SPECIALTY RX FACTS

22Mar/100

Rx Manufacturers Beware: REMS May Be In Your Future

Risk Evaluation and Mitigation Strategies (REMS) are not limited to drugs new to the marketplace. In fact, the FDA recently approved such a program for erythropoiesis-stimulating agents (ESAs) that takes effect March 24, this Tuesday. When REMS are required for products that are already on the marketplace and have relatively wide use, this could offer a whole new set of complications for all stakeholders. With specialty therapies that treat smaller patient population and with rare conditions that have no therapeutic options, it can be hard to balance making that drug available and not knowing what the safety profile is. Applying ETASU [i.e., Elements to Assure Safe Use] to drugs that have larger target populations, such as opioids or erythropoietin stimulating agents will have a much greater impact on health care delivery systems. With health plans, REMs may result in changes to formulary preferencing, changes in utilization management criteria and additional communications to patients and providers. All stakeholders should expect more administrative complexity with a drug already on the market compared to a new drug. It is possible with some products that a new REMS could force the manufacturer to go to a more costly and less accessible specialty pharmacy distribution system. It will often be likely that if a REMS program is required for a drug already on the market, prescribers and members must still meet all requirements of the REMS program. This will require additional resources from all stakeholders including the patient, doctor, distributor and pharmacy. Manufacturers should plan on request for updated resource requirements both in people and financial. D2 can assist with real world solutions in a new universe of REMS

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