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Characteristics and challenges of the clinical pipeline of digital therapeutics by Patel, N.A., Butte, A.J., npj Digit. Med. 3, 159 (2020)
Digital therapeutics are a hot topic, everyone talks about them. But what are they exactly? They are
Evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease (The Digital Therapeutics Alliance).
So far, in the US, they can be approved by the FDA with a similar framework as medical devices (e.g., de novo or 510k), and can even be reimbursed in some cases. There is no similar regulatory pathway in Europe.
🗝️ Why it matters: Digital therapeutics are a game-changer way to deliver therapeutic interventions. They are very scalable (i.e., could be sold at a competitive price vs. pharmaceuticals), and can be accessed by anyone who has a smartphone or a laptop. Contrary to drugs or medical devices, the risk for side effects is limited by design. They have attracted a lot of VC funding in the past few years.
🔎 Primary indications for DTx: DTx most obvious conditions are for diseases that are:
Chronic: as it justifies interacting with the software on a regular basis
Behavior-modifiable: the patient can change their behavior by using the software which prevents or treats the condition (e.g., diabetes, addictions…). It is a more scalable way to deliver care than in-person psychological services.
With suboptimal management by existing pharmaceutical therapies
✅ Findings: In some cases, DTx have been able to replace completely pharmaceutical therapies. Yet comparative studies are missing to assess how efficient they are compared to these.
🚀 Opportunities and challenges ahead:
DTx enable to better monitor patients adherence to a treatment which can be useful for physicians to track them, and better treat them. However, patient’s adherence on the long haul will also depend on the UX-UI of the software, including its user-friendliness for older patients.
The regulatory and reimbursement landscape for DTx is only nascent, especially in Europe. There is still significant uncertainty for DTx companies about market access. The FDA has yet to bring a dedicated software-as-a-medical-device framework for them. Such change is needed as they are software-based and will be updated as new software/algorithm versions are needed. The FDA could replicate what reviewers on the App Store do: when you launch a new app, there is a thorough review to release it on the App Store. After launch, every time there is an update, there is a shorter review. The FDA launched a pilot program in 2017 with 9 companies, and released a first discussion paper on “a possible regulatory approach to premarket review for machine-learning-driven modifications”.
Physicians need to be educated to DTx, and for the older guard, it may take a while to trust and adopt them.
Cybersecurity and data rights need to be considered for DTx. Patient data could be jeopardized in case of a cyberattack, and their whole treatment plan on hold.
The FDA has defined two “tiers” of devices according to their perceived cybersecurity risk: Tier 1 (higher cybersecurity risk) devices are those (...) for which a cybersecurity breach affecting the device could directly result in patient harm(...). Tier 2 (standard cybersecurity risk) devices are those for which the criteria for a Tier 1 device are not met.
Currently, DTx manufacturers have to follow guidance on how to document cybersecurity risks for their software. However most of them don’t present the information in a comprehensive way, and there is no audit about the real cybersecurity threat faced by the software. Ideally, these cybersecurity audits should be performed on a yearly basis to account for changes in technology (e.g., new encryption standards).
Reimbursement: at this point, there is no guidance from the Centers for Medicaid and Medicaid Services (CMS) on reimbursement of DTx. However, both CVS and ExpressScripts (the two largest pharmacy benefit managers) added a few DTx to their “digital health” formulatories meaning that consumers from these payers can get access to these selected DTx. So far to be reimbursed, DTx were relying on the FDA National Drug Code to receive reimbursement. However, starting in September, DTx will have to transition to unique device identification (UDI - see more on my article about medical device safety) which will present a new challenge for manufacturers.
Digbi Health was founded in 2018 as a digital therapeutics to reduce obesity and inflammatory illnesses.
🤯 The problem: Obesity is linked to a large number of diseases such as diabetes. It increases the risk of suffering from severe covid-19 symptoms and cardiovascular diseases. Bariatric surgery is an effective way to lose weight however as any surgery it is invasive and risky. It also creates important side effects.
🤗 The solution: Digbi sends a kit to the patient enabling them to perform a gene and a microbiome analysis. Based on the results, they provide health reports along with personalized food and exercise recommendations. Then the program guides the patient through meal planning and helps them through 1-to-1 sessions with a health coach. They can also interact with other patients following the same program as their app includes community features. The app enables them to track their progress on a daily basis (no calories counting though) and get better educated about nutrition and exercise.
Digbi also has a program centered around microbiome health for patients suffering from irritable bowel syndromes, acid reflux etc…It offers the same type of features and coaching as for patients who wish to lose weight.
👩🏻🌾 Go-to-market strategy: Digbi seems to be focused on a B2B acquisition strategy.
Digbi has a number of providers that they partner with. They enable providers to track their patient progress on a dashboard. However, some of the features they offer (e.g., meal planning, coaching) can replace some of the work done by providers especially dieticians and I wonder if they feel threatened by the solution. It could explain why most of the providers listed on their partnership page are MDs.
They also market their solutions to employers as a benefit for their employees.
Their biggest move is to be reimbursed by payers. They partnered with their first insurer Blue Shields of California in 2019 and have not listed new insurers since then. They just released a report about the improved outcomes found in Blue Shields patients and will surely use these results to show their ROI to leads.
They are also working on a regulatory pathway to be cleared by the FDA as a treatment for functional bowel disorders.
📈 The traction: Digi raised a $5.4m series A with Accel last month.
Orla DTx was founded last year in Finland as a spin-off from the healthcare division of the Finish teleoperator Elisa Oyj. The founders bought out the assets from Elisa Oyj including an anticoagulant DTx developed with Roche. They are now seeking new medtech/ pharma companies to develop DTx for new indications based on their know-how. I really liked how clear their value proposition is on their website.
That’s a wrap for today! Don’t hesitate to reply to this email with comments, I read and answer all emails :)