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.