The Artificial Heart Prototypes, Policies, and Patients (1991) / Chapter Skim
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Appendix E: Assessing the Cost-Effectiveness of the Development and Use of the Total Artificial Heart
Appendix E: Assessing the Cost-Effectiveness of the Development and Use of the Total Artificial Heart
Pages 262-284
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From page 262... ...
He worked closely as a consultant with committee members and project staff to develop both the model and the estimates. The Markov model estimates were prepared using a software package called Decision Maker (Version 6.2)
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From page 263... ...
As discussed in Chapter 4, the number of potential heart transplant recipients greatly exceeds the available supply of donor hearts. Several types of longterm mechanical circulatory support devices are being developed in order to treat these heart failure patients.
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From page 264... ...
Structure of the Model The clinical process of receiving a TAH was conceived of as a Markov process in which the typical patient moves through a sequence of potential "states" on a monthly, probabilistic basis. The cost effectiveness of TAH implantation was considered relative to two alternative therapies conventional medical treatment and heart transplantation.
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From page 265... ...
The panel members were asked to predict the probabilities and outcomes of the events associated with the 10 states in the Markov model. For each state, they estimated the annual probability that a TAH recipient would experience the state, the probability that death would result, the number of days spent in the hospital in both routine and intensive care, and the associated physician fees (see supplementary Tables E.14 and E.15 at the end of the appendix)
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From page 266... ...
TAH, total artificial heart. TAH recipients are also subject to complications including infection, thromboembolism, bleeding, and psychological problems.
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From page 267... ...
device cost and hospitalization) Hard device failures Soft device failures Infection Thromboembolism Bleeding Psychological complication Other complications Well-functioning device $ 45,600 $ 157,000 $ 19,500 $ 74,800 $ 20,400 $ 17,000 $ 30,900 $ 20,700 $ 26,700 $ 800 Conventional medical therapy All forms of care $ 4,800 Heart transplantation Evaluation (5 patients)
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From page 268... ...
This can be compared to $77,700 for the initial heart transplantation hospitalization, including the costs of evaluations of four other candidates who did not receive a transplant and procurement of the donor organ. Complications and device failures can also lead to costly hospitalizations, ranging from $19,500 per hard device failure to over $30,000 for bleeding or other complications.
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From page 269... ...
The 3 percent discount rate is used for all base case simulations. Base Case it is instructive first to compare TAH survival results using the event simulation with the experts' overall TAH estimates, and with their estimates for heart transplantation.
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From page 270... ...
Survival probabilities for TAH recipients are significantly poorer than the survival experience expected in the future for heart transplant recipients, based on either event simulation or overall estimates. Tables E.6A and E.6B summarize costs, survival, and cost-effectiveness results for the base case for the three alternative therapies.
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From page 271... ...
artificial heart $-29.4 -6.~S D -5.57 D (line 2 - line 1) COST-EFFECTIVENESS OF THE TOTAL ARTIFICIAL HEART TABLE E.6A Cost-Effectiveness Results for Base Case: Cost and Outcomes by Therapy Aggregate LY QALY Therapy Cost (K$)
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From page 272... ...
Operative 0.10 0.15 $291 3.6 2.7 $ 80 $109 mortality Hard failure 0.85 0.50 $327 4.3 3.1 $ 76 $106 mortality Hard failure rates $282 3.3 2.4 $ 86 $117 Years 1-7 0.05 0.10 Years 8 and 9 0.15 0.15 Year 10 and later 0.50 0.50 Soft failure rates Years 1-3 0.05 0.10 Years4-7 0.10 0.10 Years 8 and 9 0.15 0.15 Year 10 and later 0.30 0.30 Infection/year 0.05 0.15 Emboli/year 0.10 0.15 Bleeding/year 0.10 0.15 Other complications 0.20 0.25 All of above All of above and costs 25% higher $303 3.8 2.8 $ 80 $110 $299 3.8 2.8 $ 79 $108 $299 3.8 2.8 $ 79 $108 $306 3.9 2.8 $ 78 $108 $300 3.7 2.7 $ 80 $110 $313 2.6 2.0 $108 $142 $366 2.6 2.0 $126 $165 Improving Cost-Effectiveness (changes that lower the C/E ratio) Operative mortality Hard failure rates Years 1-7 0.05 Years8and9 0.15 Year 10 and later 0.50 Soft failure rates Years 1-3 0.05 Years 4-7 0.10 Years 8 and 9 0.15 Year 10 and later 0.30 Infection/year 0.05 Emboli/year 0.10 Bleeding/year 0.10 Other complications 0.20 All four lower complications and lower hard failure mortality 0.10 o.os o.os o.os o.so o.os o.os o.os 0.30 0.02 0.08 0.05 0.15 $307 4.2 3.0 $312 4.2 3.1 $73 $102 $73 $102 $293 4.0 2.9 $73 $101 $299 4.0 2.9 $75 $299 4.0 2.9 $75 $293 3.9 2.8 $75 $298 4.1 3.0 $73 $337 5.0 3.6 $67 $103 $104 $103 $101 $ 95
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From page 273... ...
All of above All of above and costs 10% lower 6.1 6.1 4.3 4.3 $5s $ 78 $ 73 $51 NOTE: Alternative cost estimates reflect change to hospital and physician costs; device cost is unchanged. K$, $1,000; LY, life years gained; QALY, quality-adjusted life years; C/E, cost-effectiveness.
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From page 274... ...
Table E.8 compares the cost-effectiveness estimates generated here with those found for other heart disease treatments from previous studies. It is clear that the value of $105,000 per QALY for the TAH is considerably beyond the upper bound of what many would consider as generally acceptable for medical treatments and procedures.
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From page 275... ...
High risk Low risk Mobile Coronary Care Units Percutaneous Transluminal Coronary Angioplasty Severe angina Mild angina Automatic Implantable Cardioverter Defibrillator (AICD) a Electrophysiologic Testingb Heart TransplantationC Implantation of Total Artificial HeartC Cost per Life Year or QualityAdjusted Life Year Gained (in 1991 dollars)
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From page 276... ...
who would not have received the device otherwise. The second benefit, the reduction in device cost, will affect not only this 12-15 month cohort, but
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As explained above, two different, essentially unrelated benefits may result earlier availability and lower device cost. TABLE E.10 Investment in Artificial Heart R&D: Cost Streams for Three Scenarios Scenario ($ millions)
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From page 278... ...
In the base case, considering the R&D investment stream and the future reductions in device cost, the marginal cost per QALY is approximately $97,000, lower than the $105,000 under the treatment CEA because the TAH price does not remain a constant $100,000. The two alternative scenarios, although involving higher R&D costs, result in lower device costs for a time and in the device becoming available sooner.
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From page 279... ...
C $ 97,000 $ 94,000 $ 93,000 Incremental R&D cost-effectiveness, compared with Scenario 1 (per QALY) NA $ 41,000 $ 44,000 NOTES: Assumptions applicable to all scenarios: 2,000 patients per year; R&D investment during 1994-2003; 3 percent discount rate; 2.85 net QALYs gained per TAH recipient; total costs and total QALYs are discounted to 1991; horizon is 2039 for all three scenarios.
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From page 280... ...
. Alternative outcomes with device cost at $78,500 assume investment Scenario 2; those with device cost at $70,000 or $50,000 assume investment Scenario 3.
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From page 281... ...
At approximately $100,000 per QALY gained, its C/E ratio is substantially less favorable than the C/E ratios for heart transplantation and renal dialysis and, therefore, many would currently regard it as questionable or borderline on a cost-effectiveness basis. The experts' vision of the TAH describes a technology that could in the future provide
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From page 282... ...
Preoperative stay Those who die or have complication 40 Discharged with no 30% 30% 25% complications 17 20% 5% Rejection Conventional medical therapy Establish drug regimen 20 30% ALOS, average length of stay; ICU, intensive care unit or coronary care unit; TAH, total artificial heart. clinical benefits that many patients would like to have available.
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From page 283... ...
Also, although computationally complex, the models, especially for heart transplantation and conventional therapy, are crude approximations of what could be developed from current literature, given more resources and time. The cost parameters attempted to measure economic costs to society, but given the lack of accurate information on something as basic as the cost of a day in an intensive care unit, the cost estimates should also be considered approximations.
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From page 284... ...
1990. Myocardial revascularization for chronic stable angina: Analysis of the role of percutaneous transluminal coronary angioplasty based on data available in 1989.
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