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

Chapter: Appendix 14: Melanoma

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Suggested Citation:"Appendix 14: Melanoma." 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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APPENDIX 14
Melanoma

Melanoma arises from melanocytes, which are pigment cells normally found in the epidermis and occasionally in the dermis. Melanocytes that invade the dermis and deeper tissues mark the development of invasive malignant melanoma.

Malignant melanoma can be clinically divided into four main types: superficial spreading melanoma, nodular melanoma, lentigo maligna melanoma, and acral lentiginous melanoma.

DISEASE BURDEN

Epidemiology

For the purposes of the calculations in this report, the committee estimated that there are approximately 35,000 new cases of melanoma every year in the United States. The incidence increases with age. See Table A14–1.

Disease Scenarios

For the purposes of the calculations in this report, the committee assumed that melanoma is represented by 4 disease scenarios by time of diagnosis: local disease (82% of new cases) and regional disease with no subsequent metastases (8% of new cases) from which there is recovery, regional disease with subsequent metastases (6% of new cases), and metastatic disease at diagnosis (4% of new cases). The latter two disease scenarios are associated with premature death. The health utility indexes associated with melanoma range from .93 for

Suggested Citation:"Appendix 14: Melanoma." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table A14–1 Incidence and Melanoma

Age Groups

Population

Incidence Rates (per 100,000)

% Distribution of Cases

<1

3,963,000

0.0

0.0000

1–4

16,219,000

0.0

0.0000

5–14

38,056,000

0.2

0.0022

15–24

36,263,000

2.7

0.0279

25–34

41,670,000

8.6

0.1030

35–44

42,149,000

14.9

0.1808

45–54

30,224,000

20.7

0.1798

55–64

21,241,000

27.4

0.1673

65–74

18,964,000

33.3

0.1815

75–84

11,088,000

36.1

0.1153

85+

3,598,000

40.8

0.0422

Total

263,435,000

13.2

1.0000

 

Total Cases

34,753

23 months of recovery and follow-up from non-metastatic disease to 0.18 for 3 months of treatment for metastatic disease. See Table A14–2.

COST INCURRED BY DISEASE

Table A14–3 summarizes the health care costs incurred by melanoma. For the purposes of the calculations in this report, it was assumed that local disease is associated with costs for outpatient surgery, four specialist physician visits per year for 2 years and, for 75% of patients, 2 physician visits per year for 5 years. Regional disease with no subsequent metastases was associated with outpatient surgery and six specialist physician visits. The recovery phase for this scenario was assumed to involve slightly more physician visits and folllow-up surgery for 90% of patients.

Regional disease associated with development of metastatic disease was associated with costs including extensive surgery, follow-up treatment, multiple visits to a specialist physician and after-care treatment. Patients who present with metastatic melanoma at diagnosis are assumed to require in-home care and multiple visits with a physician for 3 months.

VACCINE DEVELOPMENT

The committee assumed that it will take 7 years until licensure of a therapeutic melanoma vaccine and that $360 million needs to be invested. Appendix 31 summarizes vaccine development assumptions for all vaccines considered in this report.

Suggested Citation:"Appendix 14: Melanoma." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Table A14–2 Disease Scenarios for Melanoma

 

No. of Cases

% of Cases

Committee HUI Values

Duration (years)

Local disease

28,498

82.00%

 

surgery

 

0.84

0.0833 (1 month)

recovery

 

0.93

1.9167 (23 months)

Regional at diagnosis, no metastases

2,780

8.00%

 

treatment phase

 

0.84

0.5000 (6 months)

recovery

 

0.93

1.5000 (18 months)

Regional at diagnosis, develop metastatic disease

2,088

6.00%

 

treatment

 

0.63

1.0000 (1 year)

premature death

 

0.00

13.4023 (quality-adjusted life expectancy)

Metastatic at diagnosis

1,390

4.00%

 

treatment

 

0.18

0.2500 (3 months)

premature death

 

0.00

13.5750 (quality-adjusted life expectancy) or 5.9855 (unadjusted life expectancy)

Table A14–3 Health Care Costs Associated with Melanoma

 

% with Care

Cost per Unit

Units per Case

Form of Treatment

Local disease

surgery

100%

$2,000

1.0

outpatient surgery

recovery

100%

$100

4.0

physician b/year

follow-up

75%

$50

2.0

physician a/year

Regional at diagnosis, no metastases

treatment phase

100%

$2,000

1.0

outpatient surgery

 

100%

$100

6.0

physician b

recovery

90%

$100

4.0

physician b/year

 

90%

$2,000

1.0

follow-up treatment

follow-up

75%

$100

2.0

physician b/year

Regional at diagnosis, develop metastatic disease

treatment

100%

$4,000

1.0

surgery

 

100%

$2,000

1.0

follow-up treatment

100%

$100

12.0

physician b

100%

$3,000

1.0

aftercare

Metastatic at diagnosis

 

100%

100

6.0

physician b

treatment

100%

$3,000

1.0

aftercare

Suggested Citation:"Appendix 14: Melanoma." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

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 newly diagnosed cases of melanoma. It was assumed that 90% 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 $500 per dose and that administration costs would be $10 per dose. Default assumptions for therapeutic vaccines of a 3-dose series and 40% effectiveness were accepted. Table 4–1 summarizes vaccine program assumptions for all vaccines considered in this report.

RESULTS

If a vaccine program for melanoma were implemented today and the vaccine was 100% efficacious and utilized by 100% of the target population, the annualized present value of the QALYs gained would be 51,000. 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 14,000.

If a vaccine program for melanoma 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 $130 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 $36.1 million.

If a vaccine program for melanoma 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 $53.2 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 $36.7 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 melanoma vaccine.

If a vaccine program were implemented today and the vaccine were 100% efficacious and utilized by 100% of the target population, the annualized present value of the cost per QALY gained is -$1,500. A negative value represents a

Suggested Citation:"Appendix 14: Melanoma." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

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 $800.

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

READING LIST

Miller BA, Kolonel LN, Bernstein L, et al. (eds). Racial/Ethnic Patterns of Cancer in the United States 1988–1992, National Cancer Institute. NIH Pub. No. 96–4104. Bethesda, MD, 1996.

Suggested Citation:"Appendix 14: Melanoma." 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 14: Melanoma." 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 14: Melanoma." 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 14: Melanoma." 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 14: Melanoma." 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 14: Melanoma." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 243
Suggested Citation:"Appendix 14: Melanoma." 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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