Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 313
Vaccines for the 21st Century: A Tool for Decisionmaking
APPENDIX 26
Streptococcus pneumoniae
DISEASE BURDEN
Epidemiology
For the purposes of the calculations in this report, the committee estimated that there are approximately 6.4 million cases of Streptococcus pneumoniae in children 4 years of age and under each year in the United States. An additional 1 million cases were assumed to occur in people between the ages of 5 and 64 years of age and 400,000 cases in people 65 years of age and older. The number of deaths in those 3 age groups were estimated to be 1,450, 16,000, and 30,000, respectively. See Table A26–1.
Disease Scenarios
For the purposes of the calculation in this report, the committee assumed that S. pneumoniae disease manifests as bacteremia and sepsis, pneumonia, otitis media/sinusitis/bronchitis, and meningitis. The percentage of cases in the 3 age groups who experience these disease states can be found in Table A26–2. The health utility index (HUI) associated with these various scenarios ranges from .9 for sinusitis (10 days duration) to .16 for hospitalization for severe bacteremia and sepsis and .6 for neurologic sequelae of meningitis (lasting for the lifetime).
OCR for page 314
Vaccines for the 21st Century: A Tool for Decisionmaking
Table A26–1 Incidence of Streptococcus pneumoniae for Age Groups <5, 5–64, and >65
Age Groups
Population
Incidence rates (per 100,000)
% Distribution of Cases
Cases
LESS THAN 5 YEARS
<1
3,963,000
18,167.74
0.1128
719,987
1–4
16,219,000
34,905.47
0.8872
5,661,319
Total
2,422.35
1.0000
6,381,306
5–64 YEARS
5–14
38,056,000
467.19
0.1676
177,796
15–24
36,263,000
467.19
0.1597
169,419
25–34
41,670,000
467.19
0.1835
194,680
35–44
42,149,000
467.19
0.1856
196,918
45–54
30,224,000
467.19
0.1331
141,205
55–64
21,241,000
852.19
0.1706
181,015
Total
402.77
1.0000
1,061,032
GREATER THAN 65 YEARS
65–74
18,964,000
1,182.19
224,191
75–84
11,088,000
1,182.19
131,082
85+
3,598,000
1,182.19
42,535
Total
151.01
397,808
COST INCURRED BY DISEASE
Table A26–3 summarizes the health care costs incurred by S. pneumoniae infections. For the purposes of the calculations in this report, it was assumed that general patterns of health care are the same for each age group in a scenario. Outpatient care for bacteremia/sepsis and for pneumonia was assumed to involve two physician visits, prescription medication, and an inexpensive diagnostic test. Hospitalization costs are also assumed in be incurred for some patients. For more severe cases (e.g., those requiring hospitalization), specialist physicians are included instead of generalists, who would be utilized for less severe infections.
Milder manifestations of S. pneumoniae (e.g., otitis media in children under 5 years of age and sinusitis/bronchitis in people over 5 years of age) were assumed to be associated with costs for general physician visits, prescription mediation, and (in half the cases) a diagnostic procedure (culture).
Acute treatment of meningitis was assumed to require hospitalization, specialist physicians, and expensive diagnostic procedures. It was assumed that a small percentage of patients with meningitis experience lifelong neurologic sequelae requiring multiple visits to a specialist and some sort of physical or other rehabilitative therapies for the disability.
OCR for page 315
Vaccines for the 21st Century: A Tool for Decisionmaking
Table A26–2 Disease Scenarios for Streptococcus pneumoniae Infection
No. of Cases
% of Cases
Committee HUI Values
Duration (years)
<5 YEARS OF AGE
Total Deaths (from acute infection)
1,450
Total Cases
6,381,306
BACTEREMIA/SEPSIS
6,216
0.10%
Bacteremia/Sepsis
1,243
0.02%
outpatient care only
0.93
0.0274 (10 days)
ICU
0.16
0.0055 (2 days)
inpatient after ICU
0.46
0.0137 (5 days)
Bacteremia/Sepsis—inpatient (no ICU)
3,730
0.06%
0.71
0.0110 (4 days)
Bacteremia/Sepsis—inpatient; complications
1,243
0.02%
0.59
0.0137 (5 days)
PNEUMONIA
62,161
0.97%
Pneumonia—outpatient care only
6,216
0.10%
0.82
0.0274 (10 days)
Pneumonia
55,944
0.88%
inpatient
0.71
0.0137 (5 days)
outpatient after inpatient
0.81
0.0137 (5 days)
Pneumonia with emphysema
932
0.01%
inpatient
0.64
0.0384 (14 days)
outpatient after inpatient
0.82
0.0384 (14 days)
OTHER RESPIRATORY
6,312,729
98.93%
Otitis Media
0.74
0.0110 (4 days)
Sinusitis, bronchitis
0.90
0.0274 (10 days)
MENINGITIS
200
0.0031%
Meningitis
160
0.003%
ICU
0.24
0.0055 (2 days)
inpatient after ICU
0.28
0.0274 (10 days)
Meningitis—inpatient (no ICU)
40
0.001%
0.39
0.0137 (5 days)
Meningitis—inpatient acute complications
30
0.0005%
0.27
0.0384 (14 days)
Meningitis—neurologic sequelae
60
0.001%
0.60
26.6824 (quality-adjusted life expectancy); 73.4869 (unadjusted life expectancy)
5–64 YEARS OF AGE
Total Deaths (from acute infection)
15,584
Total Cases
1,061,032
BACTEREMIA/SEPSIS
17,915
1.6884%
Bacteremia/Sepsis—outpatient care only
3,583
0.34%
0.93
0.0274 (10 days)
Bacteremia/Sepsis
3,583
0.34%
ICU
0.16
0.0055 (2 days)
inpatient after ICU
0.46
0.0137 (5 days)
OCR for page 316
Vaccines for the 21st Century: A Tool for Decisionmaking
No. of Cases
% of Cases
Committee HUI Values
Duration (years)
Bacteremia/Sepsis—inpatient (no ICU)
10,749
1.01%
0.71
0.0110 (4 days)
Bacteremia/Sepsis—inpatient, complications
3,583
0.34%
0.59
0.0137 (5 days)
PNEUMONIA
179,145
16.8840%
Pneumonia—outpatient care only
71,658
6.75%
0.82
0.0274 (10 days)
Pneumonia
107,487
10.13%
inpatient
0.71
0.0137 (5 days)
outpatient after inpatient
0.81
0.0137 (5 days)
Pneumonia with emphysema
2,687
0.25%
inpatient
0.64
0.0384 (14 days)
outpatient after inpatient
0.82
0.0384 (14 days)
OTHER RESPIRATORY
861,667
81.2103%
Sinusitis, bronchitis
0.90
0.0274 (10 days)
MENINGITIS
2,306
0.2173%
Meningitis
1,845
0.17%
ICU
0.24
0.0055 (2 days)
inpatient after ICU
0.28
0.0274 (10 days)
Meningitis—inpatient (no ICU)
461
0.04%
0.39
0.0137 (5 days)
Meningitis—inpatient, acute complications
346
0.03%
0.27
0.0384 (14 days)
Meningitis—neurologic sequelae
692
0.07%
0.60
19.8289 (quality adjusted life expectancy at onset); 43.3814 (unadjusted life expectancy at onset)
65 YEARS AND OLDER
Total Deaths (from acute infection)
29,592
Total Cases
397,808
BACTEREMIA/SEPSIS
23,555
5.92%
Bacteremia/Sepsis
4,711
1.18%
outpatient care only
0.93
0.0274 (10 days)
ICU
0.16
0.0055 (2 days)
inpatient after ICU
0.46
0.0137 (5 days)
Bacteremia/Sepsis
14,133
3.55%
inpatient (no ICU)
0.71
0.0110 (4 days)
Bacteremia/Sepsis—inpatient; complications
4,711
1.18%
0.59
0.0137 (5 days)
PNEUMONIA
235,550
59.21%
Pneumonia—outpatient care only
141,330
35.53%
0.82
0.0274 (10 days)
OCR for page 317
Vaccines for the 21st Century: A Tool for Decisionmaking
No. of Cases
% of Cases
Committee HUI Values
Duration (years)
Pneumonia
94,220
23.68%
inpatient
0.71
0.0137 (5 days)
outpatient after inpatient
0.81
0.0137 (5 days)
Pneumonia with emphysema
3,533
0.89%
inpatient
0.64
0.0384 (14 days)
outpatient after inpatient
0.82
0.0384 (14 days)
OTHER RESPIRATORY
138,333
34.77%
Sinusitis, bronchitis
0.90
0.0274 (10 days)
MENINGITIS
370
0.09%
Meningitis
296
0.07%
ICU
0.24
0.0055 (2 days)
inpatient after ICU
0.28
0.0274 (10 days)
Meningitis—inpatient (no ICU)
74
0.02%
0.39
0.0137 (5 days)
Meningitis—inpatient, acute complications
56
0.01%
0.27
0.0384 (14 days)
Meningitis—neurologic sequelae
111
0.03%
0.60
6.9071 (remaining quality adjusted life expectancy); 11.2664 (unadjusted life expectancy at onset)
VACCINE DEVELOPMENT
The committee assumed that it will take 3 years until licensure of an S. pneumoniae vaccine and that $240 million needs to be invested. Table 4–1 summarizes vaccine development assumptions for all vaccines considered in this report.
VACCINE PROGRAM CONSIDERATIONS
Target Population
For the purposes of the calculations in this report, it is assumed that the target population for this vaccine is the annual birth cohort and people 65 years of age. It was assumed that utilization would be 90% and 60% respectively.
OCR for page 318
Vaccines for the 21st Century: A Tool for Decisionmaking
Table A26–3 Health Care Costs Associated with Streptococcus pneumoniae Infection
Cost per Case
Cost per Unit
Units per Case
Form of Treatment
<5 YEARS OF AGE
Bacteremia/Sepsis
outpatient care only
$100
$50
2.0
physician a
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic a
ICU and post-phase
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
inpatient (no ICU)
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
inpatient; complications
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$500
$500
1.0
diagnostic c
Pneumonia
outpatient care only
$100
$50
2.0
physician a
$50
$50
1.0
diagnostic a
$50
$50
1.0
medication b
inpatient
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
outpatient after inpatient
$100
$50
2.0
physician a
$50
$50
1.0
medication b
$50
$50
1.0
diagnostics
Other Respiratory
otitis media
$50
$50
1.0
physician visits
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic a
Meningitis
ICU and non-ICU
$7,000
$7,000
1.0
hospitalization
combine meningitis for costs
$450
$150
3.0
physician b
$50
$50
1.0
medication b
$100
$100
1.0
diagnostic b
$500
$500
1.0
diagnostic c
inpatient, acute complications
$7,000
$7,000
1.0
hospitalization
$900
$150
6.0
physician b
$50
$50
1.0
medication b
$100
$100
1.0
diagnostic b
$500
$500
1.0
diagnostic c
Meningitis: sequelae
lifelong annual costs
$600
$100
6.0
physician b
$300
$50
6.0
physical therapy, other services
OCR for page 319
Vaccines for the 21st Century: A Tool for Decisionmaking
Cost per Case
Cost per Unit
Units per Case
Form of Treatment
5–64 YEARS OF AGE
Bacteremia/Sepsis
outpatient care only
$100
$50
2.0
physician visits
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic a
ICU and post- phase
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
inpatient (no ICU)
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
inpatient; complications
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$500
$500
1.0
diagnostic c
Pneumonia
outpatient care only
$200
$100
2.0
physician b
$100
$50
2.0
diagnostic a
$50
$50
1.0
medication b
Pneumonia with and without emphysema
inpatient
$4,000
$4,000
1.0
hospitalization
$450
$150
3.0
physician c
$100
$100
1.0
diagnostic b
$50
$50
1.0
medication b
outpatient after inpatient
$100
$50
2.0
physician visits
$50
$50
1.0
medication b
sinusitis, bronchitis
$100
$50
2.0
physician a
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic b
Meningitis
ICU, post-ICU, and non-ICU
$7,000
$7,000
1.0
hospitalization
$450
$150
3.0
physician c
$50
$50
1.0
medication b
$100
$100
1.0
diagnostic b
$500
$500
1.0
diagnostic c
Meningitis: sequelae
cost per year for life
$300
$50
6.0
physical therapy
$600
$100
6.0
physician b
>65 YEARS OF AGE+
Bacteremia/Sepsis
outpatient care only
$100
$50
2.0
physician a
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic a
ICU and post ICU phase: inpatient
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
OCR for page 320
Vaccines for the 21st Century: A Tool for Decisionmaking
Cost per Case
Cost per Unit
Units per Case
Form of Treatment
inpatient (no ICU)
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
inpatient; complications
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$500
$500
1.0
diagnostic c
Pneumonia
outpatient care only
$100
$50
2.0
physician a
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic a
inpatient
$4,000
$4,000
1.0
hospitalization
$300
$100
3.0
physician b
$100
$100
1.0
diagnostic b
outpatient after inpatient
$100
$50
2.0
physician a
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic a
Sinusitis, bronchitis
$100
$50
2.0
physician a
$50
$50
1.0
medication b
$50
$50
1.0
diagnostic b
Meningitis
all meningitis combined
$7,000
$7,000
1.0
hospitalization
% cases now corrected
$450
$150
3.0
physician c
$50
$50
1.0
medication b
$100
$100
1.0
diagnostic b
$500
$500
1.0
diagnostic c
annual costs for life
$300
$50
6.0
physical therapy
Vaccine Schedule, Efficacy, and Costs
For the purposes of the calculations in this report, it was estimated that this vaccine would cost $50 per dose and that administration costs would be $10 per dose. Default assumptions of a 3-dose series and 75% effectiveness were accepted. Table 4–1 summarizes vaccine program assumptions for all vaccines considered in this report.
RESULTS
If a vaccine program for S. pneumoniae were implemented today and the vaccine were 100% efficacious and utilized by 100% of the target population, the annualized present value of the QALYs gained would be 265,000. Using committee assumptions of less-than-ideal efficacy and utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the QALYs gained would be 120,000.
OCR for page 321
Vaccines for the 21st Century: A Tool for Decisionmaking
Although the number of cases of disease are much higher in children under 5 years of age, the largest number of lost QALYs are associated with disease in people 65 years of age and older. This discrepancy is caused by the much higher mortality rate and more severe morbidity in the older individuals compared to younger people.
If a vaccine program for S. pneumoniae were implemented today and the vaccine was 100% efficacious and utilized by 100% of the target population, the annualized present value of the health care costs saved would be $1.6 billion. Using committee assumptions of less-than-ideal efficacy and utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the health care costs saved would be $815 million.
If a vaccine program for S. pneumoniae were implemented today and the vaccine was 100% efficacious and utilized by 100% of the target population, the annualized present value of the program cost would be $1.1 billion. Using committee assumptions of less-than-ideal efficacy and utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the program cost would be $675 million.
Using committee assumptions of time and costs until licensure, the fixed cost of vaccine development has been amortized and is $7.2 million for a S. pneumoniae vaccine.
If a vaccine program were implemented today and the vaccine was 100% efficacious and utilized by 100% of the target population, the annualized present value of the cost per QALY gained is -$2,000. A negative value represents a saving in costs in addition to a saving in QALYs. Using committee assumptions of less-than-ideal utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the cost per QALY gained is $1,000.
See Chapters 4 and 5 for details on the methods and assumptions used by the committee for the results reported.
READING LIST
Baron RC, Dicker RC, Bussell, KE, et al. Assessing Trends in Mortality in 121 U.S. Cities, 1970–79, from All Causes and from Pneumonia and Influenza. Public Health Reports 1988; 103:120–128.
Breiman RF, Spika JS, Navarro VJ, et al. Pneumococcal Bacteremia in Charleston County, South Carolina: A Decade Later. Archives of Internal Medicine 1990; 150: 1401–1405.
CDC. Defining the Public Health Impact of Drug-Resistant Streptococcus pneumoniae: Report of a Working Group. Morbidity and Mortality Weekly Report 1996; 45:1–2.
CDC. Increasing Pneumococcal Vaccination Rates Among Patients of a National Health-Care Alliance—United States, 1993. Morbidity and Mortality Weekly Report 1995; 44:741–742.
OCR for page 322
Vaccines for the 21st Century: A Tool for Decisionmaking
CDC. Pneumococcal and Influenza Vaccination Levels Among Adults Aged Over 65 Years—United States, 1995. Morbidity and Mortality Weekly Report 1997; 46:913–926.
CDC. Prevention of Pneumococcal Disease. Morbidity and Mortality Weekly Report 1997; 46:1–24.
Fedson DS. Pneumococcal Vaccination in the Prevention of Community-Acquired Pneumonia: An Optimistic View of Cost-Effectiveness. Seminars in Respiratory Infections 1993; 8:285–293.
Fedson DS, Shapiro ED, LaForce FM, et al. Pneumococcal Vaccine After 15 Years of Use—Another View. Archives of Internal Medicine; 154:2531–2535.
Institute for Advanced Studies in Immunology and Aging. Improving the Performance of Influenza and Pneumococcal Vaccines in Adults. Working Group Meeting—November 1995; Washington, DC.
King JC, Vink PE, Farley JJ, et al. Safety and Immunogenicity of Three Doses of a Five-Valent Pneumococcal Conjugate Vaccine in Children Younger Than Two Years With and Without Human Immunodeficiency Virus Infection. Pediatrics 1997; 99:575–580.
Kronenberger CB, Hoffman RE, Lezotte DC, et al. Invasive Penicillin-Resistant Pneumococcal Infections: A Prevalence and Historical Cohort Study. Emerging Infectious Diseases 1996; 2:121–124.
Lave JR, Fine MJ, Sankey SS, et al. Hospitalized Pneumonia—Outcomes, Treatment Patterns, and Costs in Urban and Rural Areas. Journal of General Internal Medicine 1996; 11:415–421.
Loughlin AM, Marchant CD, Lett SM. The Changing Epidemiology of Invasive Bacterial Infections in Massachusetts Children, 1984 through 1991. American Journal of Public Health 1995; 85:392–394.
Markowitz JS, Pashko S, Gutterman EM, et al. Death Rates among Patients Hospitalized with Community-Acquired Pneumonia: A Reexamination with Data from Three States . American Journal of Public Health 1996; 86:1152–1154.
Sisk JE, Moskowitz AJ, Whang W, et al. Cost-effectiveness of Vaccination Against Pneumococcal Bacteremia Among Elderly People. JAMA 1997; 278:1333–1339.
Tuomanen EI, Austrian R, Masure HR. Pathogenesis of Pneumococcal Infection. The New England Journal of Medicine 1995; 332:1280.
U.S. Bureau of the Census. Statistical Abstract of the U.S.: 1995 (115th edition). Washington, DC, 1995.
Wenger JD, Hightower AW, Facklam RR, et al. Bacterial Meningitis in the United States, 1986: Report of a Multistate Surveillance Study. The Journal of Infectious Diseases 1990; 162:1316–1323.
Representative terms from entire chapter:
life expectancy
