Pharmacists Are Key Partners in Navigating Treatment With B-Cell Therapies

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Pharmacists play a crucial role in bridging communication gaps, supporting both patients and clinicians in navigating complex treatment decisions. In a Pharmacy Times Clinical Forum moderated by Jacci Bainbridge, PharmD, FCCP, MSCS, FAES, professor in the Department of Clinical Pharmacy and vice chair of research in the Department of Neurology at the University of Colorado Skaggs School of Pharmacy at the Anschutz Medical Campus in Aurora, panelists discussed the evolving role of pharmacists in shared decision-making (SDM) and the importance of collaboration in managing patients with relapsing multiple sclerosis (MS), particularly in relation to treatment with B-cell therapies.

Pharmacists are actively involved in SDM, a process that ensures patients feel empowered to participate in their treatment decisions. This approach improves patient satisfaction, health outcomes, and medication adherence.

“Once the patient is in the clinic and gets prescribed the medication, then we [as pharmacists] go over the medication with them. Oftentimes, we run into this problem where the patient would hear about the medication and be like, ‘Whoa, what if I don’t want to put myself at risk for infections, especially during the height of COVID-19? Maybe I need to go back to the doctor.’ And that creates delays,” Christian Sileo, PharmD, CSP, a clinical pharmacist at Ochsner Health in New Orleans, Louisiana, said during the Clinical Forum. “Specifically, within the neurology department, we established ambulatory care pharmacists within the clinic to work together with the physician and say [to the patient], ‘Hey, we’re going to assess your disease with the physician and nurse, and then we’re going to give you a few options to discuss with the pharmacist as far as what the adverse effect profile looks like.’"

Sileo noted that the pharmacist’s role in SDM becomes even more important when the treatment is highly complex with many considerations involved in treatment selection.

“[These treatments] have quite a few nuances as far as bradycardia monitoring or special genotype monitoring,” Sileo said. “So we are very involved with SDM because our physicians…are really putting a lot of effort into making sure patients are informed and motivated to start therapy, because you really get people on board if you have them involved in the process."

Despite the benefits, both clinicians and patients face various challenges when implementing SDM. For clinicians, long-standing traditions of physician-driven decision-making, concerns about patient litigation, and time constraints may hinder effective communication. Patients, on the other hand, may encounter health literacy issues or cultural barriers that affect their understanding and involvement in treatment discussions. To address these challenges, pharmacists play a vital role in ensuring that patients receive the information they need in a format that is accessible and comprehensible to them.

Overcoming Barriers to SDM

Several panelists shared insights into methods they have found to be successful in overcoming common barriers to SDM. Jason Noel, PharmD, MPA, BCPP, associate professor at the University of Maryland School of Pharmacy in Baltimore, works with individuals with intellectual and developmental disabilities, and he emphasized the importance of educating patients in a way that accommodates potential cognitive limitations. Sileo and Millad J. Sobhanian, PharmD, BCPS, a clinical pharmacy specialist in neurology at the University of Maryland Medical System, discussed the role of pharmacists in clinical settings, particularly with B-cell therapies, noting the importance of collaborating closely with physicians to ensure patients understand their treatment options. Additionally, the panelists touched on the significance of laboratory monitoring to ensure patient safety, especially when dealing with complex therapies requiring ongoing assessment.

Barriers such as insurance coverage issues and step-therapy protocols were also addressed. The panelists noted that pharmacists are essential in helping patients navigate obstacles by advocating on their behalf and managing insurance requirements. Panelists also emphasized the importance of improving health literacy and cultural sensitivity to facilitate better communication and ensure patients fully understand their treatment choices.

Patient-Centered Care in MS

Patient autonomy is very important in SDM, especially when family members are involved in treatment decisions, the panelists explained. For example, in one patient case where a patient’s family members spoke English but the patient herself did not, the patient’s health care team brought in an interpreter to ensure the patient was included in the decision-making process. Interpreter services can be critical to ensure the patient’s voice is heard, even when the patient’s family is able to translate. For example, if patients need to rely on family members for translation to health care professionals, unknown family dynamics could be at play and influence the information that is relayed, and family members may also have varying skill levels in translating accurately. For these reasons, an interpreter can ensure all necessary information is communicated to the health care team rather than relying solely on family members to translate.

Treatment Options and Considerations in MS Care

The panel discussed various treatment options for MS, including subcutaneous vs oral therapies and newer medications such as ublituximab (Briumvi; TG Therapeutics). Whereas efficacy among B-cell–depleting therapies is generally similar, safety profiles can differ. For example, ofatumumab (Kesimpta; Novartis Pharmaceuticals) may have a gentler effect compared with ocrelizumab (Ocrevus; Genentech), potentially reducing the risk of adverse events (AEs). Regular monitoring, such as tracking IgG levels, is essential for ensuring patient safety and detecting signs of disease progression.

“Between the B-cell–depleting therapies, at our institution, basically it’s ofatumumab or ocrelizumab, and sometimes rituximab [Rituxan; Biogen and Genentech],” Sobhanian said. “We are looking currently at subcutaneous ocrelizumab as well as ublituximab, which is the new kid on the block, so to speak, and from a safety standpoint and efficacy standpoint, they are fairly comparable. The nice thing with ublituximab is that it has a 1-hour infusion vs 4 to 6 hours with pretreatment and all that.”

From an AE profile standpoint, Sobhanian noted that ofatumumab tends to be better tolerated because of the subcutaneous administration.

“Our patients seem to do a little bit better [with ofatumumab] because you’re depleting a little bit more gently, I guess,” Sobhanian said. “That’s how I work it into the discussion with patients. I explain, ‘With ocrelizumab, you’re doing an IV and you’re hitting all the B cells and wiping them and then giving yourself time to recover. With ofatumumab, you’re doing it more gently and letting it slide down and keeping them low, but perhaps that swing is what may lead to some of those AEs like the infectious risk, etc.’ I also incorporate what we use for monitoring and how we can say maybe you’re at an increased risk. We use IgG a lot to monitor. So that goes into part of the discussion, and we explain, ‘If it stays above x number, you’re probably OK.’”

Sobhanian explained further that in the University of Maryland Medical System, they have a specialty pharmacy that conducts regular check-ins and calls with patients to discuss questions and symptoms they might be having.

“We have our own templated notes that assess patients for the head-to-toe symptoms of MS. We get their baseline for cognitive issues, mood, fatigue, incontinence, etc, and we ask very basic questions,” Sobhanian said. “Since we’re pharmacists, we don’t go into the weeds, but we assess the patients’ symptoms with questions [such as], ‘Compared with how you were before treatment, where are you in terms of these particular symptoms?'"

Sobhanian noted that these questions are looking to assess new or worsening symptoms that could be a sign of relapse.

“We don’t really have any specific biomarkers for efficacy other than imaging, and that’s handled by our providers, of course. We do ensure patients are keeping up with their monitoring and keeping up with their visits and their testing that’s needed while they’re on therapy,” Sobhanian said. “I think therapy is very much patient centered in that way, where we’re asking these more subjective questions, and that certainly is a helpful tool for us to pick up on some of those maybe subclinical symptoms and signs of progression that may not be as [clear as] an MRI finding, a hyperintensity, or a relapse but [may be signs of an] insidious progression that’s ongoing that could be a sign that they’re getting worse.”

Managing Multiple Conditions and Treatment Complexity

Managing patients with multiple autoimmune conditions, such as MS and type 1 diabetes, requires careful coordination between specialties. The panel discussed the importance of managing disease burden and activity when determining the most appropriate therapy. For some patients, treatment preferences, such as opting for infusions to accommodate travel schedules, must be considered. The need for close collaboration across specialties, including neurology and endocrinology, is key to providing comprehensive care.

“I’ve seen quite a few of our patients [with MS] with multiple autoimmune conditions. They might have inflammatory bowel disease, arthritis, type 2 diabetes, or type 1 diabetes, and I think that really highlights the importance of making sure you have things in the [electronic medical record (EMR)], whether it’s Cerner or Epic. Seeing patients inside the same health system is a huge benefit [for that reason],” Sileo said.

Sileo explained further that treatment selection should also be assessed in relation to the other medications the patient may be on for other conditions.

“Ofatumumab on its own is probably not a huge immunosuppressant, but then once you’re adding in a JAK inhibitor, we really should carefully think about that,” Sileo said. “So just make sure you’re clearly communicating that plan. That way, if that endocrinologist wants to hop in, they can clearly see how long they’ve been on therapy, what the goals are, and why it’s important to continue.”

Overcoming Administrative and Financial Barriers

The discussion also touched on the financial and administrative challenges of MS treatment. Barriers such as formulary restrictions, prior authorizations (PAs), and the influence of pharmacy benefit managers often delay access to necessary therapies. Pharmacists play a crucial role in managing these challenges by facilitating insurance appeals and ensuring patients receive the treatments they need.

“We work with the physicians, and we were able to impact their behaviors, how they chart, what they document, and that’s really been a huge assistance on our end to help us get things approved, whether it’s through appeal or just PAs. Regardless, we need that,” Sapan Patel, PharmD, a specialty pharmacy manager at MedStar Health in Hanover, Maryland, said. “We really need it spelled out because that’s what helps get the insurance to pay for it.”

Sileo agreed with this sentiment, noting the importance of physician education to support this process.

“We’ve done a lot of provider education as far as if you don’t want to use this medication, tell us why in the chart, because we can write a paragraph in the PA, and who knows if they’ll actually read it,” Sileo said. “Also, sometimes we get denials and the doctor is like, ‘Oh, they can’t use that medication because x, or they already tried it,’ and it’s like, ‘Well, why wasn’t that in the EMR?’ So, definitely a lot of provider education is needed.”

Sileo noted that it’s also important to not lose momentum in the process of getting the authorization.

“If something’s denied, next step is message the provider. I personally write in a field letter or medical letter of necessity and then send it over to the provider for notes,” Sileo said. “I’ve gotten so much great information. A lot of them have these studies just ready to go, but they don’t put them in the EMR, and how would you know? So communication is just really important.”

In this way, close collaboration with specialty pharmacies is essential for treating patients with MS effectively. The panel emphasized the importance of proactive steps, such as conducting formulary checks and quickly submitting appeals.

“When I see patients, I do put in my own note documenting if they had failed [therapy for] something in the past or a reason why they can’t be on a particular therapy. We do have the specialty pharmacy that we work very closely with, and I have a technician, and she does the PAs, so I make sure that she has my note in there. If she has the provider’s notes in there, they indicate if a particular therapy is preferred for whatever reason or others are contraindicated,” Sobhanian said. “Our administrative assistants have all these appeal templates for all the MS therapies that I’ve written up, and we’ve pulled in all the studies and the data, and they fill those in whenever they can, and we tweak it to match the patient.”

Sobhanian explained further that at the initial visit, her team begins the start forms.

“So when we get that denial back, they can just go straight into the free drug process to get set up…especially for Medicaid and Medicare patients,” Sobhanian said. “We can do a formulary check before we even start this, and I’ll say, ‘Hey, I want to start [fingolimod (Gilenya; Novartis Pharmaceuticals)] or [ozanimod (Zeposia; Bristol Myers Squibb)],’ and they can determine which one is going to go through more seamlessly, and that helps guide us too, and it works 7% of the time.”

Conclusion

Pharmacists are essential in advancing SDM in the care of patients with MS, particularly in the context of complex therapies such as B-cell treatments. By serving as key communicators between patients and other clinicians, pharmacists help ensure that patients are informed and involved in their treatment choices, which enhances satisfaction, adherence, and overall health outcomes.

Through collaboration with physicians and other health care providers, pharmacists address barriers to care, including health literacy, cultural sensitivities, and administrative challenges. As MS care continues to evolve, the role of pharmacists will remain integral to improve treatment adherence, manage patient safety, and advocate for optimal patient care amid the complexities of multiple autoimmune conditions and insurance obstacles.