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April is National Cancer Control Month, and this week we are joined by Dr. Gerold Bepler, president and CEO at the Barbara Ann Karmanos Cancer Institute in Detroit. Dr. Bepler discusses the unique role cancer centers play in preventing and treating cancer, the importance of 340B to Karmanos and its patients, how Karmanos is addressing racial and ethnic disparities in cancer treatment, and the partnership it has formed to expand access to cancer research and treatment in rural communities. Before the interview, we recap 340B Health’s recent virtual Hill Day.
340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.
Speaker 1 (00:04):
Welcome to 340B Insight, from 340B Health.
David Glendenning (00:12):
Hello from Washington DC, and welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm David Glendenning with 340B Health. This episode is sponsored by Huron. Huron is a global consultancy that collaborates with clients to drive strategic growth, ignite innovation, and navigate constant change. Through a combination of strategy, expertise, and creativity, Huron helps clients accelerate operational, digital, and cultural transformation, enabling the change they need to own their future. For more information, please visit huronconsultinggroup.com.
David Glendenning (00:54):
Our guest today is Dr. Gerold Bepler, President and CEO of the Barbara Ann Karmanos Cancer Institute in Detroit. Dr. Bepler is a world renowned thoracic oncologist, and we spoke with him about some of the impressive work that 340B hospitals such as Karmanos are doing in the oncology treatment and research spaces. April is National Cancer Control Month, so we thought there was no better time to discuss the role that 340B helps play in these areas. But before we go to that interview, let's take a minute to cover some of the latest news about 340B
David Glendenning (01:30):
More than 300 340B professionals took to Capitol Hill recently, virtually of course, for a Hill Day advocacy event organized by 340B Health. The event gave participants the opportunity to meet with more than 250 members of Congress and their staff to discuss the importance of protecting 340B. There are 70 new members of Congress this year, which provides opportunities for educating freshmen lawmakers about drug pricing issues in addition to keeping up those conversations with returning members. If you are a 340B Health member who was unable to make it to Hill Day this time, you will have a chance later this year to participate in the next one.
David Glendenning (02:20):
The conversation centered on the harm being caused by drug company attacks on partnerships with community pharmacies, by efforts to turn discounts into rebates, and by Medicare reimbursement cuts for many hospitals. The meetings took place just after Xavier Becerra was sworn in as Health and Human Services Secretary, a position in which he will have tremendous influence on these issues. As California Attorney General, Secretary Becerra expressed strong support for 340B, and he did so again during his Senate confirmation hearings. Now hospitals are hoping to see those statements of support translated into official department policy.
David Glendenning (03:06):
And now, for our feature interview with Dr. Gerold Bepler with the Karmanos Cancer Institute. Dr. Bepler has been the Institute's President and CEO since 2010. He has spent his career researching risks, progression, treatments, and outcomes related to lung cancer. Miles Goldman sat down with Dr. Bepler to learn more about how his Institute's work intersects with 340B. Here he is with that conversation.
Miles Goldman (03:33):
Thank you, David. I'm joined by Dr. Gerold Bepler, the President and CEO of Karmanos Cancer Institute. Dr. Bepler, thank you so much for taking the time to join us today.
Dr. Gerold Bepler (03:44):
You're welcome. Thank you.
Miles Goldman (03:46):
Let's discuss the Karmanos Cancer Institute. What should our listeners know about the Institute and the patients it serves?
Dr. Gerold Bepler (03:53):
The Barbara Ann Karmanos Cancer Institute is actually one of the oldest cancer institutes in the United States. It started in the 1940s under a different name, Michigan Cancer Foundation, and has really contributed to major advances in the field of oncology, perhaps most notably a lot of the cell lines that were used for development of Tamoxifen were started here. MCF7, for example. We were also really early in drug development. And as a, quote, side product, three of the first four FDA approved AIDS drugs were actually developed here, AZT and dideoxythiacytidine. And we became NCI-designated as a comprehensive cancer center in 1978. So we have been NCI-designated for quite a long time.
Dr. Gerold Bepler (04:49):
And then in the 2000's we actually purchased the inpatient and outpatient services from another hospital here in the city of Detroit. So we are one of the freestanding cancer hospitals in the United States with designation as a comprehensive cancer center. And the population we serve is spread mostly throughout the state of Michigan, but because we are in the city of Detroit our primary patient population that comes directly to our hospital here downtown is really the population of the city of Detroit. So we see a very high proportion of uninsured or under-insured patients. 15% to 20%, on average, of the patients we see fall into this category. About another third of the patients that we see are insured through Medicare.
Miles Goldman (05:42):
And you mentioned just a couple moments ago that Karmanos is a National Cancer Institute designated comprehensive cancer center, and I believe that you're one of only 51 in the country. What does this designation specifically mean for your patients?
Dr. Gerold Bepler (05:57):
What it means for our patients is that we truly are a fully comprehensive cancer center, meaning that what we do is basic science laboratory research to evaluate how cancer grows, how cancer progresses, what mechanisms cancer uses to actually stay alive so that we can develop new targets and new drugs. That we also have a large population sciences program that, of course, specifically focuses on cancer risk and cancer epidemiology and how to leverage early detection and how to leverage prevention for people who are at risk to develop cancer. That we have a genetics counseling program. That we have a large clinical trials program so that we have access to the newest drugs that are under development through pharmaceutical industry and through other cancer centers, and that we can provide this treatment to our patients early and that we overall have a comprehensive, integrated plan for our patients to receive treatment in multi-disciplinary teams, which means we have surgeons, radiation oncologists, medical oncologists, radiologists, pathologists, geneticists, clinical trialists all sitting at the table to discuss each patient before we make a decision on how to proceed.
Miles Goldman (07:33):
As a cancer hospital, Karmanos is a 340B covered entity. How does 340B help you provide care to patients with cancer?
Dr. Gerold Bepler (07:41):
Well yes, we are a 340B hospital because we fall into the category of a disproportionate share hospital. As a result of this, we get access to discounts for buying drugs. And of course, within the treatment of cancer, there is a very large number of drugs, particularly in the last 20 years, that are very costly yet very effective for the treatment of cancer. So as a result, I would say that truly, being a 340B hospital, it provides advantages to every single patient that we see. And there are plenty of examples for this. For example, oftentimes we get patients referred from outlying hospitals because they have a specific disease with a molecular abnormality and there is a drug that specifically targets this molecular abnormality. And then the cost for this drug is in the realm of $10,000 or $15,000 per month.
Dr. Gerold Bepler (08:45):
And their insurance covers a portion of it but not sufficient, so that patients really can't afford the treatment. And as a result, we have established a specialty pharmacy that falls under our 340B program that allows us to provide directly financial assistance to the patients. In 2020 we were able to provide assistance to our patients to cover costs for $1.7 million. So that really makes a giant difference. We also directly follow up with the patients. We get their medication, we ship it to the patients. We have follow-up phone calls with the patients to specifically instruct them on how to take their medications, to explain all the side effects, to call us right back if they have any side effects so that we can make sure that they don't just, quote, discontinue the drug, but maybe reduce the dose or hold it for one day and then restart it to really optimize the benefit that patients can derive from the drugs through our specialty pharmacy and direct patient calls.
Miles Goldman (09:53):
And you were saying cancer drugs are really expensive. And I imagine they're going to become even more expensive as these really exciting new therapies come to be for patients as we move forward in the coming years. What role do you envision 340B having as even more expensive, more specialty drugs are available?
Dr. Gerold Bepler (10:11):
You probably know that some of the latest new drugs that have come on the market are costing, unbelievable, close to $600,000 per month for treatment. I can only see the 340B will play an increasing role in giving our patients really a chance to get the best treatment for their disease, which will prolong their life and definitely improve the quality of life for them.
Miles Goldman (10:41):
Still thinking about 340B, drug companies have unilaterally decided not to provide discounts to hospitals using community pharmacies. How are these actions affecting Karmanos's ability to care for patients?
Dr. Gerold Bepler (10:54):
In some other locations that we have that are further away from us, more in Northern Michigan, there definitely has been an impact because we have to then think about, are there alternative drugs that we could give to the patient? And that's oftentimes not the case. And we have recognized this to be a major issue for compliance of patients with their medication, because it's hard for them to get the drugs in time and to really also understand how best to take their medication.
Miles Goldman (11:26):
I appreciate you sharing that with us. Another 340B issue cancer hospitals and some rural hospitals have been facing is accessing 340B discounts on orphan drugs when they're used for off-label purposes or to treat common conditions. How has this issue affected Karmanos?
Dr. Gerold Bepler (11:44):
If you are a dish hospital, and again Karmanos Cancer Center in the Detroit area is a dish hospital, then are actually allowed to use the 340B discounts for orphan drugs outside of the FDA approval. So it really affects Karmanos Cancer Institute in different ways. It impacts us more in the outlying areas where our 340B comes under rural access hospital. And it's tragic. I have to say this shouldn't really be the case because again, as pointed out earlier, these drugs are so extraordinarily expensive that literally no one can afford to pay hundreds of thousands of dollars per year for their drug that keeps them alive.
Miles Goldman (12:35):
How do cancer institutes work together with other 340B hospitals to advocate for the program?
Dr. Gerold Bepler (12:41):
Well, there are multiple associations within the realm of cancer that are of course very interested in making sure that we have the ability to provide our patients the best treatment based on science. One of these organizations is the American Association of Cancer Institutes, or AACI, which represents probably at the present time somewhere around 80 to 90 or maybe even 100 cancer institutes across the United States. And they have a very strong advocacy program that specifically focuses on issues surrounding 340B. And because 340B legislation also changes frequently, it is crucially important to be part of a larger organization that has the ability to not just impact legislation but also understand the language in proposed new legislation so that you can make sure you are compliant with the 340B program moving forward.
Miles Goldman (13:47):
Do you ever speak to other hospital CEOs about how you're working together to advocate for the program?
Dr. Gerold Bepler (13:53):
Oh, yes, we do that rather frequently at medical societies such as AACI, but also other organizations. For example, the American Society of Clinical Oncology, ASCO, is also very active in that arena. And then also, just within the NCI, we have get-togethers of cancer center directors and we discuss these issues just because, in the last 10 to 15 years, the drug pricing has escalated to a degree where it really impacts our ability to provide the best care for patients.
Miles Goldman (14:31):
I'm glad you mentioned AACI because I know they're focused on addressing health disparities in cancer care. How do you believe we should be approaching this important topic to reduce and eventually eliminate the disparities in cancer prevalence?
Dr. Gerold Bepler (14:44):
This is a very complex topic, and even so this is super high on the agenda right now. It is actually not new and has been recognized for many years. It is based on the fact that different racial and ethnic groups have different risks to develop cancer. And also, when they develop cancer, the cancer may behave biologically different among the racial and ethnic groups. So for instance, it is well-known that breast cancer, for example, in African American women oftentimes is so-called triple negative breast cancer, which is a more aggressive form and harder to treat. So what we are doing to really raise awareness of this is we have multiple different programs that address this. We have developed an Office of Cancer Health Equity and Community Engagement under the leadership of Dr. Thompson, which specifically engages different communities in Southeast Michigan and across the lower peninsula to find out what the concerns are of community leaders within their specific communities from a point of view of cancer, to then tell these representatives what it is that the Karmanos Cancer Institute right now is researching.
Dr. Gerold Bepler (16:08):
Then we try to come together to see how we can match these requests from the community and what we are capable of doing together in order to really ultimately develop treatment. Screening, early detection, exercise programs and food programs and whatever else it takes in order to reduce cancer risk and also improve outcome for patients that have been diagnosed with cancer. We are also increasingly trying to address differences in the biology between cancers from different racial and ethnic groups from a point of view of basic science to actually try to understand, specifically understand why is it that cancers in this group is more aggressive than in the other group, and are there drugs that we need to develop that specifically address cancer in the population that has either a higher risk to get the disease or a more aggressive form and, as a result, a much worse outcome than others?
Miles Goldman (17:16):
I understand Karmanos has created a cancer network that effects care in rural communities.
Dr. Gerold Bepler (17:22):
If you look across the landscape of cancer in the United States, it is very apparent that NCI-designated cancer centers are clustered in big population areas and metropolitan areas, and as a result it is so much more difficult for rural populations to gain access to the latest treatments that are not yet FDA approved and still under development. So what we did is we basically joined a community-based health network called McLaren Healthcare that really operates hospitals throughout the lower peninsula in the state of Michigan. And we joined McLaren specifically with a goal to raise the level of quality of cancer care in the community, and also to provide this community access to the newer treatments in a much more expedited fashion.
Dr. Gerold Bepler (18:24):
So we measure quality of cares. I'm happy to report to you that quality of care has really improved across the network very substantially over that period of time. We have focused on trying to make clinical trials available to the patients in the community. And since we've done this, the enrollment of patients in the community to clinical trials has really increased five-fold. So there's still a long way to go but I think we are going in the right direction.
Miles Goldman (18:53):
Thank you for helping us learn more about the cancer network. Dr. Bepler, we appreciate you taking the time to join us today and for your insights into the connection between 340B and cancer treatment and research.
Dr. Gerold Bepler (19:05):
Thank you, Miles.
David Glendenning (19:06):
Our thanks again to Dr. Gerold Bepler for discussing the strong connection between 340B and cancer care. As we mark National Cancer Control Month, we salute Dr. Bepler, Karmanos Cancer Institute, and all the dedicated 340B providers who are making such an immense difference in the lives and health of their patients. Are you interested in learning more about how to staff your 340B program most effectively? Then be sure to register for 340B Health's April 14th webinar. You'll hear from experts on how health systems in hospitals of varying sizes set up their 340B staff and functions to optimize program operations and compliance. See the show notes for the registration link.
David Glendenning (19:53):
If you missed our March episodes, check out our discussion with Dr. John Carlo, CEO of Prism Health North Texas, a Ryan White clinic, about the importance of 340B to patients at risk of or living with HIV/AIDS. We spoke later in the month about 340B state issues with Amanda Sellers-Smith, our Assistant Counsel at 340B Health. In our next episode, we'll hear from our president and CEO, Maureen Testoni, about the top 340B issues happening right now. We welcome your episode ideas and feedback. You can email us at podcast@340bhealth.org. As always, thanks for listening and be well.
Speaker 1 (20:41):
Thanks for listening to 340B Insight. Subscribe and rate us on Apple Podcasts, Google Play, Spotify, or wherever you listen to podcasts. For more information, visit our website at 340bpodcast.org. You can also follow us on Twitter, @340bhealth, and submit a question or idea to the show by emailing us at podcast@340bhealth.org.