In weathering the demise of Pear Therapeutics, the digital therapy industry is looking for a path to prescription reimbursement and focusing on over-the-counter products.
Pear Therapeutics, once one of the most notable companies in the digital therapy industry, was forced to declare bankruptcy in April and then sell off assets in May. Michael Pace, Founder and Director The chief executive officer of PalmHealthco, which advises digital therapy companies, is optimistic about the future potential of digital therapy but says more research is needed before the field is fully defined. enough.
“We still have some reasonable hurdles for the industry to overcome,” says Pace.
Advocates of digital therapy are finding ways to avoid a repeat of the Pear by focusing on return routes. Industry trade group Digital Therapy Alliance spent last week at Capital Hill lobbying in favor of the Digital Therapy Prescription Act, which was endorsed by Senator Jeanne Shaheen (DN.H.) introduced in the Senate in March. The proposed law would provide Medicare and Medicaid coverage for prescription digital therapy and establish a payment method through the Centers for Medicare and Medicaid Services.
According to Megan Coder, policy director and founder of the Digital Therapeutics Alliance, digital therapy uses software to deliver medical interventions to patients with specific diseases or conditions. body. This definition is part of recent efforts by the Digital Therapeutics Alliance to provide a framework for the construction industry. Documents from the alliance cover how it defines the industry, what policies the industry should support, and how companies can deploy and scale products. She says these efforts will help the digital therapy industry advocate for reimbursement pathways in Congress.
“The lack of Medicare-Medicaid benefits for digital therapies is preventing patients from accessing these therapies. That’s one of the reasons why policy is so important,” said Coder. important to us and the industry in general.”
As the industry copes with a lack of return routes, companies are taking alternative approaches to growth. Akili Interactive, a company that has developed a Food and Drug Administration-licensed video game treatment for children with ADHD, is trying to expand its reach. It. Last Wednesday, the company rolled out a direct-to-consumer digital therapy for adults 18 and older.
The spokesperson said Akili will use the Food and Drug Administration’s enforcement decision for mental disorders to bring the therapy to market. The enforcement decision was first implemented in April 2020 as part of flexibility in COVID-19 reimbursement and expanded availability of digital health therapeutic devices for disorders. mental disorder.
Akili is identifying the most suitable market for its new therapy when deciding to execute roadmap expires in November. With EndeavorOTC Adult Therapy, the company will study how adults use it in real time. This gives the company an opportunity to refine its approach.
Dr Scott Kollins, Akili’s medical director, said: “Outcomes for people with ADHD have not changed much. “Access to those treatments needs to improve, but there are also additional options out there.”
EndeavorOTC is largely the same as its therapy EndeavorRx, which was approved by the FDA for use in patients 8 to 12 years of age by FDA prescription in June 2020. However, the children’s product includes one application. Use a carer companion to monitor cognitive metrics through behavioral health, cognitive effort, and other areas. This is not currently available in over-the-counter products.
For EndeavorOTC, the subscription price will be as high as $29 per month or a year of access for $99.
Rick Anderson, president of digital therapy company DarioHealth, says a direct-to-consumer approach can be successful for companies operating in nascent areas such as digital therapy.
“You can reach your target audience much faster,” says Anderson. “They can make their own decisions, so you don’t have much of a hitch.”
It remains to be seen how successful Akili can be in marketing its products to adults. Experts say the move could give the company valuable insight into another market.
“It allows an organization to get hands-on experience with a product in the marketplace,” says Pace. “Imagine releasing drugs that have never been approved by the FDA and you can get people to use them even in a clinical trial setting, [but] in a real-world context.”
The announcement comes at a critical time for the company. Akili had one of its only digital health IPOs last year. The company’s shares debuted at $36.06 in August and are currently trading at $1.31 a share. In January, it laid off 30% of its workforce, according to Securities and Exchange Commission filings. Despite these challenges, executives remain optimistic about the company’s future.
“Once we are able to attract and build commercial momentum with products for ADHD, that will allow us to start thinking about how we expand into other indications,” said Kollins. how”.
