November 17, 2020
HOW DIGITAL THERAPEUTICS ARE TRANSFORMING HEALTHCARE
Digital therapeutics (DTx) are an innovative way to engage patients in their treatment. Through the use of apps and games, DTx are evidence-based interventions that can help prevent, manage, or treat medical conditions by gamifying elements of treatment. This session gave an overview of DTx, provided real-world examples, and laid out the business case for DTx. The discussion was led by Joris van Dam, the leader of Digital Therapeutics initiatives at Novartis Institutes for BioMedical Research.
Opening Remarks and Housekeeping Mariana Amaya, PMCQ Board Member
- We will continue to host our events virtually until early next year.
- Our next meeting is on December 15th. Join us at lunch time to learn about gender disparity in healthcare. Esteemed researcher Gillian Einstein will provide an overview of the issue, as well as some reasons why it is important to consider sex and gender in clinical research.
- This year’s holiday networking event will be virtual, but we’ll still make it fun! It will be held December 17th from 7:00 to 8:00 pm.
- The PMCQ Board is using your shared insights to plan our next season. If you have any further suggestions, please reach out to one of the Board members.
- Thank you to Lemieux Bédard for doing the creative for this event and Novartis for their sponsorship of the event.
Introduction of speaker Ben Massingham, Transformation and Innovation Head at Novartis Canada
This meeting featured the following speaker:
- Joris Van Dam: Head of Digital Therapeutics at Novartis Institute for BioMedical Research in Cambridge, MA
What are digital therapeutics?
- DTx are high-quality, clinically-validated software applications to treat, prevent or manage a medical disorder or disease.
- Examples of DTx:
- Cognitive behavioural therapy delivered through a mobile phone
- A video game to train cognitive function, motor function, or eye function
- Immersive relaxation, diversion pain management techniques delivered through virtual reality
- A sensor-connected device to deliver biofeedback therapy
- A computer algorithm that makes real-time dosing decisions based on sensor readings
- Targeted transdermal/transcranial nerve/neurostimulation
- DTx can be used in a variety of health categories, including mental health, diet and nutrition, mobility and function, and medication management (e.g. insulin dosing for diabetes).
- The technology is about taking medicine that has already been proven to work and delivering it in a new setting.
- DTx are delivered through various consumer digital devices (e.g. mobile, iPad, audio, virtual reality, etc.)
What are the potential benefits of digital therapeutics?
- Benefits include:
- Access and engagement
- Easier access for patients
- Stigma reduction
- Integration with social technologies to foster engagement and adherence (e.g. gaming)
- Quality control
- The quality of face-to-face therapy is variable and doesn’t always follow evidence-based guidelines, but the quality of DTx is consistent (although not always better)
- Opportunities for personalization
- Devices offer personalized therapeutic content
- Based on individual patient needs
- Examples of DTx with demonstrated benefits:
- Welldoc for managing glucose in diabetes: “I really believe this program saved my life. My A1c was 11.6% and now is 7.4%. I know I have more to go, but I finally feel like I can do it.” – Sharon P., clinical trial patient, Baltimore, MD
- reSET/reSET-O for substance/opioid use disorder: more than two-fold increase in abstinence
- Somryst for insomnia: the majority of patients no longer met clinical criteria for insomnia at the end of the 9-week treatment
- Endeavor for ADHD: statistically significant improvement on a change in the Attention Performance Index
- Freespira for panic attack disorder: 82% reported Panic Disorder Severity Scale decrease of ≥ 40%; 86% were panic attack free
- Sleepio: 28% lower total healthcare costs in the cohort of Sleepio users, as compared to the matched-control group
- So Omada: significant reduction in risk for 3 chronic diseases — type 2 diabetes (-30%), stroke (-16%), and heart disease (-13%)
- When used in combination with pharmacotherapy, DTx can lead to:
- Improvement of quality of life
- Reduced overall healthcare resource utilization
- Improved adherence to medication
- Delay of primary disease progression
How is a digital therapeutic developed?
- By and large, follows the same steps as a pharmaceutical, except the first step:
- Technical Development
- Clinical Development
- Regulatory Development
- Commercial Development
- Technical development is the step that is different because it involves incorporating a user-centric design for target audiences. Other elements of technical development include:
- Using clinical-grade, consumer-oriented content and adapting it to the local cultural context of users
- Applying a behavioural science perspective for improved engagement
- Using medical device-grade parts to ensure quality
- The clinical development stage is basically a randomized, controlled trial, with some differences:
- Not as many studies needed for the program — they used to follow the same clinical trial program for pharmaceuticals, but now they can condense it into one submission study if that study is well designed with quality control.
- The intervention can continue to be refined and improved, even during the clinical development stage — it’s called “adaptive design”.
- There is a placebo effect when patients see data, so for blinding, the developers make two versions of the intervention — one with therapeutic content and one without.
- The regulatory framework is its own class; the main point to note is if enforcement discretion applies, or if the product is a medical device. (See Joris’s slides below.)
- Frameworks around the world are improving over time as we gain familiarity with these products.
- The biggest challenge in developing DTx is the commercial development, because this step has to be thought out before the rest of the development happens.
How will digital therapeutics transform the healthcare system?
- They address public health challenges, like obesity, for which there are many risk factors, and can be used in a complementary way with pharmacotherapy.
- DTx can address some of those risk factors that cannot be treated with pharmaceuticals (e.g. changing behaviours to treat sedentary lifestyles).
- DTx will eventually have a standard checkbox in electronic medical record systems.
- DTx will become a key pillar in the digital health system (which includes digital medicine and digital health).
- Good DTx factor in the following:
- Convenience: providing care outside of the medical office, but also fitting into existing medical structures
- Performance: a clinical benefit – strip away the digital aspect and what do you have left?
- Insights: knowing how every patient is doing in real time and using those insights to make the intervention better
- Trust: getting informed consent
Q: How do DTx make money?
A: There are multiple ways to make money. Don’t underestimate the out-of-pocket market, especially in pediatrics. Some DTx are medical devices that are reimbursable. Some are like pharmacotherapies that are reimbursable. There is no one correct route. The best advice is to think about whether a prescription is really needed for your product. A real-life example where a prescription is needed is the smart inhaler created by Propeller Health — they initially went direct to patients but then the inhaler got more technologically advanced and the creators felt it would be beneficial for the doctors to know about this, so the inhaler became a prescription product. An example of where prescription may not be needed is a tool to treat depression, say, specifically in diabetes patients. Endocrinologists don’t treat depression and don’t want to start, so it shouldn’t be a prescription product.
Q: What are the downsides of DTx?
A: They offer a lot of value but getting reimbursed for this value is hard. Pharmaceuticals tend to decrease in cost over time until there is loss of exclusivity, at which point the manufacturer needs to market a new product. With DTx, the price goes up over time because the product is constantly making improvements.
Q: How do you ensure patient data are used properly?
A: Informed consent is important and actually making sure patients are informed. Most people just scroll through fine text. We need to do a better job to ensure rigorous compliance with international laws on data privacy. If you’re not comfortable with managing data, partner with a company that is comfortable.
Q: Can you talk more about AI?
A: This is where “insights” from the key takeaway is important. AI can help bring the right treatment at the right time for a patient by anticipating the patient’s needs.
Q: What are the benefits to patients, payers, and HCPs?
A: Patients: access and reducing stigma. Payers: when combined with pharmacotherapy, DTx can improve quality of life, which has a pharmacoeconomic benefit. DTx decrease health resource utilization and increase adherence. HCPs: get rid of some of the more routine interventions that are less interesting to treat.
Q: Can use DTx to monitor the efficacy of drugs?
A: Yes, but a tool that does monitoring alone is called digital medicine. If the product monitors and treats, then it is DTx.
Q: What about partnering with digital wearables that are already measuring physiological parameters and tailoring it to the area being studied?
A: The real gold mine is pushing the therapeutic content that the patient needs right when they need it. That’s what can be done with DTx if combined with digital wearables.
Q: How do IP patents for DTx work?
A: The mechanism is the same but with less protection because patents in software are harder to defend than patents in chemistry.
Q: How will the role of the physician change?
A: It depends what the HCP primarily treats. A doctor that treats diabetes may not be interested in treating depression in diabetic patients, so this is something they might be happy to delegate.
Freelance Medical Writer
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