Early Commercialization Planning Is Key for PDT Success, Patient Access

Alex Kilgore, PharmD, product manager on AmerisourceBergen's Global Products & Solutions team, spoke with First Report Managed Care on the current prescription digital therapeutics (PDTs) market and how innovative technology can support the rapid commercialization of these products. 

Can you tell our readers a bit about yourself and your background?

I am a pharmacist by background, and prior to joining the Global Products & Solutions team at AmerisouceBergen, I was a member of AmerisourceBergen’s consulting arm, Xcenda.

For about the past 2 and a half years or so, I have been involved in the digital therapeutics space, starting with early payer market research around receptivity, interest in coverage for digital therapeutics, and how payers are managing these products, which rolled into some consulting opportunities for commercialization, go-to-market planning, and creating some of those roadmaps for bringing products to market. I have since to the Global Products & Solutions team, where I help lead the development of AmerisourceBergen's digital therapeutic products and solutions, as we look at both our commercialization support and our additional distribution of digital therapeutic products.

AmerisourceBergen's uniquely positioned in this space, as we’re typically viewed as a drug distribution company. However, as we look at our portfolio of solutions, we have a lot of other commercialization support within our AmerisourceBergen ecosystem, from early product road mapping and group purchasing organization (GPO) services, like I had mentioned, all the way through to our downstream distribution support. We've been very focused in the digital therapeutic space and are excited to continue to build out some of these solutions to help overcome some of the challenges.

What are some of the major challenges associated with PDTs?

Digital therapeutics are, in general, a very different modality of health care than most people are used to. The process of prescribing an app is novel in the space. A lot of providers and patients are comfortable with the prescription process for physical pharmaceutical medication. This is very different in terms of how prescribers are able to access and prescribe these products, how these are reimbursed and paid for, and downstream to how patients are enrolling and continuing to engage with these tools, is all new. 

As we look at how these products are categorized, there are a lot of points of confusion. From a patient perspective, we look at the abundance of health applications, all the way to these clinically validated PDTs that have gone through evidence generation—clinical trials in many cases—and have demonstrated positive outcomes for patients in certain therapeutic areas.

One of the main challenges is the lack of familiarity of how these products fit into care for patients.

Another challenge, especially as we look at DTx West and a lot of conference discussions, is reimbursement. There is still a lot of development that needs to happen in the digital therapeutic space. How do we standardize reimbursement mechanisms for these products? Who is paying for these, and what does that look like? How can we support patients so that they can afford these therapies and can see the benefit of using these digital therapeutic products?

Those are really the biggest challenges that we see today. And again, as we look at clinical evidence that is, in many cases, driving the uptake of these products we are asking: how can we continue to mature that evidence and distill the value of these digital therapeutic products as essential. As we look at perceptions from stakeholders along that value chain down to patient outcomes, how we can drive those forward?

Can you tell me more about AmerisourceBergen's technology solution to address these challenges?

AmerisourceBergen is filled with big believers in this space, and we are definitely aware of the challenges. As I mentioned, we are fairly new in terms of bringing products and solutions forward, but we have been active in this space in various capacities for the last couple years. 

As we look at our technology solutions, we have a variety, just in terms of creating commercialization support for digital therapeutics and realizing that this is a new segment of care. This is not your traditional pharmaceutical company in many cases. These are technology products. These are, in a lot of cases, health tech startups, and we are creating solutions that support this area and its unique challenges.

From provider support services, we are developing DTX Connect where we are creating electronic health record integrated solutions for that prescribing mechanism. To support that, I mentioned earlier the challenge which exists for prescribers, knowing how to prescribe and get these products to patients, but we are also exploring pharmacy support services. 

A lot of our traditional services, we can apply to commercial support—adapting to digital therapeutic space, patient support, early market access consulting, and go-to-market planning—and the full life cycle of these digital therapeutics. We are supporting end-to-end commercialization as a commercialization partner.

As we look at our technology solution, DTX Connect is focused on provider solutions, and how we can make digital therapeutics an accessible treatment option for patients and providers. We identify that as one of the key challenges for uptake. That is what we are building out today, and we also have the additional suite of commercialization support that AmerisourceBergen offers, specific to digital therapeutic products.

Which patient populations do you envision DTX helping the most?

The patient populations today, just given the nature of these digital therapeutic products, have really been focused on behavioral health. As we look at the ways that a lot of these products leverage cognitive behavioral therapy (CBT) to support different therapeutic areas that have CBT within the treatment recommendations. It has been really fascinating to see the growth of those indications leveraging CBT.

Along with that, there are more advances every day both in clinical evidence and technology that are starting to expand into additional therapeutic areas that are also fascinating. Especially as we look at some of the virtual reality applications, some of the gamified treatments, there's a lot of therapeutic areas outside of the initial mental and behavioral health sectors. So it's been exciting to see how this area continues to support therapeutic areas that we would not have thought of in the early days of digital therapeutics, as well as how we can continue to support that evidence to identify those new patient populations that will see the benefit from these products.

The DTX space is still developing, which means a lot of questions still need answers. What do stakeholders need to do or need to know to ensure patients have access to these products?

There are lots of moving parts that are still being worked through today. I think the one thing that comes to mind in terms of supporting and making sure that patients have access is really thinking of that commercialization early, and how you can, as a digital therapeutic company, think creatively around how we can make sure that patients have access to this, and how you can be able to evolve. As we look at reimbursement, patient provider access, all these different areas, whereas solutions continue to develop and evolve, be able to move with that and have more of a creative commercialization plan in place to support making sure that there are mechanisms for patients to have access get ironed out. 

I think the earlier you can look at how you're going to commercialize these products will really help expedite that path to patient access as we look at digital therapeutics.

Where do you see the future of PDTs headed?

Particularly in my role and as a pharmacist, I see so much potential and value in the digital therapeutic space, and the way that these products can be worked into the recommended treatment for patients based on the outcomes we anticipate. 

It's exciting, and I feel that the future of these products, especially as we look at different pieces of legislation being brought forward to create payment mechanisms for these products, the issues of how we can continue to drive access in this space with be worked out. This is just going to continue to grow in terms of how it can positively impact patients. Once these infrastructure and mechanistic issues start to get solved, that is where we will start to see the value and the opportunities really start to unlock in terms of driving more clinical evidence, simplifying the pathway for these products to get into the hands of patients, add value, and see the positive outcomes that patients can experience with this.

There is need for additional support to keep the patient engaged and empowered to take ownership and an active role in their health care. I think digital therapeutics are a way to start to bridge that gap where we can have that continuous engagement with patients and help them live healthier lives.

As I said, I am very passionate about this space, and I think the pharmacist in me loves this space and the opportunity it presents. AmerisourceBergen's going to continue to be active in supporting all these challenges that we talked about and help drive this space. 

With being a new section in health care, it is very collaborative and there is a lot of support from the digital therapeutic space to work together to drive this forward, which is exciting. I expect a lot of tremendous progress in this space over the next couple years.