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Vaccines for the 21st Century: A Tool for Decisionmaking (2000)

Chapter: Appendix 20: Respiratory Syncytial Virus

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Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

APPENDIX 20
Respiratory Syncytial Virus

DISEASE BURDEN

Epidemiology

For the purposes of the calculations in this report, the committee estimated that there are approximately 5 million infections with respiratory syncytial virus (RSV) each year in the United States. It was assumed that 1 million RSV infections occur in children under 1 year of age, 2 million RSV infections in children between the ages of 1 and 4 years of age, and 2 million RSV infections in people 5 years of age and greater. The number of deaths due to RSV infection in those three age groups is 300, 200, and 20, respectively. The mortality in the third age group is seen in those 65 years of age and older. See Table A20–1.

Disease Scenarios

For the purposes of the calculation in this report, the committee described disease states associated with RSV infection as either a mild upper respiratory or related condition (pharyngitis/otitis media) or as bronchiolitis/pneumonia. It was assumed that in children 4 years of age and under the relative distribution of cases between those two scenarios is 60% and 40% respectively. In people 5 years of age and older, it was assumed that 80% of infections manifest as pharyngitis/otitis media and 20% as the more severe lower respiratory disease. The health utility index (HUI) and time in that state range from 7 days at an HUI of .9 (pharyngitis) to 7 days at an HUI of .5 (inpatient treatment of bronchiolitis/pneumonia). See Table A20–2.

Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table A20–1 Incidence Rate for Respiratory Syncytial Virus Infection

Age Groups

Population

Incidence Rates (per 100,000)

Cases

<1

3,963,000

25,233.41

1,000,000

1–4

16,219,000

12331.22

2,000,000

5–14

38,056,000

822.19

312,892

15–24

36,263,000

822.19

298,150

25–34

41,670,000

822.19

342,606

35–44

42,149,000

822.19

346,545

45–54

30,224,000

822.19

248,498

55–64

21,241,000

822.19

174,641

65–74

18,964,000

822.19

155,920

75–84

11,088,000

822.19

91,164

85+

3,598,000

822.19

29,582

Total

263,435,000

 

COST INCURRED BY DISEASE

Table A20–3 summarizes the health care costs incurred by RSV infections. For the purposes of the calculations in this report, it was assumed that treatment of pharyngitis and otitis media are associated with physician visit, diagnostic, and medication (over-the-counter, symptomatic treatment). It was estimated that 100% of children 4 years of age and under incur such treatment but that approximately 50% of people 5 years of age and older seek such medical treatment.

It was assumed that the majority of cases of lower respiratory infections are treated as an outpatient and involve costs similar to that for pharyngitis, but with the addition of an extra physician visit. For the small number of cases of lower respiratory disease which is treated as an inpatient, hospitalization costs are added to the costs similar to that incurred as outpatient treatment. It was assumed that while 100% of children 4 years of age and under receive treatment for lower respiratory infections, only 50% of people 5 years of age or older who are not hospitalized for lower respiratory RSV infections seek medical treatment.

VACCINE DEVELOPMENT

The committee assumed that it will take 7 years until licensure of a RSV vaccine and that $360 million needs to be invested. It was assumed that the same vaccine would be used in infants and in adolescent girls. Table 4–1 summarizes vaccine development assumptions for all vaccines considered in this report.

Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table A20–2 Disease Scenarios for RSV

 

No. of Cases

% of Cases

Committee HUI Values

Duration (years)

AGE<1

 

Total Deaths

300

 

Total Cases

1,000,000

 

Upper Respiratory

pharyngitis, otitis media

600,000

60.00%

0.90

0.0192 (7 days)

Bronchiolitis/pneumonia

outpatient only

340,000

34.00%

0.75

0.0274 (10 days)

Bronchiolitis/pneumonia

60,000

6.00%

 

inpatient

 

0.50

0.0192 (7 days)

outpatient

 

0.75

0.0082 (3 days)

AGE 1–4

 

Total Deaths (from acute infection)

200

 

Total Cases

2,000,000

 

Upper Respiratory

pharyngitis, otitis media

1,200,000

60.00%

0.90

0.0192 (7 days)

Bronchiolitis/pneumonia

outpatient only

760,000

38.00%

0.75

0.0274 (10 days)

Bronchiolitis/pneumonia

40,000

2.00%

 

inpatient

 

0.50

0.0192 (7 days)

outpatient

 

0.75

0.0082 (3 days)

AGE 5+

 

Total Deaths (from acute infection)

20

 

Total Cases

2,000,000

 

Upper Respiratory

pharyngitis, otitis media

1,600,000

80.00%

0.90

0.0192 (7 days)

Bronchiolitis/pneumonia

outpatient only

396,000

19.80%

0.75

0.0274 (10 days)

Bronchiolitis/pneumonia

4,000

0.20%

 

inpatient

 

0.50

0.0192 (7 days)

outpatient

 

0.75

0.0082 (7 days)

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 all adolescent girls (age 12 years) and all infants. For this example, the committee included adolescent girls in order to induce immunity that would protect the neonate. Infants are immunized to protect against disease after 1 year of age. It was assumed that 50% of adolescent females and 90% of infants would utilize the vaccine.

Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table 20–3 Health Care Costs Associated with RSV Infections

 

% with Care

Cost per Unit

Units per Case

Form of Treatment

AGE<5

 

Upper Respiratory

 

pharyngitis, otitis media

100%

$50

1.0

physician a

 

100%

$50

1.0

diagnostic a

100%

$50

1.0

medication b

Bronchiolitis/pneumonia

 

outpatient only

100%

$50

1.0

physician a

 

100%

$50

1.0

diagnostic a

100%

$50

1.0

medication b

Bronchiolitis/pneumonia

 

inpatient

100%

$4,000

1.0

hospitalization

 

100%

$50

2.0

physician a

100%

$50

1.0

diagnostic a

100%

$50

1.0

medication b

AGE 5+

 

Upper Respiratory

 

pharyngitis, otitis media

100%

$50

1.0

physician a

 

100%

$50

1.0

diagnostic a

100%

$50

1.0

medication b

Bronchiolitis/pneumonia

 

outpatient only

100%

$50

1.0

physician a

 

100%

$50

1.0

diagnostic a

100%

$50

1.0

medication b

Bronchiolitis/pneumonia

 

inpatient

100%

$4,000

1.0

hospitalization

 

100%

$50

2.0

physician a

100%

$50

1.0

diagnostic a

100%

$50

1.0

medication b

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 RSV 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 33,000. Using committee assumptions of less-than-ideal efficacy and utilization and including time and monetary costs until a vaccine program is implemented, the annualized

Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

present value of the QALYs gained would be 14,000. Slightly over half of the loss is accounted for by disease in children under 1 year of age. Deaths of very young infants contribute substantially to loss of QALYs.

If a vaccine program for RSV 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 $1.15 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 $490 million.

If a vaccine program for RSV 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 $1.05 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 $570 million.

Using committee assumptions of time and costs until licensure, the fixed cost of vaccine development has been amortized and is $10.8 million for a RSV 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 -$3,000. 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 $6,500.

See Chapters 4 and 5 for details on the methods and assumptions used by the committee for the results reported.

READING LIST

CDC. Update: Respiratory Syncytial Virus Activity—United States, 1996–7 Season. Morbidity and Mortality Weekly Report 1996; 45:1053–1055.

Committee on Infectious Diseases and Committee on Fetus and Newborn of the American Academy of Pediatrics. Respiratory Syncytial Virus Immune Globulin Intravenous: Indications for Use. Pediatrics 1997; 99:645–650.


Dowell SF, Anderson LJ, Gary HE, et al. Respiratory Syncytial Virus Is an Important Cause of Community-Acquired Lower Respiratory Infection among Hospitalized Adults. The Journal of Infectious Diseases 1996; 174:456–462.


Fisher RG, Gruber WC, Edwards KM, et al. Twenty Years of Outpatient Respiratory Syncytial Virus. Pediatrics 1997; 99:E7.


Hall CB. Respiratory Syncytial Virus. In: Textbook of Pediatric Infectious Diseases. RD Feigin and JD Cherry eds. Philadelphia, PA: WB Saunder Company, 1992, pp. 1633–1656.

Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Hall CB, McCarthy CA. Respiratory Syncytial Virus. In: Principles and Practice of Infectious Diseases. GL Mandell, JE Bennett, Dolin R eds. New York, NY: Churchill Livingstone, 1995, pp. 1501–1519.


Meissner HC, Groothuis JR. Immunoprophylaxis and the Control of RSV Disease. Pediatrics 1997; 100:260–263.


Paradise JL, Rockette HE, Colborn DK, et al. Otitis Media in 2253 Pittsburgh-Area Infants: Prevalence and Risk Factors During the First Two Years of Life. Pediatrics 1997; 99:318–333.

Prober CG, Wang EEL. Reducing the Morbidity of Lower Respiratory Tract Infections Caused by Respiratory Syncytial Virus: Still No Answer. Pediatrics 1997; 99:472–475.


Rodriguez WJ, Gruber WC, Welliver RC, et al. Respiratory Syncytial Virus (RSV) Immune Globulin Intravenous Therapy for RSV Lower Respiratory Tract Infection in Infants and Young Children at High Risk for Severe RSV Infections. Pediatrics 1997; 99:454–461.


Ventura SJ, Martin JA, Mathews TJ, et al. Advance Report of Final Natality Statistics, 1994. Monthly Vital Statistics Report 1996; 44.

Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 279
Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 280
Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 281
Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 282
Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 283
Suggested Citation:"Appendix 20: Respiratory Syncytial Virus." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
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Vaccines have made it possible to eradicate the scourge of smallpox, promise the same for polio, and have profoundly reduced the threat posed by other diseases such as whooping cough, measles, and meningitis.

What is next? There are many pathogens, autoimmune diseases, and cancers that may be promising targets for vaccine research and development.

This volume provides an analytic framework and quantitative model for evaluating disease conditions that can be applied by those setting priorities for vaccine development over the coming decades. The committee describes an approach for comparing potential new vaccines based on their impact on morbidity and mortality and on the costs of both health care and vaccine development. The book examines:

  • Lessons to be learned from the polio experience.
  • Scientific advances that set the stage for new vaccines.
  • Factors that affect how vaccines are used in the population.
  • Value judgments and ethical questions raised by comparison of health needs and benefits.

The committee provides a way to compare different forms of illness and set vaccine priorities without assigning a monetary value to lives. Their recommendations will be important to anyone involved in science policy and public health planning: policymakers, regulators, health care providers, vaccine manufacturers, and researchers.

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