“If DTx are not covered by commercial and government payers, the rest of the process of providing patients with the care they deserve is broken,” says Andy Molnar, Digital Therapeutics Alliance (DTA) CEO. In an interview with The Sidebar, Andy discusses how DTA plans to scale up the development of evidence-based digital therapeutics.
Can you tell us what DTA initiatives you are most excited about this year?
We’ve decided to focus on three things this year.
Number one is community building. If we want to continue changing the healthcare delivery ecosystem, we need every stakeholder on board. Not only DTx developers – but also patient advocates, providers, lawyers, and people that understand how to bring new technologies to market.
We opened up our community, becoming more open to dialogue with digital health enthusiasts and also skeptics. We realize the complexity of the shift that DTx brings in patients’ lives and healthcare professionals’ work. It is also our responsibility to provide guidance throughout this transformation in healthcare.
The second priority is clear reimbursement policies and guidelines. It is still a disparate, nascent industry. DTx companies are looking for different ways to ensure their solutions are covered in the healthcare system. Sometimes, it’s not understandable why company A has their product reimbursed while company B does not.
The competition must be based on clinical evidence and measurable benefits, not on the ability to fit a product into the existing infrastructure.
And finally – commercial acceleration. We’re looking to ensure that startups have the right resources if they’re going to launch, raise money, or go through clinical trials. They must truly understand what’s required to get coverage from payers around the world.
By embracing these three pillars, we aim to move things forward.
The road to reimbursement for DTx is not easy. Payers rightly demand real-world evidence showing that products perform well beyond a clinical trial setting, as well as published studies proving DTx has both a therapeutic benefit for patients and an economic one for payers. Unfortunately, gathering all of this data does not necessarily guarantee reimbursement.
The reimbursement mechanisms are our focus at the Digital Therapeutics Alliance. It’s still on the digital therapeutic company to prove that their product is clinically effective, engaging, and secure. It should be the same as pharmaceuticals or medical devices.
It’s simple: if your solution is clinically effective, it should get covered, and if it’s not, it will not be covered and will lose out to competitors.
Unfortunately, as an industry, we’re not yet at that point where we can look at data and make decisions regarding the clinical value or benefits. Why? Because the guidelines for software as a medical device don’t exist.
We’re talking to legislators and policymakers around the world to ensure that a common and sustainable reimbursement framework will be put in place so companies don’t have to worry about payers saying: “I don’t know how or why to pay for this.”
DTA has recently released a brand new DTx Value Assessment & Integration Guide. It shows healthcare decision-makers – whether health systems, insurance companies, or payers – how to evaluate DTx products.
The members of DTA focus on clinically validating their products to ensure efficacy and safety to help patients improve their lives. Now, we have to make them available.
Of course, reimbursement is not the only challenge. There is also the matter of making DTx easier to prescribe and onboard patients. DTx prescriptions can’t simply be sent to a CVS to be filled. What solutions are available for this problem?
I would say – the suitable distribution model.
Where should patients get access to the solution and instructions on how to use it? Should DTx be shipped to their homes or e-mailed to them? Should patients be contacted by phone? Or should we develop a framework in which DTx are dispensed in a pharmacy? There are many potential solutions for making DTx more accessible.
But, I still have to refer back to the source of all problems – reimbursement. Even though it is not the only challenge, it’s the main challenge. It breaks the rest of the process for getting patients the healthcare they deserve.
Imagine your doctor prescribed you a drug for high blood pressure, and you couldn’t get it for a couple of months because your insurance company wasn’t sure if it could pay for it. And now, imagine you have insomnia, and you get DTx prescribed. However, the DTx are not covered by your insurer, and you have to find a way to access the product. In both cases, you are lost in the system; you can’t start your therapy. But how many stories do you hear about people not being able to get blood pressure medication?
Without the right reimbursement model, we can’t continue working on the distribution channels.
As you can see, the funding challenge returns whenever we want to address another issue at a lower priority level.
Let’s turn to Digital Health Applications (DiGA) introduced in Germany in 2019. Studies suggest that only 50% of physicians in Germany are aware of or understand what DiGAs are. There is clearly a knowledge gap here. What will the DTA be doing to educate healthcare professionals about DTx and PDTs?
Education is at our core; it’s how we started.
When I was working as a market access manager for digital therapeutics developers, patients had very little understanding of the healthcare apps they were downloading.
Today we are building a new, patient-oriented pathway for using digital therapies. Apps and digital platforms are becoming clinically validated, and users can get guidance from their doctors. It improves digital health literacy and also contributes to more equality in healthcare.
But there is still considerable work to be done in terms of educating healthcare professionals about DTx and PDTs. As DTA, we not only participate in meetings, workshops, and conferences in the US, APAC and European regions – where our Founder Megan Coder is very active – but we aim to be a convener.
We want to build a community of stakeholders who are looking to drive this industry forward. As a connector in the DTx market, we want to facilitate education among providers, payers, and policymakers. Putting these pieces of the puzzle together is needed in order to scale access and build the infrastructure to integrate DTx into healthcare ecosystems.
Sidekick Health – which has recently joined the Digital Therapeutics Alliance – and Pfizer announced a rollout of integrated digital therapeutic offerings for atopic dermatitis. How do you see the openness of the pharma industry to cooperate with DTx companies?
I think it’s huge!
Pharma companies are undergoing an industry transformation following the overall digital transformation. The biggest shift is that they can start to look at a person’s entire care. It’s an entirely new approach since DTx offer an extension of the power of medicines.
I don’t simply mean companion apps that guide patients on how to take medicines.
It’s about genuinely looking at the clinical endpoints associated with using software in conjunction with medication, which can not only help you understand a disease, condition, or disorder but also achieve better outcomes.
What trends regarding DTx do you expect in the upcoming 2-3 years?
I hope that governments understand the value of this technology, particularly in underserved and underprivileged communities. We really need to see a change in how these products are perceived by doctors, patients, and insurance companies.
In the next five years, we’re going to see DTx start to take off.
I’m looking forward to a world where DTx are prescribed on a regular basis. But, we have a long way to go before this happens.
Let me give you an example: Two years ago, I talked to my doctor when I started experiencing insomnia problems. I didn’t want medicine; I wanted cognitive behavioral therapy. And my doctor said, “How do you know what that is?“ I replied, “I work in digital health.” She answered, “What is digital health?“ I told her that my friends had created an app teaching people how to change certain behaviors to improve sleep quality. She reacted with, “That’s amazing! Please tell me how it works.”
It describes well the challenges that are ahead of us.
The opportunities that technology offers are enormous. Patients can finally access new therapies to manage chronic diseases, including mental disorders, diabetes, panic attacks, asthma, and high blood pressure. These are serious health issues that affect the everyday quality of life. If there’s a solution out there, patients will want to use it. So I also expect bottom-up acceleration.
I see technology being recognized as a solution that addresses inequalities in health. Rural communities deserve the same quality of care as those living close to big healthcare centers. We have to create a healthy ecosystem that leaves no one behind and enables citizens to access care wherever they are.
However, to make a difference, we have to ensure that DTx solutions get into the hands of underserved and underprivileged communities. It’s another challenge we want to tackle as the Digital Therapeutics Alliance.
Want the latest in digital health and news delivered directly to your inbox? Sign-up for The Sidebar now. (Don’t worry, you can unsubscribe at any time.)