Rebecca Willumson:
Hi there. I'm Rebecca Willumson. I'm the publisher of Fierce Pharma, and I'm joined today by Corey Ford, Senior Director of Patient Access Strategy at Xcenda and Colleen Cummins, Product Director at Lash Group, focusing on affordability services, both of which are a part of AmerisourceBergen. So today we're going to be discussing the importance of affordability for patients, specifically as it relates to copay solutions. So Corey and Colleen, thanks so much for joining me today.
Colleen Cummins:
Thank you for having us. Excited to be here.
Rebecca Willumson:
So before we dive in, can you each share a bit about your background and your current roles?
Colleen Cummins:
I'm Colleen Cummins, Director of Product Management, focusing on Lash Group's affordability services. I've been with Lash Group for about a year and a half, and I've been working in patient support services for about 10 years. As the Director of Product Management for Lash, the affordability space encompasses a whole range of offerings, from copay, patient assistance, free goods dispense and fulfillment. My position really is focused on looking future thinking. So where is the industry going in the next two to five years? And how can we react, prepare, and plan for that?
Corey Ford:
Great. Thank you, Colleen, and thank you, Rebecca. I'm Corey Ford. I'm a Senior Director and I lead up Xcenda's patient strategy or patient support strategy team. At Xcenda, we are the consulting arm of AmerisourceBergen. Given our focus on the patient access space, we work very closely with our colleagues at Lash Group on these programs. We help our clients create the strategy for their patient support program, and we provide a specific lens of what's going on externally in the broader healthcare landscape as it relates to healthcare policy, what payers are doing. And then once that strategy is complete, we turn it over to the Lash Group to help operationalize. I've been doing this now close to 15 years, and I'm very fortunate on a day in and day out basis. Able to marry a love of healthcare policy with a passion for patient access and just very thankful for the opportunity to speak with you today.
Rebecca Willumson:
All right. Well, thank you both. Corey, let's start off with you. We know that affordability is a key barrier for patients to access therapies. Can you discuss the current state of copay and why it's a topic that's top of mind for a lot of people right now?
Corey Ford:
Yeah, absolutely. So affordability is a pretty significant topic in the United States today, and there's really reasons for that. The first is really trying to get a sense of what the financial state of Americans are in the United States today. We know that we're coming out of the COVID-19 pandemic, and a lot of Americans are struggling financially. Prices are rising. Consumer confidence is going down. There have been a number of surveys out there that have really tried to gauge what this has meant for Americans. I mean, there was one survey that found 72% of Americans reported that they were financially unhealthy. Another one found that close to a third of US households stated that they could not afford an unexpected expense greater than $300. I think this just demonstrates the financial vulnerability that a lot of patients are having right now within the United States.
I think the second thing to look at is what commercial payers have been doing, as they've been placing more and more of the financial burden onto patients. This has been going on for a number of years now. We've seen higher enrollment into high deductible health plans. Once a patient has navigated or exhausted a deductible, the out-of-pocket costs can be high as well, particularly for specialty and high cost medications. For those drugs that may be administered by a physician in a healthcare setting, that cost can be 20% of the price of a drug. On the pharmacy benefit side, if the drug is accessed from a retail or specialty pharmacy channel, then those costs can be even higher.
The Kaiser Family Foundation was founded in 2021. The average co-insurance for specialty medications on the pharmacy side is 27% of the cost of the drug. On the individual side, market side, it's even higher. We've done some analytics of the exchange market and found that a lot of this cost sharing can even eclipse 40% of the cost of the drug. Now, the Affordable Care Act did institute and implement out-of-pocket maximums, which then require that plans cannot charge a patient anymore from an out-of-pocket standpoint once a patient has hit a certain threshold, but these have been creeping up on an annual basis as well. So when you take both of these major trends into account, it can have a pretty significant impact on patient adherence to medications. We did a study several years ago at Xcenda that found once you get to a cost of $25 for an out-of-pocket expense, medication adherence can start to decline by upwards of 10%, and as costs get higher, that rate gets higher as well.
Rebecca Willumson:
So Corey, following up on this, can you describe the copay landscape a bit more and what manufacturers can expect over the next year?
Corey Ford:
Yeah, absolutely. So I think the copay and affordability landscape has really been volatile in the last few years, and it's really spurring on this move from more of a traditional copay model that was focused on, it was a transactional based model, to more of a patient centered one that is incorporating more financial services into it. That traditional copay model looked like, again, as I mentioned, it was focused on transactions. It was focused on managing the eligibility and the value of each transaction. Manufacturers I think really understood this particular model very well, but it was commoditized. Really cost differentiator or the cost of the programs was the differentiator. But now we're seeing this move where the models are now focused more on patients and their ability to pay with a more holistic view of financial wellness. It's really trying to optimize the patient experience.
There's been a couple of reasons why we're seeing this transition occur. The first again is going back to what commercial payers have been doing. They have been implementing over the past few years, some pretty restrictive models on the copay assistance that pharmaceutical manufacturers may be providing. And what these models do, you may have heard of them, they're called copay accumulators or copay maximizers, they allow a patient to utilize copay assistance, but whatever the manufacturer is contributing, it is not included in the patient's out-of-pocket cost calculation for the purposes of navigating the deductible or hitting that plan out-of-pocket maximum. So this can be a pretty significant problem if the patient exhausts what the manufacturer may allow in a given year, but they're still well short of hitting their plan's out-of-pocket maximum. So what do they do in this gap of time when they have to maybe pay hundreds or thousands of even dollars out-of-pocket for these drugs?
The second thing that is really spurring on this move as well has been a relatively recent regulation from the federal government that is putting more the onus, the responsibility on manufacturers and industry to ensure that the full copay benefit goes directly to the patient, that they can mitigate the impact of copay accumulators. This will go into effect in 2023. So given these two major trends, what payers are doing and what we're seeing on the regulatory front from the federal government, it's spurring on this move to the more patient centered model that is incorporating some of these financial services.
Rebecca Willumson:
All right. Thank you. Now Colleen, expanding upon Corey's comments on the 2023 CMS copay rule, could you discuss the importance of this regulation on patients and on copay programs?
Colleen Cummins:
Absolutely. Corey did a great job of building a foundation there, so I'm happy to launch off of it. The CMS rule scheduled to go into effect on January 1st of 2023 essentially states that manufacturers must ensure the full benefit of their copay assistance is provided entirely to the patient and that no pharmacy, agent or other entity receives a price concession. That's a very heavy weight to bear for any manufacturer, when we think about how plan benefit structures have evolved today, lack of transparency and visibility that manufacturers have into how those funds are being applied within those benefit designs. CMS has stated that by not applying manufacturer assistance to patient deductibles and out-of-pocket max calculations, those funds provided by the manufacturer become more akin to a discount to the plan, which is not what manufacturers are intending when offering cost assistance to patients.
Colleen Cummins:
I think when we think about those patients, as manufacturers and as an industry, it's important that we recognize that there is inevitable change coming for these patients, whether that be changes in operational program design benefit caps, which patients are often very familiar with, whether it be the introduction of alternate payment methods or new ways of accessing copay funds. I think that recognizing the impacts that those change on patients and being proactive in the way that we address that to help them navigate those changes is going to be very critical.
Rebecca Willumson:
So Colleen, what type of impact do you see this having on patients who are trying to gain access to their medications?
Colleen Cummins:
As Corey mentioned, the cost sharing burden has significantly shifted to the patient in recent years. We see more high deductible plans today. We see patients expected to pay more out-of-pocket for medications, as the prevalence of specialty products has risen. Our American population does not feel financially healthy. A large portion are worried regularly about how they're going to afford their healthcare, and many patients rely on manufacturer funded assistance to afford those medications. The patients who are using this manufacturer assistance, they're very comfortable with the program designs as they are today. So as those program designs change, adherence to therapy is going to be a really important aspect. Patients oftentimes, when they can't afford their medications, simply stop filling them. So ensuring that patients are aware of the new program, aware of how they access their funds, and are comfortable going into this new wave of change is going to very much help that potential drop off or the potential access issues that may be posed by introducing changes to patients who are not quite ready for them.
Rebecca Willumson:
So Corey, going back to you, with the new 2023 CMS rule, what can brands and manufacturers anticipate?
Corey Ford:
That's a great question, and I think Colleen did a fantastic job of laying out just what the imperatives are in front of industry right now. What they can anticipate, if they're not already anticipating, is that it's a new world in terms of the financial assistance and copays specifically what they're providing for their patients. Manufacturers are now going to have to re-shift their thinking. And again, as I mentioned, moving from this traditional model to a more patient centered model that's incorporating some of these new financial services. Essentially what this means is manufacturers are going to have to ensure that this copay benefit, that the funds that they are going to be providing are being conveyed to the patient, so to speak, before it's even going to be used at a retail pharmacy, in coordination with a specialty pharmacy or even at a provider's office.
Corey Ford:
So this is going to put a required additional patient participation during the enrollment process within the copay program to ensure that the accounts that may be set up now are properly established. I think we may see the emergence now of new payment channels. Some that may be like a debit card or a direct push pay. They are becoming much more relevant and solutions now to mitigate the impact of copay accumulators. This is kind of the thinking. This is what manufacturers now have to embrace, this new world and these new approaches, if they are going to fulfill the requirements that Colleen mentioned regarding the rule from CMS, not only to fulfill those requirements, but to try and mitigate the impact of copay accumulators and what they have been doing and what their impact is on patients as well.
Rebecca Willumson:
I have a final follow-up question for both of you. What are some key action steps that manufacturers can take now to help plan for these changes?
Corey Ford:
It's a great question. Both Xcenda and Lash Group and AmerisourceBergen more broadly, we have been helping a number of our manufacturer partners within this space. Really the way that we are thinking about this is from a short term and a long term perspective. Short term is getting ready for 2023, trying to be in compliance with this rule, finding the right solution to make sure that you are meeting the requirements of the rule. But it even goes beyond that, not just the right solution, but it's also modeling the financial impact, as Colleen mentioned, really trying to get a sense of what these new models, what the regulation, what it means from a financial perspective for your copay programs, so that you can be prepared to appropriately and adequately philanthropically support your patient population into the future.
From a longer term perspective, it's really trying to get a sense of where commercial payers are going to be going in terms of these strategies that we've mentioned. And it's also engaging the patient advocacy community as well, as they've been some of the ones who've been on the front lines in trying to educate and influence policy makers on this topic.
Colleen Cummins:
I would agree with Corey. What we've seen so far is a focus from manufacturer partners on the financial analysis and the impact. So what does this mean to me today if I do need to improve my copay assistance in my best price, my AMP calculations? What is that gap that I need to fill? I think the next wave and the real attention needs to be on those operational changes, whether it be new payment methods, new eligibility criteria, but ways to restructure those programs to more future proof and safeguard them as we move into 2023 and as we proceed forward.
Rebecca Willumson:
All right. Well, that feels like a perfect place to wrap up. Corey and Colleen, thank you so much for joining me today. I think this was great conversation.
Corey Ford:
Thank you so much, Rebecca.
Colleen Cummins:
Thank you for having us. It was great to be here.
The editorial staff had no role in this post's creation.