Comparison of cost-effectiveness of implantable cardioverter defibrillator therapy in patients for primary prevention in Latin America: an analysis using the Improve SCA study

Figures & data

Table 1. Model input parameters.

Model parameters	Base case value	Standard error		Distribution		Reference
Monthly risk of mortality (ICD Therapy)
Sudden cardiac death	0.0007	0.0003		Beta		‎^8
Non-sudden cardiac death	0.0014	0.0004		Beta
Non-cardiac death	0.0005	0.0003		Beta
Unknown death	0.0013	0.0003		Beta
Monthly risk of mortality (No ICD Therapy)
Sudden cardiac death	0.0028	0.0005		Beta		‎^8
Non-sudden cardiac death	0.0021	0.0004		Beta
Non-cardiac death	0.0010	0.0004		Beta
Unknown death	0.0014	0.0004		Beta
ICD-related probabilities
Initial operative death	0.0002	0.00002		Beta		‎^11
Continue ICD therapy after shock	0.0034	0.0002		Beta		‎^5,12,13,17,25,33
Discontinue ICD therapy after shock	0.0001	0.00007		Beta
Lead replacement (initial implant)	0.0004	0.0005		Beta		‎^15,16
Lead replacement (replacement implant)	0.0008	0.0009		Beta		‎^21
Lead dislodgement (initial implant)	0.018	0.0012		Beta		‎^15,16
Lead dislodgement (replacement implant)	0.005	0.0009		Beta		‎^21
ICD infection (initial implant)	0.0244	0.0049		Beta		‎^18,19
ICD infection (replacement implant)	0.0432	0.0064		Beta
Utility
Annual utility of heart failure patient	0.837	0.007		Beta		‎^8
ICD complication state	0.7408	0.0112		Beta
Model input parameters, country-specific
Model parameters	Colombia		Mexico		Uruguay
Costs, LCU
Initial ICD implant procedure	$2,157,233^a		$161,205^a		$456,482^a
Replacement ICD implant procedure	$2,157,233^a		$161,205^a		$331,689^a
Lead replacement	$4,524,463^b		$68,583^b		$232,781^a
ICD generator removal	$1,473,095^a		$68,583^c		$173,644^a
ICD lead dislodgement	$1,473,095^a		$68,583^c		$107,987^a
ICD inappropriate shock	$2,487,381^c		$45,131^d		$56,164^c
ICD infection	$25,896,485^a		$76,313^a		$130,233^a
Monthly inpatient cost	$703,148^d		$2,954^a		$11,521^b
Monthly outpatient cost	$399,473^d		$2,449^e		$2,989^b
Discount factor (%)
Costs	5.0^e		5.0^f		5.0^d
Outcomes	5.0^e		5.0^f		5.0^d
	^aSocial Security Institute (ISS) 2001 fee schedule, increased by 30%. ^bISS 2001 fee schedule, increased by 30% plus Medtronic’s list price of cardiac lead. ^cProcedures from Turakhia et al (2017)‎^34, priced according to ISS 2001 fee schedule, increased by 30%. ^dTamayo et al (2013)‎^20. ^eLocal HTA guidelines.‎^23		^aMexican Social Security Institute (IMSS) DRG November 2018 ^bIMSS unit costs 2018 and weighted lead replacement price. ^cIMSS unit costs 2018. ^dProcedures from Turakhia et al (2017)‎^34 ^eTamayo et al (2013)‎^20, priced according to IMSS fees. ^fLocal HTA guidelines.‎^22		^aNational Resource Fund (FNR). ^bObservatorio del Sistema de Salud del Uruguay. ^cProcedures from Turakhia et al (2017)‎^34, priced according to FNR fees. ^dLocal HTA guidelines.‎^24

Local currency units: Colombian pesos COP$, Mexican pesos MXN$, Uruguayan pesos UYU$.

Abbreviations. ICD, Implantable Cardioverter-Defibrillator; LCU, Local Currency Unit.

Figure 1. Model schematic.

Table 2. Base case scenario results.

Base case scenario results			Colombia	Mexico	Uruguay
Undiscounted	ICD Therapy	Aggregated costs (LCU^a)	$170,751,553	$1,318,578	$3,025,052
		Aggregated costs (PPP Adjusted^b)	$123,994	$133,634	$109,351
		Effectiveness (life-years)	9.72	13.91	9.52
		Effectiveness (QALY)	8.19	11.71	8.02
	No ICD Therapy	Aggregated costs (LCU^a)	$100,032,746	$629,155	$1,294,250
		Aggregated costs (PPP Adjusted^b)	$72,641	$63,763	$46,785
		Effectiveness (life-years)	7.56	9.70	7.43
		Effectiveness (QALY)	6.38	8.19	6.28
	Differential	Cost (LCU^a)	$70,718,807	$689,423	$1,730,802
		Effectiveness (QALY saved)	1.80	3.52	1.74
		ICER (Costs per QALY saved, LCU^a)	$39,200,164	$195,751	$994,538
Discounted	ICD Therapy	Aggregated costs (LCU^a)	$132,937,755	$911,631	$2,383,754
		Aggregated costs (PPP Adjusted^b)	$96,535	$92,391	$86,169
		Effectiveness (life-years)	7.36	9.25	7.23
		Effectiveness (QALY)	6.20	7.79	6.09
	No ICD Therapy	Aggregated costs (LCU^a)	$79,017,109	$456,244	$1,025,640
		Aggregated costs (PPP Adjusted^b)	$57,380	$46,239	$37,075
		Effectiveness (life-years)	5.97	7.04	5.89
		Effectiveness (QALY)	5.04	5.94	4.97
	Differential	Cost (LCU^a)	$38,957,646	$455,387	$1,358,114
		Effectiveness (QALY saved)	1.15	1.85	1.12
		ICER (Costs per QALY saved, LCU^a)	$46,729,026	$246,016	$1,214,937

^aLocal currency units: Colombian pesos COP$, Mexican pesos MXN$, Uruguayan pesos UYU$.

^bLocal currency adjusted to international dollars using PPP Conversion Factor for private consumption from the World Bank - World Development Indicators, accessed online 11 June 2020.

Abbreviations. ICD, Implantable Cardioverter-Defibrillator; LCU, Local Currency Unit; QALY, quality-adjusted life year; ICER incremental cost-effectiveness ratio.

Figure 2. One-way sensitivity tornado charts. ¹Includes device cost. Abbreviations. ICD, Implantable Cardioverter-Defibrillator; QoL, Quality-of-Life; COP, Colombian Pesos; MXN, Mexican Pesos.

Figure 3. Probabilistic sensitivity analysis scatterplot.

Figure 4. Cumulative deaths by country. Abbreviations. ICD, Implantable Cardioverter-Defibrillator; SCD, Sudden Cardiac Death; HFD, Heart Failure Cardiac Death; OCD, Other Cardiac Death; NCD, Non-Cardiac Death.

Zhang S, Ching C-K, Huang D, et al. Utilization of implantable cardioverter-defibrillators for the prevention of sudden cardiac death in emerging countries: improve SCA clinical trial. Heart Rhythm. 2020;17(3):468–475.

 PubMed Web of Science ®Google Scholar

Hammill SC, Kremers MS, Stevenson LW, et al. Review of the registry's fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm. 2010;7(9):1340–1345.

 PubMed Web of Science ®Google Scholar

Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010;122(16):1553–1561.

 PubMed Web of Science ®Google Scholar

Turakhia MP, Zweibel S, Swain AL, et al. Healthcare utilization and expenditures associated with appropriate and inappropriate implantable defibrillator shocks. Circ Cardiovasc Qual Outcomes. 2017;10(2):1941–7713.

 Web of Science ®Google Scholar

Tamayo D, Rodríguez V, Rojas M. Outpatient and inpatient costs of heart failure in two hospitals in Bogotá. Acta Med Colomb. 2013;38(4):208–212.

 Google Scholar

Mabel MV, Aurelio MM, Hectro ECJ. Manual para la elaboracion de evaluaciones economicas en salud. Bogotá DC: Instituo de Evaluacion Tecnologica en Salud; 2014.

 Google Scholar

Evaluación de Tecnologías para la Salud: Documento Metodologico. Centro Nacional de Excelencia Tecnologica en Salud; 2017. Available from: http://www.cenetec.salud.gob.mx/descargas/detes/metodologico_ETES.pdf

 Google Scholar

Guía metodológica para estudios de evaluación económica de tecnologías sanitarias. MERCOSUR; 2013. (Resolución N° 03/13). Available from: http://www.sice.oas.org/trade/mrcsrs/resolutions/Res0313_s.pdf

 Google Scholar