Drug pricing is not a new issue, but it has only become more visible with the rise of new—and very expensive—treatments that could become one-time cures for diseases once considered incurable or that have historically needed chronic or lifelong treatment.
Consider the sticker prices for Kymriah and Yescarta, the first two CAR-T treatments to get FDA approval; they go for $475,000 and $373,000, respectively. Gene therapies are facing a similar challenge, with the companies developing them banking on a shift in thinking about how the healthcare industry approaches disease.
“These are one-time treatments that hopefully have curative effects and that’s exactly what all of us in society should want,” Sarepta Therapeutics CEO Doug Ingram told FierceBiotech last summer. “The interesting thing is, the healthcare system is going to have to evolve and embrace these things.”
On the device side, there are a number of players working on robotic exoskeletons to help paralyzed people walk again.
“It’s a very great vision,” said Stéphane Bédard, president and CEO of B-Temia, a Quebec City-based company developing what it calls dermoskeletic devices to assist human mobility.
But like gene therapy, it’s an expensive one. Israel-based ReWalk Robotics has an FDA-approved exoskeleton, but has struggled to get its $71,000 device to patients. It has also faced challenges getting insurers to sign on to cover the device, but made some headway in 2017 when a Florida court ruled Blue Cross Blue Shield of Florida must cover the cost of the device for a plan member with a spinal cord injury.
Bédard reckons companies such as B-Temia will pave the way to getting reimbursement for this type of robotic device. Most robotic exoskeletons are designed for paraplegics, with the goal of replacing their gait and restoring one’s ability to walk. B-Temia is thinking bigger—instead of focusing on gait, its artificial intelligence-powered dermoskeleton is designed to help people with whatever movements they need assistance with, from walking and climbing stairs to getting out of a chair or bending over to tie a shoe. Accordingly, the device is named Keeogo, for “keep on going.”
B-Temia is selling Keeogo in markets that treat it as a class 1 device, which is not specific to any indication and doesn’t need a prescription from a physician. These include Canada, Australia, Hong Kong and Japan. For markets that treat it as a class 2 device, like the U.S., the company is in talks with regulators to figure out the best way forward.
Alongside its medical program, B-Temia is also working on a military version of the exoskeleton to improve soldiers’ strength and endurance and also to reduce musculoskeletal injury. The device is currently in trials with the U.S. Army.
With its more holistic approach, B-Temia is looking to help people with all kinds of ailments, including neurodegenerative diseases such as Parkinson’s and multiple sclerosis, spinal cord injuries and even orthopedic conditions such as osteoarthritis. Prescribing B-Temia’s dermoskeleton for a patient with osteoarthritis of the knees could postpone or ward off altogether knee replacement surgery, a costly and painful procedure.
“There’s some traction on the market,” Bédard said. He’s seeing demand for devices like Keeogo but finds that payers prefer to “reimburse pills,” such as pain medication and anti-inflammatory drugs, over the course of many years. They calculate that route to be less expensive than a “one-shot device” with a price tag of $100,000.
“The economic and mathematical model must be changed to analyze [payers’] involvement. There is a huge change that must come for us to get to that point [of getting reimbursement.] But it will happen within some years, for sure. So we just need to survive until then,” Bédard said.
Bédard thinks the development and pricing of robotic exo- and dermoskeletons will eventually follow the trajectory of other types of devices.
“We are at the beginning of this technology. … Think about the flat-screen TV. I would say, 10 years ago, a 28-inch flat-screen would be around, say, $5,000. Now, it’s $200.”
It took the flat-screen TV, a “very well-known” and arguably more mainstream device, more than a decade to get to an affordable price point, he said. So we shouldn’t expect robotics companies to do in one year something that other companies in other industries took much longer to do, he said.
“The cost-benefit analysis of technology needs to be shifted. … There is data showing that this [device] can save money, but society is conservative and needs time to change,” Bédard said.