launch of this device in Europe, with a number of successful implants already in 2014. The company noted that upgrading customers to this new platform “should be fast” as there is no need for extensive training and clinicians are “very eager” to get their hands on this exciting new technology. The company added that “for these reasons, we believe SAPIEN 3 will quickly become the leading transcatheter valve in Europe.” Source: Edwards - SAPIEN 3 TA / Tao Overview Description Next-generation balloon-expandable transcatheter heart valve designed for both transapical and transaortic approaches; features the Certitude delivery system History In a clinicaltrials.gov posting for the company’s CE Mark trial dated March 7, 2013, Edwards indicated that Edwards SAPIEN 3 is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement.