AppliedVR's flagship VR device for chronic lower back pain now in network for Highmark members

Pittsburgh-based Highmark has signed on as AppliedVR's first commercial payer partner, making its flagship VR device for chronic lower back pain a covered treatment for more than 4 million plan members.

Immersive therapy startup AppliedVR announced today that Highmark's landmark decision to adopt coverage for RelieVRx will make the FDA-authorized device more accessible to individuals to help manage chronic lower back pain at home.

The program consists of a headset and software guiding patients in pain management exercises. It represents a novel home-based solution for treating chronic pain. The company says RelieVRx serves as a cost-effective, non-pharmacologic adjunctive therapy clinically proven to significantly reduce pain intensity and interference across sociodemographic groups.

"[Highmark] is definitely one of the more forward-thinking plans out there. They had some real challenges and needs in the marketplace from their own patient population. We're super excited to have them as the first major payer to be able to step up and say, 'We recognize the value of what you're bringing in, the efficacy of what you're bringing in. We know it makes sense for patients," Matthew Stoudt, co-founder and CEO of AppliedVR, said in an interview with Fierce Healthcare.

Highmark's decision to expand coverage for RelieVRx helps to pave the way for more commercial health plans, self-insured employers and other payers to take a closer look at the VR-based therapy, Stoudt said.

"When you walk in and talk to the next payer and the next payer, and they say, 'Great, who's covering you?' Rather than saying, 'Well, you know, we're in pilot phase here,' we're actually going to turn around and say, 'Here's who we have,'" he noted.

Highmark’s decision to cover RelieVRx follows a thorough evaluation of AppliedVR’s extensive clinical studies, including a large study with more than 1,000 participants that found RelieVRx can have a clinically meaningful impact on reducing pain intensity and interference. Eligible commercial members aged 18 and older diagnosed with moderate to severe chronic lower back pain can now obtain a prescription for RelieVRx from their healthcare provider without prior authorization.

“We are committed to leveraging technology to enhance health outcomes while reducing costs,” said Matt Fickie, senior medical director for Highmark, in a statement. “RelieVRx from AppliedVR provides our members suffering from chronic low back pain a scientifically backed, in-home immersive non-opioid treatment option.”

Patients using RelieVRx undergo a 56-session, multimodal program, featuring daily VR sessions that address the bio-psycho-social aspects of pain. RelieVRx is self-administered by patients in their own homes and has an easy-to-use interface, according to executives. In clinical testing, RelieVRx usability ratings were consistently high (A+), which was largely consistent across subgroups.

"We're trying to take a very systematic approach. Rather than trying to do a broad-based commercial launch, we're focusing regionally, where Highmark has nearly a 50% market share, which is going to be in Pennsylvania, Delaware, West Virginia, and a smaller position in New York," Stoudt said. "We're going out and talking to the doctors, focusing first on Allegheny Health Network, and then also talking to a lot of the other pain doctors in those key markets to say, 'Look, you don't have to do the heavy lift anymore of trying to fight the insurance companies because you have Highmark providing this as a covered product.' We're taking a very methodical approach to develop the success around this."

Stoudt said AppliedVR also is piloting its RelieVRx with two "leading payers." 

"We're seeing really strong early success and this, again, continues to point to why we believe so deeply that what we're bringing to the marketplace works with patients, works with doctors, and it's meeting an unmet need for the payer," he said.

The company says it now works with 200 leading health systems and thousands of healthcare professionals globally, used on more than 60,000 patients.

Chronic pain imposes a significant economic burden on the U.S., estimated at $635 billion annually, and is a primary driver of the opioid crisis. More than 72 million Americans suffer from chronic lower back pain, which also is a leading cause of disability.

AppliedVR's RelieVRx program offers individual battling chronic lower back pain access to a noninvasive, drug-free option that enables them to self-manage their pain from the comfort and convenience of their homes, Stoudt noted.

"The promise of technology has always been this idea of accessibility. Once you bring in the payer piece of this, now you can actually start to live up to the promise of meeting patients where they are versus forcing patients to go into a facility to find their healthcare. We're really seeing that prove out in spades, and it was part of the whole value proposition for Highmark as members were experiencing long wait times because of the lack of physicians," he said.

AppliedVR took a methodical approach to getting its novel device into the marketplace, Stoudt noted. AppliedVR's flagship product, the RelieVRx program, was granted marketing authorization by the Food and Drug Administration in 2021 for chronic lower back pain. 

AppliedVR's RelieVRx program is the first VR-based, prescription therapeutic to receive Breakthrough Device Designation and De Novo authorization by the FDA for chronic lower back pain.

"We went through FDA as hardware, software device combo, because that actually gave us a reimbursement pathway that already exists versus trying to fight that fight to get a new code or new category created," he said. 

The company also has prioritized conducting research to demonstrate the therapeutic benefits of its VR therapy for treating chronic lower back pain at home. In November 2023, the company unveiled the results of a large randomized controlled trial (RCT) that found AppliedVR's RelieVRx program produced clinically meaningful improvements in clinically severe and diverse adults with CLBP.

"That also enables us to do a deeper dive and do segmentation on it, and we're continuing to track that up for two years post-intervention," Stoudt said. "As you think about the things that are required for reimbursement, you've got to have the data, you've got to have the pathway."

“RelieVRx is based on decades of clinical evidence demonstrating the transformative potential of immersive therapeutics to reshape the body’s response to pain, and we are committed to building an even greater body of evidence that continues to set the industry standard," he said.

The company scored that pathway back in March 2023 when the Centers for Medicare and Medicaid Services (CMS) granted the company a unique Healthcare Common Procedure Coding System (HCPSC) Level II code for RelieVRx and placed it in an existing benefit category: durable medical equipment.

"All of that then has put us in this position now where we talk about this as being that inflection point for the business where we can we've done the investment, we've developed the data that we need, and now it's about starting to bring it to market on a scaled basis," Stoudt said.

Highmark has been pushing forward to cover novel digital therapies for its members. The payer-provider organization announced in 2022 that it planned to expand insurance coverage for some prescription digital therapeutics cleared by the FDA, marking a major step forward for app makers in the market. At the time, it was the first large commercial insurer to signal it intends to pay for claims for the use of apps that help treat psychiatric disorders and other complex conditions. 

Earlier this year, Highmark began covering Cognoa's Canvas Dx, an FDA-approved autism diagnostic tool.

AppliedVR is not a digital therapeutic, Stoudt noted, as DTx typically refers to app-based tools and RelieVRx is a medical device. But, Stoudt notes that many DTx companies have struggled in the healthcare market because they didn't create a pathway for reimbursement and didn't invest in high-quality data.

"Wen we first started, we said we were going to set the standard for the quality of our data and the quality of the studies that we run. As a result, I think that when we walk in and we talk to the payers, we have that credible body of evidence," he said.

AppliedVR has hit several other major milestones the past year. VA Immersive, a division of Veterans Health Administration (VHA), extended its contract with AppliedVR to expand military veterans' access to virtual reality-based therapy for chronic pain. AppliedVR and the VA have been collaborating since 2020 when the two organizations piloted VR-based solutions to comfort veterans in palliative care and help improve the quality of life of veterans experiencing general chronic pain, stress and anxiety in a variety of healthcare settings.

VHA provides care to more than 9 million veterans nationwide.

RelieVRx also was added to the Department of Veterans Affairs' Federal Supply Schedule (FSS), Defense Logistics Agency's Electronic Catalogue for Medical Supply Chain (ECAT), and the Department of Defense’s Distribution and Pricing Agreement (DAPA), allowing government customers to make streamlined purchases. RelieVRx is currently used in more than 40 Veterans Affairs (VA) sites.

The company also recently expanded into the Worker’s Compensation market.