Addressing Adherence, Access, and Cost Challenges in MS: Steven Kheloussi, PharmD

As multiple sclerosis (MS) treatment grows more complex—with expanding therapeutic options, evolving monitoring requirements, and rising costs—health systems, payers, and care teams face increasing pressure to balance access, adherence, and affordability.

In this interview with The American Journal of Managed Care^® (AJMC^®), Steven Kheloussi, PharmD, principal consultant at Kheloussi Consulting, highlights the critical role pharmacists and care coordination teams play in bridging these gaps, from supporting medication adherence and navigating prior authorizations to ensuring patients receive timely, appropriate therapies. Kheloussi also addresses persistent challenges, including high rates of nonadherence, administrative barriers that delay treatment initiation, and the tension between cost-containment strategies and individualized, evidence-based care.

This interview was lightly edited for clarity.

AJMC: How can health systems better support medication adherence and monitoring for patients on complex regimens?

Kheloussi: Pharmacists can really help with that process, I think. I previously worked in a health system that had multiple sclerosis Medication Therapy Disease Management—MTDM—pharmacists whose role was to help patients through the medication aspects of this disease. It was setting realistic expectations with the patient when they were first initiated on therapy about what to expect when it came to the drugs’ efficacy, the side effects that they should be watching out for and should notify their health care providers about, and any monitoring requirements. And—as I talked about earlier­—pharmacists play key roles in prior authorization, navigation, and identifying patient assistance programs through the pharmaceutical manufacturer or other foundations.

One of the most valuable aspects that has really contributed to better monitoring and better adherence is just routine follow-up, especially during the early stages of therapy. This has helped identify barriers that these patients were facing, like tolerability, any sort of lifestyle factors that are leading them not to be adherent, or maybe injection fatigue. We have oral options now that we didn't have back in the day, so is there an opportunity to switch the patient to something that they're more likely to be adherent to if their reason for nonadherence was injection fatigue? Another factor is cost, if they're running into any barriers with their insurance or their assistance program.

Some studies point to nonadherence rates as high as around 50% for injectable therapies, and it's a little lower, but still unnecessarily high, for those oral therapies that I just mentioned. Discussing that up front and setting those realistic expectations with the patient can really help encourage open, honest conversations from the patient side. Moving forward, I think one of the problems that we always face as pharmacists is that patients don't feel like they can be honest about nonadherence, because it feels like they failed. It feels like they are not doing what we tell them to do. But that's not at all the case, and it's a misconception that patients tend to have. Setting the expectation up front that we need you to be adherent to these therapies, and if you're not, we're going to work with you to figure out something that works, can really help patients through that, as well.

AJMC: What strategies can be used to manage escalating costs of MS therapies while maintaining quality outcomes?

Kheloussi: This is probably the hardest question to answer, because I think realistically, every payer's goal is going to be to reduce costs while improving outcomes—in any disease, not just MS. Across the board, I think that’s what payers are aiming to do. But in MS, I think it's so hard. It boils down to ensuring that patients have appropriate access to therapies through, sort of, an open formulary and benefit design that allows them to access those evidence-based therapies that they really need, but also balancing that with the population-level considerations that we always consider from the payer perspective, right?

Using MS as an example, the older therapies are now coming out to be a little bit less effective than some of the newer therapies. And that creates a challenge, because the older therapies are some of those generically available, lower-cost options. Unfortunately, if you look at the numbers, the dollars and the cents of it, [those older therapies] are where payers and employers want to go with this. And I think patients do, as well, because they have lower co-pays and lower out-of-pocket costs, whether it's deductibles or any coinsurances. But I think the key here is that just because it's the cheapest option doesn't mean that it's the most appropriate for the patient. So, I think payers are going to rely on other ways to control costs outside of the normal formulary and utilization management restrictions that they tend to put in place to control costs—and I think they are doing that more now than they have historically been.

Those are some of our most effective tools, and they can't necessarily be applied as readily or as effectively as we want them to be here, so that creates a challenge. It’s an opportunity to incorporate other strategies, like case managers, for instance, who need to be involved in these high-cost patient care scenarios where we want to ensure appropriate evidence-based medication use, and we want patients to be adherent. It leads to higher costs up front, but it saves a lot of costs downstream in terms of worsening disease, hospitalization, and even indirect costs, like loss of productivity. There's certainly a desire to keep this as low-cost as possible, but there's also a significant desire to improve the outcomes, which I think trumps that cost-saving perspective that payers typically have. In this case, we're seeing that in the prior authorization criteria. There are less requirements to fail other drugs than there historically have been, because it's leading to more opportunity for patient-provider choice in that shared decision-making approach. There's certainly an opportunity there to allow providers to exercise their clinical judgment in ways that historically, formularies didn't allow because utilization management restrictions drove patients to those lower-cost generics in the absence of some of these newer data that say that maybe those older drugs aren't the best ones for those patients.

AJMC: What are the most effective ways to address insurance barriers, prior authorizations, and step therapy requirements that delay MS treatment?

Kheloussi: From my experience, it's transparency and communication. Payers need to be transparent with their prior authorization criteria as much as possible, the reason being that there are many situations in which prior authorization requests are denied because the provider is not submitting the correct information, not because the patient doesn't meet those criteria, but just administratively, that information is not making its way to the payer. I've seen that firsthand in that we would make outreach calls from the payer side to the provider, asking for very particular pieces of information because they just didn't submit it the first time around, and that would speed up the process. If we couldn’t get in touch with the provider's office, it would slow down the process while we waited for that information after we left the voicemail, or something like that. There's certainly an opportunity for more transparency from the payer side, because there's other data in other disease areas that show that embedding prior authorization criteria into electronic health records will speed up that process from the provider side—they will provide exactly the information that is needed, and it improves approval rates significantly, which is the ultimate goal.

I think there's a misconception about prior authorization that it's this evil tool that payers put in place to deny necessary care. That's the exact opposite of what is true. I think prior authorizations are well-intentioned. There are clinical reasons, not just cost-saving reasons, why these are put in place to ensure patients are getting appropriate medications and necessary medications while helping to control costs. I think that by villainizing prior authorization in general, it leads to this misconception that prior authorization is just in the way and that it's a barrier that payers put in place for whatever reason. But if payers are transparent about this, the criteria are clear, and providers stick to those criteria, then providers can get those prior authorization requests approved in a timely manner, and payers can meet that goal of ensuring appropriate medication use.

The other side of this is the communication piece. When it comes to denials, there is the possibility that patients get lost in the shuffle, and they end up not filling any drug. That is the exact opposite of what the payer wants. That leads to worse outcomes and higher downstream costs. So, it's not in anybody's interest—let alone the patient and the provider—to have that patient get lost in that prior authorization process. When there is an opportunity for an appeal, providers can communicate with those health plans, pharmacy benefit managers, etc, to plead their case one-on-one with a provider from the payer side. The problem, though, is that communication, from what I've heard, is not always as open as it needs to be, and those opportunities for peer-to-peers are seemingly less available than they need to be.

Overall, I would just stress the need for transparency and giving providers a really good idea of what needs to be met up front, and then communication if that prior authorization is denied to allow the provider to share their side and clarify why a certain drug is the most appropriate, even though the patient may not have met that criteria.

AJMC: How can pharmacists and pharmacy teams contribute to improved access and affordability for patients with MS?

Kheloussi: I think there are so many different roles for pharmacists, especially in the care of patients with MS, to help people get the most out of therapies. They can have an active role in ensuring that patients receive medications in a timely manner, whether that's by helping the patients and providers to navigate that prior authorization process or identifying which medications are preferred on formularies—again, so that the prescriber doesn't necessarily need to prescribe the wrong thing first. If they're between 2 therapies and one is on the formulary and one is not, pharmacists can help navigate that and help the patient leave with a prescription that is going to be covered rather than one that is going to need some additional review. I do think that most of these drugs do require prior authorization, and again, that's an important role for pharmacists to help with that. In an ideal world, pharmacists embedded into these MTDM clinics or within an ambulatory care setting, an outpatient provider, or an outpatient specialist office can help submit those prior authorization requests even before the patient leaves the office that day. They're not going to get an answer right away, but at least they know that they're not necessarily going to have to send the patient to the pharmacy to get that prior authorization denial to then potentially fall through the cracks and delay that process. Pharmacists embedded in those settings can really help with that.

Working with patients on those patient assistance programs is important, as I talked about before, as is coordinating care with specialty pharmacies to ensure that the specialty pharmacies are filling in a timely manner. The other aspects of this that I want to highlight are—and specialty pharmacies play an important role—first, there's this timeframe from when the medication is shipped to when it gets to the patient. There are a lot of things that can happen in that timeframe, and I think the specialty pharmacists and the pharmacists that get embedded in these care coordination roles can play an important role in making sure that the medication is not getting shipped at a time when the patient is not going to be home. They can work around patients’ schedules as much as possible and coordinate with the insurer to ensure that an early refill is available if the patient needs it before they head out on a vacation, or that it's not going to sit on their stoop for days before they get home from vacation or whatever the case is. Even something as small and simple as just making sure that the drug actually reaches the patient is really important. Drugs are not always going to be shipped directly to the patient, so explaining how and when patients can expect to get their medication administered by a health care provider is important, and so is helping patients understand their insurance benefits when it comes to provider-administered medications, since they typically fall under the medical benefit, not the pharmacy benefit. It can also be confusing, because if it's getting filled at a specialty pharmacy and shipped directly to a provider, known as white bagging, there's some benefit confusion that patients can run into there. Making sure that they're not double billed and clarifying some of those expectations is crucial, and pharmacists have roles with that as well.

I would also say that when it comes to the medications, just making sure that patients are being monitored appropriately is so important. We talked earlier about making sure patients understand that the pharmacist is a very accessible and frontline option for them to reach out to with medication-related questions. As it is for any disease, but especially when it comes to these biologic, disease-modifying therapies, it's really important that these patients understand what their options are and who they can call if they have questions, because side effects may not be minor, right? It's important that they understand upfront what they need to do, but also that they have this resource that they can reach out to if they have any questions moving forward.