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Cost-Effectiveness of Left Ventricular Assist Devices (LVADs) as Permanent Implants for End-Stage Heart Failure
David Samson Blue Cross and Blue Shield Association
Technology Evaluation Center, University at Albany
Thanks to: Alan M. Garber Stanford University
Gillian Sanders Duke University
Naomi Aronson Blue Cross and Blue Shield Association Technology Evaluation Center
Copyright 2004 Blue Cross Blue Shield Association
Copyright 2004 Blue Cross Blue Shield Association
Rose et al.NEJM, 2001;345:1435
REMATCH Trial
REMATCH: destination therapy, in contrast to bridge to transplant
129 patients with NYHA Class IV end-stage heart failure,
contraindications for heart transplantation, randomized to LVAD or
optimal medical management (OMM)
Median survival: LVAD - 408 d, OMM - 150 d ( 8.5 mo, p=0.001)
Rate of all serious adverse events per patient-yr:
LVAD - 6.45, OMM - 2.75, rate ratio (95% CI): 2.35 (1.86 - 2.95) Copyright 2004 Blue Cross Blue Shield Association
REMATCH Trial
Copyright 2004 Blue Cross Blue Shield Association
0.0
0.2
0.4
0.6
0.8
1.0
months from randomization
Su
rviv
al
0 6 12 18 24 30
LVAS, n=OMM, n=
6861
4128
3316
154
73
REMATCH, all cause mortalityFeb. 2002 update
LVASOMM
CDRH-FDA, CSDAP,03/04/02
REMATCH Trial
• 1 yr median NYHA Class: LVAD - II, OMM - IV (p<0.001)
• 1 yr mean SF-36 PF: LVAD - 46, OMM - 21 (p=0.01)
Copyright 2004 Blue Cross Blue Shield Association
Class I: No limitation on physical activity (sx > ordinary activity)
Class II: Slight limitation on physical activity (sx ordinary activity)
Class III: Marked limitation on physical activity (sx < ordinary activity)
Class IV: Inability to carry on physical activity (sx at rest)
REMATCH Trial
Copyright 2004 Blue Cross Blue Shield Association
Thoratec,FDA, CSDAP,03/04/02
Month
LVAD% NYHA
I/II
OMM% NYHA
I/II
0 0 0
1 54 0
3 68 3
6 80 9
9 82 0
12 71 0
18 44 0
24 71 33
Structural Components of CEA
• Time horizon, perspective: Lifetime (3 years), payor
• Patient population, setting: REMATCH patient selection, sites
• Strategies: LVAD, OMM
• Markov model: 2-state (analogous to 3-state)
• Quality of life focus: NYHA functional class categories
• Valuing of Costs: 2002 $ USCopyright 2004 Blue Cross Blue Shield Association
Markov Model
Copyright 2004 Blue Cross Blue Shield Association
Alive Dead
p11 1
NYHA III/IV
p11p22
Dead
NYHA I/II
p12
p12
p13 p231
p21
2-State:
3-State:
Cycle-Specific Calculation of QALYs, Costs
QALYt = St [(PI/II*UI/II)+(PIII/IV*UIII/IV)]t/12
Ct = St [(Prehosp*Crehosp)+(Poutpt*Coutpt)]
Copyright 2004 Blue Cross Blue Shield Association
• t = monthly cycle
• St = survival probability
• PI/II, PIII/IV = probability of being in NYHA class categories
• UI/II, UIII/IV = utility of being in NYHA class categories
• Prehosp, Poutpt = probability of being rehospitalized, outpatient
• Crehosp, Coutpt = cost of being rehospitalized, outpatient
Parameter Estimates
• Survival, LVAD:OMM HR=0.52 95% CI: 0.34, 0.78
• Survival extrapolation interpolation stop & drop, 2 setsto 0% @ 3 yr
parametric models
• NYHA I/II utility 0.81 0.50 - 1.00
• NYHA III/IV utility 0.55 0.30 - 0.80
Copyright 2004 Blue Cross Blue Shield Association
Parameter Estimates• LVAD Prehosp 0.22 0.10 - 0.35
• OMM Prehosp 0.15 0.05 - 0.30
• LVAD Cimplant $277,001 $125K - $425K
• LVAD/OMM Crehosp $39,896 $10K - $70K
• LVAD/OMM Coutpt $1,719 $250 - $3,250
• Discount, costs/utilities 3% 1% - 5%
Copyright 2004 Blue Cross Blue Shield Association
Results: Baseline, Sensitivity Analysis on Survival Relation
Copyright 2004 Blue Cross Blue Shield Association
CostDifference
QALYsDifference
ICER($/QALY)
95% CIL $304,652 0.226 $1,350,746
Baseline $338,882 0.422 $802,674
95% CIU $424,253 0.948 $447,645
Sensitivity Analysis on Survival Extrapolation
Copyright 2004 Blue Cross Blue Shield Association
Extrapolation MethodCost
DifferenceQALYs
DifferenceICER
($/QALY)
Linear interpolation $338,882 0.422 $802,674
Stop & drop $334,896 0.398 $840,738
Gompertz/exponential $334,711 0.395 $846,888
Exponential $362,866 0.566 $641,592
Sensitivity Analysis on Cost of Implantation
Copyright 2004 Blue Cross Blue Shield Association
Cost of Implantation ICER ($/QALY)
$125K $442,644
$200K $620,289
$275K $797,934
$350K $975,579
$425K $1,153,224
Sensitivity Analysis on Cost of Implantation
Copyright 2004 Blue Cross Blue Shield Association
Sensitivity Analysis on NYHA Utilities
Copyright 2004 Blue Cross Blue Shield Association
UtilityNYHA I/II
ICER($/QALY)
0.50 $1,588,874
0.75 $887,689
1.00 $615,890
UtilityNYHA III/IV
ICER($/QALY)
0.30 $708,363
0.55 $802,674
0.80 $925,955
Sensitivity Analysis on NYHA Utilities
Copyright 2004 Blue Cross Blue Shield Association
Sensitivity Analysis on NYHA Utilities
Copyright 2004 Blue Cross Blue Shield Association
Sensitivity Analysis on Rehospitalization/Outpatient Costs
Copyright 2004 Blue Cross Blue Shield Association
Cost ofRehospital-
izationICER
($/QALY)
$10K $701,399
$40K $803,026
$70K $904,652
Cost ofOutpatient
CareICER
($/QALY)
$250 $792,915
$1,750 $802,879
$3,250 $812,844
Sensitivity Analysis on Probability of Rehospitalization
Copyright 2004 Blue Cross Blue Shield Association
ProbabilityRehospital-
izationLVAD
ICER($/QALY)
0.10 $679,442
0.23 $802,879
0.35 $936,174
ProbabilityRehospital-
izationOMM
ICER($/QALY)
0.05 $867,072
0.18 $786,574
0.30 $706,076
Sensitivity Analysis on Discount Rate
Copyright 2004 Blue Cross Blue Shield Association
Discount Rate
UtilityICER
($/QALY)
CostICER
($/QALY)
0.01 $784,499 $806,703
0.03 $802,674 $802,674
0.05 $821,103 $798,770
Conclusions
• CEA results most sensitive to cost of LVAD implantation
• In 1-way and 2-way sensitivity analyses, ICERs < $500K/QALY depended on unrealistic assumptions, especially about cost of LVAD implantation
• Destination LVADs exceed common CE standards
• Results raise questions of resource use for end-of-life care
Copyright 2004 Blue Cross Blue Shield Association
References
• CDRH-FDA. Presentation to FDA-CSDAP, March 4, 2002.
• Frazier et al. Ann Surg, 1995;222(3):327-38.
• Frazier et al. Ann Thorac Surg, 1994;57:1416-22.
• Gelijns et al. Ann Thorac Surg, 1997;64:1312-9.
• Moskowitz et al. Ann Thorac Surg, 2001;71:S195-8.
• Moskowitz et al. Ann Thorac Surg, 1997;64:1764-9.
• Oz et al. Ann Surg, 2003;238(4):577-85.
• Rose et al. N Engl J Med, 2001;345(20):1435-43.
• Samson. TEC, 2004;19(2):1-36 (bcbs.com/tec/vol19/19_02.html)
• Thoratec. Presentation to FDA-CSDAP, March 4, 2002.Copyright 2004 Blue Cross Blue Shield Association