Economics of Cancer Biomarkers

Abstract

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.

Payment for Cancer Biomarker Testing

“…Efficient use of a specific molecular-based therapy absolutely requires an appropriate cancer biomarker 2 ''to define subsets of patients who have a prognosis or response to a particular type of therapy that differs from the mean. '' 3 Successful cancer biomarkers ''provide a reliable, predictive correlation to differential patient responses'' 4 and address direct anticancer efficacy. 5 Molecular-based cancer therapy has shown benefit with certain subsets of cancer patients, such as patients with colon, breast, and lung cancer.…”

“…2 Payers view cancer biomarker tests ''as medical advances with potential to add value'' and are increasingly demanding strong evidence of value-linking biomarker testing and patient outcomes-to make increasingly value-based coverage and payment decisions. 4 ''[T]he cost-effectiveness of a [cancer biomarker] screening test will be dependent upon the costs of the future events avoided as well as the cost of resources and infrastructure required to set up the test within a healthcare setting.'' 4 ''Economic considerations include but are not limited to test and treatment costs, impatient and outpatient resource utilization, insurance coverage, and provider reimbursement.''…”

“…4 ''Economic considerations include but are not limited to test and treatment costs, impatient and outpatient resource utilization, insurance coverage, and provider reimbursement.'' 4 Ultimately, ''[t]he cost of the test is not as important as the impact that the test has on the longer-term health outcomes.'' 4 The decisive question is whether outcome improvement is attained at a ''reasonable'' additional cost compared with existing technology.…”

“…4 Ultimately, ''[t]he cost of the test is not as important as the impact that the test has on the longer-term health outcomes.'' 4 The decisive question is whether outcome improvement is attained at a ''reasonable'' additional cost compared with existing technology. 4 Without evidence of clinical utility in improving patient outcomes, payers will consider such tests ''financially wasteful at a time when it has become critical to control increasing health care costs.''…”

“…4 What is required are ''large observational studies that can link the outcome of the biomarker to a longer-term health outcome, and are able to show a cost benefit.'' 4 …”