The Artificial Heart Prototypes, Policies, and Patients (1991) / Chapter Skim
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3. Decisions for Future Research and Development
3. Decisions for Future Research and Development
Pages 44-64
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From page 44... ...
AS discussed further in Chapter 9, the NHLBI artificial heart program is unusual among health care R&D programs in that government funds have provided almost all of the support for developing the long-term, fully implantable devices that are the subject of this study. In making decisions about activities of the artificial heart program, NHLBI and not-for-profit research organizations use approaches and methods very different from those used by industry in allocating funds to R&D programs (a topic discussed briefly at the end of this chapter)
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From page 45... ...
. NHLBI, National Heart, Lung, and Blood Institute; CHD, coronary heart disease; TAH, total artificial heart; VAD, ventricular assist device; R&D, research and development.
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From page 46... ...
JUDGMENT-BASED DECISION MAKING Traditionally, within NHLBI as in many other organizations, most R&D funding allocation decisions are made on the basis of professional judgment, either individual or collective, about the relative merits of the alternatives under consideration. Rarely is any quantitative approach used, or even a systematic application of specific criteria.
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From page 47... ...
examined the costeffectiveness of developing and implementing two cancer-prevention research strategies by determining cost-effectiveness ratios that compared the projected benefits of each strategy to their R&D and health care costs.
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From page 48... ...
For decisions that involve broad options, such as allocating funds between basic research and applied R&D or between alternatives that include combinations of programs with little in common, cost-effectiveness analyses or detailed assessments of criteria are not likely to be feasible. If officials explicitly state applicable criteria, however, they improve the likelihood that their judgment-based decisions will be both more reasonable and more consistent over time, even if they do not evaluate alternatives with precis~on.
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From page 49... ...
Government agencies, philanthropic foundations, and other groups that support health care R&D seldom experience direct monetary benefit from their research commitments, and thus they cannot use financial or economic analysis alone. Priority-setting criteria have been developed to identify particular areas of health care or specific technologies that warrant intensive clinical study; see, for example, criteria for clinical conditions to be given high priority for examination by the Public Health Service's new effectiveness program (IOM, 1989)
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From page 50... ...
. The expected impact of each technology on overall health care costs, including the cost of manufacturing and using each alternative R&D output.
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From page 51... ...
This criterion encourages allocation decisions that are based on the expected health benefit to individual patients. Life expectancy gains can be estimated by expert clinicians, and improvement in healthrelated quality of life can be assessed by using estimates of "before and after" measures as well as by explicitly taking the risks of the new R&D output into account.
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From page 52... ...
This consideration will be particularly important for technologies such as mechanical circulatory support systems (MCSSs) , insofar as the Medicare program's decisions are concerned, because endstage heart disease disproportionately affects older persons.
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From page 53... ...
In an era of enhanced consciousness about health care costs, using anticipated cost-benefit ratios or costeffectiveness measures (e.g., cost per incremental quality-adjusted life year, or QALY) reflects the relative potential of each R&D output for accomplishing gains in health-related quality of life.
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From page 54... ...
The issue of spin-off or spillover discoveries, just discussed in connection with cost-effectiveness analysis, is a related, more concrete example of the value that can result in other fields from targeted research. Still, it may be similarly difficult to evaluate.
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From page 55... ...
Impact on health care costs. The expected impact of each technology on overall health care costs, including the cost of manufacturing and using each alternative R&D output, is another important criterion for allocation decisions.
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From page 56... ...
This occurred, for instance, when thrombolytic therapy was introduced as a treatment for acute myocardial infarction, leading to increased use of coronary angiography and angioplasty (Steinberg et al., 1988~. This criterion thus makes explicit a potential constraint on diffusion that is often not considered but can be important.
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From page 57... ...
The development of the surgical technique of heart transplantation raised issues about the process for equitably distributing very limited benefits, while development of the TAH raises particular issues of access. (See Chapter 8 for further discussion of ethical considerations pertaining to R&D decisions.)
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From page 58... ...
The committee rated this criterion fairly low for two reasons: the general difficulty of comparing such alternatives in quantitative terms, and the belief that such allocation decisions are more appropriately made through the budget process of the administration and Congress. Extent of existing R&D support.
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From page 59... ...
Still, if most long-term production of mechanical circulatory support devices eventually comes from foreign manufacturers and few controls are placed on the devices' use, the aggregate cost of importing
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From page 60... ...
The rest of this section discusses how that might be done and offers a relatively simple formula that would help to quantify the process, by creating a C/E ratio that expresses the value of each alternative research proposal as the R&D cost per a measure of net health outcome added as a result of applying the specific R&D project's output. This situation was not directly involved in the committee's study, however, so this formula has not been used in this report.
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From page 61... ...
. This approach avoids the troublesome problem of converting what may be an uneven time stream of treatment costs into an annual equivalent.
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From page 62... ...
Other typical considerations, particularly with potential Class III devices, include these time and cost factors: · special testing requirements to determine the product's safety, efficacy, and in vivo durability; · quality assurance measures that are much more costly for complex medical devices than, for instance, for a chemical compound; · the length of time before a return on the investment can be realized, because of the delays inherent in the FDA and third-party payer approval processes; and
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From page 63... ...
options according to explicit criteria. To illustrate the process and form a starting point for NHLBI, the committee identified 18 criteria and ranked them as "more important," "important," or less so; these or similar criteria can be used systematically to provide a rational basis for funding allocation decisions.
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From page 64... ...
1988. Cost and procedure implications of thrombolytic therapy for acute myocardial infarction.
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