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Video Transcript: Patient Assistance Programs in the New Decade: Analysis and Best Practices for Pharmaceutical Manufacturers

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Gina: Growth in the uninsured and underinsured populations. Health reform and new technologies’ impact on patient access. Economic pressures and patient assistance programs. How are pharmaceutical manufacturers processing all these issues to ensure appropriate access to their products? Join us to find out. “In the Know” starts now.

Hello and welcome to “In the Know,” your source for insight and analysis on the issues that matter to specialty pharma. I’m your host, Gina Clark.

Today, we’ll turn our attention to uninsured and underinsured Americans. Specifically, we’ll discuss how pharmaceutical companies are addressing the needs of these populations through patient and co-pay assistance programs. We’ll also explore how these programs continue to evolve in response to forces like healthcare reform, personalized medicine and comparative effectiveness.

Here with us today is Nancy McGee, chief operating officer for Lash Group, a national leader in the development of pharmaceutical product support programs. Thanks for joining us today Nancy.

Nancy: Thanks Gina.

How has the economic recession changed the U.S. uninsured and underinsured populations, and what are the current and future needs of these populations?

Nancy: Well that’s a really great question because it’s one that our manufacturers are asking us just about everyday. So with the recession and with the financial hits occurring within the US, two patient populations have been growing at a very rapid pace: the uninsured, so patients who don’t have insurance, as well as the under-insured, the patients who do have insurance but either can’t afford their deductable or can’t afford their co-pay. So essentially, with the uninsured, those may have been patients who were working and maybe paid for healthcare on their own, but now they’re not working because they’re unemployed. So really, healthcare takes a back burner to paying the rent or buying food. So, the uninsured market has grown in a huge way and we estimate the population to be about fifty-two million here in America. The under-insured is a little bit harder to detract because on paper it looks like they’re covered by insurance; however, there are issues that are affecting that patient that they’re accessing their benefit: it may be too much to pay for or it may be that they’re not accessing their benefit. And so, as a result, with the recession, it’s really been a growing population because that affordability issue is certainly there.      

How are pharmaceutical companies approaching the uninsured and underinsured populations today—in terms of assessing the populations' impact on their product, as well as designing programs to meet their needs?

Nancy: Fortunately, manufacturers have really looked at these two patient populations for years and years. Certainly they want to have a good handle on the percentage of the population that is insured, uninsured, and under-insured. So they’ve really geared programs over many, many years to really address all three of those patient populations. But because of the recession, those numbers have dramatically changed. So what manufacturers are doing now is really going back and having a look at their programs to make sure that they’re adequately making sure that patients have access to their technologies and so, in many cases, they have to retool their programs and come up with new guidelines and broader bandwidths of assistance to really help these patients. 
  
How has this changed over time, and what has prompted these changes?

Nancy: Well the collapse of the banks and the recession has really prompted these changes because that’s when we really saw unemployment rise, and across our patient assistance programs and co-pay programs, we saw dramatic rises in patients contacting the hotlines and looking for assistance. So many of our manufacturer’s clients looked at their programs that have been in existence for years and years and did an analysis to make sure that those patient populations, if they had grown, to really make sure that the criteria for the program were updated so that those patients could be helped. Without updating the criteria, really, those populations are growing and those patients may not have access to treatment or they may be making decisions and not to be getting treatment at all or they may be non-compliant with their medicine. So really, taking a hard look at how the recession might have made these populations grow for a particular product is really very important. 

Does the approach to patient and co-pay assistance programs differ significantly between large pharmaceutical companies and smaller biotech firms, especially given the gap in resources?

Nancy: Well, I think the good news is that all of the manufacturers have an interest in making sure that all the patients have access to their products. And so they all, whether they’re small or large, they all want to achieve the same thing, which is to make sure that the patients have access. So certainly there are differences in terms of a large company having more resources to have a larger program, but certainly small companies also participate in offering their products through a patient assistance program and really examining whether that kind of assistance could be given from a co-pay consideration as well. So whether they’re large or they’re small, I think their unifying purpose is to make sure that patients have access, and there are ways for both kinds of companies to really serve the market place and make sure that patients can get their medicine and can stay on therapy.

In what ways does this differing approach between large and small manufacturers impact patient care in the specialty space?

Nancy: Well it’s really dependent on what type of product the large manufacturer might be making versus a small one. So if a small company has a novel treatment and it’s the only treatment for a particular disease state, it’s going to be really important for that manufacturer to consider all three sectors of the market place: the insured, the uninsured, and the under-insured. And that smaller manufacturer will have to make decisions about tradeoffs and how to make sure that the largest cohorts of patients possible can have access to their treatment. And I think that’s a challenge that small biotechs have these days, is really to balance how much assistance they can give versus really making sure that their company is really moving forward. On the large pharma side, I think large pharma has been very innovative in really examining their criteria and then looking actively for ways to make sure that patients stay on therapy, whether it’s a compliance program or it’s patient adherence, I think that’s really helping patients have positive outcomes and it’s a positive way to apply funds to make sure that the patients who have overcome insurance barriers or who have gone through assistance programs really stay on therapy. And really, that’s what everyone is looking for.

What can smaller firms do to ensure appropriate access to their products?

Nancy: Well I think the best thing that any manufacturer can do, whether they’re large or small, is really to do their homework. When I talk about homework, it’s homework that really has to do with coverage and payment methodologies and really seeing how payers may perceive their product and see through the value messaging a manufacturer might want to give a payer to make a compelling story for coverage and adequate payment. And a way to do that is really to look at the value message for the product and ensure that there are endpoints in the phase three clinical trial that serve those payer needs. And as we see trends like comparative effectiveness or we see new molecules that come out that might have to do with personalized medicine, at the end of the day those endpoints that are important to payers are going to be critical. If those endpoints could be gotten in the phase three clinical trial, that will serve up coverage and payment later, as well as serving those populations that may be underserved.

In what ways might health reform proposals help or hinder access to care?

Nancy: Well I think health reform is really very exciting, because it doesn’t matter which side of the bench you sit on, really, the outcome of health reform is to make sure that the people have access to healthcare. Now a concern is, well, if we made all of the uninsured people insured that’s a good story because it’s more access to treatments people need. But if people who are insured can’t afford their benefits, then they’re under-insured and that means they can’t afford their co-pay, they may not be able to afford their deductable. So manufacturers are going to need to continue to keep a sharp eye on that patient population, to make sure they’re not lost. So suddenly a patient population that they knew very well in their patient assistance programs, the uninsured, becomes insured through health reform, but perhaps they’re underinsured because they can’t access their benefit. So that’s a very important segment to keep an eye on, as health reform comes to light in whatever form it actually comes out in.    

Where do trends like comparative effectiveness and personalized medicine fit into our discussion around patient assistance program design and implementation?

Nancy: Well I think those endpoints really come down to doing the homework and having manufacturers do studies to really understand what endpoints payers are going to be looking for, because when you have things like comparative effectiveness and very complicated products, like a personalized medicine type molecule or treatment, payers are going to want to know more about that product so they can make adequate coverage and payment decisions. Comparative effectiveness really looks at clinical data, so a manufacturer can have any type of great program but at the end of the day they don’t have the clinical data to really support their use, so that the payer understands the value message and the product outcome for the patient, then a program Is a program, and the data is the thing that really rules at the end of the day. So an investment in clinical data, understanding messages that will be important to payers, will be critical. 

How is technology adoption in the care environment (i.e. EHRs, e-prescribing, Web portals) affecting patient access? Where is there room for further improvement in this area?

Nancy: Well I think everything electronic is very exciting because, from a physician office perspective, from a pharmacy perspective, those environments have really existed on the fax machine. So, it’s very exciting to see a movement towards electronic technology because I think it brings greater transparency to payers, physicians, and to patients. So having things moved to a more transparent environment where physicians can really understand where patients have sought the treatments they’re on, I think we’re going to see improvements in quality and in outcome. So, those things are very important. However, from the doctors’ office perspective, there is going to be an investment that’s needed, an investment in technology, an investment in education, and really a change in workflow. And so those are considerations to really think about as we move forward into a more electronic environment, but I think it’s exciting.          

With the healthcare environment in the midst of such a potential change, are there any best practices you can share as it relates to patient and co-pay assistance program design?

Nancy: Yeah, for co-pay programs there are certainly a variety of programs that are out there. I think a model that really helps from a pharmacy benefit perspective, as well as a medical benefit perspective, is sort of the best of both worlds. So there are claims based programs that build off the technology and the work processes that pharmacies have and that physicians’ offices have, and this means that when a patient goes in for treatment, from a pharmacy perspective they just continue to file a pharmacy claim, from a physician’s perspective it’s just like building a secondary or tertiary payer, and from the payer’s they don’t have to do anything. So it’s a stream-like process that helps on both sides of the fences, whether it’s a pharmacy benefit or a medical benefit, it’s a process that both of those environments really understand and it’s easy for the patient. So I think that programs that are streamlined that really build off existing technologies are cost effective and they are the ones that are going to be used the most frequently.

What metrics can pharmaceutical manufacturers put in place to measure the effectiveness of their patient and co-pay assistance programs?

Nancy: Well I think the most important endpoint to look at is whether or not patients are dropping off of therapy. So if a patient has enrolled in either one of those programs, you’d hope for a product that needs consistent dosing and that the patient is coming back for the repeated prescribed doses, and if they’re falling out, that means that something is wrong with the program. And going back to reassess if there were barriers, if it was too complicated, those are important things to look for in order to metric whether your program is really working correctly.

Thank you Nancy for sharing your perspective on these issues.

Nancy: Thanks Gina.

And thank you for joining us—we’ll be back soon with another, all-new webisode. Until then, if it’s on your mind, it’s In the Know.

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