Cardiac Resynchronisation Therapy in Patients with Moderate to Severe Heart Failure in Germany: A Cost-Utility Analysis of the Additional Defibrillator

Abstract

Background Cardiac resynchronisation therapy (CRT) is a well-established form of treatment for patients with heart failure and cardiac dyssynchrony. There are two different types of CRT devices: the biventricular pacemaker (CRT-P) and the biventricular defibrillator (CRT-D). The latter is more complex but also more expensive. For the majority of patients who are eligible for CRT, both devices are appropriate according to current guidelines. The purpose of this study was to conduct a cost-utility analysis for CRT-D compared to CRT-P from a German payer's perspective. Methods A cohort Markov-model was developed to assess average costs and quality-adjusted life-years (QALY) for CRT-D and CRT-P. The model consisted of six stages: one for the device implementation, one for the absorbing state death, and two stages ("Stable" and "Hospital") for either a CRT device or medical therapy. The time horizon was 20 years. Deterministic and probabilistic sensitivity analyses and scenario analyses were conducted. Results The incremental cost-effectiveness ratio (ICER) of CRT-D compared with CRT-P was €24,659 per additional QALY gained. In deterministic sensitivity analysis, the survival advantage of CRT-D to CRT-P was the most influential input parameter. In the probabilistic sensitivity analysis 96% of the simulated cases were more effective but also more costly. Conclusions Therapy with CRT-D compared to CRT-P resulted in an additional gain of QALYs, but was more expensive. In addition, the ICER was subject to uncertainty, especially due to the uncertainty in the survival benefit. A randomised controlled trial and subgroup analyses would be desirable to further inform decision making.

Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk

“…The robustness of the analysis was confirmed through various sensitivity analyses. Indeed the ICER falls well towards the lower range of those reported in previously published cost-effectiveness studies of other cardiovascular procedures in Germany, which range from €24,659/QALY for additional defibrillator use for cardiac resynchronization [ 26 ] to €50,570/QALY for radiofrequency catheter ablation to treat paroxysmal AF [ 27 ].…”

“…As Germany has no official cost-effectiveness threshold, we assumed a hypothetical willingness to pay (WTP) threshold of €35,000/QALY. This threshold has also been used by other cost–utility studies for cardiovascular disease conditions in Germany and reflects the upper threshold boundary of the UK National Institute for Health and Care Excellence (NICE) [ 25 , 26 ].…”

“…Other costs considered Pacemaker procedure €1584 €1584 Gutmann et al [39] Pacemaker complications (monthly) €123 €123 Hadwiger et al [26] Rehospitalization €5787 €5787 2019 G-DRG F62B [40] Reintervention €25,463 €25,452 Assumed equal to cost of initial procedure plus rehabilitation associated with procedure AF atrial fibrillation, DS disabling stroke, SAVR surgical aortic valve replacement, TAVI transcatheter aortic valve implantation performed by varying inputs using confidence intervals and ranges from the literature where available and, plausible ranges where data were unavailable as specified in Supplementary Material, Table S3. Overall parameter uncertainty was addressed by a probabilistic sensitivity analysis.…”

Infections associated with cardiac electronic implantable devices: economic perspectives and impact of the TYRX™ antibacterial envelope

“…In NYHA Class III patients with wide QRS duration, ICERs of £24 875–£28 646 were estimated for CRT-D compared to CRT-P in a comprehensive analysis from the UK National Health Service perspective. 51 A recent analysis for Germany reported an ICER of €24 659 for CRT-D compared to CRT-P. 52 An analysis from a US Medicare perspective reported an ICER of $43 678 for CRT-D vs. CRT-P, based on the REVERSE trial. 53 The CardioMems implantable pulmonary artery pressure monitor was estimated to have an ICER of $71 K in NYHA Class III patients in the USA, 54 and ICER between £22 342–£25 464 per QALY gained (€28 709–32 721) from the UK National Health Service perspective.…”

Economic evaluation of remote monitoring of patients with an implantable cardiac defibrillator (REMOTE-CIED study)

“…We used a willingness-to-pay of €25.000 based on previously published studies on the cost effectiveness of cardiac resynchronisation therapy devices in HF patients in Germany. 43,44 Probabilistic analysis. Three sources of uncertainty were evaluated simultaneously in the probabilistic analysis: uncertainty from imputation, parameter uncertainty in the unit costs, and case-mix uncertainty.…”