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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).



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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).

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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.

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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)

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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)

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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.

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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

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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

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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.

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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.

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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.