Developing an Evaluation Tool for a Risk Minimization Action Plan (RiskMAP) as Part of an sNDA Submission

Case Study

Risk management program development always involves multiple stakeholders. But when there are strict regulatory requirements, specific financial considerations and clinical practice standards, on top of a principal need to ensure appropriate use of medication, the precise integration of these elements is critical for success.

A client recently approached PPD to help with developing an evaluation tool for a risk minimization action plan (RiskMAP) as part of an sNDA submission. The company needed a novel solution for a product with a black box warning. These products are often subject to the most intense RiskMAP control efforts, including controlled distribution. The main challenge consisted of designing and implementing a solution where costs were not disproportionate to the expected market penetration of the product.

For the initial approach, PPD’s pharmacoepidemiology and risk management team evaluated FDA advisory committee reference material for similar risk management plans. From this assessment, the team made an informed recommendation to the client. In turn, PPD developed an innovative RiskMAP evaluation tool that addressed regulatory expectations and minimized the burden on patients and healthcare providers without creating unnecessary expense to the client.

PPD’s evaluation tool involved a targeted patient survey designed to elicit comprehensive information from relatively few questions as compared to other risk management plans for similar commercial products, which employed burdensome patient surveys and costly, restrictive performance-linked access systems. The RiskMAP evaluation tool is now administered on a fixed schedule throughout the duration of active treatment and for three years after treatment discontinuation. The patient survey is available in three modalities of administration:

• Self-administration via PPD GlobalView a proprietary Web-based electronic data capture interface
• Traditional mail
• PPD’s Professional Contact Center using experienced healthcare professionals

As a result, PPD was instrumental in helping the client obtain sNDA approval from the FDA and manage the financial parameters of its product strategy while ensuring minimal burden to the healthcare community.