Navigating the Patient Journey in Specialty Pharmacy

Autumn Zuckerman, director of specialty pharmacy at Vanderbilt University Medical Center, and JoAnn Stubbings, a professor at the University of Illinois at Chicago College of Pharmacy, discuss the role of specialty pharmacists in guiding patients throughout their journey.

Note: In the introduction of this interview, the survey regarding drive-thru pharmacies was incorrectly attributed to the Pharmacy Quality Alliance. It was a product of Pharmacy Quality Solutions.

Aislinn Antrim: Hi, this is Aislinn Antrim from Pharmacy Times. Before we get started, one of our top articles is about a survey from the Pharmacy Quality Alliance, which found that adults are more comfortable receiving testing and treatment for COVID-19 at drive-thru pharmacies rather than at locations without a drive-thru option. So, there's more of that on Pharmacy Times. Today, I'm speaking with Autumn Zuckerman, director of specialty pharmacy at Vanderbilt University Medical Center, and JoAnn Stubbings, a professor at the University of Illinois at Chicago College of Pharmacy. So, to get us started, can you both just tell us what you mean by “the patient journey” in specialty pharmacy and how is it unique compared to another pharmacies?

JoAnn Stubbings, MA, BSPharm: Yes, it's a great starting question. The specialty pharmacy patient journey is a process, and it starts at the point that the patient has symptoms or is diagnosed, and it goes all the way through the treatment and all the way through to completion or discontinuation of therapy. Some patients who are prescribed a specialty medication never get their prescriptions filled or don't take them in the right way because of roadblocks in the specialty patient journey, so that's why it's so important and there are a lot of differences between specialty pharmacy and non-specialty pharmacy. The main one is what people think of first, is that the drugs are much more expensive. So, there's fewer medications but they're more expensive on an individual basis, and the statistics that we know of is that generally just 2% of patients take specialty or are prescribed specialty medications. However, those drugs account for almost 50% of total drug spending. And so, for specialty pharmacies, actually, it's very risky to have a specialty pharmacy because you have a huge investment in medication and inventory is a lot more costly. These drugs cost anywhere from a thousand to 15, 20, 30 thousand dollars per month. There are a lot of extra steps in dispensing a specialty medication, so there's a lot of work to be done by pharmacists and technicians before the specialty drug is given to the patient. Obviously, there’s a higher cost, and so it takes more personnel and systems, so it’s more expensive for the pharmacy to dispense that prescription. Usually it requires prior authorization. But that being said, it’s very rewarding to pharmacists and technicians because it allows them to practice at the top of their license and work as a team with providers.

Aislinn Antrim: Autumn, did you want to add anything?

Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP: Sure. I think that's a great summary. Oftentimes we think the differences are in that complexity of helping patients access treatment. I think one other difference is that you usually can't go down to your local pharmacy and just pick it up. There's complexities in logistics of how these medications are shipped to the patient and that's something that we have to talk about from the beginning for them to understand that this will probably be shipped to you, it needs to be refrigerated, and kind of all those logistics around not just going down to their local store and picking it up. So, that's another complexity that's added to the specialty patient journey.

Aislinn Antrim: And that’s definitely important. Where does it begin? What sorts of patients are specialty pharmacists engaging with from a clinical standpoint, what sorts of illnesses or diseases are you dealing with?

JoAnn Stubbings, MA, BSPharm: The patient journey begins when the patient experiences symptoms or has a diagnosis that requires a specialty medication. So, the first thing is they're usually referred to a specialist, and so they have to go through the process of recognizing that they need some kind of treatment and actually they get a referral to a specialist that could possibly be at a different clinic or a different medical center. And then, [in] the patients that we see there's 2 top conditions that are most commonly seen in specialty pharmacy, and that's all the cancers and also autoimmune disorders such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, Crohn's disease. But also, there's a lot of other conditions that require specialty medications such as hepatitis C, multiple sclerosis, pulmonary arterial hypertension. And then—this is important for pharmacy—there are other conditions that are very common for community pharmacies to dispense but these also can be considered specialty medications, such as transplants, HIV, sickle-cell disease, and now we're also starting to see specialty medications in migraine and hypercholesterolemia. And so these are drugs that, if a community pharmacy might not have specialty pharmacy accreditation, it will also participate in the specialty pharmacy space because it’s kind of creeping into the disorders that we don't typically see in the specialty space, such as migraines.

Aislinn Antrim: Interesting, that's an interesting shift. Can you both just walk through kind of overview of the patient journey. Of course, they're all unique and unique patients have different needs, but what sorts of considerations do you often run into in a specialty pharmacy?

JoAnn Stubbings, MA, BSPharm: Well, I can start out with three sections and then Autumn can help elaborate on each of these. So, the journey kind of has 3 parts to it, and the first part is before treatment, like when the patient is diagnosed and when they are in the process of getting the prescription. The second step is during treatment. After they get their first medication, first prescription, and they are taking it for any period of time. And then the third step is completion, whether they stop that treatment or switch to another drug. And so, I'll just talk about some of the roadblocks before treatment and then I'll pass it on. Before treatment, one of the big roadblocks is getting access to the medication, and there's 2 big factors that may prevent it. The first one is prior authorization, and the second one is financial access because the drug could be approved but then they might have a $2000 copay. And so, the main reason why people don't take their medications or don't get their prescription or don't take it appropriately is because the different points in the journey are not fully managed, so this is the role for the specialty pharmacist and the technician.

Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP: Sure, yeah, and then once they're on treatment there's a lot of different transitions that can happen to that patient. They can change providers, they can move geographic locations, their financial status and coverage can change, and a lot of patients are in and out of the emergency department because of their condition, so the specialty pharmacists often serve as the coordinator of care for all of those different transitions. One thing, to speak to JoAnn’s point, is the financial aspect of it. So, we tell our patients if you change your insurance or you lose your insurance, we want to be your first call because we need to help make sure we can set you up for additional assistance or try to get the medication approved for you through your new insurance. So, that really helps with adherence and persistence to therapy. And then, in addition to the financial changes and the sites of care changes, a lot of these medications require monitoring, so we're not just filling the medication every month without checking on the patient. We want to see, are they actually benefiting from it? And if they're not let's take them off of this high-cost therapy or switch to something else that might help. If they are benefiting from treatment, is it still safe for them? Are we monitoring their labs, are we looking at imaging to make sure that this is still the best possible drug? So, it's a really rewarding role and I think a really important role for a pharmacist to continue monitoring patients even after they start treatment and really longitudinally, sometimes through the completion of the treatment in the cases such as hepatitis C, but most of the time life-long as new medications emerge and as patients either progress or do better with their diseases.

Aislinn Antrim: Very interesting. Shifting gears a little bit, these patients are dealing with some more serious and scary diagnoses, things that are there are a lot to take in. How can specialty pharmacists help with some of the fears and anxiety that they're experiencing?

Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP: Yeah, I'm so glad you asked about that because I really think that is one of the most important roles of the specialty pharmacists. Oftentimes, health system specialty pharmacists are really one of the first health care providers that patients talk to after their they receive this diagnosis, and not only have they received a difficult diagnosis but now they're faced with taking medications that often have serious and scary side effects. Rarely do we say, “You know, you should be fine, this medication doesn't have a lot of side effects” More often than not we spend 40 minutes to an hour counseling patients on, “You're probably going to have these side effects, [and] here's how you manage them,” or “Here's how you prevent them.” So, I think specialty pharmacists have a unique opportunity to calm some of those fears that patients may have about the diagnosis or the drug by normalizing their experience, preparing them for the side effects that are going to occur, and then reinforcing that we’re going to be with them every step of the way, checking in on them, seeing how they're doing, and then being available 24/7. So, oftentimes we’re their counselor and their cheerleader and, really, their confidante throughout the entire course of treatment. I'll just say during the pandemic, you know, this has been especially true. We had a lot of patients contact us about fear of continuing their medications, so we've really spent a lot of time on the phone with patients counseling them and saying what we know and what we don't know and recommendations during this time. So, that's an important role during the pandemic because we have 24/7 access to our patients and a lot of the work is done via telephone or video, and so this has really helped. The transition during the pandemic was pretty seamless because patients knew that they had complete, full-time access and they could ask questions, not just about their specialty medication but all their other medications. So, this is also an opportunity for pharmacies to comprehensively manage everything for the patient, not just the specialty medication but their primary care meds, as well.

Aislinn Antrim: Excellent. Speaking of cost, you both mentioned it and the high costs that are definitely a huge concern. How are specialty pharmacists positioned to help patients access those medications from the financial aspect of it?

JoAnn Stubbings, MA, BSPharm: So, I can talk about it and then I'll pass it onto Autumn to talk about the specifics of this. So, there are external strategies and internal strategies. So, the first thing that the pharmacy will need to do is identify a person or people that will address the financial problems, because this is something that has to be addressed before the prescription is handed to the patient. You can't give a prescription to a patient, say the copay is going to be a thousand dollars, and then figure it out. So, usually it's a very good technician that's a good problem solver that can do this, but a pharmacist or any other type of person can as well. So, there's external and internal strategies, and “external” just means programs that are outside of the

pharmacy that the pharmacy can access to help the patient. I think the most common is the copay card, so people with commercial insurance can access copay cards that will cover most or all of their co-payment. There's also samples that can be provided to the patient to bridge them over for a month or a few months, pharmaceutical assistance programs that are basically free drugs from the company if the patient qualifies, and one of the really common things that that we access

are foundations. And the foundations can be used for people on government programs like Medicare Part D and where they can't use a copay card, but they can use a foundation. These are independent foundations that provide money for co-payment. And a recommendation that I made in our presentation and I'd like to emphasize again is there's a website, it's really helpful. You can go on the website and see all the foundations and search by disease state and see which ones have programs that have money available and which ones don't, and this is updated real time every day. So the website is, and it's really great for that purpose. Internal strategies are things that the pharmacy can do to help the patient as well, and these are things like 90-day fills, providing discounts to the patient, providing payment plans if they can't pay all of their copay at one time, and things like that. If the pharmacy has the ability to do that, that would be great. Looking at generic drugs, looking at biosimilars if available, and something Autumn mentioned that's really important is doing a full clinical assessment to determine if this drug is really the best option for the patient because there might be a therapeutic substitution that's more cost effective and that would be better. And that's an important role for the pharmacist.

Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP: Yeah, I think that was a great summary of really what tools we use. And the other thing that I would mention is that these tools are available to everyone, whether they go to a health system specialty pharmacy or not. But I think what the health system specialty pharmacy does a lot is it’s really invested in helping the patients get these tools so that they can start treatment. Because we're physically embedded in clinic in a lot of places or at least really close to the clinic we see that patient in clinic and then we're invested, we’re going to see them at follow up and we’re invested in exploring all possible avenues to make it affordable for patients. So, there's been a couple great studies, one out of the University of Chicago that showed that after they integrated a specialty pharmacist or health system specialty pharmacist there was an increase in the use of these financial assistance tools. I think the Chicago case specifically saved patients about $315,000 over 6 months in oncology with just 75 oncology patients. So, yes, they are out there, and JoAnn talked about what we use, but it's also important to have the specialty pharmacist integrated so we take advantage of these tools.

Aislinn Antrim: Absolutely. We've been hearing from many people that the economic issues related to the COVID-19 pandemic have affected medication adherence in the community setting. Is that an issue you've also seen in the specialty field and how can specialty pharmacists intervene with adherence issues?

Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP: Yeah, so, at this time—and JoAnn can talk to what they've seen at UIC—but we have not seen a significant impact on adherence to therapy. There have definitely been a few instances where providers are holding immunosuppressive therapy in certain patients with infections, but the main recommendation at this time is to continue treatment. And I think the reason that we haven't seen a big impact on adherence is because of the specialty pharmacists and the important role that they play. So, to help mitigate any potential adherence issues we've transitioned patients from 30 to 90 day fills or have helped them obtain or early refills where that's appropriate, and we've also appealed to insurance companies to waive labs or monitoring that's needed if that’s appropriate and safe for the patient. I'm coordinating patients so they can get the lab and monitoring that is needed closer to their home where they feel a little bit safer. So, I think those actions by the specialty pharmacists have really helped patients stay adherent to therapy. There is an increasing concern that they will have more uninsured patients as the financial issues continue, but I think that gets back to what we were just talking about where the specialty pharmacists are really in an important position to help patients access all possible avenues to stay on treatment. I think the full financial impact is yet to be seen but we're confident in our ability to help patients remain on necessary therapies.

JoAnn Stubbings, MA, BSPharm: Yes, absolutely. The only thing I would add is that the specialty practice model is proactive, and so we were well positioned to address any of the financial or adherence issues that the patients had because we weren't waiting for them to call up and order their refill, we were proactively calling them once the shutdown started and we called the patients and arranged for early refills [and] got the overrides that were needed to get them the 90-day fills. And also, because specialty pharmacy has required assessment generally on a monthly basis or at each refill, we are able to monitor adherence pretty closely. So, the practice model was well positioned to be able to pivot and address these issues.

Aislinn Antrim: Excellent. Finally, just in general can you speak about the value of pharmacists and how they're so important in patients’ lives?

Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP: The value of the specialty pharmacist in helping patients to access treatment, adhere to treatment, and really get the best possible outcome of treatment really cannot be overstated. I think even prior to treatment initiation, as we've mentioned, specialty pharmacists are often responsible for selecting the most appropriate therapy based on the patient's clinical and financial profile or reviewing that prescribed medication to ensure access for the patient. As JoAnn mentioned and we talked about in our presentation, we then help patients obtain insurance approval and financial assistance that's needed, as we've talked a lot about. We provide extensive counseling. As I stated, sometimes it

takes up to an hour to fully educate the patient and/or their caregiver on what to expect from treatment, and then, as I mentioned, we provide significant mentoring to patients to ensure not only safety but also effectiveness and being proactive and changing therapy so that patients are really getting the best possible benefit or changing to a different medication that may give them a better effect. And then the last thing is just monitoring them through the multiple transitions of care. So, for some of these patients, we see them from their pediatric clinic, you know, to geriatric clinic. Really, it's a lifelong therapy, so you can imagine during that time there's a lot of changes in the patients’ lives and in their healthcare status that can impact their specialty therapy. So, it's important for the specialty pharmacists to really be an anchor during therapy that they can rely on to make sure that we are helping them deal with complex, challenging, and sometimes lifelong therapies. And we really embrace that role and I think that specialty pharmacists often feel very fulfilled in their job because of the important role that we do play in the patient care journey.

JoAnn Stubbings, MA, BSPharm: Yep, that's great. The only thing I would add is that the specialty pharmacists and the technician, the whole pharmacy, is part of the provider team and that's a really rewarding part of the job, and it helps to improve outcomes. So, everything that Autumn mentioned is not done in a vacuum, it's done in collaboration with the provider so it can be something where there's even a collaborative practice agreement and the pharmacist has a lot of opportunities to make changes or authorize refills or things like that, or it can just be as simple as constant communication with the provider that maybe the patient is having an issue with adherence or is not taking the drug appropriately and maybe a dose needs to change. So, this is all done in collaboration with the provider on a team which very much contributes to improved outcomes.

Aislinn Antrim: Absolutely. Well, thank you both so much for joining us. Now we're going to hear from some of our other MJH Life Sciences brands on their latest headlines.