Prioritizing Patient Voices in Drug Development and Coverage

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Jasmine Patel: My name is Jasmine Patel. I'm a senior principal within Envision Parma Group and I sit within our strategic consulting team. I have over a decade of experience working with patient organizations, advocacy groups, professional societies, public affairs firms, health care agencies and biopharma companies to meaningfully integrate the voices of patients and care partners into health care decision making.

Jessica Krauser: I'm Jessica Krauser. I'm a marketing advisor for Two Labs, which is an Envision Pharma company. I'm also a Parkinson patient, which now turned me into an advocate. I co-founded a nonprofit for Parkinson's Awareness called the 5KforJK. And I also host a podcast for Parkinson called The Secret Life of Parkinson's. 

How would you describe the current state of collaboration among payers, manufacturers, and the development of costs associated with patient care? Do you see opportunities for growth and enhancement? 

Jasmine Patel: I can particularly speak from the lens of what's important to patients. And it's important that there's strong collaboration between payers and manufacturers. It's crucial I think. But what often lacks is a focus centered around the needs of patients. And where this can be enhanced is really prioritizing the incorporation of patient voices into critical discussions, whether it's unmet needs, generating real-world evidence, for example, assessing treatment gaps, highlighting coverage barriers, which is such a key point for patients. 

It's not a one-size-fits-all approach when it comes to coverage. Patients have unique needs [and] they have unique barriers. They have different health goals and outcomes. It's really important to understand that. And what both manufacturers and payers should be doing is collaborating with patient advocacy groups who have direct and regular connections to patient communities. And they should be collaborating with them early and often, not necessarily at a single point in time to understand what is important to patients. Because this understanding is key to accurately reflecting the day-to-day challenges of patients. 

How and where in this development process would you propose more consideration be given to patients’ voices? 

Jasmine Patel: That's a great question. And as I said before, it's not a single point in time. We always say that perspectives from patients and patient leaders should be incorporated during trial ideation as early as possible. Oftentimes what happens is patients are kind of presented with a half-baked idea and by that time its far too late. It's important to get ducks in a row from the beginning so that there is greater alignment, greater collaboration. [It's important to reach an] understanding of where we're going, where we're headed, so that we can work towards that end goal together. And [to understand] when patients should be involved as early as possible when there's an idea in place to even develop a treatment for an unmet disease or an unmet need for a patient. 

In your opinion, what deficiencies exist in drug development concerning patient coverage? 

Jasmine Patel: Every company has a want and a need and does do it to different extents. Where you see a lot more early collaboration with patients and patient organizations, is particularly in the ultra-rare disease space where it's hard to find these patients. And patient organizations in these rare disease spaces are created even before there's a drug for these conditions, because at the end of the day, what these patients and especially their caregivers want is some sense of normalcy. They want these patients to live long, fruitful lives. 

I won't name a particular drug, but I'll name a disease area. So, a disease area where we have seen a lot of collaboration between patients, patient organizations, and manufacturers is in psoriasis, for example. There are different outcomes that are important to patients who are living with these skin conditions. And there's a difference between, okay, what takes away the symptoms versus what gives them that level of comfort and that confidence to be able to wear, short sleeve shirts, to be able to wear their shorts again, go on the beach, go in a pool. And sometimes that type of outcome measure of [a] sense of normalcy is important, confidence is important. Obviously there are clinical criteria that are important from a medical standpoint. 

What's [also] important, though, is that patients are not so in tune with that type of medical terminology. It's important that the way it's described in clinical trials is something that resonates with patients. 

But as I said, in ultra-rare disease space, in rare disease spaces, there is a lot of collaboration, especially in the clinical trial ideation phase when the clinical trial is being designed, because what is really challenging for these rare disease companies is recruiting patients to these clinical trials. It's hard to find these patients because they're far and few in between. And anytime there's an opportunity to connect with a patient organization that has direct connection and access to a patient community. this is where you're going to see a lot more collaboration, a lot more excitement, a lot more understanding and buy-in towards this potential clinical trial and also the potential that this treatment may provide to patients.

Jessica Krauser: So Jasmine, let me know if you disagree with this, but I would have to say just at least from my standpoint that there's not a lack of trying or effort from a manufacturer's standpoint in getting to know the patient and getting to know who they're targeting. I think where there is a huge opportunity is, are the patients being brought in at all the right times and actually being infused almost into the culture of the organization? And also because we're getting to these ultra-rare type diseases or we're getting to these different specific types of cancer, let's say, or that there are not types of Parkinson yet, but once we get to that level, are they finding clinical trials and finding people like me? Or, is it still they're sticking with the stigma of the over 60-year-old men? Again, manufacturers are connected to patients, but are they doing it in the most effective and efficient way? Would you agree? 

Jasmine Patel: Yeah, I mean, I think a lot of it depends on how well kind of patient engagement strategies incorporated into the company. But to your point, Jess, there's different points and times where they could be engaging strategically around different things. 

Jessica Krauser: Yeah. 

Jasmine Patel: So, when it comes to deciding the inclusion and exclusion criteria of a clinical trial, for example, making sure that the clinical trial and the patients who are included in these clinical trials truly represent the population that are affected by these conditions. When it comes to publishing data, making sure that any data that is published is accessible to patient communities, that patient communities can understand exactly what the science is saying, so that they can truly understand their own condition and be able to communicate it to their community, to their doctors, etc. 

Patients living with rare conditions experience a diagnostic odyssey. And where there's less awareness about a rare disease, for example, these patients will oftentimes see multiple clinicians to try and find the right diagnosis. This is why it's important that information is accessible to patients that it's understood by patients and part of being able to provide those types of acceptable resources to patients is co-creating resources with patients. Manufacturers can have some sort of forum to understand from individuals the type of education that resonates with them, what the differentiated needs are for different kinds of people. Because as I said, it's not one-size-fits-all. And, ultimately, we want to make sure that whatever information is put out there reaches the patients they're meant to serve and that it's something that is used as a tool that they can feel empowered to communicate to different stakeholders, whatever stakeholder they need to communicate with at that time.

When it comes to preparing for launch of the drug, for example, again, patient communities play a critical role in making sure that patients who are waiting for a treatment now know that something is coming to the market that can potentially benefit them. And then once the drug is in market, if there are access barriers, which oftentimes there are, it's going to be these patient communities that elevates the barriers that are faced in the real world to guide manufacturers. “Hey, this is a challenge I'm experiencing right now, getting access to this drug." But also they can be the ones communicating to payers, “Hey, this is the outcome to this access challenge I'm experiencing, it's caused a flare up in my condition," or "I'm dealing with worsening outcomes right now," because time is of the essence when it comes to access to medication.

How can patients better educate themselves about disease states and medical trials when translating clinical findings into the patient experience can be difficult? 

Jasmine Patel: As I said, I talked about patient organizations. Patient organizations are kind of a central resource to patients living with different diseases. There are disease-specific organizations, there are organizations that are much more high level that kind of cover just a general health concern. And it's these patient organizations that play this critical role in providing that lay language education to patients. You know, they create different types of tools and resources. They do webinars, infographics, surveys, and they share the survey responses with patients back to them, obviously anonymously. They do different things to educate patients about, “Hey, here's what the community needs. Here's the information that you say you need in a way that's understandable to you," things like that. 

And you asked the question about clinical trial data. Plain language summaries are something that have become more and more valuable to patient communities, but also to health care providers. They love plain language summaries because it's something that is a quicker read. It's easier to understand. Anytime there's a plain language summary that complements a publication of clinical trial data, it is something that is truly valued by patients and patient organizations. I think the greatest challenge that we hear all the time is that when these plain language summaries become public, where are they? How can we make sure that the availability of these plain language summaries are reaching the patient communities they're developed for? 

That goes back to the original piece of just having collaborative relationships with patient organizations. And again, it's something that is no longer a novel thing used in many, many different companies that are patient advocacy leaders who are responsible for bringing that patient voice into the company, building collaborative relationships with patient organizations, and kind of getting the pulse on what is needed for the patient community to give those insights back into the company so that company is really positioning themselves that they are developing tools that are meaningful to patients. 

But ultimately, again, patient organizations are so important and we just have to make sure that if there's some sort of advancement in a clinical trial that there's just transparency around it so that information can be timely to patient communities. 

Coverage is often reliant on expected patient profiles. What can payers, manufacturers, and patients do to be inclusive of populations that may not fit outdated or too narrow patient profiles? 

Jasmine Patel: I think this is exactly back to my point of, how are you generating evidence? And as I said, these patient organizations, they have connections to patients, they have also connections to different health care providers who are kind of expert in this area, who are the ones who are diagnosing and trying to treat these patients, especially, you know, if there are no FDA-approved treatments for that specific condition. And this is where manufacturers and payers can collaboratively benefit with partnerships with patient organizations to collect and analyze real-world data. Different patient organizations have different capabilities, but there are many that have their own registries. They publish their own data. They [provide] regular feedback to patients and publish experience data into scientific journals. And it's these kinds of experiences that should inform manufacturers but also payers on, "Hey, here are the patients that are actually impacted by these conditions."

And again, that insight can go all the way back to a clinical trial. Back to my point of making sure that these manufacturers have the right inclusion and exclusion criteria, because if it's not kind of set correctly from the beginning, the long term ramifications can be great, especially when it comes to access coverage for patients. You know, if at the time there are access barriers after a new treatment is launched on the market and should be available to patients but patients are not getting it, this is where patient advocacy groups play a critical role in really building those relationships with payers, trying to explain to them, show them data that, hey, this is who you're missing in your coverage policies. And this is the ramifications that these coverage policies have on these patients.

So data can be generated at different points in time. There are even patient organizations today who kind of show data on what happens when patients don't get access to the treatments that have been prescribed to them by their HCPs and the impact that has on their health and their outcomes. So data is powerful. It's important that data is collected in the right way and data is used to tell an important story, ultimately focused on here's what's important to patients and here's what their needs are. 

Yes, everybody is a patient at some point in their life but ultimately we are all people at the end of the day and kind of this is the mindset we should live by when it comes to creating solutions that are meant for people. We have to make sure that those people have a seat at the table, they're involved, their voices heard, their voices implemented, it is critically important. There are more and more efforts that are focused on making sure people as a whole have the opportunity to have that seat at the table. There are different payers who also have seats at the table open for a patient. But, I think knowing where that seat is, how to get it, it's a confusing process. And again, it goes back to my point around transparency and making sure information is accessible. 

Please share any key highlights from your Asembia conference session. 

Jasmine Patel: This panel is really a combination of sharing insight, but also sharing what we see as best practice. Jess is going to be moderating what we think is going to be a very important panel. And on the panel is going to be myself. And although I'm not a patient, I have been in kind of patient engagement and patient advocacy my whole career. And we're also going to be there with somebody named Tina who has very interesting experience around navigating a cancer diagnosis.

What we're trying to do here is just cultivate a dialogue that highlights the importance of engaging patients and advocacy communities throughout drug development. And some of the things that, for example, I will personally talk about is guidance on when and how to bring patient engagement and patient advocacy into planning and how to make sure your patient engagement plans are strong, that they're strategic, that there's something that's actionable, things like that. And I'm sure, Jessica, you should expand on what you hope to cover, but they both, Jessica and Tina, will have a lot of insights to share from their own personal experience, getting the diagnosis and then, you know, even with Tina and getting treatment for their own conditions that they live with. 

Jessica Krauser: What I hope that people will walk away with from that session is everybody goes about their day-to-day work, right? We get busy, we get caught up, and I think just constantly having that reminder of what they're doing this for. And not even people who are on a patient advocacy team or patient program type team, it's everybody within the organization always having in the back of their mind what the patient is going through, what the patient is dealing with. Because without that, there's no leading star. Like that's what they should be always focused on. And I know we can all say of course that's what we're focused on but it's to truly know the depths of all of the you know almost like the lifestyle you know because people can say you know well this this new drug and the way it's applied it's going to be a game changer it's like and I'm not I don't even have an example but it's like is that going to be useful for my type of lifestyle? Again, having Parkinson as a 40-year-old woman who's still working and has two kids and running around. You know what I mean? There are just different things that getting people to view it, view patients like we said earlier as we're all human. So, giving us a seat at the table, viewing us as equals [is the first step].

Jasmine Patel: This topic can go on for hours and days, in my opinion, because this is a very high level bird’s eye view, and it's not as simple as one, two, three. There are things to consider and think about, especially as manufacturers engage patients and patient organizations, and also as payers engage patients and patients organizations. But at a high level, I think the most important takeaway is not to forget the people who, at the end of the day, are consumers of these treatments. 

Jessica Krauser: Just to reiterate what Jasmine said earlier, [what I think] is the most critical piece, is there is no specific point in time to bring the patient in. It's starting right from the beginning and constantly having them throughout the whole process along the way. It's not just sharing the marketing materials and making sure it's something that they understand. It is literally starting from the beginning and really creating that as a culture for your organization.
 

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