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).
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.
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) |
|
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) |
|
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.
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 |
|
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 |
|
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.
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.
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