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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
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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.
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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
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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
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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.
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Representative terms from entire chapter:
target population
