Box 4. Box 4 Small-biotech case study: CardioVascular BioTherapeutics centralizes healthcare value

Small, nimble biotech companies are ideally positioned to quickly adapt their development and commercialization processes to the current environment, centralizing healthcare value and capitalizing on the opportunities offered by an OBA paradigm. One of our clients, CardioVascular BioTherapeutics (CVBT; Henderson, NV, USA), is such a company. CVBT's mission includes the development of fibroblast growth factor-1 (CVBT-141H), a protein angiogenesis therapy for patients with advanced coronary artery disease and severe angina. Now in phase 2 of development, CVBT has consistently focused its attention on the drug's healthcare value, right alongside a demonstration of efficacy and safety.

"Proving that CVBT-141H grows new blood vessels, increases perfusion and alleviates angina is essential for CVBT," says Daniel Montano, the company's CEO. "But just as important is proving that CVBT-141H is cost-advantageous to use. CVBT's healthcare value strategy is a critical component of our overall commercialization plan," he adds.

From the earliest stages of development, Montano's strategy has been to understand and address payer needs, as well as to ensure the development of a therapy that payers, as key decision-makers and customers, would value. To this end, CVBT developed a preliminary healthcare value proposition for CVBT-141H during phase 1, mining clinical and economic benefits throughout the continuum of care that a late-stage cardiac patient would require.

"In our discussions with payers, they are astonished when we show them that we have a value proposition model at all for CVBT-141H, much less one which indicates use of our drug could reduce treatment costs of these expensive patients by 20% over a five-year period. The benefits that CVBT has already reaped in our payer relationships have surpassed our expectations," Montano says.

In addition to collecting clinical data, Montano indicated CVBT is rigorously collecting data needed to drive CVBT-141H's value proposition, including resource utilization, quality-of-life and long-term outcomes data. "The analytical process for maximizing healthcare value has informed our entire development process and taken us in unexpected directions," Montano comments. "It has helped direct us down pathways for clinical development and created a pricing scenario that promises great returns to our shareholders while still respecting the healthcare system's needs," he adds.