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Transcription:

Mike: Hello and welcome to Avalere’s first episode in our podcast series focused on specialty pharmacy stakeholder perspectives. My name is Mike Schneider and I am a Principal in the Market Access practice here at Avalere. I am joined today by Ernie Shopes, Senior Vice President of Products and Client Delivery at Creehan and Company, and Joel Wright, CEO at AllianceRx.

In today’s episode, we will discuss the outlook for specialty pharmacy, with a focus on the pipeline and landscape of the business.

To get us started, as specialty medications continue to consume a greater share of overall drug spend, it is important to note the larger trends underlying this dynamic and how stakeholders are meeting the challenges. Generally, in the specialty pharmacy (SP) landscape, which trends are you seeing in the pipeline, and are there any new therapeutic areas that will have an impact on the SP business over the next few years? Why don’t we start with you, Joel?

Joel: Great. Good morning! I think the trends we see right now really focus on smaller patient populations, whether in rare, orphan, or ultra-orphan categories. Then, of course, with cell and gene therapy (CGT) we are getting into truly individualized medicine. A lot of those tend to be in the oncology space, but not all of them. Specialty pharmacies are looking at many diseases across these categories.

Mike: Great, thank you, Joel. How about you, Ernie?

Ernie: Thanks, Mike, and thanks, Joel. I would also add the concept of biosimilars. It is not new but had a lot of buzz a few years back and has been slow to take hold. I think we will see that concept coming to life very soon, as we thought would it be a few years ago, which will be another area that the pharmacies will need to react to.

Mike: Thanks, Ernie. Excellent point. Most of the news these days is about COVID-19 and its impact on American society. How is the virus potentially impacting the types of patients that specialty pharmacies will see?

Joel: I think the first thing we are seeing is a 54% decrease in physician visits across the country, so patients are not getting mammograms, colonoscopies, or skin tests—a lot of the very standard, normal diagnostic tests. We anticipate a decrease in new scripts, and potentially a decrease in volume in the immediate term. But as we come out of that, we expect that we will likely see an increase back to the normal level in that space. But, with that, we are going to see patients that were diagnosed later. We could potentially see a patient who would have been stage 1 or 2 come in as stage 3 or 4. Patients may be sicker as they are entering the channel and will need more intensive care from that point forward.

Mike: Thanks, Joel. Ernie, is there anything you would like to add around the impact of COVID-19?

Ernie: Sure. These are interesting times, and I think we have all gotten a jump start on technology, with working virtually, telehealth, and doing a lot more via video from home. It is very interesting for me to see how telehealth will take hold, potentially in a much bigger and broader way, and what that will really do. Joel mentioned the difficulty in getting the diagnostic tests and such. When you look at the specialists that may have full schedules already, what does that landscape look like if they are able to utilize telehealth? Does that broaden the capability to get more patients through the process? Maybe not with their diagnostic tests, but it allows for interactions with specialists in a different way. How does that affect the flow of prescriptions into the process?

Mike: Excellent, thank you. There are therapy-specific programs designed to offer specialty patients dedicated support for specific disease states. These therapy programs seamlessly merge education, digital tools, and clinical expertise dedicated specifically to a given disease. Ernie, what is your perspective on how these therapy programs might work now with everything we have going on?

Ernie: Sure. Thanks, Mike. I think specialty pharmacy has always approached disease management differently, which is why it is specialty with a high touch. There are multiple models in place that work today with centers of excellence by disease. The pharmaceutical world places a lot of emphasis on the specialty pharmacy for the natural pressures such as adherence to drugs and dispense, as well as complexity around drugs with a Risk Evaluation and Mitigation Strategy (REMS) program. From my experience, it has always been a balance between best clinical practice and contractual obligations as margins compress. Clinicians and all stakeholders want to do what is best for the patient. While there are supplied resources to do so, generally you cannot keep patients on the phone for an exhaustive clinical analysis. Often due to low interest or lack of time. From a technical perspective, there are other tools and digital offerings, which have received a lot of attention and patient engagement lately. Joel may be also be able to speak to this as well, but the Multiple Sclerosis (MS) disease state has been an early adopter and focused with digital offerings and self-service capabilities with hopefully more to come.

Mike: Joel, anything that you would like to add?

Joel: I would agree with Ernie. We are seeing a significant increase in the tools that patients want to use to manage their health and be part of their healthcare. They want to see where their prescriptions are in the process with better visualization of their lab and test results. At AllianceRx, we are working to bring that level of engagement to patients and are very excited about the progress. Ernie’s comment around MS is a good one. Typically, patients that are younger in their 30-40s, who are internet savvy, and want to interact through their mobile device. We are seeing the same thing with Cystic Fibrosis (CF) and with other disease states, that are going to be long-term and life-long diseases. These patients do not want to be on the phone every month for 6-10 minutes. Patients would rather manage their health and still get the care they need in a way that is more technology savvy.

Mike: Very informative answers. In addition to type of specialty medicines in the marketplace, it is important to understand how and why they are administered, and how they are paid for. While not appropriate for all specialty drugs, we are seeing patients switch for physician-administered to self-administered drugs in certain categories, especially with the stay at home orders. Joel, what you are seeing and how could these switches potentially impact your organization in the future?

Joel: That is a great point, and a great question. COVID-19 has also had an impact on patient transitions. We are seeing that with innovation, more therapies can be self-administered. Patients would rather the opportunity to self-administer, than schedule a doctor’s visit and potentially risk exposure to COVID-19 or be immunocompromised. At AllianceRx, we prioritize patient education for those who may transition from a physician- or nurse- administered drug. It is important to not only educate on how to self-administer, but also deepen understanding of the clinical warning signs of potential issues, and ensure patients have access to the additional supplies needed in their homes. This is how we operate as a specialty pharmacy, recognizing the needs of a patient in a transition and being able to support them appropriately.

Mike: Thanks, Joel. Ernie, is there anything you would like to add from your perspective?

Ernie: As an extension of what Joel mentioned, with self-administered injectables it brings the home nursing aspect in differently, as we move forward. Home nursing is not new to specialty pharmacy. There is plenty of coordination between the pharmacy and nursing agencies, with many nurses going into patient homes. I also think with advanced tracking in this area, this will lead to more broadly shared data for care coordination. We touched on the digital offering, with many educational videos from the specialty drug manufacturers that provide patients with self-injectable support, while also having the option to reach back out to the pharmacy or physician for assistance.

Mike: Great. Is there a particular specialty pharmacy issue that keeps you up at night? Joel, from your perspective, what might that issue be for you, and why?

Joel: Well, the good news is that I don’t sleep much. There is plenty that keeps me up at night. The science is moving very quickly, and it is incredible to see the technology breakthroughs. But our payment systems and the ability to keep up with it is difficult. We must evolve and there is no clear path on how to do so. The industry needs leadership to get through that. I think we are going to move from a point of simply paying for consumption of a medication to an outcomes-based payment system that tracks efficacy and guarantees of efficiency over time. When you look at cell and gene therapy, there is a potential 5-15-year tracking period. There will be significant requirements on these manufacturers. It will be important for specialty pharmacies to understand how to help them, as well as help the payers understand and contract for that, while having visibility to the data. Right now, I have been thinking about how we will position ourselves in that space.

Mike: Great. Ernie, what keeps you up at night?

Ernie: Like Joel, I do not sleep a lot either. From a technology perspective, ensuring the systems are available that are flexible and configurable to meet the demands we may not know of yet. We have talked about cell and gene therapy, orphan drugs, and complex disease states that need to be able to shift rapidly. We need the systems in place that can turn on a dime. We come from the specialty space of years ago with an understanding that the ability to adapt is how business and contracts are won and patients are served with improved quality of life. Also, access to data that will allow people to make faster decisions while tracking and reporting can support more proactive interventions. That coupled with predictive analytics, which can help us understand which markers patients may have, and who may need more attention. Joel mentioned, while some patients with chronic illness understand their disease state very well and remain adherent to their therapy, others may not. Some complex disease states and side effects that may force patients to move away from their therapy, which can cause additional problems.

Using predictive analytics and broader data sets to identify those patients allows our pharmacy partners to focus on those patients with the greatest impact. These are the things we are thinking about to help our pharmacy customers serve patients better, while also ensuring the user experience with our systems are reducing burden in an already difficult situation.

Mike: Great! Thank you, Ernie. Are there any additional closing thoughts, either of you may have, as we continue to think about the outlook of specialty medicines and specialty pharmacy? Joel, I will turn to you first.

Joel: I appreciate the opportunity to participate in this discussion. I also appreciate the work that Avalere does to help shape the thought process around where the industry is going. I think it is an incredibly exciting time to be a part of this industry but also an incredibly challenging one. It is going to be an exciting ride over the next few years.

Mike: Great! Ernie, any closing thoughts from you?

Ernie: Yes, I agree with Joel. Thank you for the opportunity to speak. We need to work together to identify creative solutions as the industry evolves. There is much more to learn, so it will continue to evolve with pressures for all stakeholders. Specialty pharmacy is in the middle of the payer and the pharmaceutical manufacturer, which may in some cases have conflicting objectives or incentives. Opportunities like value-based contracting are bringing stakeholders together in unique ways and we will need to continue to work together through those creative solutions.

Mike: I agree with both of you. As a healthcare industry, working together as different stakeholders will be the way forward. Ernie and Joel, thank you for joining us today. Your insights have been invaluable. Thank you to our listeners for tuning into the podcast, please stay tuned for more episodes in our specialty pharmacy series. If you would like to learn more information please contact us at www.avalere.com. Thank you!