ABSTRACT
OBJECTIVE: The authors evaluated the cost-effectiveness of a FISH assay in melanoma diagnosis in the USA. METHOD: A model was developed simulating the addition of FISH to the diagnosis of suspected melanoma. A decision analytic module simulated diagnosis using microscopic assessment alone versus addition of FISH (sensitivity: 92%; specificity: 94%). The authors simulated a clinical setting in which an initial excisional biopsy microscopic assessment (sensitivity: 73%; specificity: 78%) was followed by dermatopathologist assessment (sensitivity: 89%; specificity: 79%) for inconclusive results. Diagnostic strategies 1 and 2 added FISH to the initial and dermatopathologist assessments, respectively. A Markov outcomes module simulated patients' remaining lifetime, including treatment. RESULTS: In diagnostic strategies 1 and 2, the cost per quality-adjusted life year gained was US$14,930 and 43,925, respectively, versus no FISH. Cost per misdiagnosis avoided was US$3292 and 3759, respectively. Sensitivity and specificity without FISH were both ≥88%; however, addition of FISH exceeded US$100,000/quality-adjusted life year. CONCLUSION: In specific clinical settings, FISH could be cost effective for melanoma diagnosis.
Subject(s)
In Situ Hybridization, Fluorescence/methods , Melanoma/diagnosis , Skin Neoplasms/diagnosis , Cost-Benefit Analysis , Decision Support Techniques , Female , Humans , In Situ Hybridization, Fluorescence/economics , Male , Markov Chains , Melanoma/economics , Melanoma/pathology , Middle Aged , Models, Economic , Quality-Adjusted Life Years , Sensitivity and Specificity , Skin Neoplasms/economics , Skin Neoplasms/pathology , United StatesABSTRACT
PURPOSE: The US Food and Drug Administration recently approved the first 4th-generation HIV test. This study evaluated the cost-effectiveness of the 4th-generation assay versus a 3rd-generation test in screening for HIV infections in the United States. METHODS: An exploratory microsimulation model was developed that follows hypothetical individuals and simulates the course of HIV/AIDS, treatment with highly active antiretroviral therapy, and transmissions. RESULTS: With a 1% HIV prevalence, screening 1.5 million individuals with the 4th- versus 3rd-generation assay resulted in detection of 266 additional HIV cases at an incremental cost per additional HIV case detected of $63,763, an additional 489 life years and 395 quality-adjusted life years (QALYs), and 26 HIV transmissions prevented. Although lifetime costs were increased by $33.6 million, the incremental cost/QALY gained was $85,206. The 4th-generation test was more cost-effective in high incidence settings. The number needed to screen to detect one additional HIV case was 5,635. CONCLUSIONS: Screening using the 4th-generation assay may be cost-effective for HIV detection in appropriate settings, resulting in increased case identification, fewer transmissions, extended life, and increased quality of life. With early and accurate detection, this 4th-generation test may provide a suitable alternative to current 3rd-generation tests.
Subject(s)
HIV Antibodies/blood , HIV Core Protein p24/blood , HIV Infections/diagnosis , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , Cost-Benefit Analysis , HIV Infections/drug therapy , Humans , Quality-Adjusted Life YearsABSTRACT
Cancer accounts for approximately 13% of all deaths worldwide, and in 2010 the estimated total cost of cancer in the USA was more than US$263 billion. Biomarker use for screening, monitoring, diagnosis and treatment optimization has the potential to improve patient outcomes and reduce costs associated with inappropriate (or suboptimal) therapeutic regimens. Since a new technology may have additional initial cost, a policy question arises regarding whether the improvement in outcomes is attained at a 'reasonable' additional cost compared with existing technology. This paper presents an overview of health economic issues surrounding biomarkers in general, with a focus on cancer care and treatment optimization in particular. While this article is not a systematic review of the literature, it includes relevant examples to provide a real-world perspective.