Cell and Gene Therapy in Oncology, Part III

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Tune into another episode of the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the final in our series on cell and gene therapies, experts from our Market Access practice discuss the need for patient support in cell and gene therapies, and the role that manufacturers and other stakeholders can play in providing it.
“Leveraging real-world claims data and socioeconomic status data to help understand the patient population will be a benefit for manufacturers as they're looking to build out additional support services to ensure that they're reaching patients in an adequate manner.” Michael Kearney


Amelia Nell , Consultant I, Policy

Amelia Nell supports clients with evidence-based research and analysis that spans healthcare sectors and stakeholders.

Brigit Kyei-Baffour , Principal, Market Access & Reimbursement

Brigit Kyei-Baffour advises clients on issues related to market access, policy, and reimbursement strategies for digital health, diagnostic, medical device, and pharmaceutical companies.

Guest Speaker
Michael Kearney , ,

This interview was originally published as a podcast. The audio is no longer available, but you can read the transcript below. For updates on our newly released content, visit our Insight Subscription page.

If you would like to watch the video version, please visit our video page.


Amelia Nell

Hello and welcome to another episode of the Avalere Health Essential Voice Disease Education series. In this series, we will be covering topics on a wide range of different therapeutic focus areas.

My name is Amelia Nell and I’m a senior associate in our policy practice here at Avalere Health. And I’m joined today by Brigit Kyei-Baffour, an associate principal in our market access practice, and Michael Kearney, a consultant in our market access practice.

Welcome to you both. In our last video, we had explored opportunities to pursue value-based arrangements for cell and gene therapies, and today we’ll explore the need for patient support when it comes to CGTs and the role that manufacturers and other stakeholders can play in providing that support.

So to start us off, Michael, wondering if you could tell us a bit about how patients access treatment for cell and gene therapies today and why that might look different from other treatments.

Michael Kearney

Great question, Amelia. A major differentiating factor is actually the number of authorized treatment centers. Usually there’s a fairly small subset of providers or sites that can actually administer these treatments.

Specifically for CAR-T, those providers need to be a part of a accredited organization through the Foundation for the Accreditation of Cellular Therapy. Also, in some cases, for other CAR-T, a lot of these require a REMS requirement and specific capabilities that providers must manage, like side effects like cytokine release syndrome.

So being able to manage these types of considerations is also something that patients will need to consider as they’re looking to potentially receive CAR-T treatment. For gene therapies, while these are oftentimes administered in the outpatient setting, I think there’s still that kind of limiting factor in the number of specialists who can actually provide these treatments. And that goes for the same for CAR-T as well.

And what does this mean for patients? I think given the limited number of treatment centers out there for both CAR-T cell therapy and gene therapy, patients have to consider not only what they’re paying for these drugs, but also how are they going to get to the treatment centers? Transportation, lodging, meal plans, things like that are all considered potential barriers for patients getting these types of therapies.

Brigit Kyei-Baffour

Those are all great points, Michael, and I would say in addition to the cost sharing for these products, these therapies can be quite high. It is possible for patients to reach their deductible or even their out-of-pocket max in a single appointment. And of course that can be a challenge for many patients who may not have disposable funds.

And it’s also important to keep in mind that many patients eligible for cell and gene therapies may have already completed previous lines of treatment and subsequently exhausted their funds at that time. And so these are definitely factors that weigh heavily on patients in terms of thinking about access to care and what some of the respective barriers might be.

Amelia Nell

Thanks Brigit and Michael. I think that was very helpful and I think given all the challenges that you just outlined, what type of support is there currently available for a lot of these cell and gene therapy patients?

Brigit Kyei-Baffour

Amelia, that’s a great question. There are varying levels of support that are provided by different entities. So I’ll spend some time talking about the patient support programs first, the manufacturer patient support programs. They can provide a wide range of support offerings that could include financial support such as copay or cost-share support that helps patients meet their out- of- pocket cost-share liability.

There’s also reimbursement support that’s provided to providers to help with things like benefit verification and prior authorization, sometimes field team support and coordination with specialty pharmacies.

There is also treatment journey care coordination that is typically provided via care teams that are assigned or designated to patients to help with things like understanding their insurance coverage, identifying insurance, helping with coordinating office visits and any follow-up support.

There’s also free drug programs for uninsured and underinsured patients to help with providing access to therapies. And what we’re seeing more and more recently is access to care offerings such as site-of-care locators or provider identification tools that help patients identify providers and treatment facilities to help them access treatments in addition to transportation support.

Michael, is there anything else you’d like to add here?

Michael Kearney

Yeah, specifically on the transportation piece, I think a number of manufacturers are looking to offer these types of services. I know that some are already, but even with that, they are limited in some respect.

So oftentimes, as we found in some research that we’ve done, patients are having to travel far and wide to reach these types of treatment centers. And there are certain restrictions around what manufacturers can offer in terms of transportation support services.

So while they’re a start, there’s certainly a lot more out there in terms of what can currently be done to make sure that these patients are actually receiving the transportation support that they need.

Brigit Kyei-Baffour

And I would say in addition to that, in addition to manufacturer support programs, there’s also patient advocacy groups. And these groups can provide also a range of services to qualified patients that can span from copay relief to help alleviate out-of-pocket burden.

They’re also providing case management services to help patients with insurance re-enrollment and also helping them understand their coverage benefits. And they’re also providing nonmedical expense support similarly to the manufacturer patient support that can help provide support with things like transportation and cost-of-living expenses.

Michael Kearney

Yeah. I think in terms of other types of entities offering services, hospital systems themselves are certainly starting to offer services, things like social services. Just making sure as patients come in, particularly those heavily seen in the Medicaid space coming in, getting support to make sure that they understand what types of tools are out there is certainly a first step in ensuring that patients are at least getting access to these and know about them.

Some health systems are even building off of what I mentioned before about transportation. Some are adding transportation services, but I think there certainly is a gap in the understanding of where these patients are coming from.

And so I think that transportation piece is something that is going to continue to be built out as more and more cell and gene therapies come to market.

And then coordination of care. We’ve spoken to a number of people in the marketplace specifically around coordinating care. And as you’re looking to help patients through the entirety of the patient journey, not just diagnosis, but through first, second, third line of care, and potentially by the time they get to CAR-T, offering services to make sure that the patient has a smooth transition throughout that and understand all the respective components to make sure that they’re receiving the adequate care that they need to for the best possible outcome.

Amelia Nell

Yeah, thanks Michael. And sort of building off that last question, one last question for you and Brigit. How do you expect patient support for these therapies to develop in the future? And I’m thinking in particular, how can manufacturers or what can manufacturers do to assist these patients?

Brigit Kyei-Baffour

Yeah, that’s a great question, Amelia. I think in the future, we’ll likely see manufacturers developing more innovative and comprehensive ways to provide support that sort of expand beyond some of the traditional modes of patient support.

And I think we’re starting to see increased flexibilities allowed via the OIG public opinions, which I will caveat that those are specific to, or can be specific to a manufacturer specific to a program.

I think they are a good indicator that there is a potential path forward for manufacturers to be able to address some of the socioeconomic risk factors that patients may experience across payer channels.

And these programs can be used to help close the gap on some of the health disparities that hinder access to care. And so as we’re starting to see more to Michael’s point in the realm of transportation support, helping with lodging and meals and things of that nature, more partnerships with community-based organizations, I think that that’ll be something that will continue to trend in the future.

Michael Kearney

Yeah, and building on that a little bit, leveraging not only claims data, but socioeconomic status data to pinpoint specific areas and affordability barriers that patients face. We know, based on research that we’ve done, that given the concentration of these qualified treatment centers, FACT- accredited sites, they’re in certain parts of the country and that may not be easy for a lot of folks to get to.

And then you layer on socioeconomic factors to that. Obviously that burden exacerbates a little bit. So leveraging real-world claims data and socioeconomic status data to help really understand the patient population, I think will really be a benefit for manufacturers as they’re looking to build out additional support services to ensure that they’re reaching patients in an adequate manner.

Amelia Nell

Well, thank you Brigit and Michael. I really appreciate the discussion on patient support services. That wraps up our three-part series on cell and gene therapies, but we do continue to work on these therapies daily with a wide variety of engagements with our clients, and we welcome listeners or viewers to reach out with questions or if you’d like to discuss any of the topics covered today.

Amelia Nell

So thank you for tuning in to Avalere Health Essential Voice, and please stay tuned for more episodes in our Disease Education series. And if you would like to learn more, please visit us at avalere.com/podcasts.

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