Brian:

Okay, so we’re going to continue to move along to try to keep ourselves on time here. So, we’re going to move into the second session, which is entitled, “Putting the Patient First.” Our presenter is Paula Bickley, the Vice President, Market Access, Biologics by McKesson.

At Biologics by Mckesson, Paula expanded access to and affordability for oncology therapies, while also developing payer solutions that drove cost-effective risk management and cost-effective patient care. She came to Biologics in 2007 and was an integral part of the team that helped fuel the company’s impressive growth. Throughout her nearly 30 years in health care sales and physician practice management, Paula has focused on business and program development, contracting revenue cycle management sales, and operating strategy development. I’m going to turn it over to  Paula for “Putting the Patient First,” and again, if you have any questions, please submit them and we’ll have a Q&A at the conclusion of the session. Thanks.

Paula Bickley:

Good morning Brian, and thank you. I’m gonna do a sound quality check. Everything okay with sound quality?

Brian:

You sound great.

Paula:

Okay, good, wonderful. Well, many thanks to PBMI today, to today’s sponsors and other faculty. I am welcoming you from wherever you are, whether that’s in your kitchen or bedroom or closet hiding from your kids. I am in the basement of our mid-century brick ranch in Raleigh, North Carolina. You may hear the dryer buzzer go off, you may hear my dog Pete, my nine-year-old dog Pete, chase squirrels as he dreams right here by my feet. But at any rate, I hope today you’ll be able to take away some information from our discussions today that validates your personal thinking and your professional strategy. So this is what I can do. Let’s be real, and let’s get started in just a second.

So here these are the learning objectives we want to touch on today, and while you’re reading these or or finish reading these, I do want to share that there are some overarching themes that that I want you to take away, and and they’re this. Like all providers, specialty pharmacies are highly specialized healthcare providers that have the obligation and unique training to provide high quality cost-effective care. They’re not just lick it, stick it, ship it kind of put-through machines. They really do have to have the expertise and the will and the courage to take exceptionally good care of patients amidst the the many challenges that we’ll talk about today.

I also want to make sure that I weave in a lot of concrete evidence that shows how much value there is, the tremendous value frankly, in providing exactly what the patient needs during their course of treatment. You know, the right treatment provided through very carefully choreographed care care coordination. I want to make sure we understand not only the value to the patient but the value to all the stakeholders in healthcare today. And you know I’ll highlight that, but by providing a very detailed look at specialty pharmacy dispensing workflow and patient care management strategies–

And there’s another thought I want to weave in, and it harkens back to a few of the comments that Alex made in her keynote address today, which I thought was was so good. There is value in, and again I’m gonna gonna try to illustrate that to you today, but I believe there is a business case and an argument that suggests that some of the value that specialty pharmacy provides today is really hidden by how healthcare is delivered, especially in these specialty pharmacy or pharmacy medical mutually exclusive benefit silos. So, let’s get started.

The title of my presentation is “Putting the Patient First,” and I want to really talk about what does that really mean? I mean, that’s a marketing tagline we hear often–patient-focused, patient centric. And I want to go beneath that to really talk about what that means, especially from my point of view as a specialty pharmacy provider. First and foremost, it means getting the right drug to the right patient at exactly the right time. And while that that sounds straightforward, it’s really anything but. There are formidable barriers facing patients and providers that make it difficult to access, afford, and manage these highly complex and high-cost treatments. And again, we’re going to weave through some examples today that quantify that for you and for all of our attendees. Alex made a critically important point earlier when she said that preventing utilization could be a double-edged sword. Are we actually preventing cost, or are we delaying treatment and driving higher costs later?

At the pharmacy I support, to get the right drug to the right patient at the right time takes the unique subject matter expertise of at least 13 [team members] for every dispense. And we’ll talk about who those 13 team members are. Getting the right drug to the right patient at the right time conversely means not dispensing therapy to a patient for which there’s no evidentiary support, therapies that could in fact hasten the patient’s demise. And that is an equally complex and fraught transaction that requires equal significant expertise and, frankly, it takes courage.

Imagine a pharmacist talking to a physician to challenge the basis of his or her treatment decision or to to look for more evidence as to why this is the right treatment for this patient at this time. If that pharmacist is not as clinically expert, or not clinically expert or confident in his or her knowledge, that can obviously be a challenging conversation. Getting the right drug to the right patient at the right time is a complete, complex, carefully choreographed dance that manages a multitude of logistics. Is this oral treatment taken with an office administered IV or some other treatment? Is it a product or therapy that requires cold chain or sub-zero shipping excursions? Is it a product that can actually be shaken or shouldn’t be shaken in route, and so needs to be couriered point-to-point and accompanied by by a courier? There’s just, especially in cancer, which is the therapeutic area that that Biologics focuses on, all those considerations come into play for every dispense, every patient. Putting the patient first means taking good care of their prescriber, good care of the physician who is is coordinating their treatment and recommending and prescribing their treatment in the U.S. health care system today.

There’s a study that reveals that the work it takes an oncology practice to get approval for treatment, to get paid for treatment, to fight denials for treatment; the cost of that, the administrative cost of that, is equivalent to the salary of one oncologist per year. So, that’s what we’re trying to prevent. Keeping that prescription that we receive from a provider one directional, moving forward, letting them focus on the complexities of their own clinical practice and let[ting] us take on the burden and the administrative responsibility to get that therapy to that patient exactly on the date the provider wants it there.

Finally, it means, putting the patient first, means getting to know the patient. Getting to know the patient–where they are, who they are. Establishing trust with that patient over a series of clinical touch points that help us understand where they are going to run into compliance or adherence risks. And we do that before we start to dispense treatment, as we do the workflow that that gets the first dispense out the door. We’ve got specialists who are doing financial and social assessments for the patient caregiver, assessing what’s the relative strength or availability of caregivers for this patient or not? What is their quality of life? Do they understand their diagnosis? Do they understand the goals of the treatment they’ve been prescribed? So, you know, all of that happens really well in advance of the first treatment, of the first pill that the patient takes.

And it really officially starts with a pharmacist onboarding call that I’m going to talk about in more detail as we get deeper into the presentation, but it’s that pharmacist onboarding call where we really get to know what are the barriers for this patient and this treatment to comply? And those barriers are as unique as the patient. Just calling out a few that that we know are big red flags for compliance success: is English their second language? Has the patient been in in treatment previously and is already symptomatic when they start this oral cancer treatment? Again, going back to their their social network, their caregiver network, is it there? Can we engage with those caregivers directly? Can we count on them to be a clinical resource and an emotional resource for the patient? How well does the patient understand the disease? And you know, in a special note, are finances an issue for this patient? Does this patient fear the ability to afford this therapy?

And here’s why this is all so critical. Here’s why putting the patient first is tantamount to creating a healthcare system that we can sustain. Putting the patient first is really designed to address the staggering cost associated with a lack of treatment adherence, with poor compliance, with poor adherence. And then, furthermore, with the reduced productivity, the absenteeism, the presenteeism that our employers face for patients that are diagnosed and initiate treatment for complex disease. These are astonishing metrics.

One-hundred billion dollars in the U.S. health care system today is spent on medication-related hospitalizations, of which nearly 90 percent of it is classified as “avoidable.” It accounts for 1/3 or 2/3s of hospitalizations today. Medication non-adherence may cause as many as six of every ten inpatient hospitalizations. Total cost to the health care system is $290 billion dollars. And this is a study that was first produced in 2018, and work on it continues. And it has to be said for those of our friends in biopharma who are bringing these important and complex treatments to market, it does drive significant financial losses to patients to pharma, for patients that failed to adhere to their treatment regimen or fail to stay on on treatment. So, the the last the last ribbon at the bottom–again, very recently studied–but I think looks at it from a very important provider point of view, and that is the losses from reduced productivity for patients in their first year following a cancer diagnosis. And there’s another. I’m going to pop to another slide in just a minute, but just to sit on this for just a minute. This is this is significant because it’s not just reduced productivity for the patient, but there’s also documented and quantifiable reduced productivity for their primary caregivers, a spouse, a child, a parent.

You know, and even a diagnosis as significant and as threatening as cancer, for which patients should theoretically understand if they don’t comply they could hasten their demise, but the unadjusted medication non-adherence cost produced in 2019 by the British Medical Journal suggests that cancer is among the most costly therapeutic areas when it comes to the financial toxicity. And for the entire system, but for the patient and also just the cost associated with with medication non-adherence. So putting the patient first and helping them adhere to their therapy is is also something that is challenging just given how rapidly the market is evolving, how rapidly the market is changing.

Again, I hearken back to a few of the comments that Alex made, but she talked about the consolidation of providers. The supply channel, the chart on the left indicates since 2010 and through current, the increasing number of newly approved therapies that are coming to market in limited distribution–specialty pharmacies, with five or fewer specialty pharmacies. And that’s perhaps a good thing. It it does consolidate it, does create some consistent data channels. It does centralize data, but it also makes it challenging I think for providers, for patients, when they must get their therapy from a particular specialty pharmacy and coordinate that care with a large number of other providers.

The chart in the middle, again I think dovetails with a number of important points that Alex brought out this morning. And this is the fact that therapeutic areas, and again, therapeutic areas like cancer and other complex diseases are increasingly competitive themselves. Not long ago, this chart is a scatter plot that shows–the size of the of the bubbles are the size of the patient population, the quadrants speak to either the cost or the shipping or treatment complexities, dosing complexities–what’s implied (and there’s Pete, I hope you’re enjoying Pete’s coughing fit). But at any rate, what’s implied as you move from left to right on that chart is just the passage of time. So, in that upper right hand corner, that’s really where specialty pharmacy exists. Those are highly complex, rapidly increasing therapeutic alternatives for small patient populations that are highly costly and very challenging and complex to dose.

It’s in that environment, you know, again just an anecdote about cancer. I’ve been at Biologics for 13 years and have seen probably 50 products that are first in class come to market. [In] 2013, there were no oral treatments available for women with advanced metastatic ovarian cancer. Within 18 months, there were three. And so, as those therapeutic areas become increasingly competitive themselves, pickers tend to drive more aggressive utilization management strategies, step edits. Meaning a patient needs to try and fail one therapy before another therapy is approved. Formulary positions that really drive very high cost and and patient financial responsibility. So really, as those therapeutic areas themselves become flushed with a higher number of treatment alternatives the potential for treatment delay or treatment denial really increases accordingly.

And finally, on that third graphic to the right, and this is not even current, but I talked a little bit about this medical exclusivity between a medical and pharmacy benefit silo. All of us carry at least two healthcare cards, right? We carry our medical card–mine happens to be Cigna PPO–and that’s the card I present when I go to my doctor. If I go to the hospital, if I have a diagnostic test or have physical therapy, I also carry my pharmacy card–in this case, CVS Caremark–and that’s the card I present to pharmacies. My contention is that it is that mutually exclusive benefit silo that, as how health care is delivered today, that really creates significant challenges for patients who require complex treatment. You know, it’s the carve-out model. It’s the carve-out model, where the payer or the medical plan carves out the pharmacy benefit to to another party. You know, it’s the interplay between those or the mutual exclusivity that I think can really drive some potential barriers to patients and also make it difficult for especially pharmacies to really show their value.

You know, so in that carve out model I think PBMs–and this is okay, this is a business strategy, there’s no value judgment here–but you tend to show value by discounts. You tend to show value by lowering the unit cost of healthcare. If you think about that first slide and the significant and staggering cost that’s associated with hospitalizations and other care related to the side effects and the complications of non-adherence, if a specialty pharmacy is doing a clinically expert job or playing a very valuable role in keeping the patient on treatment–keeping them out of the hospital, keeping them out of emergency rooms, lowering the incident rate of the most serious side effects–that’s actually avoiding spend saving money. None of which really at this point shows up on a PBM P&L. And again, I could have quoted from Alex’s presentation most of mine. Really, we need to really drive innovation discussions transparency and real commitment to bringing that value-based concept that, value- and outcomes-based focus over to the pharmacy benefit, just like we’ve done on the medical side for some time.

Putting the patient first is important, and again it requires the unique and collaborative subject matter expertise of at least 13 people, and we’ll talk about who those people are as we go forward. At Biologics and most specialty pharmacies, it’s really the pharmacist that takes the lead all the way through and up to the first dispense. And when they’ve got those first two inches right–when they’ve got those patients onboarded and have explained to them the therapy they’re taking, have explained to them how to take it, what are the side effects to consider, do they understand the goals of treatment, do they do they understand the therapy, and do they understand the underlying diagnosis–and we get that patient started effectively. And we’re going to talk a bunch more about that in just a minute. If they pass the baton once the patient’s on treatment to a specially trained nurse, and there have been many studies that try to that really look at all of the aspects of non-compliance, all of the strategies that that a payer or provider or practice would put into place. And what it comes down to is that the single best predictor of patient compliance is a strong nurse-patient relationship. And so we want, after the patient initiates treatment as onboarded by the pharmacist, we want a nurse to be there that understands their compliance risk and is really working with them to establish trust, to establish goals that help them optimize their management of these therapies.

There’s a study out of the Lineberger Comprehensive Cancer Center run by Ethan Bosch that shows the value in that second ribbon, of what it means to a patient to simply have an outlet, a trained ear, a trained and listening ear to be able to report their side effects and their symptoms. In Ethan’s first study, the patients who were able to establish a nurse relationship to whom they could on a regular basis talk about their experience, they live two months longer. In a study completed by Biologics, in that bottom ribbon, what we found is that if we could make through our nurses tiny adjustments, tiny adjustments in a patient’s care plan, that they would stay on treatment significantly longer and they would manage it significantly better. So again, two of the most important people in the whole specialty pharmacy healthcare provider continuum are that pharmacists who get the patient started those first two inches right and then that nurse who takes the clinical lead from there.

So this could be my conclusion slide, but I want to stop here and just reset. At least what I’ve tried to convey and what the data absolutely validates is that if we can put the patient first and if we can get the right drug to the right patient at the right time, if we can in fact effectively engage, if we understand the patient, meet them where they are, design a customized patient management plan that addresses their very unique combination of compliance risks, we’re going to drive lower cost and we drive better outcomes. And if we could, you know, I’m hopeful and optimistic and, you know, pie-in-the-sky focused enough to say if we could change the paradigm from focusing on the unit of health care cost and instead focus on doing the absolute right thing for the patient, at least when it comes to these very high cost very complex therapies, we’re going to change that paradigm. We focus on doing the right thing for the patient, our contention is, and I think the data obviously supports that, the cost takes care of itself and it takes care of itself through ensuring that patients are taking the appropriate therapeutics, that their adherence is significantly, markedly better, that we are keeping patients on therapy but also keeping them out of the hospital and out of ERs as it relates to the serious side effects that can sometimes emerge. We’ve got data that we’d love to talk about that shows even if patients are placed in a hospital, that we’ve seen their hospital stays significantly compressed when there’s a specialty pharmacy trained nurse who’s part of that care coordination team and continues to support the patient even during their hospital stay. And finally, I think our patients overall have a much lower incident rate of those most serious side effects.

So, PBMI asked me to do a little bit of a deep dive into the dispensing workflow, and admittedly this is a bit high level, but I think I’m looking here for similarities and consistencies obviously across the specialty pharmacy continuum. But admittedly, much of this is what I know best, and that’s what we do at Biologics for our cancer patients and our complex care patients. But the first step actually happens long before the provider submits a referral to Biologics, and that’s the work that happens when a specialty pharmacy has a specially trained group of provider-facing liaisons that teach them what specialty pharmacy is, that teach them how to originate a complete referral, and that’s a very complex transaction. The prescription is just one of many things that a specialty pharmacy may need to see in order to advocate for the provider’s treatment decision and keep that referral one directional, moving forward. They need to see clinic notes, they need to see the evidentiary support for the treatment, they need to understand the treatment history, see actual lab studies, scans, genetic mutational studies. Those are the kind of things that we need to see when we get the prescription or the order so that we can start that process immediately to understand what it’s going to take to get approval for and to get that product in the patient’s hands as quickly as possible.

These liaisons also teach providers about the various access channels that that come with all these different therapies, and our provider-facing liaisons, and again that these are prevalent and in many specialty pharmacies they’re going to intervene on some of the most complex orders and be a go-between to to find someone in that practice that the pharmacy can connect with to make sure we’ve got what we need to move forward. So again, it starts to emerge long before we get the order, and it’s really the important first step to getting the right drug to the right patient at the right time.

Once we’ve received the order, we need to move quickly. We need to be efficient. We may need to move quickly, so our referral receipt and intake is designed to make sure we’ve got what we need to keep the the prescription moving forward, to keep it one directional, to advocate on the provider’s behalf. And we get that done within an hour, and if it’s not all there or if we don’t have what we need, including down to the ICD-10 code we’re going to be back in touch with that practice. That’s really the first important QA check done by a certified pharmacy technician to really make sure that we’re not going to run into any barriers later.

Once we have got a clean referral and it’s complete, we move it into the benefit investigation, the benefit verification team. And they are unique team made of two very critically important experts. One is especially designed to work through the payer’s prior authorization process to submit that first request to make sure that it’s complete, to make sure that it’s appropriate, to make sure that it includes all of the information that the payer has typically asked for for that therapy. It’s where we find out the very first time what the patient’s financial responsibility is going to be and it’s at that point we communicate that back to the provider to make sure they are comfortable with our benefit investigation results, benefit verification, and do we have a go and a green light at that point, to really start talking to the patient, because that’s where we need to start engaging with the patient.

Our patient patient access specialists are trained to do very careful, very comprehensive financial assessments to make sure that the patient, to really understand the limitations of the patient’s ability to afford what are sometimes very formidable co-pays. There’s a study done by CMS that at five hundred dollars–and I actually think this is high, I’m surprised it’s this high in the real world. At Biologics, we see the dollar amount that presents a significant barrier much lower than that. But at $500, CMS confirmed that one out of every four patients decides not to initiate treatment. So, in addition to the patient access specialists who are working directly with payers to to get those prior authorization discussions moving and resolved, we’ve got a whole other group of folks that all they do is talk to the patient about the financial implications of their treatment and secure any financial agreements they may need, whether it’s by the manufacturer or through one of the non-profit copay funds for copay foundations to help mitigate and lower their overall cost.

And I did a little bit of a prelim of that, but again, following that initial benefits investigation and benefit verification, the real work to get approval to dispense happens. And it’s happening on very clear and consistent work streams both to address affordability barriers as well as administrative barriers by the payer.

That high touch dispense is really where we move the the referral the prescription from our front line teams into our oncology or complex care pharmacy clinic, and it’s really here where the pharmacists, the nurses, the certified pharmacy technicians really become the lead to get that first order out the door to the patient. And if we’re able to do that, there’s an important day zero conversation that happens, and I talked about it later, and again it’s it’s where the pharmacist is getting the first two inches of their ongoing specialty care right. And on day zero, number one pharmacies are not going to dispense product in most cases until they’ve absolutely confirmed where the patient is, what the shipping logistics are, when the patient will be home to accept the package. These, again, these are highly complex, very sensitive, sometimes cold chain shipped products, and so we really need to make sure there’s somebody waiting at the end of that dispense, at the end of that shipment journey to accept that package. But we also during this shipping logistics transaction set up what we call the day zero pharmacist onboarding appointment, and that’s when the pharmacist again talks through all those dimensions that I mentioned earlier. The goals of treatment, the underlying diagnosis, how to take the treatment, what are the likely side effects of the treatment, when to dose, how to dose, tips on dosing. But it’s also here with a where they complete this risk assessment I’ve alluded to just a couple of times, and it’s that risk assessment across multiple dimensions that is trying to essentially score the patient’s ability to comply. That score then drives the frequency, the content, and the goals that our specially trained nurses deploy as they support the patient once treatment begins.

And so as I said, I mean, the data and the studies are clear. It’s one of the most important, if not the most important relationship that a specialty pharmacy patient can have during their episode of care. It’s the person who educates, assesses their progress, establishes goals, teaches them again these ongoing tricks to to really comply. I mentioned one of the PARP inhibitors that came to market in 2013, and it was initially formulated with 16 pills a day, eight pills in the morning and eight pills at night, big pills. Nothing wrong with it, amazing treatment, and obviously much needed treatment for women who had already gone through multiple lines of treatment–chemotherapy, surgery, radiation treatment–for their metastatic ovarian cancer. But these patients were tired and again symptomatic from previous treatment, so a lot of what our nurses did when that product was first available, that therapy was first in their hands and they were initiating treatment, is teach them kind of unusual head positions–lower the chin to to be able to open up their throat and swallow these larger than normal pills, take it with milk to help really make the process of swallowing easier to create some viscosity–I think of it every time I have to take an Advil. My tendency is to throw my head back but really I think of our nurses’ voices and I drop my chin, and it really is much easier to take even an Advil at that point.

And finally, you know, specialty pharmacy specialty care, oral complex cancer treatment, complex care, multiple sclerosis treatment, I mean, any therapeutic area, it’s a long slog. Patients are on these therapies living longer, taking these therapies perhaps for the rest of their lives, and some of the side effects may not emerge until three or four or five cycles along, and so it’s it’s critically important that the ongoing care driven by the nurses, our certified pharmacy technicians, and our pharmacists really recognizes that high compliance in the first two cycles doesn’t guarantee strong compliance throughout the entire course of treatment. One of the things our certified pharmacy technicians do every month is a pill count on day 23 as we’re planning on and working towards the work it takes to get their next fill out the door. If they even are going to have a next fill, they’ll do a pill count, and it’s that pill count [that] is critically important to know whether the patient is actually complying with treatment. If the pill count is too low, you may have a patient who says, “One pill makes me feel great; I’ll take two.” If the pill count is too high, you may have a patient who’s starting to take half the dose to extend the treatment. And obviously those are critically problematic treatment issues in ongoing complex cancer care. Non-compliance with therapies can actually increase resistance to the disease for some therapies, and certainly there are studies to that effect. And those of you who are on the call who are clinicians who are involved in taking care of patients certainly know that sometimes it is documented that non-compliance can actually drive disease resistance. So those pill counts are critically important, and they are always a trigger to refer at that point the patient back to our pharmacist, who will obviously reach out to their oncology provider, their complex care provider, and make sure there hasn’t been a dose change, and make sure that this patient is still moving forward with treatment. What it also allows us to do is reset the the dispense and the refill date so that we can allow this patient to deplete the inventory of treatment they have on hand before we send out another dispense, so that’s that’s clearly an in obvious cost savings and avoided an unnecessary medical spend that we’ve been able to achieve through what’s a seemingly simple conversation.

So coming to the end here, and just want to again talk through and recap on some of the main points that I spoke to throughout the presentation and then give us time for some questions and answers. I did say, I said early on that taking care of each patient and every patient requires the unique and collaborative subject matter expertise of at least 13 individuals, and if you look at the upper right hand corner, biopharma and payer experts, my job at Biologics is to work with payers, is to negotiate contracts that give us access to patients through their specialty pharmacy networks. My partners on the biopharma facing team are actually responsible for getting access to these products. We call that the barbells of patient access. We have to have access to the products, we have to have access to the patients in order to really serve those patients. It goes far beyond that, though. We are students of the industry. When we are supporting the launch of a new product, we are deeply knowledgeable and deeply aware of the clinical aspects of that treatment, of the therapeutic landscape that that treatment is entering, of the potential access challenges of the patients who would be likely candidates for these therapies and the providers who are likely giving care to them already. So we have to be students of the industry. I talked in detail a moment ago about our provider-facing liaisons. Again, their primary job is to teach providers how to work effectively with specialty pharmacy and their main goal is to have the providers build an outward mindset among our prescriber base. Think about what Biologics or any specialty pharmacy needs when they receive a prescription, if they’re going to compress the time from referral to treatment initiation, if they’re going to advocate on the provider’s behalf, if they need to speak to somebody, if they need to speak to Jane and Jane’s on vacation, who knows what Jane knows when Jane’s not there.

Again, I talked a lot about our intake and patient access specialists, and their job is to get prior authorization for these therapies so that we can dispense on the provider’s behalf and then understand what the patient’s financial challenges are and do all possible to help mitigate those, to help defray the cost. Our clinical care team, I hope I’ve been able to speak to the role of the pharmacist in getting those first two inches right and getting patients on therapy and taking and handing the baton off effectively to our nurses so that they know before they even engage with the patient what challenges that patient’s going to have based on these risk assessments that our pharmacists do. Our patient care coordinators mention them briefly, not by name, those are our certified pharmacy technicians who are responsible for making sure that the patient gets their refills with no delay in treatment or doesn’t get their refills if there is no continued treatment or doesn’t get their refill until they’ve depleted the inventory they have on hand if there’s been some kind of dose modification in early cycles. So, they’re critically important to the patient and to obviously the overall healthcare ecosystem to avoid unnecessary spend and business intelligence they’re our data team. And again, I hearken back to some of the points that Alex made, which I think are very compelling. They are collecting a tremendous amount of data that helps all of us understand what does early therapy adoption look like, what is the payer response to these therapies, where is the variability in treatment sequencing from one cancer center to another, one region to another, is that important, is that significant. They do a lot of data collection for our own internal continuous improvement process to allow us to shave time off our prior authorization workflow to take even more time out of the dispense time frame, and they they also are primarily responsible, and again Alex mentioned this as well, they’re aggregating data that documents the relative safety and efficacy of these newly approved therapies once they’re available in the market.

So 30 seconds to close, and then I’m happy to take as many questions as as we have out there and happy to hear your responses and your feedback and to have you challenge some of the information I’ve presented today. But what I’d love for you to take away is that while putting the patient first centricity, patient focus, are ubiquitous in healthcare today, I’d like for you to understand at least from the specialty pharmacy perspective that we don’t consider that a marketing tag line. It’s rigor and discipline and continuous learning that helps us get the right drug to the right patient at the right time, and once having done that help the patient manage the therapy to optimize their outcome, whatever that means. And it doesn’t mean continuing them on treatment if they’re showing no clinical benefit. Those decisions happen every day just like the decisions that happen to try to keep the patient on therapy. Especially pharmacies work on highly specialized dispensing platforms collecting very important sentinel data that helps them understand the patient experience, helps them understand the the relative safety, I said, and efficacy of the therapy as it is available to patients for the first time commercially. That they understand whether or not they are impacting the patient’s care treatments. Do we understand what a patient would have done, what would their alternative care decision have been, if we had not been able to speak to them, to talk to them about managing their side effects. And finally it recognizes that our health care system today has a lot of inherent conflicts. There are inherent conflicts built in between providers and payers, biopharma and payers, biopharma and patients. But it recognizes that each of those stakeholders has a strategy, deserves to drive their strategy, has their own unique subject matter expertise, and at the end of the day, if we partner effectively, has the ability to influence the care that the patient receives. They have the ability to influence whether or not the patient successfully completes or manages the course of treatment, so I hope you’ve found some nuggets today that you can think about as you go back to your work and your responsibilities, but I do thank you very much for your time today and would be happy to take your questions. Feel free to contact me; I want to continue the conversation for those that are interested and feel strongly about some of the information I’ve presented today, and I did include the study attributions for most, actually much, of the data that I presented. So at this point, I’ll turn it back to Brian and see whether or not we’ve got some questions from the audience.

Brian:

Great Paula, thank you so much. Actually, we do have a number of questions. First one is from a pharmacy perspective. Can you think of a scenario that you’ve encountered where the patient was not put first and how the specialty pharmacy was able to kind of jump in and assist and change that dynamic again?

Paula:

Poor Alex, thank heaven she went first because I was rethinking a few points. I mean, I didn’t rethink the content of the presentation, but I certainly thought of a few things I wanted to to parallel with hers. I go back to that statement, “Treatment,” let’s let’s see if I can quote her word for word. “Treatment,” somebody help me here. Let me go back. Alex made a critically important point. “Preventing treatment utilization is a double-edged sword.” And I’ll learn how to pronounce that word, if I ever have to say that again. Is the system preventing cost or delaying treatment that will generate higher costs later? So I talk about the the prior authorization process and the, you know, the challenges that come with that, and frankly I think those are important intersections in a patient’s care prior authorization. And the ability for the payer to weigh in presents a pause that allows all the stakeholders to really align. Is this the right care for the patient, is this the right time? So I do not resent or or believe that prior authorization is inappropriate in high-cost specialty care, but it is not always a straightforward conversation. And if if we have not done the work, we need to encourage and compel the provider to be very clear about their treatment decision and to be very strongly an advocate of their treatment decision. And if the evidentiary support is there and we still can’t get a PA approved, I think that’s a challenge, because I think what can happen is the patient may not initiate treatment. The provider may have a sense of learned helplessness. The provider may not be quick to recommend that treatment for the next appropriate patient, and we may very well be creating some downstream cost that we don’t anticipate. Again that’s a little theoretical, but I’ve seen us fight through those barriers enough with that framework in mind.

Brian:

Okay, another question that came in. Your chart showing the increase in the number of specialty orals available in limited pharmacy distribution distribution is interesting. Can you speak a little more about why that trend is happening? What are the benefits to patients, pharma, and other stakeholders within a limited distribution model?

Paula:

Yeah, I’ll pop back to that slide if that’s okay. I’m sorry, there it is right? There it is. Yeah, so I think I’ll speak to it from my point of view, but again in the panel today I’d love to hear others weigh in on this. I do think that because many of these highly complex and toxic treatments come to market with the rims, that’s a federally mandated risk mitigation strategy that requires the pharmacy to be certified and trained especially on how to dispense and keep patients safe on these on these treatments. So I think keeping a tightly held network of certified clinically expert pharmacies, I think is an important consideration for some of these products that come with FDA-mandated rounds Alex’s point. And we just, we cannot shy away from it. We have to be transparent about this. A tightly held specialty pharmacy network drives better, more actionable data for every stakeholder in the healthcare ecosystem, but especially for biopharma. So our ability to understand the post-market, the post-clinical trial, how these products are being adopted once they’re commercialized, how these products are being taken, what are the treatment variability, the sequencing variations, from cancer center to cancer center or from region to region, what is the payer’s response to these newly approved therapies. You know, those those smaller networks are held to a very high data standard, and they’re held to a very high treatment standard. All of the programs that we support, for which Biologics is one of a limited number of specialty pharmacies, we are held to extraordinarily high key performance metrics, KPIs, service level agreements, about how quickly we get patients on therapy, about our documentation of adverse events and the time frames and the guardrails around that. So I think it’s a safety mechanism, but I think it drives better quality and understanding of the patient and provider experience and the therapeutic experience once it’s available commercially.

Brian:

Excellent, and we have time for one more quick question, nice easy one. Did Diologics conduct the 2018 adherence study?

Paula:

No, no, no, no, no, no sir. The study about the 290 billion dollars in annual cost for related to treatment non-adherence?

Brian:

Yes.

Paula:

Is that one? It’s a multitude of studies. Express Scripts played a role in it, Kaiser played a role in it. It’s a bit of a meta-analysis pulled from a variety of study sponsors in that year. And I did include the study attributions in the last slide, so happy to make that available. And please feel free to email me if anybody would be interested in seeing the complete studies. And I’m sorry, I hope I’m not making your eyes bleed. I’m trying to get back to that to that slide.

Brian:

Not a problem. Thanks, Paula, we’re right up at five minutes to the hour, so we are going to take a five-minute break and we will continue with our panel discussion at the top of the hour. And as I mentioned earlier, please keep the questions coming, and if we can’t get to everything we will use the final session of the afternoon in the panel to address any questions that we don’t get to. So thank you once again, and we’ll see you back in five minutes. Thanks.

Video link: https://players.brightcove.net/10203567001/ypowsehlI_default/index.html?videoId=6204789731001