Optimizing MS Therapy Management: REMS and Routes of Administration

In this episode, Optimizing MS Therapy Management: REMS and Routes of Administration, Millad Sobhanian, PharmD, BCPS, and Kiranpal Sangha, PharmD, explore the key stakeholders involved in developing REMS programs for MS therapies and highlights critical considerations for selecting between oral, injectable, and infusion treatment options.

Developing an effective Risk Evaluation and Mitigation Strategy (REMS) program for multiple sclerosis (MS) therapies requires collaboration among a range of stakeholders, each with defined responsibilities. Key participants include healthcare providers, who ensure appropriate patient selection and ongoing monitoring; pharmacists, who manage program enrollment, patient education, and adherence; manufacturers, who design and implement REMS requirements; and regulatory agencies, such as the FDA, which oversee compliance and patient safety. Additional stakeholders may include nurses, patient advocacy groups, and specialty clinics, all contributing to education, support, and timely reporting of safety data. Understanding each stakeholder’s role is essential for creating a REMS program that both ensures patient safety and facilitates access to therapies.

In parallel, selecting the optimal route of administration for MS therapies involves several considerations. Oral therapies may enhance convenience and adherence but require monitoring for gastrointestinal or systemic effects. Injectable therapies, including subcutaneous or intramuscular options, necessitate patient training and management of injection-site reactions. Infusions, administered in clinical settings, offer controlled delivery and monitoring but may impact healthcare resource utilization and patient schedules. By integrating knowledge of REMS requirements with practical considerations around therapy administration, healthcare teams can optimize treatment strategies, improve adherence, and support patient safety while navigating the complex landscape of MS care.

Led by the moderator, the neurology pharmacists examine the following critical questions:

When building a REMS program, who are the main stakeholders involved and what are their respective roles?

What are the key considerations for the different routes of administration for MS therapies, i.e. oral, injections, and infusions?

Throughout the conversation, the experts provide a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

The next episode in this series, Redefining Treatment Success and Monitoring in nrSPMS, features the panelists advancing their conversation on multiple sclerosis and focuses on the balance between objective clinical measures and patient-reported outcomes in assessing MS progression, how health plans can redefine treatment success to include long-term functional outcomes in nrSPMS, and the evolving role of prior authorization and coding, particularly with emerging therapies like BTK inhibitors.