Case Studies

Coverage Analysis - Drug Delivery System

Insight

A medical device company introduced a novel drug delivery system. The system used electrical fields to conduct active agents across the epidermis and into the circulation, and the product could be used with a number of different suitably polarized pharmacological agents. The product was reimbursed by government and commercial payors, and it was billed per treatment episode. Clinical data supporting the use of this device was weak, and the peer-reviewed literature focused on adverse events associated with the use of the system. Commercial payors became aware of this device after their medical directors began to refuse payment due to safety concerns.

Strategy

The Blue Cross Blue Shield (BCBS) Association’s Technology Evaluation Center (TEC) completed a health technology assessment of the device, and the Association determined that the system failed to meet their five criteria. Moreover, the Medical Advisory Panel of BCBS voted that the device did not meet criteria for any indication. This determination, and the ensuing withdrawal of coverage, almost immediately resulted in decreased sales for this company, as well as its three competitors.

Execution

The Aequitas Group was engaged to advise the company concerning the negative decision. The research team reviewed the published literature, as well as company’s patient registry data. It became evident that the BCBS analyses had over-stated the adverse reaction profile of the device. The Aequitas Group reinterpreted the data and completed several statistical analyses, which quantitatively refuted the BCBS interpretation. The team authored a health technology assessment that incorporated our findings and interpretation, and the client submitted this to the Association for consideration. After reviewing our analysis, BCBS reversed their negative determination. This resulted in resumption of coverage as well as sales of the product.