Case Study 4 – Advisory Board Summit

Identifying the Issue
A device manufacturer was conducting studies to obtain FDA expanded indication approval for its product currently marketed for other uses. They wanted to obtain commercial payer medical directors’ assessments of the technology and the study endpoints in order to evaluate potential market adoption and payer coverage policy support.

The Role of DK Pierce & Associates
DK Pierce maintains a panel of leading commercial payer experts. The majority of the private payer medical directors on our panel oversee large national and regional health plans. In order to create a benchmark for payer perspectives on the device, DK Pierce proposed that an advisory board summit meeting be conducted and undertook the following actions:

• Scheduled summit advisors
• Developed lines of questioning to support meeting objectives
• Conducted pre-meeting preparation with advisors
• Created curriculum and facilitated the meeting
• Developed a comprehensive summary report

Demonstrated Outcomes
Significant insights were obtained as a result of this advisory board summit meeting. Modifications were made to the clinical trials to minimize risk and optimize marketing activities at new indication launch. Following are the modifications made and the results:

• Marketing tactics were altered to emphasize individual claims support activities.
• Clinical data was reevaluated in terms of workplace productivity issues and subsequent market messaging.
• Manufacturer refocused payer strategy from large commercial payers to worker’s compensation and disability marketplaces.
• Manufacturer obtained novel appreciation of reimbursement financial drivers and the risk bearing entities’ issues and influencers.