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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.
Narration (00:04)
Welcome to 340B Insight from 340B Health.
David Glendinning (00:13)
Hello from Washington, D.C., and welcome back to 340B Insight, the premier podcast about the 340B drug pricing program. I'm your host, David Glendinning with 340B Health. Our guest for this episode is Tina Do with Yale New Haven Health. Specialty drugs are playing an increasingly important role in patient care and in 340B. With more complex and high-cost therapies in the pharmaceutical pipeline,
David Glendinning (00:40)
Hospitals need to plan well in advance for how they will obtain these drugs and provide the clinical services and other support patients need to use them successfully. Tina recently presented at the 340B Coalition Summer Conference on specialty drugs and 340B. While she was there, we sat down with her to discuss why 340B hospitals should be monitoring the pharmaceutical pipeline, the extensive planning that can be necessary before bringing new specialty therapies.
David Glendinning (01:09)
Into a health system and the challenges hospitals face in gaining access to limited distribution drugs. Here's that conversation. I'm here with Tina Do with Yale New Haven Health. She is the Associate Director of Clinical Strategy and Business Development and the Interim Associate Director of Retail and Home Infusion Pharmacies. So a bit of a mouthful for a title. Thank you, Tina, so much for being here and welcome to 340B Insight.
Tina Do (01:38)
Thank you for having me, David. I'm super excited to be here.
David Glendinning (01:41)
You presented at this conference on the topic of specialty drugs and a 340B. Before we get to that discussion, please tell us a little bit about Yale New Haven Health and the patient's user.
Tina Do (01:55)
Definitely. Yelney Haven Health is a large nonprofit academic health system. We have five hospitals that spans across the coastline of Connecticut and Rhode Island. We also have a medical group and are affiliated with Yale Medicine. We have almost about three million outpatient encounters on an annual basis and help.
Tina Do (02:23)
patients with chronic, complex, and rare diseases. And from an outpatient pharmacy services perspective, we have ambulatory clinical pharmacy services. We also have a specialty pharmacy for retail pharmacies and growing and a home infusion pharmacy, which allows us to have this continuum of care to serve patients in a variety of different settings.
Tina Do (02:48)
And our goals across the health system as well as pharmacy is really to focus on the coordination of care, reducing barriers to access for our patients if possible, and improving patient outcomes.
David Glendinning (03:04)
Excellent. Thank you. And I understand specialty drugs is is really in your wheelhouse professionally. And we all know and I know many of our listeners know specialty drugs have become an increasingly important and large part of the three forty B program. So maybe you could explain for those who are just catching up a little bit why this is such a significant issue for three forty B hospitals.
Tina Do (03:28)
Specialty drugs and pharmacy is near and dear to my heart and has boomed a lot in the past years. There has been a significant increase in numbers of specialty drugs in development in the pharmaceutical pipeline, with more than 70% of the pipeline being specialty drugs. And there's also been an increase in these ultra-specialty drugs called cell and gene therapy.
Tina Do (03:56)
Which are in the millions of dollars. So very expensive, very complex and very complicated therapies. And when we think about three forty B in alignment with the pipeline trends and national trends, there has been a significant increase in purchases in the specialty high cost dollar pharmaceuticals. I do wanna say that
Tina Do (04:21)
340B enable our hospitals and many hospitals to obtain these drugs at a discount, but also it actually allows us to have and provide the infrastructure to support our patient care across all the complexity, the adverse effects that they may deal with, and the adherence and compliance and assistance that they need there, which is very important. And as the pipeline grows, what we see is that.
Tina Do (04:50)
The focus is on these really complicated, complex and expensive drugs. And so being able to provide the quality care and having the ability to provide access to patients is really important.
David Glendinning (05:03)
I know one of your key messages from your presentation was that hospitals when it comes to this pharmaceutical pipeline really need to be monitoring it very closely. Why is that so important for hospitals?
Tina Do (05:16)
For me, I believe that everything starts with understanding what's coming. And so when we think about new drug therapy strategies, it is really helpful to look at the pharmaceutical pipeline and see the trends, where it's heading, and what that trend means for us, and are we positioned in the right place? And so when you look at the
Tina Do (05:41)
pipeline and you are able to identify drugs 12 to 18 months before going to the the market, you will be able to have very strong strategic and proactive conversations with different stakeholders in pharmacy and also outside of pharmacy. This is because some of the drugs may not just depend on us getting access, but it may require MRIs and other machines and clinical services where
Tina Do (06:10)
Business planning is really important and resource allocation is really important. The other thing to discuss through is the intensity of the clinical demand and the financial impact of the system. Talking about payer strategies, are the medications in your contracts, which locations will be administering the medication? How would that look like? And do you have the infrastructure in place?
Tina Do (06:40)
And so these conversations are really complicated and takes time with many stakeholders. And if you wait until the medications are in the market, the first question that you'll get is, when can we give the medication? And most likely you'll be delayed because you haven't had all this infrastructure in place or resources needed to support the patient.
David Glendinning (07:02)
Yeah, you seem to be alluding to the the very real fact that bringing a new specialty therapy i into a health system involves so much more than just ordering a medication. So w what are some of the sort of chest pieces that need to move around here? What do hospitals need to have in place ahead of time?
Tina Do (07:20)
Depending on where you believe that the drug will be administered, there are many different components that a system can think through. One big question to talk about and think through is access. So is this a limited distribution drug? Which specialty distributor will you be able to obtain the medication from? Do you have the medication in your payer contracts? Do you even have patients who are interested in receiving these complicated
Tina Do (07:49)
expensive therapies or prescribers who are interested in prescribing those medications. And so those pieces are really important to discuss through. The other part is PNT. If you are looking at administering it in the inpatient setting, that requires a lot of conversations. And then from outpatient setting, you also want to take a look at the limit distribution drug requirements. And if you meet those requirements,
Tina Do (08:19)
And if you have the infrastructure in place in order to deliver that drug. For smaller health systems, it may be helpful to have a coalition or join different groups so that you can advocate together in order to gain access. Our clinician relationship is also really important. Building the rapport with our clinicians not only help you put together a good clinical service, but also have advocacy on your side.
Tina Do (08:48)
So we've had experience where clinicians will advocate together with us as well as separately in order to gain drug access. And some of these conversations take years, which is why it's really important to do that. The other piece to think about is infrastructure. So from an operational perspective, you may need an authorized treatment center. You may need a very strong cold chain management, especially for cell therapy.
Tina Do (09:14)
And you just need to understand if you have all the logistics in place with storage and handling and the chain of custody for some of these really expensive drugs. the other piece is purchasing. You need to determine if you're able to purchase from a 340B account, WAC account, a GPO account, and what those rates would be or the costs would be. And then from a clinical monitoring standpoint, like we mentioned earlier.
Tina Do (09:42)
Do you have the MRI machines that you may need for some of these? Or do you have the documentation to see that the patient received their echoes? That may be part of the REMS requirement. And then the other piece that is really important is hub services. So patient assistance programs, medication assistance programs. More likely than not, these expensive drugs, patients will need assistance to navigate the complexity there. And so in general,
Tina Do (10:10)
Very complicated, lots of coordination. So you will need multidisciplinary teams to be focused on basically bringing in these drugs and also administering them and helping patients throughout the journey.
David Glendinning (10:23)
I your presentation highlights a bit of a success story involving Yale, New Haven health's specialty pharmacy and a new cardiac therapy. Can you walk our listeners through that example a little bit?
Tina Do (10:35)
Yeah, this is a great story for us. It took us two years of advocacy and teamwork in order to gain access to a drug called Mavicamton, which is a novel cardiac myosin inhibitor oral drug for patients with obstructive hypertrophic cardiomyopathy. This drug was identified by us to be of an interest to gain access through the pipeline.
Tina Do (11:04)
But also because we had patients on clinical trials and we wanted to have seamless transitions of care. But once the drug was released into the market, we were unable to gain access, but we continued to serve and provide care to the patients. We worked really closely with our clinicians, our heart and vascular clinical leadership in order to advocate to gain access. We continued to serve those patients even though we did not dispense the medications.
Tina Do (11:33)
And then from a pharmacy perspective, we actually embedded an ambulatory pharmacist into the service to continue to serve patients as we advocate to gain access together with the clinicians as well as separately. And so together we continue to support the center of excellence in hypertrophic cardiomyopathy that we have at the hospital. And over time, with many letters and conversations and meetings and teamwork.
Tina Do (12:02)
We were able to gain access to the drug and have been able to serve more than 30 patients on this. And year over year, we have shown positive outcomes, positive adherence, and have passed all the REMS audit that the manufacturers provided. And then we also gain access to Aficampton, which is another medication within the same class.
David Glendinning (12:26)
What a wonderful story for those 30 patients. That's that's excellent. Your presentation also features another success story, this one about home infusion involving several rare disease therapies. So maybe you could speak a little bit more about what that says about the role that integrated pharmacy services plays in this.
Tina Do (12:45)
When we think about pharmacy services, we also want to think about the different formulations. So there are specialty infusion drugs. And what we wanted to do was ensure that if our patient is going through retail, they can get retail medications. If they're in our specialty pharmacy, they can get those subcutaneous or oral drugs. And then when they move over into infusions, we still are part of the care team and are able to provide specialty infusion services.
Tina Do (13:15)
And so we partner really closely with our clinician in this service as well. We work closely with our director of Nord Center of Excellence, and we work very closely with our prescribers to make sure that patients are being seamlessly served. And so we've been able to provide enzyme replacement therapy to patients with Frabry's disease, pompe's, gouchers, and neiman-pick disease.
Tina Do (13:44)
And we've served 10 patients and still growing. Obviously, it's a rare disease, but it's been super helpful for patients to receive therapies in their home and very convenient for them there. And so the collaboration amongst our teams with our clinicians, our patients, our pharmacy service allows us continuum of care so that patients don't need to leave the system and have to work with other providers. Our home infusion has been.
Tina Do (14:12)
allowed us to expand that access, which is super important, especially for patients with rare diseases who have a lot other things that they need to worry about. We want to reduce the burden as much as we can.
David Glendinning (14:25)
You had mentioned limited distribution drugs before, and I imagine many of these therapies are available only through those limited distribution networks. What challenges does that create for three forty B hospitals like yours?
Tina Do (14:39)
Limited distribution drugs are quite a challenge, especially when we look at the pipeline, there are more and more focus on orphan indications, which tends to be limited distribution drugs. And so by identifying these drugs early and in advance, you'll be able to understand if your organization, your clinicians, your system are interested in providing and prescribing these drugs.
Tina Do (15:08)
And then from that standpoint, you want to understand what we talked about earlier. What are the requirements? How can we get access to it? Building the relationship with the manufacturers. More often than not, I'm having conversations a year in advance to express our interests and start to leverage our value proposition, even before the medications are in the market. And then the other piece that's really important for 34B entities to think about is
Tina Do (15:36)
Some of these you may want to have value propositions by having accreditation. So it could be URAC Rare Disease Centers of Excellence. It could be other certifications or training that a pharmacist or other team members can have. And so developing very strong and robust patient management programs is really key. Having those hub services medication assistance programs and prior authorization support is also really important.
Tina Do (16:05)
And strengthening that reimbursement and looking at your payer contracts is also very important so that we can ensure patients have access across all the integrated pharmacy services. And I think I've mentioned this before, but being able to utilize those 340B savings in order to have those resources and additional services is very important for patients who need more intensive care, especially with rare diseases.
David Glendinning (16:31)
Bringing this whole conversation back to 340B, there's often a misconception out there that we often have to battle that 340B is simply about purchasing drugs at a discount and nothing more than that. In your view, how does specialty pharmacy demonstrate that there is a broader value to 340B?
Tina Do (16:53)
340B definitely supports more than the medication itself. It helps our health system invest in services, in resources like pharmacists, nurses, clinicians, and so much more to provide better patient care to our patients in our community. And this has allowed us to provide very strong and high quality.
Tina Do (17:21)
clinical care for patients by providing patient education, you know, adherence supports, refill reminders, prior authorization support, medication assistance, everything that can remove the burden and stress in a patient. That is really our goal because we just want the patient to get better and have better quality of life. And for patients with high cost therapies in particular,
Tina Do (17:50)
We definitely want the patient to successfully start the therapy, but also be able to manage their side effects and be able to maintain these complex therapies while working alongside their clinicians, us, and all the other care team members. And 340B savings really allows us to do that. Without those additional resources, the patients may be left to figure out how to take these medications on their own and not know how to handle.
Tina Do (18:19)
adverse effects when it comes up.
David Glendinning (18:22)
to ask you to look ahead a little bit and think about what should three forty B hospitals be doing now to prepare for the next generation of specialty therapies that might be over the horizon at this point.
Tina Do (18:36)
It is a very exciting time for the pharmaceutical pipeline products for sure. And so I would say definitely monitor the pipeline continuously and assess and see if you are interested in those medications, build that foundation, have those conversations so that you're being proactive and not retroactive or reactive to the situation with the medication coming out into the market.
Tina Do (19:03)
And then the other piece is strengthening partnerships if you don't already have it with clinicians, with manufacturers. And if you have a bigger health system that have payer innovation departments or government relations or clinical centers of excellence, very important to build those relationships because it all helps with efficacy and helps with access as well.
Tina Do (19:30)
And then if you're able to, building a specialty pharmacy or services to be able to provide and deliver those services for patients is really, is really important. And then to be honest, prepare for the continued growth and trend of rare diseases and cell and gene therapy, because it is here to stay with the advancement in our technology. It's just going to rapidly accelerate and then continue to leverage 340B.
Tina Do (19:58)
to improve patient access and provide those resources to help with the community in the patient care.
David Glendinning (20:03)
Yes, it certainly seems like these advancements do make for exciting times. Okay, with the specialty drugs pipeline only only getting larger and more interesting. And I'm so grateful to you for coming here and sharing your expertise, not just with the attendees here, but with our listeners as well. So thank you very much for your time, Tina. We really do appreciate it.
Tina Do (20:24)
Thank you for having me.
David Glendinning (20:26)
Our thanks again to Tina Do for joining us. Her experiences at Yale New Haven Health demonstrate why preparing for new specialty therapies involves much more than simply purchasing the drugs. Hospitals need to plan ahead, build strong partnerships across their health systems, and have the clinical and operational infrastructure in place to support patients throughout their treatment. We will be back in a few weeks with our next episode. In the meantime, as always, thanks for listening.
David Glendinning (20:55)
And be well.
Narration (21:00)
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 at 340B Health and submit a question or idea to the show by emailing us at podcast at 340bhealth.org.