Pharmacists Compare Experiences With Multiple Sclerosis at Large Academic Institutions, Small Private Practices

Caring for patients with multiple sclerosis (MS) can look very different depending on the type of facility available, according to presenters in a session at the Consortium of Multiple Sclerosis Centers 2024 Annual Meeting. However, the pharmacist speakers all agreed that regardless of resources available, optimal patient care is always top priority.¹

Megan Schneider, PharmD, is a clinical pharmacist with Vanderbilt University Medical Center, where she works as part of the health system specialty pharmacy caring for patients with MS. She explained that their health system-integrated specialty pharmacy is quite unique compared with community or non-integrated specialty pharmacies.¹

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“When you think about a specialty pharmacy, they’re typically going to be organized based on their disease state,” Schneider explained. “They’re often accredited by a third-party organization, and then sometimes they have to be separated into various departments depending on the filling stage, so you’ll have different teams managing those parts of the billing, as well.”¹

The MS specialty pharmacy team at their medical center has 3 full-time pharmacists, 2 certified pharmacy technicians, 1 shared technician, and 2 shared floater pharmacists. There is also a separate infusion team for infusions billed to pharmacy benefits, as well as 10 physicians, 1 physician’s assistant, and 2 fellows. The specialty pharmacy fills for around 670 patients with MS each month, with a focus on self-administered medications and the necessary education, insurance authorizations, and financial assistance.¹

Schneider emphasized that the major strengths of their model are the integration within the care team, the patient-centric approach, and reduced burdens for both patients and clinic staff. Additionally, she said they have increased efficiency, a focus on value-based care, increased adherence rates, improved clinical outcomes, greater continuity of care, greater cost savings, and improved patient and provider satisfaction scores.¹

“I’ve had a lot of patients who come to us, and they’ve been seen in a private practice where they didn’t have a pharmacist or the bandwidth to manage some of these complex medications,” Schneider said. “And oftentimes, they end up not getting started on the medication because either the provider has difficulty getting it approved or, once it’s approved, that process to get billed through the specialty pharmacy is really cumbersome and they don’t always have an advocate in their court to take that on for them.”¹

All patients who receive care through the health system specialty pharmacy receive refill reminders and adherence support; free shipping, delivery, and ancillary supplies; managed prescription renewals; 24/7 access to an on-call pharmacist; assistance in obtaining financial services; and a managed reminder queue for prescriptions needing refills. Schneider added that Vanderbilt recently reclassified the technicians as reimbursement specialists, highlighting their crucial role in handling those processes.¹

The pharmacists handle pre-treatment assessments, support the patients and providers in selecting the optimal therapy, assist with clinically complicated prior authorizations, provide education and injection training, and order and review baseline tests or labs prior to therapy initiation. They also provide ongoing medication safety and efficacy monitoring, and notify the provider of any changes, adherence challenges, or safety concerns.¹

Managing disease-modifying therapies (DMTs) can be a complex and challenging process, Schneider said, requiring the pharmacists to educate patients about adverse effects, costs, and ongoing monitoring needs. Before treatment is even initiated, the pharmacists begin educating patients on both common and rare adverse effects (AEs) and provide mitigating strategies.¹

“I always think about a patient looking online and finding out that there’s an increased risk of cancer, and even though it’s really small, I think it’s really important to talk to patients ahead of time, just so that they [don’t] read it and get shocked,” Schneider said. “There’s also patients who, if you mention that a medication can cause [gastrointestinal] upset, they may say ‘I’m not taking that.’ So, I think having those really open, honest conversations at the beginning is very helpful to set your patient up for success.”¹

The importance of such conversations extends beyond just large academic institution-based specialty pharmacies, said Julie Kidd, PharmD, MPH, BCPS, a clinical pharmacist a Roanoke Area Multiple Sclerosis Center in Virginia. Kidd said their facility is much more limited, with 1 physician, 1 physician’s assistant (who recently graduated and does not yet handle complex patients with MS), 1 pharmacist, 2 medical assistants, and 2 front office staff. They have 2 practice site locations, 1 of which sees general neurology patients and the other focuses specifically on MS.¹

At their facility, Kidd said the clinical pharmacist works collaboratively with the physician to see patients, discuss DMT options, order baseline labs, manage symptoms, and ensure that MRIs are ordered. She added that by handling patient conversations about selecting and managing DMTs, she frees up the physician to complete other duties around the clinic.¹

In between patient visits to the clinic, she often handles phone calls to patients, writes appeal letters or peer-to-peer appeals for DMTs, and handles research coordination for clinical trials. As the only pharmacist on staff, Kidd said she wears a lot of hats.¹

“Whenever we talk about new research we’re going to do, the company sponsoring it is like, ‘Who’s in charge of this duty?’ and that’s me,” Kidd said. “Then they’ll say ‘Well, what about this duty?’ and I say, ‘That’s me again.’ They get a little confused, but then they get it, and we just make it work. So, I just really want to emphasize that we are a skeleton crew.”¹

Managing clinical trials is a large part of Kidd’s role. The Roanoke Area Multiple Sclerosis Center is currently enrolled in 4 clinical trials, and Kidd screens and enrolls patients according to each trial’s inclusion and exclusion criteria. She also maintains the ongoing data collection points; reports AEs, hospitalizations, and other required information; maintains documentation in the study binders; and has monthly meetings with the study sponsors. She emphasized that this is a great roll for pharmacists, because they already know which DMTs patients are taking and understand the end points and data necessary for the research.¹

One trial, the VERISMO trial, is a post-marketing safety study to determine the incidence of all malignancies and breast cancer in patients with MS who are receiving ocrelizumab (Ocrevus; Genentech). Kidd said that when she started in her roll there were 2 patients enrolled from their facility, and now there are more than 40. Enrolled patients are followed for 5 years to evaluate for the incidence of cancers, and specifically breast cancer, with the goal of understanding whether ocrelizumab causes breast cancer or if its incidence in previous clinical trials was by chance.²

Similarly, Kidd works with patients who are enrolled in the CLICK-MS and MASTER-MS trials, which are phase 4 trials collecting real-world effectiveness and safety data with cladribine (Mavenclad; EMD Serono) in patients with relapsing MS. The CLICK trial is investigating the transition to injectable cladribine, whereas the MASTER trial is investigating the transition to cladribine from oral or infusible treatments. At different time intervals, patients complete questionnaires about their satisfaction with cladribine, and Kidd said enrollment is up from 1 to around 10 patients since she started.³

Finally, the TREAT-MS trial is investigating traditional versus early aggressive therapies for MS in order to identify the most appropriate strategy for patients with MS, especially shortly after diagnosis. Kiss said this trial’s findings will help inform patients and the health care community about whether patients would most benefit from earlier, aggressive therapy or starting with a more traditional, less aggressive therapy.⁴ Kidd said one notable challenge with this trial is the need for a second blinded physician scorer, since their facility has 1 physician. However, she said Johns Hopkins flies down a second physician periodically and they see participating patients on the day that second physician visits.

All of these trials highlight the great role pharmacists can play in clinical research, whether at a large, academic institution or a smaller private practice. Both Kidd and Schneider said that ultimately, what matters is that patients receive the best possible care, regardless of the setting they’re in. Collaborating with physicians can open doors for pharmacists to be more involved in patient care and decision-making, and Schneider emphasized the extensive collaborative practice agreements she works under in Tennessee.¹

“I highlight that because I think Tennesee really sees the value in pharmacists being a member of the health care team, and is trying to look ahead to patient care in the future,” Schneider said.¹

References

1. Schneider M, Kidd J, Montgomery J, Saunders S. Back to the Future: Ask the Pharmacist. Presented at: Consortium of Multiple Sclerosis Centers 2024 Annual Meeting. May 29-June 1, 2024; Nashville, Tennessee.

2. Wormser D, Evershed J, Ferreira G, Stokmaier D, Wang Q, Ziemssen T. VERISMO: A Post-Marketing Safety Study to Determine the Incidence of All Malignancies and Breast Cancer in Patients with Multiple Sclerosis Treated With Ocrelizumab. Presented at: American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, Pennsylvania.

3. Miravalle AA, Katz J, Robertson D, et al. CLICK-MS and MASTER-2 phase IV trial design: cladribine tablets in suboptimally controlled relapsing multiple sclerosis. Neurodegener Dis Manag. 2021;11(2):99-111. doi:10.2217/nmt-2020-0059

4. The Treat-MS Clinical Trial for Multiple Sclerosis (MS) Patients. TREAT-MS. Accessed May 30, 2024. https://treat-mstrial.org/