Cost-utility and cost-benefit analysis of TAVR availability in the US severe symptomatic aortic stenosis patient population

Figures & data

Figure 1. State-of-the-art decision tree. All lines indicate branches of the decision tree. The rectangular nodes name each branch, and the values in each associated circle indicate the percentage of the previous branch that moves into subsequent nodes. Abbreviations: MM, medical management; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.

Table 1. Terminal state utilities.

Treatment	TAVR				SAVR			MM
Risk Group	Low	Intermediate	High	Prohibitive	Low	Intermediate	High	Low	Intermediate	High	Prohibitive
Proportions	0.181	0.202	0.025	0.013	0.060	0.068	0	0.096	0.108	0.162	0.084
Age 65–79 years	0.095	0.106			0.024	0.027		0.010	0.012
Age ≥80 years	0.086	0.096			0.010	0.011		0.008	0.009
LE ≥1 year										0.087	0.045
LE <1 year										0.075	0.039
Costs	$155,634	$149,551	$176,043	$217,066	$185,052	$172,939	$185,702	$189,945	$73,672	$81,191	$115,509
Age 65–79 years	$165,769	$200,805			$197,976	$230,854		$239,147	$159,659
Age ≥80 years	$117,482	$127,133			$135,966	$147,387		$46,231	$43,136
LE ≥1 year			$176,043	$217,066						$110,820	$154,805
LE <1 year										$81,191	$51,723
QALYs	9.39	5.38	5.20	2.97	9.30	5.00	4.08	4.50	1.56	1.63	1.45
Age 65–79 years	10.54	8.92			10.46	8.40		5.74	3.59
Age ≥80 years	5.19	3.94			5.02	3.54		1.01	0.88
LE ≥1 year			5.20	2.97						2.25	1.99
LE <1 year										0.65	0.62
Salaried labor (h)	803	75	57	32	741	66	40	210	16	14	10
Age 65–79 years	1,315	565			1,225	521		396	189
Age ≥80 years	72	22			63	19		8	4
LE ≥1 year										17	13
LE <1 year										7	5
Unpaid Work (h)	13,500	7,338	7,284	4,283	13,296	6,961	5,712	6,826	2,280	2,474	2,260
Age 65–79 years	15,341	12,661			15,147	12,304		8,819	5,574
Age ≥80 years	7,055	5,183			6,780	4,789		1,435	1240
LE ≥1 year										3,413	3,081
LE <1 year										985	963
Active leisure (h)	9,678	4,879	4,709	2,615	9,469	4,585	3,580	4,345	1,336	1,406	1,230
Age 65–79 years	10,856	8,005			10,648	7,709		5,541	3,074
Age ≥80 years	5,358	3,545			5,112	3,244		965	753
LE ≥1 year										1,949	1,685
LE <1 year										555	519

This table summarizes an average patient’s terminal state utilities by treatment and risk group in the shaded rows. Non-shaded rows detail any adjustments to utilities made when a patient has a differing age or life expectancy. Abbreviations. LE, life expectancy; MM, medical management; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.

Table 2. Cost-utility and cost-benefit analyses results.

Measure	TAVR available	TAVR not available	Incremental impact
CUA results: impact of TAVR availability on treatment costs and QALYs
Cost	$138,010	$125,202	$12,808
QALY	4.86	3.36	1.50
Net benefit	$590,990	$378,798	$212,192
ICER	–	–	$8,533
CBA results: impact of TAVR availability on active time
Quantity of active time
Salaried labor (h)	287	146	141
Unpaid work (h)	6,970	4,935	2,035
Active leisure (h)	4,638	3,182	1,456
Total (h)	11,895	8,263	3,632
Value of active time
Salaried labor ($)	$4,701	$2,095	$2,606
Unpaid work ($)	$104,780	$69,048	$35,732
Active leisure ($)	$69,626	$44,626	$25,000
Total ($)	$179,108	$115,769	$63,338
Rate of return: incremental cost of TAVR availability vs. active time gained
			394.52%

Net monetary benefit is reported assuming a value of $150,000 per quality-adjusted life year. Abbreviations. CBA, cost-benefit analysis; CUA, cost-utility analysis; ICER, incremental-cost effectiveness ratio; QALY, quality-adjusted life year; TAVR, transcatheter aortic valve replacement.

Figure 2. Incremental cost, incremental benefit, and net benefit of TAVR availability, both per-patient and aggregate. Abbreviations. B, billion; QALY, quality-adjusted life year; SSAS, severe symptomatic aortic stenosis; TAVR, transcatheter aortic valve replacement.

Table 3. Scenario and sensitivity analyses results.

	CUA				CBA
	ICER	Cost difference	QALY difference	RoR (%)	Salaried labor (h)	Unpaid work (h)	Active leisure (h)	Value
Base case	$8,533.37	$12,807.98	1.50	394.52	141	2,035	1,456	$63,338.19
Scenario analyses
“Historical practice” tree	$20,173.73	$13,013.55	0.65	52.73	18	857	607	$19,876.01
30% of SSAS patients are prohibitive risk	$9,518.80	$11,326.35	1.19	340.10	110	1,607	1,154	$49,847.35
Low-risks are 50% of non-prohibitive risks	$3,964.04	$5,459.65	1.38	1,000.63	149	1,851	1,371	$60,090.47
Projection of low-risk TAVR proportion	$8,533.37	$12,807.98	1.50	394.52	141	2,035	1,456	$63,338.19
Increased high risk among SAVR patients	$7,922.09	$11,906.39	1.50	433.75	143	2,038	1,462	$63,550.21
SSAS population proportion of MM is 45%	$7,040.61	$7,195.84	1.02	552.79	106	1,387	969	$46,973.58
Attrition rates from clinical trials	$11,052.39	$25,154.45	2.28	253.62	184	3,076	2,229	$88,951.89
TAVR eligibility is 85.7%	$8,213.17	$15,440.28	1.88	414.10	179	2,549	1,827	$79,377.85
TAVR eligibility is 97%	$8,061.75	$17,210.81	2.13	423.89	204	2,894	2,077	$90,166.42
Medical futility is 12.1%	$12,533.91	$20,847.33	1.66	228.18	142	2,273	1,600	$68,417.14
Medical futility is 20%	$11,490.35	$18,587.16	1.62	260.41	142	2,206	1,559	$66,989.25
Medical futility is 60%	$5,151.86	$7,143.25	1.39	736.59	140	1,867	1,355	$59,759.43
Average wage is federal minimum wage	$8,533.37	$12,807.98	1.50	105.60	141	2,035	1,456	$26,333.44
Health utility discount 0%	$8,518.34	$12,807.98	1.50	392.77	134	2,035	1,457	$63,113.37
Sensitivity analyses
Mortality increases by 10%	$10,132.98	$15,089.59	1.49	315.90	141	2,030	1,443	$62,757.93
Mortality decreases by 10%	$6,710.54	$10,140.14	1.51	529.90	141	2,036	1,468	$63,872.57
Health utility increases by 10%	$7,757.61	$12,807.98	1.65	394.52	141	2,035	1,456	$63,338.19
Health utility decreases by 10%	$9,481.52	$12,807.98	1.35	394.52	141	2,035	1,456	$63,338.19
Cost increases by 10%	$9,386.70	$14,088.78	1.50	349.56	141	2,035	1,456	$63,338.19
Cost decreases by 10%	$7,680.03	$11,527.18	1.50	449.47	141	2,035	1,456	$63,338.19
Predicted time increases by 10%	$8,533.37	$12,807.98	1.50	443.97	155	2,238	1,602	$69,672.01
Predicted time decreases by 10%	$8,533.37	$12,807.98	1.50	345.07	127	1,831	1,311	$57,004.37
Discount rate is 6%	$10,073.26	$12,149.63	1.21	318.88	125	1,635	1,176	$50,891.99
Discount rate is 0%	$7,275.78	$14,082.11	1.94	480.55	161	2,623	1,870	$81,753.29

Base case CUA, CBA, and RoR results are compared to the results of each scenario and sensitivity analysis. Abbreviations. CBA, cost-benefit analysis; CUA, cost-utility analysis; ICER, incremental cost-effectiveness ratio; MM, medical management; QALY, quality-adjusted life year; RoR, rate of return; SAVR, surgical aortic valve replacement; SSAS, severe symptomatic aortic stenosis; TAVR, transcatheter aortic valve replacement.

Table 4. Breakdowns by SSAS patient group: Percentage of the SSAS population and net monetary benefits.

Group	Percentage of SSAS population (%)	CUA NMB per patient	Aggregated, weighted CUA NMB	CBA NMB per patient	Aggregated, weighted CBA NMB
(1) Prohibitive-risk TAVR patients who would otherwise receive MM	1.3	$85,297.89	$1,114.23	‒$33,748.6	‒$440.85
(2) Non-prohibitive-risk TAVR patients who would otherwise receive SAVR	6.3	$92,125.26	$5,791.62	$36,518.84	$2,295.82
(3) Non-prohibitive-risk TAVR patients who otherwise get MM	34.5	$615,465.55	$212,594.26	$123,119.33	$42,527.91

The SSAS population contains three groups of patients who receive TAVR now that it is available, instead of receiving SAVR or MM. Each group’s percentage of total SSAS patients is reported. Net monetary benefit is calculated for each group, both from a CUA and a CBA perspective. Net monetary benefit is reported per-patient and aggregated across the patient group. Abbreviations. CBA, cost-benefit analysis; CUA, cost-utility analysis; MM, medical management; NMB, net monetary benefit; SAVR, surgical aortic valve replacement; SSAS, severe symptomatic aortic stenosis; TAVR, transcatheter aortic valve replacement.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Reviewer disclosure

Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.