The successful implementation of a Risk Evaluation and Mitigation Strategy (REMS) is critical for therapeutic approval, patient safety, and commercialization. Don’t lose efficiency with REMS implementation. Leverage our lessons learned from over 120 REMS programs and counting to seamlessly navigate your product through regulatory and commercial requirements. A successful REMS program will direct the right therapy to the right patients at the right time.
Key Lessons for Seamless REMS Implementation
From the first REMS launched in the industry, our extensive experience working with many stakeholders and patient populations has taught us valuable lessons about REMS and product safety:
- Align REMS with the healthcare system: Viability in the marketplace is driven by an in-depth understanding of healthcare provider workflows and how patients access medication. Most active REMS include one or more Elements to Assure Safe Use (ETASU), which may require prescriber training, patient monitoring, or patient enrollment. If a REMS is constructed and executed appropriately, the likelihood that a healthcare provider will prescribe can increase because benefits and risks have been clearly communicated, and providers have a better understanding of the REMS program.
- Plan early for proactive risk management: Understand the product safety profile early and determine if risk mitigation strategies should be incorporated into clinical trial protocols. It’s also crucial to understand how the clinical trial population may differ from the post-approval target population (e.g., the elderly, patients on concomitant medications) and how this may affect therapeutic safety profiles.
- Communication and Collaboration Are Non-Negotiable: Determining the level of risk impacting the benefit-risk balance requires input from many different groups: regulatory agencies, patient advocacy groups, healthcare providers, and patients. Furthermore, if REMS requirements are too complicated and cumbersome, patients and prescribers may choose an alternative therapy. Therefore, develop and test strategies that educate stakeholders clearly and comprehensively.
- Aim for innovative education test strategies: REMS have brought many innovations to the marketplace, including innovative tools for patients, prescribers, pharmacists, and distributors, to communicate risk. Develop and test strategies that educate stakeholders in a clear and comprehensive manner, and make educational tools easily accessible.
REMS Compliance: IRB, EC, and FDA Insights
The Food and Drug Administration Amendments Act (FDAAA) of 2007 gave the FDA the authority to require REMS for new and existing products. Before REMS, the industry utilized Risk Minimization Action Plans (RiskMAPs) and Performance-Linked Access Systems (PLAS). UBC scientists developed one of the first PLAS instituted in 1999, which is still in effect today as a REMS. Investigational Review Board (IRB) or European Commission (EC) approval is required, followed by signed patient consent.
Expert REMS Insights from UBC Leaders
UBC’s Chief Scientific Officer, Annette Stemhagen, DRPH, FISPE, and Senior Director of Risk Management & Scientific Consulting, Rachel Bonfanti, discuss key insights learned over more than a decade of designing and implementing RiskMAPs and REMS for products in various therapeutic areas.
