Rising Costs in Idiopathic Pulmonary Fibrosis Care: The Need for Cost-Effective Care

In this video, Dr Volkmann will explore the full scope of IPF-related expenses, including inpatient and outpatient care, emergency department visits, and medication costs, while also addressing the broader societal impacts such as loss of productivity and caregiver burden.

Learning Objectives: 

• To understand the full scope of direct and indirect costs associated with IPF, including inpatient and outpatient care, ER visits, and medication costs as well as loss of productivity and societal impacts.  
• To explore the value of current and emerging therapies for IPF and identify opportunities to optimize patient outcomes while reducing the economic burden on healthcare systems.  
• To examine existing and future frameworks to accurately capture the value of IPF treatments, with emphasis on patient-centered approaches and real-world evidence.

Presenter:

Elizabeth Volkmann, MD, MS 

Dr Elizabeth Volkmann is an Associate Professor in the Division of Rheumatology at the University of California, Los Angeles, where she serves as the Director of the UCLA Scleroderma Program and the founder and Co-Director of the UCLA Connective Tissue Disease-Related Interstitial Lung Disease (CTD-ILD) Program. Her research focuses on the identification of novel biomarkers that predict response to ILD-targeted therapies. Dr. Volkmann endeavors to develop personalized treatment algorithms for patients with ILD grounded in solid translational science. She also has an enduring interest in exploring how the gut microbiome contributes to the pathogenesis of ILD and systemic sclerosis. 

Video Transcript:

Dr Volkmann: Hi, everyone, and welcome to this webinar on Rising Costs in Idiopathic Fibrosis Care: Insight into Health Care Resource Utilization and the Need for Cost-Effective Care. My name is Elizabeth Volkmann, and I'm an adult rheumatologist at the University of California, Los Angeles, where I care for patients who have interstitial lung disease due to very different causes, including autoimmune lung disease. And these are my disclosures. 

The learning objectives for today are to, first of all, understand the full scope of direct and indirect costs associated with idiopathic pulmonary fibrosis, or IPF. And this includes both inpatient and outpatient care, emergency department visits, medication costs, as well as the loss of productivity and societal impacts. We'll also explore the value of current and emerging therapies for IPF—and this is actually a very exciting time in clinical development for this disease—and identify opportunities to optimize patient outcomes while reducing the economic burden on health care systems. Finally, we'll examine existing and future frameworks to accurately capture the value of IPF treatments with emphasis on patient-centered approaches and real-world evidence. 

So, let's jump right in. We'll start to set the stage with understanding IPF. This is a rare disease but has a growing prevalence and a disproportionate impact on health care systems.  

So, IPF is a chronic, progressive fibrosing interstitial pneumonia that is of unknown cause. And it falls under the umbrella of idiopathic lung diseases. While IPF is rare, as I mentioned, the prevalence has been increasing worldwide. And this is why the early diagnosis of these patients is quite crucial for effectively managing them because they are likely to progress rapidly. So, the earlier you can guide those patients, the quicker you can intervene. But unfortunately for many of these patients, because IPF is a disease that occurs at older age, many of these patients will have comorbidities. And these comorbidities can include things like pulmonary hypertension, obstructive sleep apnea, cardiovascular disease, as well as reflux disease. And, as you probably know, the symptoms of these comorbidities can overlap with some of the presenting symptoms of IPF. And these symptoms include a persistent and dry cough, fatigue, shortness of breath, and even digital clubbing. So, again, because of the presence of these comorbidities and the overlap in the symptoms of the comorbidities with IPF, this can lead to delays in diagnosis. And because of this, IPF is associated with significant morbidity and has very poor survival.  

Unfortunately, over the last 10 years, there hasn't been significant progress in developing new therapies for IPF. About 10 years ago, two pharmacological options were approved. One was nintedanib or Ofev®, and the other was pirfenidone or Esbriet®. Both of these antifibrotic agents were demonstrated to slow the annual rate of decline in the forced vital capacity or the FVC, as well as prevent acute exacerbations. Unfortunately, no studies, however, have demonstrated that they alter disease progression, nor do they provide a meaningful improvement on survival or quality of life. In addition, the uptake of these medications has been rather low, and this is in part because of high copays, as well as side effects and payer utilization management restrictions. In addition to the pharmacological options that we have available for IPF, there are some important nonpharmacological options as well, and these include lifestyle changes. So, this would be smoking cessation, weight loss, important vaccines, vitamins and supplements, reflux management. Other nonpharmacological options include pulmonary rehab and oxygen supplementation at palliative care, which we'll talk about later in the talk. And then, for some select patients, lung transplantation may be an option. 

But beyond the drug costs, there are real drivers of IPF economics. And this includes the hospitalizations that patients have to endure, the multiple emergency department visits, and the late-stage care that are contributing to the rising costs. So, these are costs unrelated to the pharmacological options.  

So, what I mean by this is that IPF imposes a high economic burden, not just on patients, but even on health care symptoms. This is because these patients require a well-resourced multidisciplinary health care team. So, they don't just need pulmonologists, they need a lot of other specialists to care for them. They also need regular and routine monitoring. So, they're coming to the clinic many times over the course of a year, not just to see doctors, but to undergo testing. These patients will have repeated hospitalizations due to things like IPF exacerbations, but they're also more susceptible to pulmonary infections. And so, they can have hospitalizations for infections and other things that can happen as a result of them having IPF. And then, as they approach end of life—for example, a patient who, let's say, is not eligible for a lung transplant and who has progressive disease—they will need a lot of support around this time. 

IPF is associated with direct health care costs, which as I mentioned, include these inpatient hospitalizations, emergency department visits, as well as the outpatient care and monitoring, and then medications. And there’s actually real-world evidence to support these cost descriptions. So, there was a systematic literature review of 88 studies published between 2000 and 2017. And in this study, the annual per capita cost of patients with IPF in North America was estimated to be approximately $20,000. This is actually two-and-a-half to three-and-a-half times higher than the national health care expenditure. So, this is a significant cost burden for patients. And I would say that, for some patients, it's even higher than $20,000 a year. There was another systematic review of US-based cost studies published between 2000 and 2020. And, in this study, the mean direct medical costs ranged between about $23,000 to over $100,000 annually per patient with IPF and other fibrotic ILDs. And the direct costs seemed to increase after 2014, likely because that's when the antifibrotics became the standard of care. For the two IPF studies with study periods after 2014, the mean annual total cost per patient was $83,000 compared with $27,000 before 2014. So, the medications here are really contributing to the large increase in cost burden.  

Inpatient care is also very costly, and this is common even within the first year of a patient being diagnosed with IPF. So, inpatient costs relate to emergency department visits, as well as any kind of hospital stay. And these patients commonly require ICU level care because of their oxygen needs. And this is the highest level of care that a patient can receive in a hospital. So, as you can imagine, it's quite costly. If you think about all the resources that are needed to maintain and care for a patient in the ICU, this is why it's so much money for patients to receive care in this type of acute care setting. There has been a prospective review of data from an IPF Prospective Outcomes Registry. And in this study for recently diagnosed patients, there was a 30% probability of hospitalization at 12 months of follow-up. And this study included 300 patients. The mean annual costs for ICU admissions and inpatient care were determined to be between roughly $10,000 and $13,000, respectively, per patient. And you can see here in the table the different variables that went into the average resource use and cost per patient during this 12-month follow-up period and how the number of hospital days itself was a large contributor to the overall cost. So, I would say that many of these patients have frequent hospitalizations often requiring ICU level care, and the length of their hospitalization can be a big driver of the overall cost.  

End-of-life care occurs in these patients. And, typically during this time, a patient will require frequent hospitalizations, often in the ICU, and this can add to the overall cost burden. So, patients with IPF spend up to 15% of their last six months of life in the hospital, and 80% of end-of-life care actually occurs in the hospital setting. Unfortunately, palliative care, which can be a great resource for patients with IPF, is rarely implemented at earlier stages of the disease when it can probably be most impactful. And because it's rarely implemented at all, this can lead to high symptom burden, health care resource utilization, and costs. So, the reason why the end-of-life care becomes so expensive is that the patients just have a higher and higher symptom burden. And, again, because palliative care is not implemented early on, the symptom burden is not well controlled. And this can, again, lead to patients coming to the hospital more. In a retrospective analysis of the Medicare database, all-cause end-of-life costs for Medicare beneficiaries with IPF in the last three months of their lives was 3.6 times the quarterly average for initial and continuing care costs. And, again, this was largely driven by high rates of hospitalization. And, in the table below, what you can see is the overall respiratory-related utilizations and costs for these different categories. So, you can see that the end-of-life care costs, which is the first row there, really comprises the majority of the costs. But there's a lot of other remaining outpatient costs that also contribute, again, to the high-cost burden of the end-of-life care for these patients.  

Productivity loss also contributes significantly to the indirect costs of IPF. So, for example, there was a Canadian study that looked at patients with fibrotic ILD, and this study had 650 patients, and only 23% of eligible patients in the study were employed. And among those, over half reported productivity loss averaging approximately 7.8 hours per week. The things that contributed the most to productivity loss were symptoms such as dyspnea and cough. These can be really disruptive for patients. As you can imagine, if someone is having difficulty breathing, it's going to be very difficult for them to even do a simple desk job, let alone a job that might require some manual labor. In addition, cough can be very disruptive and, you know, patients can develop a lot of embarrassment about coughing during their presentations or during meetings. And, in addition, sometimes they're stigmatized because people think they're coughing because they're sick and they're contagious. And so, patients often feel very self-conscious when they're coughing about how the cough may be perceived by their coworkers. So, in this study, the estimated annual costs of productivity loss were about 11,000 Canadian dollars, the equivalent of about 8,000 US dollars per employed patient.  

There's also societal costs, including quality-of-life impacts, and we can't underestimate the caregiver burden. These are quite notable contributors to the societal costs. So, when I speak about quality-of-life costs, I want to talk about some of the other aspects of a patient's life that can be impacted by this disease. So, many patients who have dyspnea, it doesn't just occur during their waking hours, it also occurs during sleep. And this can lead to a decrease in sleep quality. In addition, patients can have a lot of GI side effects from their antifibrotic therapies that might even awaken them from sleep if they have to rush to the bathroom with diarrhea. But, in addition, these patients also have reflux disease, which often becomes worse when a patient will recline at night to sleep. And the reflux itself can awaken a patient and lead to this decreased sleep quality. There's also a loss of independence and privacy. So, as a patient requires more and more caregiver support, they can do less things on their own. And this can have a big impact on someone's mental health when they start to lose their autonomy, especially at an age before they would have expected to lose their autonomy. In addition, when a patient has these violent coughing episodes, this can lead to muscle strain in the muscles between the ribs. But also, they can have cough-related incontinence, and this can become embarrassing for them when they lose control of their urine or bowel movements. There can be an impact to their activities of daily living. But also, a lot of anxiety and depression can occur as the disease evolves, and this can be due to different causes. It can be due to a patient having to face their mortality, again, at an earlier age than they would have expected. It can be due to the social isolation because it's difficult for them to travel in public. There can be challenges physically with just transporting oxygen. And some patients feel that they're just homebound because it's too much work to transport the oxygen and worry about running out of oxygen. I mentioned the social isolation, but there's also this stigma. So, you know, a lot of patients who require oxygen might be perceived as someone who is a cigarette smoker and has COPD and may be still smoking. And, unfortunately, a lot of people in society still have this impression that when someone uses oxygen, it's because of some lifestyle choice they've made. Whereas, we know IPF is a disease of unknown etiology, and it's not the patient's fault. But a patient can really start to feel stigmatized by society when they're using oxygen therapy. You know, caregivers also have a role in helping to manage patients, but they also are human beings and are susceptible to other things that can happen to them as a result of them dedicating so much time to caring for the patient they love. So, they can also endure decreased sleep. They can have emotional well-being disruptions, a loss of their own social life. Many of them have to take out even loans to help cover the costs of these medications. And there can be a significant time burden, and they can't do any of their own self-care. And so, I really try to work with patients and their caregivers. Because I know the caregivers, if they get sick or they become compromised in terms of their health, then it's a really bad situation for both the patient and the caregiver. 

So, how does IPF strain care delivery? So, we talked a lot about the cost burden for the individual patient, for the caregiver themselves. But there's also, you know, a strain on the care delivery. Because when these patients have delays in their diagnosis, again, this sets them up for frequent hospitalizations. And this can really have high demands on all aspects of the health care system, not just the inpatient, but also the outpatient setting. So, IPF management requires regular contact with health care services and long-term care with specialized providers. So, what I mean by this is that a patient is typically seeing a pulmonologist on a regular basis and they're undergoing pulmonary function testing every three to six months. During this time, we're assessing their physiological declines among function but also screening them for hypoxic respiratory failure. In the inpatient setting, research shows that recurrent hospitalization accelerates beginning more than one year before the diagnosis and then remains elevated over the following five years. So, again, even before a patient gets their diagnosis, they often have frequent hospitalizations. They're usually misdiagnosed as having things like multifocal pneumonia, when in fact what they have is IPF and they're having exacerbations. In terms of pharmacy, there's issues with adherence and persistence to these antifibrotic therapies. These continue to be challenges for patients because of the side effects that I mentioned, but also the financial burden. And then, when you think of the palliative and end-of-life care, really we want to start implementing palliative care earlier for these patients. Sometimes people think of palliative care, and they mistake it as hospice care, but it's an entirely different thing. Palliative care is really symptom-directed care. So, it's having providers that specialize in managing these symptoms that can be quite bothersome and impact quality of life. And this really should be started at an early stage. There's no reason to wait to implement palliative care until someone maybe requires hospice care.  

Fragmented care coordination can also delay diagnoses and lead to disease progression. So, what I mean by this is that patients typically don't see the pulmonologist as their first provider when they're undergoing their diagnostic journey. They usually see their primary care provider. So, there needs to be a proper handoff between the primary care provider and the pulmonologists. This usually happens very well at ILD specialty centers, but it doesn't always work well outside of these specialty centers or even within them. And I would say that because these patients are often followed by cardiologists, sometimes even rheumatologists like me, there needs to be good care coordination between all of these specialists as you're trying to manage these overlapping symptoms due to different causes. The late diagnosis, again, delays treatment initiation. And then, this again leads to further progression of the disease. So, it's quite important for these patients to have a multidisciplinary model of care. This has been demonstrated to reduce these exacerbations, reduce emergency visits, and hopefully help improve the end-of-life process for the patients.  

How do collaborative care models reduce costs? Well, they do this in a few ways, but one is that multidisciplinary collaborative care introduced early on with an integration of palliative care can really help reduce costs for the patients and also improve their end-of-life care. But again, as I mentioned, that palliative care is typically underutilized and can be difficult to implement across different health care settings.  

So, multidisciplinary care teams usually combine pulmonologists, radiologists, pathologists, I would say rheumatologists, nurses, and palliative care professionals. Sometimes they can also include cardiologists, even oncologists, occupational therapists, surgeons, lung transplant teams. When advanced care practitioners are available, they can join these teams as well as respiratory therapists. And while MDTs have a focus on refining the diagnosis for a patient, there's also evidence that there's benefit to the management and follow-up of the patient. And I am fortunate to practice in an ILD specialty center where we created one of these multidisciplinary teams, and I will tell you that patients really perceive when their doctors are talking to each other and working together as a team. When there's this kind of segregated follow-up and the doctors aren't communicating, patients often feel like they're caught in the middle, particularly if one doctor’s recommending one thing and another doctor recommends a different thing. So, MDTs not only improve diagnostic accuracy, but they can help with the management of the patient and ensuring that best practice guidelines are followed. It's important to have these regular team meetings. And I would say that if you practice in an area where there isn't one of these MDTs available, there is a way to simulate this simply by picking up the phone and calling the other specialists who may be involved in this patient's care. I would say you can even do this with the radiologist that you work with. I find that sometimes radiologists will give me a lot more information during the MDT meeting or over the phone than they might in their report, and this could really influence how you care for the patient.  

MDTs that adopt early integrated palliative care approaches can reduce hospitalizations. So, there's different levels or types of palliative care that can be provided based on where the patient is in their overall disease course. So, I would say early on, I would get palliative care specialists involved to help with some of the common symptoms that can occur. So, this would be things like dyspnea and cough, but it could also be symptoms like diarrhea that develop as a result of a patient taking one of these antifibrotic medications. But then, over time, as the disease evolves, it can be really helpful to integrate palliative care in a different way and this way to kind of manage more complex and refractory symptoms to help prevent exacerbations. So, these palliative care specialists can help patients feel empowered and know when to increase their oxygen therapy at home. So, they avoid having one of these hypoxic episodes that might drive them to the hospital. They may be able to stay more up on the patient's vaccine so that there's a lower likelihood that they'll get, you know, a seasonal pneumonia and require hospitalization for that. And then, sort of the third level of this is when a patient really requires multi-faceted IPF care, where they're having profound distress, frequent ICU visits. And that's when the palliative care specialists can really intervene in helping to address end-of-life care decisions before a patient becomes so sick that it's difficult for them to make their own decisions. And, usually, these palliative care doctors are well trained in having these conversations. They're much better than me at doing this and making sure that the patient feels heard and their voice is listened to. So then, when that time comes where the end-of-life approaches, they really were honoring their values and what they want in that situation.  

Unfortunately, despite all of the benefits of palliative care that I just mentioned, the delivery still remains poor, and this is largely due to barriers in practice and limits in implementing multidisciplinary care. So, why does palliative care delivery remain suboptimal for IPF? Well, one is that there's limited provider training, guidelines, and awareness about IPF specific needs. There's also misconceptions, as I mentioned, that palliative care is synonymous with end-of-life care or hospice, and this can lead to late or absent referrals. And I would say this is on the part, not only of the provider, but also the patient. Because the patient in their mind may think, “Oh, I'm being referred to palliative care. My doctor is giving up on me. I have no hope.” And they may be resistant to doing palliative care. And I've had this experience before, and it sort of has changed how I approach the discussion with patients. Where, I will tell them, “You know, I really think it would be helpful since you're having these nuisance symptoms during the day that are affecting your quality of life to get a specialist involved who is familiar with managing these symptoms and has a lot more tricks up their sleeve than I do for helping with cough or with the diarrhea that you're experiencing.” And you'll be able to check in with this patient a lot more frequently than you might be able to check in with me or your pulmonologist. Usually when it's presented that way, a patient will probably be more embracing of this opportunity. And because of the pandemic, a lot of these palliative care doctors will do Zoom visits with patients of virtual appointments. And this is also really ideal for these patients who have a lot of difficulty traveling around with oxygen. So, I would say that if you're in the position of talking to a patient or referring them to palliative care, you'll want to kind of approach it in this way versus saying, “I'm going to refer you to palliative care.” Try to explain more why you're doing this. There's also some fragmented care that occurs. And so, not every patient with IPF will be close to an ILD specialty center. So, it's quite common for patients to be seen by a local pulmonologist, local primary care doctors, rheumatologists, and then maybe just go once or twice a year to a specialty center. It's really important that the two groups connect. And so, and not just expect that, you know, one doctor is going to do the palliative care, but then they're actually not doing it. So, in these patients who I care for who are followed more frequently by a doctor in the community, I check in with them. I'll say, “Do you know a good palliative care specialist in your area that you would feel comfortable referring this patient to?” And if they don't have one, then I'll propose that I refer the patient to someone who might be able to do virtual appointments. But I think having this dialogue is really important for ensuring that the referral is made and executed. Again, as I mentioned, the patients and the caregivers can sometimes be reluctant to palliative care. This is why it's so important to start this dialogue early and in a really gentle way. So, a patient knows you're not giving up hope on them. They don't need to stop their antifibrotic therapies. They can do this in conjunction with what you're doing for them to have the best overall quality of life. 

We need to talk a little bit, though, about the unmet needs in IPF. As I mentioned, there is some exciting research going on now in this area, including breakthrough therapies that could potentially shift the whole trajectory of this disease and prevent its progression.  

I'm really excited to share that a late-stage investigational therapy with the potential to impact disease progression and care utilization might become soon available for our patients. And this is nerandomilast. It's an oral preferential inhibitor of phosphodiesterase 4B or PDE4B. And topline data from the FIBRONEER-IPF trial showed that nerandomilast did indeed meet its primary endpoint of an absolute change in baseline FVC at week 52 compared with placebo. So, this was the first IPF phase three trial in more than a decade to meet its primary endpoint. And at the recent American Thoracic Society Conference in May of this year, these data were presented. And there's an article that accompanied this in the New England Journal of Medicine that was recently published. And I'm excited to share that there'll be a future webinar that will go into great detail about the exciting results of this trial. So, it's really exciting, again, to share that we might soon have a new therapy available to help our patients prevent not only the declines in FVC, but potentially exacerbations and hopefully lead to improved survival for these patients.  

I want to conclude by talking a little bit about the complex disease landscape and how our traditional frameworks fall short for caring for these patients. So, we really have to take a step back and reflect on patient outcomes and the system-wide impact.  

So, our traditional value assessment frameworks struggle to capture the full impact of therapies. So, standard quality-adjusted life-based models may overlook meaningful outcomes such as quality of life, caregiver burden, and symptom burden. So, what I mean by this is when you do a clinical trial, you're typically focused on surrogate endpoints, some kind of endpoint that's linked to survival, but not necessarily survival. But there's other things that can impact a patient's life that might not be demonstrated so clearly in the context of a trial. For example, we rarely would measure something like caregiver burden in the context of a trial. There's really no good way to do this. So, rare and progressive conditions such as IPF may require adjusted thresholds and additional value factors beyond things like cost effectiveness. What we need now is real-world data that will give us information about adherence, persistence, and treatment impact because right now these things are rather limited or even unavailable. In addition, because the IPF disease trajectory can be unpredictable, it's hard to model long-term treatment benefits. So, what I mean by this is that some patients with IPF will have a very rapid progression of their disease course. And other patients may have more stable disease for years or slow progression. And if you're trying to model the benefits of long-term treatment, you may have to adjust it depending on someone's disease trajectory, but this is rarely done.  

Value-based models that emphasize things like reduced hospitalizations could drive access to other disease-modifying therapies. So, when we think about, you know, how do we improve a patient's quality of life? One of the main ways is to try to keep them out of the hospital, right? We talked about earlier in this webinar how the hospitalizations contribute to cost burden, but they also are extremely disruptive for patients, right? And not just patients, but their entire families, because when one of your loved ones is in the hospital, everything in life gets disrupted. You know, certain caregivers might have to go on family leave to be able to be there in the hospital. If children are at home, they might need to get additional care support. So, there's multiple layers of how a hospitalization could affect the patient's life and everyone around them. The patient has needs, right? They have to access specialized health care centers. This requires them to have some awareness of where these centers are. And fortunately, there's some great resources online, such as the Pulmonary Fibrosis Foundation, which can often help point a patient in the right direction. But there's a lot of anticipation that can be helpful too. So, if a patient is educated about how their disease needed to be monitored, they might be more able to advocate for themselves if they're in the setting where they might not be getting as frequent pulmonary function testing as they need. I think it's also important for patients to know about the option of lung transplantation because, again, if a patient is selected for this, they need to understand what that process is like. It's not an easy process by any means. And so, patients have to be well informed about what the overall risks and benefits of lung transplantation are. I think the value-based models also could help align reimbursement with outcomes to help incentivize therapies that could alter disease progression, again, reduce these hospital admissions. And this could be a specialty focus value framework, like a AAA care model that emphasizes access, anticipation, and timely action across the care continuum, which is again what's demonstrated in this figure here. And then, ultimately you need collaborative models that not just involve the patients and the payers, but even the pharmaceutical companies and specialists. These are essential for implementing these value-based models, and again, helping to improve the quality of life of these patients.  

The high rates of hospitalization in late-stage care are driving the unsustainable costs of IPF. So, again, when these patients approach the end of life, they're frequently going to the hospital. As I mentioned earlier in the webinar, 80% in some studies are spending the end of their life in the hospital, and this becomes extremely expensive. And if we think that the IPF prevalence is increasing, which could be related to our improved ability to diagnose this disease, this is going to continue to drive up total health care costs. And if any of you have referred a patient to the emergency department recently, you know that there's a lot of issues now with long wait times in the emergency department. So, it's not uncommon for a patient to wait three, four days before they can even get a room in the hospital. So, they're in a really busy setting for the first four days of their hospitalization where they're not getting great care. And they're also not sleeping, not eating well. They don't even have their own restroom to use. So, I think that we really want to try to keep patients out of the hospital, especially the emergency department. The current antifibrotic therapies do not eliminate the need for this high-cost supportive care. What we need are these newer therapies that could alter disease progression, reduce acute care utilization, and ultimately help improve the quality of life for patients. And really, we need to rethink our value frameworks. You know, this is not just about who benefits in terms of survival, but we need to look at the caregiver impact, the systemwide burdens. And broader patient-centered assessment models and value-based care strategies could help us better align these incentives and then reduce the total health care costs. 

Question and Answer Portion 

Dr Volkmann: Thank you so much again for tuning in, and we're now going to transition to the question and answer portion of this program. You're welcome to write your questions in the chat, and we will address each one.  

Moderator: Great. For our first question, Dr Volkmann, how can earlier integration of palliative care for IPF realistically be implemented in non-academic settings where maybe multidisciplinary teams might be lacking?  

Dr Volkmann: That's a great question, and it's definitely possible to generate referrals for primary care, even if you don't practice in an academic center. And, usually, a patient's primary care provider will have a referral basis for palliative care providers who perhaps work in the community. And this would be a wonderful way to give this patient access to palliative care without having them have to travel to another center to receive this care. So, I would say the best starting point is their primary care provider. If the primary care provider doesn't have a referral basis for a palliative care provider, the other option would be for a patient to, let's say, contact their insurer and see whether there are any palliative care doctors that are covered under their plan. And that might be another way to find out who is in their network and who could help care for the patient.  

Moderator: Excellent. And what can be done to help shift end-of-life care to lower cost settings?  

Dr Volkmann: So, I think having these discussions with patients about end-of-life care early in the journey—obviously, you're not going to do it so early at the time of diagnosis, but as the disease becomes more advanced, it's just a good idea to check in with patients about what their preferences are. Because many patients prefer not to die in a hospital, but yet, a lot of these patients do. And I think this can be avoided if doctors and other providers will have conversations with the patients, their families, and their caregivers to make sure that, you know, their end of life goes as they desire. And so, coming up with a plan is very helpful. And this could be something like, you know, if this happens, I don't want to go to the hospital. But if I have, you know, a simple treatable infection, I will go to the hospital. And kind of coming up with plans. Obviously, you can't predict every possible scenario that could occur for a patient. But we know that often these patients will develop infections. They might need more supplemental oxygen. And, again, going over this with the patient before they're in an emergency situation is always a good idea. So, I would suggest that, as the disease advances, the patient, their caregivers have these conversations with providers to avoid going to the hospital in these situations where really they would prefer to be at home. And, again, getting involved with palliative care early can help guide this process because, you know, the pulmonologist might not even start this dialogue until a really late stage. But if palliative care is involved early, they may start it at a sooner time and, again, make sure that the patient's wishes are met.  

Moderator: Perfect. I want to address some of the payers that are in our audience today. So, how can payers support earlier use of palliative care, especially in IPF?  

Dr Volkmann: Yeah, I think that being able to give patients access to palliative care, as you've seen during this talk today, could have potentially a lot of benefit. And so, the payers would hopefully reimburse for patients getting this level of care. And this would help patients, for example, if the palliative care providers were in their network versus out of their network. Because, you can imagine, these patients have a lot of out-of-pocket costs that seem to increase more and more over time as the disease progresses. So, if a patient is, you know, presented with an opportunity to go to palliative care, but it's going to cost them quite a lot of money to do this, they may prioritize taking their medication instead, which is very logical. But, you know, we hope that we create opportunities for patients where they won't have to choose between one or the other. That they could utilize palliative care services and it wouldn't create a tremendous cost burden to them that would otherwise compromise their ability to pay for other aspects of their care.  

Moderator: Great. Thank you. We have one more question. But, just as a reminder to the attendees listening in, please feel free to throw your question in the chat and we'll be happy to share that with Dr Volkmann. One more question for you then. What data or endpoints should payers ask for in clinical trials to better understand the real-world cost impact of new treatments?  

Dr Volkmann: Yeah, that's an excellent question. And for a disease like IPF and other interstitial lung diseases, we've historically relied on the forced vital capacity as our endpoint for trials. And this is because it's a surrogate endpoint for mortality. So, declines in forced vital capacity can predict mortality in these patients. But the issue is that the FVC, you know, just represents one aspect of the patient's disease, their physiology, their degree of restriction in their lungs. And to a patient, it's not really that meaningful. What matters to patients is how they feel and how they function in their life. So, I think it's really important for clinical trials to consider patient-reported outcomes as being important endpoints. And now, there's a movement to develop composite endpoints for these trials. So, it would incorporate something like the FVC, but then also incorporate patient-reported outcomes. Some of these composite endpoints that have been proposed, including one that I've published on, included a radiological endpoint. And this becomes particularly relevant in non-IPF ILDs, for example, in autoimmune ILDs where endpoints like the FVC can be influenced by their pulmonary disease. But it can also be influenced by extrapulmonary disease. So, if a patient, let's say, has respiratory muscle weakness from myositis or they have chest wall thickening from scleroderma, this can also affect their FVC and potentially obscure treatment effects. So, I think that in the non-IPF diseases, it's really crucial to look at other endpoints besides the FVC. But, again, getting back to your question, I think the most important thing is to consider patient-reported outcomes. Because, at the end of the day, you know, we hope that our treatments affect long-term mortality, but we also want to make sure that our patients are having good quality of life. And that really hinges on their ability to feel well in their day and to function as best as they can.  

Moderator: Excellent. Thank you so much, Dr Volkmann. That concludes the question and answer portion of today's webinar. Thank you so much for joining us, and we'll see you for our next webinar.  

Dr Volkmann: Thank you. Take care.