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

Chapter: Appendix 17: Neisseria gonnorrhea

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Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

APPENDIX 17
Neisseria gonorrhea

DISEASE BURDEN

Epidemiology

For the purposes of the calculations in this report, the committee estimated that there are 1 million new cases of gonorrhea infection each year in the United States. Slightly more than half of these occur in males. It was assumed that 90% of cases occur in people between 15 and 34 years of age. Mortality was presumed to be minimal; 5 deaths were included for women per year (consequences of serious sequelae, for example). See Table A17–1 for a summary of the age distribution of gonorrhea infections.

Disease Scenarios

For the purposes of the calculation in this report, the committee assumed that 50% of cases in women are asymptomatic, but that half of those cases are detected through screening programs and receive treatment. The other 50% of cases experience mild manifestations, such as cervicitis, urethritis, or endometritis. More serious acute health consequences associated with gonorrhea infections in women include pelvic inflammatory disease (PID), salpingitis, and perihepatitis. Consequences of PID are assumed to occur with a 5-year lag from infection and include ectopic pregnancy, chronic pelvic pain, and infertility. The health utility index and length of time spent in the health state range from .85 HUI for 7 days (cervicitis) to .46 HUI for 2 days (surgery for PID) to .6 HUI for more than 20 years (chronic pelvic pain).

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table A17–1 Incidence of N.gonorrhea Infection in Women and Men

Age Groups

Female Population

Incidence Rates (per 100,000)

% Distribution of Cases

Cases

<1

1,933,000

0.00

0.0000

0

1–4

7,905,000

29.10

0.0050

2,300

5–14

18,554,000

111.57

0.0450

20,700

15–24

17,747,000

1,555.19

0.6000

276,000

25–34

20,835,000

662.35

0.3000

138,000

35–44

21,238,000

75.81

0.0350

16,100

45–54

15,447,000

29.78

0.0100

4,600

55–64

11,140,000

20.65

0.0050

2,300

65–74

10,544,000

0.00

0.0000

0

75–84

6,814,000

0.00

0.0000

0

85+

2,593,000

0.00

0.0000

0

Total

134,750,000

341.37

1.0000

460,000

Age Groups

Male Population

Incidence Rates (per 100,000)

% Distribution of Cases

Cases

<1

2,030,000

0.00

0.0000

0

1–4

8,314,000

32.48

0.0050

2,700

5–14

19,502,000

124.60

0.0450

24,300

15–24

18,516,000

1,749.84

0.6000

324,000

25–34

20,835,000

777.54

0.3000

162,000

35–44

20,911,000

90.38

0.0350

18,900

45–54

14,777,000

36.54

0.0100

5,400

55–64

10,101,000

26.73

0.0050

2,700

65–74

8,420,000

0.00

0.0000

0

75–84

4,274,000

0.00

0.0000

0

85+

1,005,000

0.00

0.0000

0

Total

128,685,000

419.63

1.0000

540,000

For the purposes of the calculations in this report, the committee assumed that 15% of cases in men are asymptomatic and untreated. The overwhelming utility index and length of time spent in the health state range from .85 HUI for 7 days (cervicitis) to .46 HUI for 2 days (surgery for PID) to .6 HUI for more than 20 years (chronic pelvic pain).

For the purposes of the calculations in this report, the committee assumed that 15% of cases in men are asymptomatic and untreated. The overwhelming proportion of symptomatic cases involve urethritis, which was assumed to be associated with an HUI of .84 and 7 days duration. A small percentage of men infected with gonorrhea experience epididymitis. The HUI and length of time spent in the health state for these manifestations range from .84 HUI for 7 days (urethritis) to .3 HUI for 3 days (hospitalization for epididymitis).

A small fraction of both men and women infected with gonorrhea experience disseminated infections. Hospitalization for these patients is associated with an HUI of .52 for 4 days; outpatient treatment is associated with a week of a higher HUI state. See Table A17–2 for a summary of the disease states associated with gonorrhea infections.

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table A17–2 Disease Scenarios for N.Gonorrhea Infection in Women and Men

 

% of Cases

Committee HUI Values

Duration (years)

WOMEN

 

Total Cases

460,000

 

Asymptomatic

50.0%

1.00

 

untreated

25.0%

 

treated (detected in screening, etc.)

25.0%

Mild (cervicitis, urethritis, endometritis, bartholinitis)

50.0%

 

outpatient

 

0.85

0.0192 (7 days)

Serious (PID, salpingitis, perihepatitis) —outpatient only

10.0%

0.63

0.0274 (10 days)

Serious (PID, salpingitis, perihepatitis) —inpatient

 

inpatient—no surgery

7.5%

0.57

0.0110 (4 days)

inpatient with surgery

2.5%

0.46

0.0055 (2 days)

outpatient after inpatient

10.0%

0.83

0.0274 (10 days)

Serious (PID, etc.)

0.8%

 

inpatient with bilateral salpingo-oophorectomy

 

0.40

0.0027 (1 day)

outpatient after inpatient

 

0.76

0.0274 (10 days)

infertility

 

0.82

23.6523 (remaining lifetime at onset)

ALL PID sequelae: 5-year lag from infection

Ectopic Pregnancy—Outpatient only

3.3%

0.58

0.0767 (4 weeks)

Ectopic Pregnancy—Inpatient

3.3%

 

inpatient

 

0.23

0.0082 (3 days)

outpatient after inpatient

 

0.66

0.0767 (4 weeks)

Chronic pelvic pain

6.6%

0.60

22.7313 (remaining lifetime at onset+5 years)

discounted quality adjusted life expectancy at age 28.7

Infertility

4.0%

0.82

22.7313 (remaining lifetime at onset+5 years); discounted quality adjusted life expectancy at age 28.7

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —outpatient only

0.5%

0.60

0.0219 (8 days)

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

 

% of Cases

Committee HUI Values

Duration (years)

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —inpatient

0.5%

 

inpatient

 

0.52

0.0110 (4 days)

outpatient after inpatient

 

0.78

0.0192 (7 days)

MEN

 

Total cases

540,000

 

Asymptomatic

15.0%

1.00

 

Urethritis

84.0%

0.84

0.0192 (7 days)

Epididymitis—outpatient

0.9%

0.46

0.0192 (7 days)

Epididymitis—inpatient

0.1%

0.30

0.0082 (3 days)

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —outpatient

0.5%

0.60

0.0219 (8 days)

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —inpatient

0.5%

 

inpatient

 

0.52

0.0110 (4 days)

outpatient after inpatient

 

0.78

0.0192 (7 days)

COST INCURRED BY DISEASE

Table A17–3 summarizes the health care costs incurred by gonorrhea infections. For the purposes of the calculations in this report, it was assumed that for mild acute manifestations in both men and women (e.g., cervicitis and urethritis), health care costs include a limited visit with a physician and inexpensive diagnostics and medications.

Disseminated gonococcal infections in both women and men were assumed to be associated with inpatient costs (hospitalization, diagnostics, specialist physicians) and outpatient costs (similar to that required for inpatient treatment but slightly fewer physician visits).

Outpatient treatment in women of more serious manifestations include increased diagnostic costs above those for cervicitis. Inpatient treatment (e.g., for PID or salpingitis) includes hospitalization costs, physician services (including surgeons and anesthesiologists for those who require surgery) and diagnostics. Outpatient costs following hospitalization include follow-up care with a specialist. Half of the cases of ectopic pregnancy were assumed to be treated as inpatient and half as outpatient. Costs include hospital costs (more for inpatient), specialist physicians, surgeons and anesthesiologists, and diagnostics. A followup visit with a specialist was also included. Chronic pelvic pain was associated with numerous physician visits, diagnostics, and medication. 75% of women with chronic pelvic pain were presumed to undergo outpatient laparoscopy, and

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table A17–3 Health Care Costs Associated with N.gonorrhea Infection in Women and Men

 

% with Care

Cost per Unit

Units per Case

Form of Treatment

WOMEN

 

Asymptomatic

 

untreated

 

treated (detected in screening, etc.)

100%

$50

1

physician a

 

100%

$50

1

diagnostic a

100%

$50

1

medication b

Mild (cervicitis, urethritis, endometritis, bartholinitis)

 

outpatient

100%

$50

1

physician a

 

100%

$50

1

diagnostic a

100%

$50

1

medication b

Serious (PID, salpingitis, perihepatitis)

 

outpatient

100%

$50

1

physician a

 

100%

$100

1

diagnostic b

100%

$100

1

medication

Serious (PID, salpingitis, perihepatitis)

 

inpatient—no surgery

100%

$4,000

1

hospitalization

 

100%

$150

3

physician c

100%

$100

1

diagnostic b

Serious (PID, salpingitis, perihepatitis)

 

inpatient with surgery

100%

$4,000

1

hospitalization

 

100%

$150

3

physician c

100%

$500

4

surgical staff

100%

$100

1

diagnostic b

Serious (PID, salpingitis, perihepatitis)

 

outpatient after inpatient

100%

$100

1

physician b

Serious (PID, etc.)

 

inpatient and outpatient

100%

$1,550

1

outpatient laparoscopy

ALL PID sequelae: 5-year lag from infection

 

Ectopic Pregnancy—Outpatient

 

PID sequela: 5-year lag

 

outpatient only

100%

$1,000

1

laparoscopy

 

100%

$500

1

surgical staff

100%

$500

1

surgical staff

100%

$50

1

diagnostic a

100%

$100

1

physician b

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

 

% with Care

Cost per Unit

Units per Case

Form of Treatment

Ectopic Pregnancy—Inpatient

 

PID sequela: 5-year lag

 

inpatient

100%

$4,000

1

hospitalization

 

100%

$150

3

physician c

100%

$100

1

diagnostic b

100%

$500

2

surgical staff

outpatient after inpatient

100%

$100

1

physician b

Chronic pelvic pain

 

PID sequela: 5-year lag

 

treatment assumed to occur 5 years after onset of infection

100%

$100

1

physician b

duration of condition: remaining lifetime

100%

$50

4

physician a

 

100%

$50

1

medication b

100%

$100

1

diagnostic b

outpatient laparoscopy

75%

$1,000

1

hospitalization

75%

$500

1

surgical staff

75%

$500

1

surgical staff

lower abdominal surgery

30%

$4,000

1

hospitalization

30%

$500

1

surgical staff

30%

$500

1

surgical staff

30%

$150

3

physician c

Infertility

 

PID sequela: 5-year lag

50%

$150

6

physician c

treatment assumed to occur 5 years after onset of infection

 

duration of condition: remaining lifetime

50%

$500

1

diagnostic c

 

50%

$250

1

procedure

outpatient laparoscopy (75% of those seeking treatment)

38%

$1,000

1

hospitalization

38%

$500

1

surgical staff

38%

$500

1

surgical staff

tubal surgery (30% of those seeking treatment)

15%

$1,000

1

outpatient surgery

15%

$500

1

surgeon

15%

$500

1

anesthesiology

in vitro fertilization (12% of those seeking treatment)

6%

$4,000

2

per trial

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

 

% with Care

Cost per Unit

Units per Case

Form of Treatment

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —outpatient

 

 

100%

$100

2

physician b

100%

$50

1

culture—gonorrhea

100%

$50

1

medication

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —inpatient

 

 

100%

$3,000

1

hospitalization

100%

$150

3

physician c

100%

$50

1

diagnostic a

100%

$50

1

medication b

outpatient after inpatient

 

$100

1

physician b

MEN

 

Asymptomatic (untreated) Urethritis

 

 

100%

$50

1

physician a

100%

$50

1

diagnostic a

Epididymitis

 

outpatient

100%

$100

1

physician b

 

100%

$50

1

physician a

100%

$50

1

diagnostic a

100%

$50

1

medication b

Epididymitis

 

inpatient

100%

$3,000

1

hospitalization

 

100%

$150

3

physician c

100%

$50

1

physician a

100%

$50

1

medication b

50%

$500

1

surgical staff

50%

$500

1

surgical staff

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —outpatient

 

 

100%

$100

2

physician b

100%

$50

1

culture—gonorrhea

100%

$50

1

medication

Disseminated gonococcal infections (bacteremia, arthritis, etc.) —inpatient

 

 

100%

$3,000

1

hospitalization

100%

$150

3

physician c

100%

$50

1

diagnostic a

100%

$50

1

medication b

outpatient after inpatient

 

$100

1

physician b

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

30% were presumed to undergo abdominal surgery. For the purposes of the calculations in this report, it was assumed that half of women infertile due to gonorrhea infection seek some kind of medical care related to infertility. This includes hysterosalphoingography, outpatient laparoscopy, tubal surgery, and infertility treatment.

Epididymitis in men was estimated to be treated primarily on an outpatient basis and includes costs for both limited visits and specialist physician visits, diagnostics, and medications. For the few patients who undergo surgery, costs for surgeons and anesthesiologist are included.

VACCINE DEVELOPMENT

The committee assumed that it will take 15 years until licensure and that $360 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 adolescents (age 12 years). It was assumed that 50% of the target population would utilize the vaccine.

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 N. gonorrhea 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 230,000. 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 47,000. Although the proportion

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

of cases are slightly higher in men than in women, the number of QALYs lost due to disease in women is over 200 fold that in men. The more severe nature of the sequelae of infection in women and the chronic nature of several of the sequelae account for this large difference.

If a vaccine program for N. gonorrhea 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 $440 million. 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 $92.1 million.

If a vaccine program for N. gonorrhea 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 $680 million. 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 $190 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 N. gonorrhea 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 $1,000. 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 $2,300.

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

READING LIST

Alexander LL, Treiman K, Clarke P. A National Survey of Nurse Practitioner Chlamydia Knowledge and Treatment Practices of Female Patients. Nurse Practitioner 1996; 21:48, 51–4.


Gutman, LT. Gonorrhea. In: Textbook of Pediatric Infectious Diseases. RD Feigin and JD Cherry eds. Philadelphia, PA: WB Saunder Company, 1992, pp. 540–552.


Handsfield HH, Sparling PF. Neisseria Gonorrhoeae. In: Principles and Practice of Infectious Diseases. GL Mandell, JE Bennett, Dolin R eds. New York, NY: Churchill Livingstone, 1995, pp. 1909–1926.


Magid D, Douglas JM, Schwartz JS. Doxycycline Compared with Azithromycin for Treating Women with Genital Chlamydia Trachomatis Infections: An Incremental Cost-Effectiveness Analysis. Annals of Internal Medicine 1996; 124:389–99.


U.S. Bureau of the Census. Statistical Abstract of the U.S.: 1995 (115th edition). Washington, D.C. 1995.

Suggested Citation:"Appendix 17: Neisseria gonnorrhea." 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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Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 257
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 258
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 259
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 260
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 261
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 262
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 263
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 264
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 265
Suggested Citation:"Appendix 17: Neisseria gonnorrhea." 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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