Vaccines for the 21st Century A Tool for Decisionmaking (2000) / Chapter Skim
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Overview of Analytic Approach and Results
Overview of Analytic Approach and Results
Pages 53-92
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From page 53... ...
The committee examined 26 candidate vaccines, but included two distinct target populations for one candidate, thus 27 separate cases (see Table 4-1~. The specifics of the calculations are described in Chapter 5 for those readers who desire more detailed explanations.
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From page 56... ...
It cannot, however, address all of the qualitative judgments that shape policy decisions. The analysis cannot provide the value judgments required to determine whether expected health benefits and costs justify a particular investment in vaccine development.
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From page 57... ...
Moreover, the analysis does not address the allocation of resources between vaccine development and the development and use of other forms of prevention or treatment. Although priority setting and resource allocation can be informed by economic analyses, they require value judgments that cannot be captured by a cost-effectiveness model.
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From page 58... ...
Some might argue that the needs of specific populations such as those defined by race, ethnicity, socioeconomic status, or health status should be given a higher priority than would be suggested by a strict ranking of costeffectiveness ratios. The responsibility for judging what constitutes an equitable allocation should lie with accountable policymakers.
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From page 59... ...
The vaccine candidates analyzed in depth were selected on the basis of their relevance to health status in the United States, not globally. Thus, for the vaccines that are likely to be used in many countries in addition to the United States, the analysis includes only a portion of the total health benefits and savings in costs of care that can be expected for relatively little additional investment in vaccine development.
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From page 60... ...
The initial period of vaccine use is also likely to be affected by efforts to "catch up" on coverage. For preventive vaccines, this would involve administering additional doses of vaccines to groups beyond the target population, thus increasing the cost of vaccine delivery and altering the assumptions regarding the timing of health benefits relative to vaccination.
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From page 61... ...
MODEL OVERVIEW The essential calculation for the cost-effectiveness ratio for each candidate vaccine is the net cost (i.e., the costs of vaccine development plus the costs of administering the vaccine to the target population, minus the saving in cost of care expected with the use of the vaccine) divided by the expected gain in health benefits.
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From page 62... ...
A health state Judged to be equivalent in quality to death would also have a weight of 0.0, meaning t a Me spent in that health state would have a QALY value of 0.0. A condition cons~dered worse than death can be assigned a negative weight.
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From page 63... ...
The HUI Mark II system was favored over DALYs because its weights are derived from community-based health-state preferences rather than expert judgment and are determined without regard to age. Another factor in the committee's decision to use the HUI Mark II was the availability from the Canadian National Population Health Survey of age-specific health status weights for a general population (Woltson, 1996~.
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From page 64... ...
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From page 65... ...
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From page 66... ...
Box 4-4 shows examples of the quality adjustment weights obtained for several health states. Quality Adjustments for Average Population Health States To measure the health benefits associated with an intervention such as the use of a new vaccine, it is necessary to compare health status with and without the intervention.
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From page 67... ...
Although an individual might be considered to experience periods of perfect health, represented by a quality-adjustment weight of 1.0, the health status of a population will reflect a range of individual quality levels and should not be represented by a quality-adjustment weight set at 1.0. The committee adopted HUI Mark II-based age- and sex-specific health status results from the Canadian NPHS (Wolfson, 1996)
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From page 68... ...
See Table 4-1 for information on the designated target population for each candidate vaccine. QALYs Gained with Vaccine Use To calculate health benefits anticipated with vaccine use, the QALYs associated with each health state were combined.
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From page 69... ...
The committee did not think that differences among the candidate vaccines in terms of development costs (or cost per dose or effectiveness) were likely to be significant enough to warrant separate analysis.
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From page 70... ...
Furthermore, such studies were not available for every condition under consideration, making it necessary for the committee to assemble those cost data in any case. The morbidity scenarios developed for use in the calculation of health benefits associated with a vaccine also provided the basic framework for the calculation of health care costs that would be averted with vaccine use.
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From page 71... ...
See Box 4-5 for examples of unit costs. Vaccine Efficacy and Utilization An additional component of the committee's analysis took into account assumptions about the efficacy of each vaccine under study and the extent to which the target population would use the vaccine.
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From page 72... ...
Also considered were specific factors that might influence the rate at which a particular vaccine would be used. For example, a 50% utilization rate by an adolescent target population for a vaccine for a sexually transmitted disease (STD)
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From page 73... ...
Although these adjustments changed the costeffectiveness ratios, only a few vaccines shifted in their cost-effectiveness relative to the other vaccines. For each of the conditions included in the study, multiple sensitivity analyses could be performed to test alternative assumptions regarding the morbidity scenarios, the quality-adjustment weights, the costs of care and vaccine development, utilization rates, and numerous other factors.
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From page 74... ...
This is consistent with preliminary analyses performed for the 1985 IOM report on the development of new vaccines, which found that estimated numbers of adverse effects produced minimal changes in the measures of disease burden and cost and did not alter the relative rankings of candidate vaccines. That committee also decided not to include estimates of adverse effects in the final analyses for its report.
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From page 75... ...
Trying to measure the health benefits produced by a contraceptive vaccine would require a determination of whose health is affected by an unintended pregnancy (the mother's health, the child's health, or the health of others in the family) , what those effects are (psychological distress or a normal life expectancy)
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From page 76... ...
The chapter then closes with the results obtained for the 26 candidate vaccines chosen by the committee for further illustration.
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From page 77... ...
Program Considerations Case 4 illustrates the selection of a target population based on age-related risk. Other important bases for selection of a target population (and tailoring of a vaccine program)
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From page 79... ...
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From page 80... ...
Vaccine delivery and development costs remain the same, and the health care costs increase 100 fold. The net cost of a vaccine strategy changes from a cost of over $400 million to a savings of almost $4 billion.
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From page 81... ...
$/QALY $89,660 $18,580 $837,629 QALYs to be gained 7,027 25,826 826 Net cost $630,009,848 $479,838,815 $692,003,742 Cost of care saved $89,990,152 $240,161,185 $27,996,258 Delivery costs $720,000,000 $720,000,000 $720,000,000 Development costs $0 $0 $0 b. Immediately available vaccine with likely effect and use (no development cost or time)
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From page 82... ...
Vaccine available, expected use, and effectiveness with addition of development cost and time $/QALY $69,368 $6,435 $239,833 QALYs to be gained 2,271 3,327 3,327 Net cost $ 157,503,581 $21,407,605 $797,835,132 Cost of care saved $76,943,500 $42,604,166 $42,604,166 Delivery costs $227,247,081 $56,811,770 $833,239,298 Development costs $7,200,000 $7,200,000 $7,200,000 Continued NOTE: "C" is the primary analysis reported in the results section
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From page 83... ...
$138,272,951 Cost of care saved $42,604,166 $4,260,416,552 $323,421,211 Delivery costs $454,494,162 $454,494,162 $454,494,162 Development costs $7,200,000 $7,200,000 $7,200,000 Continued NOTE: "C" is the primary analysis reported in the results section
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From page 84... ...
$/QALY $23,022 $18,656 Net cost $587,256,647 $475,875,000 Cost of care saved $60,743,353 $172,125,000 Delivery costs $648,000,000 $648,000,000 Development costs $0 $0 c. Vaccine available, expected use, and effectiveness with addition of development cost and time $/QALY $16,430 $18,656 QALYs to be gained 25,508 25,508 Net cost $419,089,997 $475,875,000 Cost of care saved $42,604,166 $ 172,125,000 Delivery costs $454,494,162 $648,000,000 Development costs $7,200,000 $0 NOTE: "C" is the primary analysis reported in the results section
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From page 85... ...
The cost-effectiveness ratios for vaccines X-1 through X-9 in the idealized scenario change in some fairly predictable ways. Vaccine strategies appear more cost-effective when analyzing this "idealized scenario" compared to the primary analysis reported by the committee (less-than-perfect utilization and efficacy, including development costs and time until program is stabilized)
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From page 86... ...
The candidate vaccines fall into four reasonably distinct groupings or levels: candidate vaccines that would save money and QALYs; candidate vaccines that would require small costs (<$10,000) for each QALY gained; candidate vaccines that would require modest yet reasonable costs (<$100,000)
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From page 87... ...
Four candidate vaccines fall into the favorable (III3 category: those with which a vaccination strategy would incur moderate costs (more than $10,000 but less than $100,0003 per QALY gained. The Level III vaccine candidates are as follows (in alphabetical orders:
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From page 88... ...
rotavirus vaccine to be given to infants. Seven candidate vaccines fall into the less favorable (IV)
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From page 89... ...
A fifth vaccine, against Coccidioides immitis, moved from Level IV to Level III. Challenges Licensure of the Level I candidate vaccines poses several challenges for vaccination programs and health care providers.
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From page 90... ...
However, the assumption by the committee that the vaccine would be given to high-risk populations in a very targeted manner means that program costs are low compared with the cost of annual immunization of the birth cohort of almost 4 million infants. The Level III candidate vaccines include vaccines to be given during puberty (or during pregnancy, but with a low utilization rate)
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From page 91... ...
An analysis of international disease burden would be likely to result in a more favorable cost-effectiveness result for such candidate vaccines. As this chapter illustrates, a cost-effective analysis is an important tool available to policymakers concerned with vaccine research and development, as well as with vaccine program implementation.
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