Just last week, the Food and Drug Administration (FDA) approved a prescription virtual reality treatment for patients with chronic lower back pain. EaseVRx allows people experiencing lower back pain to undergo behavioral therapy via a VR headset from the comfort of their home. We can already hear the choir of technology enthusiasts celebrating the news. While it may be refreshing to see such cutting-edge tech deployed on the medical front — usually, innovation in healthcare happens at an excruciatingly slow pace (hospitals still use fax machines!) — believe it or not, this approval is probably bad news for patients.
Here's why.
A priori, there is nothing wrong with the VR device or the treatment program it delivers. Around 46% of the 179 trial participants reported a 50% reduction in pain, compared to just 26% in the control group.
As technology progresses, the scientific community can look forward to many more studies on the effectiveness of new VR therapies. But why does the FDA have to approve a VR device when VR headsets have been in circulation for years?
The answer is that EaseVRx exists for medical purposes, and that companies aren’t allowed to advertise health benefits without first receiving permission from the FDA. Going through the FDA process is a tedious, expensive, and lengthy endeavor that innovators can’t easily undertake. When they do, they need to be able to recoup the cost, and the best way to do so is to make their treatments prescription-only.
Once something becomes prescription-only, there is no limit to how much they can charge. In the end, patients and taxpayers pay the bill through higher health insurance premiums and Medicare spending.
This is one of the reasons why innovation tends to drive prices up in healthcare, unlike in other industries.
It isn’t the first time that the FDA serves to drive up the price of innovation. Just last year, the FDA approved EndeavorRx, a video game developed to treat ADHD in children. It was available for months before it received FDA approval. But now, to download and play EndeavorRx, kids need a prescription.
What’s the alternative? We don’t want basement-dwelling web developers with Cheeto powder on their bellies peddling fake digital therapies to children on the internet. FDA scrutiny over digital therapies is warranted, and since the agency only recently started opening the way to digital therapies, now is the time to get it right by ensuring that those therapies are available over the counter, i.e., without a prescription.
Today, digital medical therapies are a lucrative industry. For innovators and investors, seeking FDA approval is a business strategy, not a way to demonstrate that their product is safe. People have been buying VR sets for years now, and they’ve been buying video games for decades; they can weigh the safety risks (if there really are any) just fine.
But the FDA also looks at whether a medical treatment is effective. In this case, there is some indication that the VR set was helpful to the trial participants who experienced lower back pain, and that’s of some value. But is the risk to people without back pain so great that EaseVRx should be restricted by a prescription? That seems hard to argue, especially since the clinical trial reported no adverse effects.
Prescriptions drive up costs. They make it more difficult for patients to access care, since they require a visit to the doctor and, sometimes, additional testing to establish a diagnosis. This diminished access reduces the supply of treatments, which leads to higher prices. If EaseVRx became available over the counter, it would be magnitudes cheaper.
These two reasons—the absence of risk and the opportunity to lower costs—explain why the Biden administration is pushing for over-the-counter hearing aids. Self-medicating by purchasing hearing aids comes with very little risk, and it’s almost guaranteed to be an instant improvement to patient wellbeing.
Similarly, if the VR platform works so well, why not let everyone try it? After all, they’ve got a serious market on their hands—between a third and a quarter of all Americans above age 18 experience lower back pain. By making the platform prescription-only, EaseVRx keeps its solution away from the uninsured and underinsured while overcharging those with insurance and taxpayers who subsidize Medicare.
The longer the FDA encourages new barriers to affordable treatment, the more money will be funneled toward prescription-only digital technologies. Instead, it should look to foster real innovation—higher quality treatments at a lower price—by encouraging innovators to cut the middleman and make their products available to the greatest number. Let’s hope it finally gets around to making that happen.
Elise Amez-Droz is a healthcare policy manager in the Washington, D.C. metro area and a senior contributor with Young Voices.