TYRX cost-effective patient populations1
- The first European cost-effectiveness analysis has been published based on the WRAP-IT randomized controlled trial data.
- The analysis estimated the lifetime impact of using the TYRX™ Cardiac Envelope (adjunctive to standard of care infection prevention) on healthcare resource use, costs, and patient outcomes in 3 European healthcare systems (Germany, Italy and England).
- The TYRX™ Cardiac Envelope is shown to be cost-effective in these selected patients, who are at increased risk of infection, when considering cost-effectiveness thresholds of €50,000 in Germany2-4, €40,000 in Italy5, and £30,000 in England6.
- The cost-effectiveness analysis was conducted by a group of WRAP-IT trial investigators together with York Health Economics Consortium (YHEC), a highly respected health economic consulting company wholly owned by the University of York. The analysis was published in Value in Health, a highly ranked publication in the field of health economics and outcomes research.
TYRX EUROPEAN COST-EFFECTIVENESS ANALYSIS
TYRX™ is cost-effective in selected patient populations, according to a recent analysis for European countries (Germany, Italy and England), published in a peer-reviewed journal1.
WHY COST-EFFECTIVENESS ANALYSIS IS IMPORTANT:
Prioritization is necessary in healthcare, due to limited budgets and virtually unlimited demands from patients and society for better healthcare.
Economic evaluations help determine where scarce resources can provide the greatest benefits.
Methods for cost-effectiveness analysis are established, by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the National Institute for Health and Care Excellence (NICE) in England, and other national & international bodies.
A therapy is “cost-effective” when the Incremental Cost-Effectiveness Ratio (ICER) is less than the threshold.
HEALTH ECONOMICS TERMINOLOGY
QALY
Quality adjusted life year – a generic measure of health that combines the quantity of life years gained (survival) and the quality of life of those extended years (utility score).
EQ-5D is a commonly used generic (not disease-specific) measure of health-related quality of life.
ICER
Incremental Cost-Effectiveness Ratios (ICERs) are estimated from economic evaluations.
Cost-Effectiveness Threshold
An ICER for a therapy can be compared with ICERs for other interventions, or with a notional threshold value of what represents cost-effectiveness. Cost-effectiveness thresholds in this analysis were: €50,000 in Germany (assumed in the absence of an official threshold2-4) €40,000 in Italy5, and £30,000 in England6.
TYRX EUROPEAN COST- EFFECTIVENESS ANALYSIS1
A cost-effectiveness analysis was performed to estimate if the TYRX™ envelope is cost-effective in Europe.
WRAP-IT study data were used extensively to inform the analysis (3-year infection rates, mortality rates, quality of life scores, quantification of resources used to manage infections).
Patient subgroups were analyzed based on risk factors known to increase infection risk. Subgroups also were defined based on an infection risk score (PADIT).
An existing decision tree cost-effectiveness model was used with a lifetime horizon.
HEALTH RELATED & COST INPUTS
MORTALITY
WRAP-IT study death rates with & without infection 41.4% & 18.0% respectively at 3Y.
QUALITY OF LIFE
WRAP-IT study EQ-5D results collected at baseline and during follow-up led to a utility decrement of 0.1 (on a scale of 0 – 1.0) post-infection, applied for 6 months duration.
COSTS
Healthcare utilization information (type, quantities) were prospectively collected in the WRAP-IT study - hospitalization length of stay, CIED* extraction and re-implantation, temporary pacing, wearable defibrillator, antibiotics - and combined with unit costs/prices and cost of the envelope for each country.
TYRX™ IS ASSOCIATED WITH COST- EFFECTIVENESS RATIOS BELOW EUROPEAN BENCHMARKS IN PATIENTS AT INCREASED RISK OF INFECTION1.
| Infections at 36 months | Infection rate without TYRX |
|---|---|
| WRAP-IT SUBGROUPS | |
| History of immunosuppression for High and Low Power | 8,0% |
| Previous CIED infection for High and Low Power | 5,8% |
| ≥2 previous CIED procedures for High Power | 4,5% |
| Generator replacement with lead modification for High Power | 4,1% |
| Generator replacement with lead modification for low power | 3,9% |
| ≥2 previous CIED procedures for Low Power | 3,6% |
| High power replacement† | 2,9% |
| PADIT SUBGROUP§ | |
| PADIT score ≥6 points | 3,3% |
IMPACT OF CIED* INFECTIONS
>3x
Mortality risk at 1 year7
23-30 DAYS
average length of patient hospital days8-10
7 days average intensive/critical care stay10-11
€21,760-€70,329
average costs to treat an infection9,10, 12-14
WRAP-IT STUDY AND EHRA CONSENSUS DOCUMENT15, 16
MOVING CLOSER TO ZERO RISK OF CIED* INFECTION WITH THE TYRX™ ENVELOPE17-23
OUTCOMES OF THE WRAP-IT STUDY, THE LARGEST RANDOMIZED CONTROLLED GLOBAL CIED TRIAL15
TYRX™ ENVELOPE SIGNIFICANTLY REDUCES CIED INFECTIONS15
WRAP-IT STUDY
The largest randomized controlled, global CIED trial
- 6,983 patients at an increased risk for pocket infection
- 25 countries
- 181 centers
- 776 implanters
PATIENT SELECTION
Included patient at increased risk of pocket infection due to:
- Any CIED generator replacement, system upgrade, or revision
- Initial CRT-D implantation
Excluded patients at highest risk of systemic infection due to:
- Hemodialysis or peritoneal dialysis Immunosuppressive agents (chronic oral or ≥20mg of corticosteroid)
- Recent (<12 months) or existing infection
40%
reduction of major CIED infections, meeting the primary objective
61%
reduction of pocket infections
SAFETY ENDPOINT MET
No increased risk of complications with use of TYRX™ through 12 months
EHRA INTERNATIONAL CONSENSUS DOCUMENT
RECOMMENDS TYRX™ CARDIAC ENVELOPE
for the ENTIRE WRAP-IT Study population and for patients with high risk factors to reduce CIED INFECTION16
EDUCATIONAL RESOUCES
ON MEDTRONIC ACADEMY
Find additional feature information along with a variety of educational resource and tools.
VISIT MEDTRONIC ACADEMY
LEARN MORE ABOUT TYRXTM ABSORBABLE ANTIBACTERIAL ENVELOPE
LEARN MOREFOOTNOTES
*
Cardiac Implantable Electronic Device.
†
Western Europe sites only.
‡
Except low power devices in English analysis.
§
12-month Padit rates extrapolated to 36 months.
||
With inclusion of risk sharing agreement currently in place between the manufacturer and English hospitals.
¶
Included in the WRAP-IT Study patient cohort.
REFERENCES
1
Boriani G et al., Value in Health 2021, doi: https://doi.org/10.1016/j.jval.2020.12.021.
2
Cameron D, Ubels J, Norström F. On what basis are medical cost-effectiveness thresholds set? Clashing opinions and an absence of data: a systematic review. Glob Health Action. 2018; 11: 1447828-28.
3
Stadhouders N, Koolman X, van Dijk C, et al. The marginal benefits of healthcare spending in the Netherlands: Estimating cost-effectiveness thresholds using a translog production function. Health Econ. 2019; 28: 1331-44.
4
Van Baal P, Perry-Duxbury M, Bakx P, et al. A cost-effectiveness threshold based on the marginal returns of cardiovascular hospital spending. Health Econ. 2019; 28: 87-100.
5
Fattore G. Proposta di linee guida per la valutazione economica degli interventi sanitari in Italia. PharmacoEconomics Italian Research Articles. 2009; 11: 83-93.
6
National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal. National Institute for Health and Care Excellence (NICE), 2013.
7
Wilkoff BL et al. Impact of Cardiac Implantable Electronic Device Infection, A Clinical and Economic Analysis of the WRAP-ITTrial. Circ Arrhythm Electrophysiol. 2020;13:e008280. doi:10.1161/CIRCEP.119.008280.
8
Egea M et al. Economic Impact associated with complications of cardiac implantable electronic devices in Spain. Poster Presentation EHRA Congress 2018.
9
Ludwig S et al. Incidence and costs of cardiac device infections: retrospective analysis using German health claims data. Journal of Comparative Effectiveness Research 7.5 (2018): 483-492.
10
Ahsan SY et al. A simple infection-control protocol to reduce serious cardiac device infections. Europace 16.10 (2014): 1482-1489.
11
Sohail MR et al. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med 2011 171(20), 1821–1828.
12
Sohail MR et al. Incidence, treatment intensity, and incremental annual expenditures for patients experiencing a cardiac implantable electronic device infection: evidence from a large US payer database 1-year post implantation. Circ Arrhythm Electrophysiol 2016;9:doi:10.1161/CIRCEP.116.003929.
13
Clémenty N et al. Infections and associated costs following cardiovascular implantable electronic device implantations: a nationwide cohort study. Europace 2018;20(12):1974-1980.
14
Burnhope E et al (2019). Economic impact of introducing TYRX amongst patients with heart failure and reduced ejection fraction undergoingimplanted cardiac device procedures: a retrospective model based cost analysis, Journal of Medical Economics, 2019 Feb 12; DOI: 10.1080/13696998.2019.1581621.
15
Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. Published onlice March 17, 2019.;380(20):1895-1905.
16
Blomström-Lundqvist C, Traykov V, Erba PA, et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), international Society for Cardiovascular infectious Diseases (iSCviD) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-thoracic Surgery (EACtS). Europace. Published online November 8, 2019.
17
Tarakji KG, Ellis CR, Defaye P. Kennergren C. Cardiac Implantable Electronic Device Infection in Patients at Risk, Arrhythm Electrophysiol Rev. May 2016; 5 (1): 65-71.
18
Bloom HL et al. Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope. Pacing Clin Electrophysiol. February 2011;34(2):133-142.
19
Mittal S et al. Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRx antibacterial envelope. Heart Rhythm. April 2014;11(4):595-601.
20
Kolek MJ, et al. Efficacy of a Bio-Absorbable Antibacterial Envelope to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Subjects. J Cardiovasc Electrophysiol. October 2015;26(10):1111-1116.
21
Shariff N et al. Health and Economic Outcomes Associated with Use of an Antimicrobial Envelope as a Standard of Care for Cardiac Implantable Electronic Device Implantation. J Cardiovasc Electrophysiol. July 2015;26(7):783-789.
22
Henrikson CA et al. Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies. JACC Clin Electrophysiol. October 2017;3(10):1158-1167.
23
Kolek MJ, Dresen WF, Wells QS, Ellis CR. Use of an antibacterial envelope is associated with reduced cardiac implantable electronic device infections in high-risk patients. Pacing Clin Electrophysiol. March 2013;36(3):354-361.
TYRX™ CARDIAC ABSORBABLE ANTIBACTERIAL ENVELOPE
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
The envelope is intended to hold the following CIED securely to create a stable environment when implanted in the body at the following locations: Implantable Pulse Generator (IPG), Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Devices (CRT-P and CRT-D); implant locations are pectoral, abdominal, or flank (lateral to the body midline and superior to the gluteal) regions.
The envelope contains the ancillary medicinal substances rifampicin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the device.
The envelope is contraindicated for use in patients with allergy or history of allergy to tetracyclines, rifampicin, or absorbable sutures; in patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition; in contaminated or infected wounds.