Unscripted - Advancing Personalized Medicine: From Promise to Practice

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Welcome to Unscripted, The AMCP podcast, a look inside managed care pharmacy. Listen in as experts explore the challenges, innovations and opportunities shaping health care for millions of patients. On this episode, my guest is Daryl Pritchard, senior vice president, science policy at the Personalized Medicine Coalition. We'll be discussing personalized medicine and where it's at today. Welcome, Daryl. Thanks, Fred. 

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It's a pleasure to get you on. So why don't we start out? Give us a little bit about your background. Okay. Thanks again, Fred. And I'm really excited to be here. Be able to talk about my background and personalized medicine. So I'm Daryl Pritchard, I'm the senior vice president for science policy at the Personalized Medicine Coalition, which is based in Washington, D.C. it's an education, advocacy and evidence development organization, a coalition of a number of different members. 

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We have over 210 members of all different stakeholder types with the shared mission to advance personalized medicine, and I'm sure that's what we're going to talk about, personalized medicine. I work in the evidence development and policy research, component of the organization where we're trying to really understand how to shape policies and practices to implement precision medicine. So when you talk about precision medicine, maybe dive a little deeper. 

00:01:19:03 - 00:01:49:07 

Give us a little definition of what that is. Sure. Personalized medicine or precision medicine. And I'm going to use those words interchangeably, although some people might think that they have some variable definitions. I'll use them. Change the same thing. What personalized medicine is, is really understanding the patient and using different tools, usually diagnostic tools, to determine what drug or what treatment will work best for that patient. 

00:01:49:07 - 00:02:15:05 

So basically it's using genetic tests or other biomarker tests to determine what treatment will work for a patient will be most effective, and also what will have the best safety profile. So basically it's diagnostic testing determined safety and efficacy of drugs. And obviously we've all heard about it made huge progress in genetic testing and understanding the genome. 

00:02:15:05 - 00:02:44:12 

And more and more is coming out every day. So where are we with that compared to how we use it? So yea, that's exactly where we are right now with personalized medicine. I think really the dawn of the idea of a personalized medicine approach occurred with the completion of the Human Genome Project in 2003, basically, roughly. And there we thought about using your genetic background, your molecular basis to determine what will be your best treatment. 

00:02:44:12 - 00:03:11:19 

What is your best course for health? Couple that with considerations of the patient's perspectives. And that's where the personalized medicine approach was. And for years after that, 2003 to 2015, really we were making the case for personalized medicine, really kind of trying to establish that this is a better approach to medicine than the standard trial and error medicine that had been practiced previously. 

00:03:11:22 - 00:03:31:00 

That, you know, we can determine what will work for you and what will be best and safest for you right up front, rather than to try medicines and be ineffective, have disease progression and move forward. I think that phase of personalized medicine is beyond us now. I think we've made the case for personalized medicine. I think many, many people understand that personalized medicine is a better approach. 

00:03:31:04 - 00:03:51:01 

So now we are at the stage where we need to implement it, and we're finding that the challenges in implementing something that seems simple. Let's do some diagnostic testing. Let's talk to a patient before we determine what to give them as treatment. It sounds simple, but there's a lot of practice and policy challenges that need to be overcome in order to do it. 

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So I would say right now, the science of developing and understanding those biomarkers that really can help determine what is your best treatment path is well ahead of the practice and policy to implement those technologies. So when we think about the use of these new biomarkers or genetic screening, and then there are steps that have to occur for that to ultimately get used by the patient. 

00:04:19:09 - 00:04:44:16 

So where are we seeing that we need to adjust policy or fix the usage of the product, etc.. Yeah. So this is exactly where we're spending a lot of our attention at the Personalized Medicine Coalition and throughout the personalized medicine community. Just a couple of years ago in 2022, in October 22nd, the Personalized Medicine Coalition work with Diet Sood, which is a data company and diagnostic company based in Northern Ireland. 

00:04:44:18 - 00:05:21:19 

But they have a great data source and we examined the falling off of patients that could get personalized medicine. And we used lung cancer, non-small cell lung cancer as the example to take a look at where patients were being lost to a personalized medicine approach. And what we found, surprisingly, was that only about 36% of all newly diagnosed lung cancer patients actually received a personalized medicine and made it all the way through the personalized medicine journey in order to get the best targeted treatment for themselves. 

00:05:21:24 - 00:05:42:18 

64% of patients were being lost to a personalized medicine approach in lung cancer. And that's astonishing because lung cancer is probably the most expansive and robust personalized medicine pathway that we can point to as an example. And can you talk about what some of those steps are, where you see that fall off as they go through their journey? 

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Absolutely. And that's what we did within this study. We looked at where patients were being lost to the personalized medicine approach. And this occurred from initial diagnosis all the way to targeted treatment to the treatment decision patients. Some patients didn't receive a biopsy, others their bio specimen was collected. The biopsy was collected, but it was botched. It wasn't handled appropriately. 

00:06:05:13 - 00:06:40:20 

We lost about 13% of all of the newly diagnosed patients because their bio specimen wasn't handled appropriately. There's an evaluation or a pathology step where more patients are being lost. But what we really saw was a lot of patients, even after they've gotten their biopsy, they didn't get biomarker testing at all. It wasn't ordered, even though it's pretty clear in lung cancer that there's a better personalized medicine approach, a better biomarker testing approach to care with biomarker testing, then without other patients, were lost because of the test processing. 

00:06:40:21 - 00:07:16:01 

Still others were lost because of the turnaround time of the testing results. Sometimes it took many weeks, even a month before the results of the test were returned to the physician and the patient, and in those cases, those patients been put on standard chemotherapies before they knew the results of their test. And the final step, where we saw the biggest drop of patients, was even after actionable results of biomarker testing were returned, we still lost 30% of patients with actionable biomarkers to the targeted treatment. 

00:07:16:01 - 00:07:43:22 

Because treatment decision was wrong, they didn't follow the results appropriately for the biomarker testing. So they had a biomarker that said you should use product A or something like that, and they didn't. That's exactly right. They didn't get the targeted treatment that was appropriate based on their testing. So they wound up getting a different treatment, which the targeted treatments that we have in lung cancer provide much better outcomes. 

00:07:43:22 - 00:08:18:14 

The overall survival is 2 to 3 times longer for patients with targeted treatments who go through the personalized medicine approach. So here we have at the last step, our seventh clinical practice gap treatment decision, we see that patients with actionable biomarkers say you could have this targeted treatment. Still don't get it. And that's a problem. Wow. I mean when you think about that across the population as I'm in population health and you say the impact of that if you get it right versus that huge drop off you saw, that's a huge potential impact on individuals and the population. 

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Absolutely. And so what do you do with that? I mean, so what's the next step here. So the next step I think it was a surprise two years ago when we published this that things were this bad. But I think that a lot of people in the field knew that we had to do a lot better at delivering care. 

00:08:36:26 - 00:08:55:12 

But when we saw the numbers come out and we I mentioned the district database, we looked at virtually all of the newly diagnosed lung cancer patients in the United States in the year 2019. To look at this. So you want to talk about a population case. And these are the numbers that we came up with. Lots of people are thinking about this. 

00:08:55:12 - 00:09:26:15 

Lots of groups are working on this. So what we need to do now is to develop a set of strategies for improving all of those different clinical practice gaps, and then implement those in the health systems. And I think there's challenges there. But I think there's also a lot of momentum. I think the report was a eye opener, and I think there's a lot of folks in the personalized medicine community, a lot of different groups, the pharmaceutical industry, the diagnostic industry, the laboratory industry that really want to see this move forward. 

00:09:26:15 - 00:09:57:02 

And I think that the health systems, the physicians themselves, the providers really want to make that improvement. Now that they've seen that these improvements need to be made. So I would make an assumption that while you did this for lung cancer, it's probably similar in other areas with the potential to use these genetic tests or biomarkers. But if you can come up with the solutions for this one group, it's probably applicable to most, if not all of the others. 

00:09:57:04 - 00:10:19:05 

That's exactly what we're saying. I think when you consider that lung cancer has this robust, personalized medicine pathway, that these numbers are probably pretty good for lung cancer, and that things are probably going worse in other cancer types and in other areas of medicine where biomarker tests are driving different care. So this is not only for lung cancer. 

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We're the only reason we're focusing on lung cancer is because it's a robust example and we can do that. But any of the solutions that we devise and implement to help in lung cancer should be applicable to all cancer types and to all biomarker testing driven disease management. Right. And I know you work with AMCP on some of this. 

00:10:37:07 - 00:11:01:29 

So what is that area and what kind of work are you doing there? So AMCP has been a great partner. When they saw how these practice gaps and the magnitude of the impact that these practice gaps are having on the delivery of personalized care, they recognized immediately that they could have an important role in bringing together the managed care health systems and payers to help address these problems. 

00:11:02:02 - 00:11:25:24 

And really, what is needed here is coordination of the community. And I think AMC stepped out to do that. They're really focused on the downstream lessons, on the practice gaps around bio specimen processing, but really on biomarker test ordering and treatment, decision making and turnaround times for these biomarker tests to connect those two, they really focused on that. 

00:11:25:27 - 00:12:06:16 

And are making the case to develop quality measures that can really shine a light and make sure that these health care systems are doing a better job of treatment. Decision of turnaround times for test results and for biomarker test ordering. By making it clear that you're you are only doing biomarker testing and so many percentage of the case, you need to do it more when you do it, when you develop a quality measure, which is what AMC is set to do, or at least coordinate communities to develop that quality measure. 

00:12:06:22 - 00:12:27:25 

You're saying this is that you're telling the community that this is not satisfactory unless you hit that measurement? Yeah, we always talked about in population health that you do all these measures to determine sort of the status of the individuals in your population, and then you segment them and ultimately you want to segment down to an end of one, right where you can know absolutely what to do for an individual. 

00:12:28:01 - 00:12:47:09 

And, you know, I think it's fantastic that we're looking at this from a biological perspective. And, you know, we've also now recognized we need to look at this from a social perspective, too, because there are lifestyle issues or access issues or others that can impact the ability to get access to these kinds of services. So it's really a fascinating area where what do you see is the future? 

00:12:47:10 - 00:13:16:05 

Is it just going to really start taking off in a lot of areas now, you think? I do think that it's becoming more and more of, you know, of sort of the directive and the objective for different disciplines in health, just to give you an idea of that, the Personalized Medicine Coalition, again, has been in an organization that's been existing for about 20 years, and we have been focused on oncology and pharmacogenomics and some rare inherited diseases. 

00:13:16:12 - 00:13:45:04 

But now our membership is filling with groups in cardiovascular health, in autoimmunity, in weight loss, asthma, there's sepsis. There's new members coming to the Personalized Medicine Coalition because this idea of really delivering a personalized approach, you know, understanding instead of trial and error, care, understanding the patient doing some molecular tests to drive their care appropriately is becoming more and more towards the standard. 

00:13:45:07 - 00:14:07:03 

And I think it should also be pointed out, I think is seeing the data. You probably know what it is of how much the cost of these tests have dropped over time. It's true some to. And this is a big point of controversy for when we talk about why some of these practice gaps exist. Is it because of some kind of financial toxicity or, or is there a coverage or reimbursement gap for expensive tests? 

00:14:07:05 - 00:14:31:04 

Some tests are very cheap. Yeah. And there's really no reason other than moving past the clinical inertia to implement those tests. Other tests we do see they are expensive and they do give payers pause. But we're seeing as you mentioned, those prices come down as they're implemented more and we're seeing the value of their implementation, making it clear that this is the approach that we need to take. 

00:14:31:06 - 00:14:48:28 

Well, that's really a fantastic overview of this area. I want to thank you all for coming on. It's been a pleasure. All right. Thank you, Fred. This was terrific. And I'm always happy to talk about how we can move personalized medicine forward. So thank you very much.