Cover Image

HARDBACK
$52.95



View/Hide Left Panel

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



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 239
Vaccines for the 21st Century: A Tool for Decisionmaking 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

OCR for page 239
Vaccines for the 21st Century: A Tool for Decisionmaking 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.

OCR for page 239
Vaccines for the 21st Century: A Tool for Decisionmaking 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

OCR for page 239
Vaccines for the 21st Century: A Tool for Decisionmaking 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

OCR for page 239
Vaccines for the 21st Century: A Tool for Decisionmaking 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.

OCR for page 239
Vaccines for the 21st Century: A Tool for Decisionmaking This page in the original is blank.