The Aequitas Group
Health Technology Assessment - Oncology
A medical device manufacturer specializing in the development of devices promoting optimal breast health launched a product that identifies early signs of breast disease. In order to determine whether the new technique would result in improved health outcomes to patients and if it was medically reasonable and necessary, The Aequitas Group conducted a Health Technology Assessment (HTA). This was used to support short- and long-term product growth, to increase reimbursement and to support market adoption and diffusion of the technology.
This assessment evaluated nipple aspiration fluid (NAF) analysis as an adjunct to Standard of Care screening techniques in asymptomatic, average risk, and premenopausal women. Focusing on data from published studies using various nipple aspirate fluid collection techniques, the assessment also evaluated whether incorporation of NAF analysis resulted in adjusted risk assessments that influenced patient management and improved breast cancer outcomes.
In addition to developing an HTA, The Aequitas Group developed a hybrid Gap Analysis to determine whether published clinical information, available coding nomenclature, and health benefit categories were sufficient to support sustainable third-party reimbursement for the device in the U.S. Specifically, the Gap Analysis determined if published clinical information supporting the device was sufficient to meet Blue Cross Blue Shield Associationís five Technology Evaluation Center (TEC) Criteria which must be achieved for reimbursement of new technologies and medications. The Gap Analysis determined whether the device required unique coding or coverage categories beyond what are currently available. The approach entailed the construction of a series of analyses, reports and a manuscript that were submitted for publication to peer-reviewed journals. The research was also used to develop educational materials that were grounded in evidenced-based messages.
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