Case Studies

Commercialization Strategy - Deep Vein Thrombosis

Insight

A U.S. biopharmaceutical company developed a radio labeled peptide for enhanced imaging of acute deep vein thrombosis (DVT). The company’s marketing strategy was focused on the economic value of the product based on cost reductions that could be realized by the healthcare system by reducing the number of stroke patients. However, there were no clinical data available to support the cost savings claim for the product in stroke patients. As a result, the company was unable to discuss cost savings as part of their value messages when detailing the product to physicians and to hospital administrators which resulted in inappropriate reimbursement.

Strategy

The Aequitas Group was contracted to help resolve the dilemmas that this client faced: a superior product that lacked clinical evidence to convince providers to use the product and a reimbursement coding issue which resulted in hospital administrators refusing to use the product.

The Aequitas Group developed a comprehensive commercialization strategy that included the development of a Health Technology Assessment (HTA), a Health Economic Analysis (HE) and a Reimbursement Strategy for the product. The results of these analyses demonstrated the safety, efficacy, cost benefit, cost effectiveness, and quality of life improvement resulting from the use of this product. Using the findings from the Health Technology Assessment and the Health Economic Analysis, The Aequitas Group quickly implemented the Reimbursement Strategy to obtain specific codes for the imaging product and the procedure. The tactics included preparation of coding applications, research and analysis, regulations review, and coverage policy development.

Execution

As soon as the product received FDA approval, coding applications were submitted and a HCPCS code for the product was obtained without the typical requirement of six months of marketing data to support the product.   The Centers for Medicare and Medicaid Services (CMS) accepted the Health Technology Assessment in lieu of the six months marketing data, as demonstration of the clinical safety and efficacy of the product as well as market acceptance of peptide imaging.

Following this successful outcome, The Aequitas Group was contracted to design a Phase IV clinical trial to collect additional data following the product launch. After only three months of data collection, The Aequitas submitted a CPT application with support from Society of Nuclear Medicine physicians, resulting in a new CPT code. These milestones were achieved in less than one year from initiation of the engagement.