Both the FDA and European Medicines Agency (EMA) have in place risk management processes to ensure that the benefits of a drug outweigh its risks. When routine risk minimization procedures are insufficient, the FDA may require a Risk Evaluation and Mitigation Strategies (REMS) on a product, and the EMA may request a Risk Management Plan (RMP). Our analysis assessed if these regulatory risk management requirements influence reimbursement outcomes. More specifically, we wanted to know if reimbursement outcomes differ significantly if a drug has only REMS, only RMP, or if it has both REMS and RMP guidelines in place. After identifying drugs with REMS and/or RMP designations from the FDA and EMA, we looked at those drugs reviewed by European HTA agencies (NICE, SMC, HAS, IQWiG, and G-BA) between 2008 and 2012. We further narrowed our search to particular reimbursement outcomes: decision, ASMR score (HAS), additional benefit score (IQWiG, G-BA), and clinical assessment, leaving us with 145 reimbursement outcomes for 32 drugs.
European Agencies Tend to Review More Drugs with RMP versus REMS
At the start of our research, we thought that REMS and RMP designations would be a red flag for HTA agencies. But analyzing by agency showed that when comparing drugs with REMS, RMP, or drugs with both, there is no significant difference in positive and negative reimbursement outcomes. This might mean that these risk management programs are successful, and that drugs are being reimbursed because risk management strategies are used they are a source of assurance for HTA agencies. In the time between our abstract submission and our presentation, the EMA changed their rules. All drugs will now receive an RMP; therefore, manufacturers will be dealing with RMPs more often.
Risk Management Schemes and the Impact on Reimbursement: It's a Win-Win!
For manufacturers, this is positive news. If you receive any type of risk management scheme, you should still launch: the data shows there is no negative effect between schemes on reimbursement. For patients, the drugs you are getting are proven safer. We continue studying how this shift compares with drugs that do not face any risk management schemes; stay tuned for our updates.
For our slide presentation, complete with exclusive figures, maps, tables, and in-depth analysis, click here.