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How digital therapeutics are revolutionising healthcare

Published on 10/06/20 at 01:06pm

Digital health covers everything from algorithms identifying new drug combinations, to mobile phone apps to help patient adherence. The past decade has seen the increasing use of smart watches, AI personal assistance and virtual reality to treat a whole host of diseases and conditions. However, digital therapeutics still have to go through government regulations, but due to the rapid evolution of technology as a whole, these processes often leave companies behind due to regulatory delays that can last years. Conor Kavanagh looks at the industry’s recent successes, but also the problems that it faces going forward.

As healthcare, medicines and quality of life improve across the globe, people are living longer but they are not living healthier. This means that many more people will be affected by the debilitating illnesses and terminal diseases than traditionally affect the elderly. This is already putting a strain on health services around the world that are struggling to meet the increasing need for serious treatment in significant amounts of the population.

One area that is seeking to offset the increase in disease is the digital health industry, and specifically digital therapeutics. The birth of the smartphone has been a revolution in monitoring patients, and new advances in virtual reality and AI personal assistance are fundamentally changing the way certain conditions are being treated.

One of the earliest advocates for digital therapeutics was dermatologist Joseph Kvedar, who worked at Massachusetts General Hospital in Boston. In 1995, he worked with the initiative Partners Connected Health at the nearby Brigham and Women’s Hospital to explore the development and application of technology for delivering care outside of the hospital or doctor’s office.  The idea has always been to extend the reach of the physicians, doctors and nurses by improving the convenience and access to care through technology.

The 2010s have seen the digital therapeutics industry gain increasing traction, and in our increasingly connected world, it seems like the future for many methods of treatment.

Electronic health records and adherence

Digital therapeutics is proving invaluable in clinical trials and with patients taking their medication, with the big pharmaceutical companies already starting to use AI tech to help improve patient adherence. Across the world, between one quarter and one half of people do not take their medications as recommended, and in the US this has been linked with 125,000 deaths with a cost of $289 billion annually.

There are notable different examples of technology that are currently tackling problems in adherence. One is a robot called Mabu created by Catalia Health. Mabu nudges people to take their medication, but also uses AI and psychological modelling to tailor conversations with individuals. Currently being used for treating patients who have suffered from congestive heart failure, rheumatoid arthritis and kidney failure, the goal of Mabu is to develop a connection between the robot and patient to provide a constant reminder to take medication.

Another tool has been created by Medisafe, with funding from Merck Ventures.  Named iCap, the Bluetooth-equipped cap fits most standard pill bottles dispensed with prescriptions in the US. It has a companion app, iSort, which is a Bluetooth-enabled weekly pill organiser for those taking multiple medications.  The two together allow users to have their medication intake automatically logged directly into the Medisafe software as the iConnect devices transmit signals when they are opened. This information is then stored in the cloud and available to the user via the Medisafe mobile app.

These types of tools are facilitated by moves to digitise most health records, making them more shareable between patient and doctor. The US federal government has spent more than $28 billion to digitise electronic health records (EHR) over the last decade. However, it is still hard for patients to access their own records from all the health institutions they have visited. Even simple things – such as the records being saved in different formats – can be a frustrating hurdle to accessing patient data.

However, digital health records are becoming increasingly easy to create thanks to smart technology, mainly phones and electronic watches. Companies like Apple have created software on their products which can easily be exported and used by doctors. Apple bought the AI startup Gliiimpse in 2016, and together they created Apple’s Health Records API based on the company’s previous work. This technology primarily uses the Apple Watch as the main health monitor, but other apps and devices can also be used. In the Health app on your iPhone, you can view data for your heart rate, sleeping patterns, workout times, distances moved, time stood up and nutrition, as well as monitoring your body’s respiratory statistics. The type of compatibility and flexibility Apple offers makes it a convenient way to monitor a patient’s health, whether they are at risk or going through a clinical trial.

Apple is also attempting to solve the problems of incompatibility of their data with certain systems by working with EHR vendors Cerner and Epic. They want to establish a two-way data flow to incentivise companies to integrate their patient recorded data into Apple’s platform.

Digital health in treating neurological conditions

While the digital health industry is making great strides in helping to monitor physical health conditions, it is revolutionising how neurological conditions are treated and diagnosed.

One of the most notable advances in technology during the 2010s was the increasing prominence of virtual reality (VR) devices. Mainly known for its use in video games, Sony, Oculus, HTC and Google have all produced multiple versions of VR headsets, and this competition has helped the technology drastically improve over the decade.

VR is now being increasingly used in the medical field to specifically treat neurological conditions and mental disorders. gameChange is one such company implementing VR to treat these types of conditions, led by Dr Daniel Freemon from the University of Oxford. They have already used VR to treat psychosis, which they accomplish by putting the patient in a virtual scenario that could be potentially distressing to someone with the condition. For example, they might be shown a doctor’s waiting room, where a man is blocking the exit and the receptionist is distressed. It teaches them to cope with uncomfortable scenarios.

This is now being extended to a clinical trial for schizophrenia. This trial sees participants choose from six scenarios like catching a bus or visiting a pub. The 432 participants can then set parameters for each of their sessions, including how challenging they want it to be, and can add more stressful factors. After three hours of this treatment, they will be assessed in their avoidance and distress in real-life situations, which will be followed up six months later. gameChange believes this type of treatment should be used in combination with traditional therapy and should not replace it.

VR is not only being used to treat neurological conditions, but also to diagnose them. A research team at the University of Cambridge developed and trialled a VR navigation test in patients at risk of developing dementia. The completion of the task requires the entorhinal cortex to be functioning properly. 45 patients with mild cognitive impairment took samples of cerebrospinal fluid to look for biomarkers of underlying Alzheimer’s, with 12 testing positive.

All the patients with mild cognitive impairment performed worse on the task compared to a healthy comparison group, and the ones with positive cerebrospinal fluid indicators performed worse still.  VR offered better results than current tests for dementia by proving more effective at separating between these higher risk and lower risk patients.

VR is not the only technology being developed to treat neurological conditions, with some types of therapy being digitised to make it more accessible. Cognitive behavioural therapy (CBT) is one that is being utilised digitally. CBT is highly structured to help identify specific current problems and try and solve them, which differs from traditional therapy approaches that will usually delve into the patient’s past issues, with the therapist recommending general life changes.

One of the most common applications for the digital delivery of CBT is for treating insomnia. One prominent therapeutic for this condition is a smartphone app called ‘Sleepio’ created by the company Big Health. Designed by Professor Colin Espie, this app features a digital animated assistant called The Proff and his narcoleptic dog called Pavlov, and has been designed to help the patient learn about their problems and goals. The patient can personalise the program to provide the relevant help they feel they need, and can keep a sleep diary to analyse what may be affecting the quality of their sleep. More people have participated in the clinical trials for Sleepio than any other prescription insomnia medication on the market according to Peter Hames, the co-founder and CEO of Big Health.

One of the big players in the traditional pharmaceutical market has also made its entrance into creating digital therapeutics to deliver CBT. Sandoz, a division of Novartis, has collaborated with Pear Therapeutics to create reSET, a CBT phone app for treating people with substance use disorder. It has been designed as a 12-week program to be used in conjunction with traditional therapy. It was approved by the FDA to treat this disorder, which is particularly prevalent in the US due to the opioid crisis. Pear also set up a patient service centre to walk patients and clinicians through the steps of setting up the app, work with the insurance companies to ensure the patient has access to treatment, and help to troubleshoot any problems with the app.

Dr Yuri Maricich, Chief Officer and Head of Development at Pear Therapeutics, said the company produced the product as there were no FDA-approved treatments for patients experiencing addiction to substances like cocaine, cannabis and methamphetamine. It was created to deliver an established neurobehavioural treatment for a traditionally face-to-face style of therapy with a doctor.

However, Maricich does not believe the tech can completely replace the human element of therapy. He said: “Addiction is a serious disease and the overall treatment plan and management of the patient should be conducted by a clinician.  reSET is a treatment that is intended as a prescription for the patient, similar to any other medication, while the patient continues to be supervised by the clinician. 

While different digital therapeutics may require varying amounts of clinician time, and have the potential to be used as clinician extenders or to partially substitute for portions of time, the clinician-patient relationship is critical to adequately diagnosing, treating and managing patients over time.”

Financial risks and FDA approval

While there have been significant advances in digital health and therapeutics, this specific sector still faces a lot of hurdles in terms of financial backing and regulatory approval.

America is one of the world’s biggest markets for health products, but the FDA can make the approval of digital therapeutics a particularly arduous process. If the digital health device or therapeutic is designed to be used “in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease”, it must follow the regulatory path for traditional treatments, according to the FDA.

The exact path and the type of clinical evidence these types of treatments must provide depend on how great a risk it poses if it malfunctions. Pear Therapeutics’ reSET had to submit results of a randomised controlled trial through the FDA’s de novo approval pathway. The de novo pathway is for products that do not have existing classification or have a similar device already on the market.

Randomised control trials take about three years, which delays the product launch even further as during this time, more research is completed and new evidence will have been published to improve the product. As the digital world moves at an extremely fast rate, this type of regulation de-incentivises the creation of innovative new products.

The FDA has recognised some of the issues and reformed this process to a degree in December 2017.  They clarified that many types of digital therapeutics will no longer be deemed as medical devices, meaning the regulatory process will be cut down. The new guidelines also outlined the kinds of changes to existing products that will require fresh approval.  The FDA also introduced a pilot scheme for pre-certification for digital companies rather than just products. These are given to those who have demonstrated excellence in software development in lower-risk devices to help streamline the process of approval.

The UK is another country that has followed suit in attempting to streamline regulations. The National Institute for Health and Care Excellence (NICE) is working with the NHS to increase their use of digital innovations. They have published new guidelines on what evidence they need to approve a digital product according to its function. It outlines what are the minimal and ideal types of evidence needed as well as appropriate economic data, as NICE, unlike the FDA, takes cost of a product into heavy consideration.

Digital therapeutics that follow the steps to be regulated by these bodies will be far more expensive than the cost of releasing an app on a mobile app store without approval or clinical backing. Lisa Suennen, leader of Manatt Phelps & Phillips digital and technology businesses, as well as the firm’s venture capital fund, believes distribution plays a role in the general expense of developing these types of products. She said that: “The biggest financial risk is in riding out the period from launch to adoption, which can be literally years.  There are very few ways to efficiently distribute these products.  At least traditional therapeutics companies have sales forces that know how to sell pills and injectables. So far these entities have struggled to distribute software.”

This distribution also ties into exposure. Due to the rapidly changing face of the industry, it is hard to make patients and doctors aware of new beneficial digital therapies for either physical or neurological afflictions. Suennen feels advertising is especially expensive because: “You have to market to them the old-fashioned way. But you have to do it with people who are familiar with selling software and can help the practice understand how to prescribe it. More important is a way for physicians and nurses to ensure patients download it, learn how to use it and get customer support.”

It is often difficult to get doctors to properly convey how the technology works and for patients to understand it, especially if they are not tech savvy. Developers that are part of large pharmaceutical companies, like Pear Therapeutics, have service centres to help these groups implement the technology properly. Maricich says that reSET has been “designed to be easy and effectively used by patients with basic technological knowledge. The patient only needs to know how to go to the app store, download the software, and follow the instructions from both the software and their healthcare provider.”

However, Suennen feels that due to most companies not having this type of service, they fail to get exposure and get their product implemented properly. She believes that: “Those who think they can sell digital therapeutics without a service program for this are sorely mistaken. And before all that, there needs to be solid clinical evidence of efficacy and, for most of the payers, also financial evidence that the outcomes and economic gain are worth the hassle.”

Many financial experts, like Andrew Hendin from Bessemer Venture Partners, believe a solution to the successful marketing of digital therapeutics is a closer collaboration between companies with tech backgrounds, like Apple, with companies who have a medical background. Suennen feels this is an essential combination but it is not as simple as getting the two to work together. “Consumer tech backgrounds are great for improving user experience of medical products, provided those tech people understand the work flows and payment streams and regulatory requirements enough to build something that will be usable by the provider/payer. But these individuals are not well-suited to building distribution models in healthcare, by and large, and often do not understand enough about reimbursement and FDA.”

It is clear that digital therapeutics hold the future of treatment in many areas of healthcare. Digital health data is already making clinical trials far easier to conduct, while digital therapeutics are helping to make patient adherence stronger in and out of trials. New technology like VR and AI assistances and companions are treating neurological conditions in ways they have never been treated before. However, it is clear more is needed in building on the steps the FDA have taken in approaching digital therapeutics in a different way compared to traditional drugs, and companies must learn how to market their tech in a clear fashion if they want it to be adopted by the masses.

 

Conor Kavanagh

As healthcare, medicines and quality of life improve across the globe, people are living longer but they are not living healthier. This means that many more people will be affected by the debilitating illnesses and terminal diseases than traditionally affect the elderly. This is already putting a strain on health services around the world that are struggling to meet the increasing need for serious treatment in significant amounts of the population. One area that is seeking to offset the increase in disease is the digital health industry, and specifically digital therapeutics. The birth of the smartphone has been a revolution in monitoring patients, and new advances in virtual reality and AI personal assistance are fundamentally changing the way certain conditions are being treated. One of the earliest advocates for digital therapeutics was dermatologist Joseph Kvedar, who worked at Massachusetts General Hospital in Boston. In 1995, he worked with the initiative Partners Connected Health at the nearby Brigham and Women’s Hospital to explore the development and application of technology for delivering care outside of the hospital or doctor’s office.  The idea has always been to extend the reach of the physicians, doctors and nurses by improving the convenience and access to care through technology. The 2010s have seen the digital therapeutics industry gain increasing traction, and in our increasingly connected world, it seems like the future for many methods of treatment. SUB-HEADING: Electronic health records and adherenceDigital therapeutics is proving invaluable in clinical trials and with patients taking their medication, with the big pharmaceutical companies already starting to use AI tech to help improve patient adherence. Across the world, between one quarter and one half of people do not take their medications as recommended, and in the US this has been linked with 125,000 deaths with a cost of $289 billion annually. There are notable different examples of technology that are currently tackling problems in adherence. One is a robot called Mabu created by Catalia Health. Mabu nudges people to take their medication, but also uses AI and psychological modelling to tailor conversations with individuals. Currently being used for treating patients who have suffered from congestive heart failure, rheumatoid arthritis and kidney failure, the goal of Mabu is to develop a connection between the robot and patient to provide a constant reminder to take medication. Another tool has been created by Medisafe, with funding from Merck Ventures.  Named iCap, the Bluetooth-equipped cap fits most standard pill bottles dispensed with prescriptions in the US. It has a companion app, iSort, which is a Bluetooth-enabled weekly pill organiser for those taking multiple medications.  The two together allow users to have their medication intake automatically logged directly into the Medisafe software as the iConnect devices transmit signals when they are opened. This information is then stored in the cloud and available to the user via the Medisafe mobile app.These types of tools are facilitated by moves to digitise most health records, making them more shareable between patient and doctor. The US federal government has spent more than $28 billion to digitise electronic health records (EHR) over the last decade. However, it is still hard for patients to access their own records from all the health institutions they have visited. Even simple things – such as the records being saved in different formats – can be a frustrating hurdle to accessing patient data. However, digital health records are becoming increasingly easy to create thanks to smart technology, mainly phones and electronic watches. Companies like Apple have created software on their products which can easily be exported and used by doctors. Apple bought the AI startup Gliiimpse in 2016, and together they created Apple’s Health Records API based on the company’s previous work. This technology primarily uses the Apple Watch as the main health monitor, but other apps and devices can also be used. In the Health app on your iPhone, you can view data for your heart rate, sleeping patterns, workout times, distances moved, time stood up and nutrition, as well as monitoring your body’s respiratory statistics. The type of compatibility and flexibility Apple offers makes it a convenient way to monitor a patient’s health, whether they are at risk or going through a clinical trial. Apple is also attempting to solve the problems of incompatibility of their data with certain systems by working with EHR vendors Cerner and Epic. They want to establish a two-way data flow to incentivise companies to integrate their patient recorded data into Apple’s platform. SUB-HEADING: Digital health in treating neurological conditionsWhile the digital health industry is making great strides in helping to monitor physical health conditions, it is revolutionising how neurological conditions are treated and diagnosed. One of the most notable advances in technology during the 2010s was the increasing prominence of virtual reality (VR) devices. Mainly known for its use in video games, Sony, Oculus, HTC and Google have all produced multiple versions of VR headsets, and this competition has helped the technology drastically improve over the decade. VR is now being increasingly used in the medical field to specifically treat neurological conditions and mental disorders. gameChange is one such company implementing VR to treat these types of conditions, led by Dr Daniel Freemon from the University of Oxford. They have already used VR to treat psychosis, which they accomplish by putting the patient in a virtual scenario that could be potentially distressing to someone with the condition. For example, they might be shown a doctor’s waiting room, where a man is blocking the exit and the receptionist is distressed. It teaches them to cope with uncomfortable scenarios.This is now being extended to a clinical trial for schizophrenia. This trial sees participants choose from six scenarios like catching a bus or visiting a pub. The 432 participants can then set parameters for each of their sessions, including how challenging they want it to be, and can add more stressful factors. After three hours of this treatment, they will be assessed in their avoidance and distress in real-life situations, which will be followed up six months later. gameChange believes this type of treatment should be used in combination with traditional therapy and should not replace it. VR is not only being used to treat neurological conditions, but also to diagnose them. A research team at the University of Cambridge developed and trialled a VR navigation test in patients at risk of developing dementia. The completion of the task requires the entorhinal cortex to be functioning properly. 45 patients with mild cognitive impairment took samples of cerebrospinal fluid to look for biomarkers of underlying Alzheimer’s, with 12 testing positive.All the patients with mild cognitive impairment performed worse on the task compared to a healthy comparison group, and the ones with positive cerebrospinal fluid indicators performed worse still.  VR offered better results than current tests for dementia by proving more effective at separating between these higher risk and lower risk patients. VR is not the only technology being developed to treat neurological conditions, with some types of therapy being digitised to make it more accessible. Cognitive behavioural therapy (CBT) is one that is being utilised digitally. CBT is highly structured to help identify specific current problems and try and solve them, which differs from traditional therapy approaches that will usually delve into the patient’s past issues, with the therapist recommending general life changes.One of the most common applications for the digital delivery of CBT is for treating insomnia. One prominent therapeutic for this condition is a smartphone app called ‘Sleepio’ created by the company Big Health. Designed by Professor Colin Espie, this app features a digital animated assistant called The Proff and his narcoleptic dog called Pavlov, and has been designed to help the patient learn about their problems and goals. The patient can personalise the program to provide the relevant help they feel they need, and can keep a sleep diary to analyse what may be affecting the quality of their sleep. More people have participated in the clinical trials for Sleepio than any other prescription insomnia medication on the market according to Peter Hames, the co-founder and CEO of Big Health.One of the big players in the traditional pharmaceutical market has also made its entrance into creating digital therapeutics to deliver CBT. Sandoz, a division of Novartis, has collaborated with Pear Therapeutics to create reSET, a CBT phone app for treating people with substance use disorder. It has been designed as a 12-week program to be used in conjunction with traditional therapy. It was approved by the FDA to treat this disorder, which is particularly prevalent in the US due to the opioid crisis. Pear also set up a patient service centre to walk patients and clinicians through the steps of setting up the app, work with the insurance companies to ensure the patient has access to treatment, and help to troubleshoot any problems with the app. Dr Yuri Maricich, Chief Officer and Head of Development at Pear Therapeutics, said the company produced the product as there were no FDA-approved treatments for patients experiencing addiction to substances like cocaine, cannabis and methamphetamine. It was created to deliver an established neurobehavioural treatment for a traditionally face-to-face style of therapy with a doctor. However, Maricich does not believe the tech can completely replace the human element of therapy. He said: “Addiction is a serious disease and the overall treatment plan and management of the patient should be conducted by a clinician.  reSET is a treatment that is intended as a prescription for the patient, similar to any other medication, while the patient continues to be supervised by the clinician.  While different digital therapeutics may require varying amounts of clinician time, and have the potential to be used as clinician extenders or to partially substitute for portions of time, the clinician-patient relationship is critical to adequately diagnosing, treating and managing patients over time.”SUB-HEADING: Financial risks and FDA approval While there have been significant advances in digital health and therapeutics, this specific sector still faces a lot of hurdles in terms of financial backing and regulatory approval.America is one of the world’s biggest markets for health products, but the FDA can make the approval of digital therapeutics a particularly arduous process. If the digital health device or therapeutic is designed to be used “in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease”, it must follow the regulatory path for traditional treatments, according to the FDA.The exact path and the type of clinical evidence these types of treatments must provide depend on how great a risk it poses if it malfunctions. Pear Therapeutics’ reSET had to submit results of a randomised controlled trial through the FDA’s de novo approval pathway. The de novo pathway is for products that do not have existing classification or have a similar device already on the market.Randomised control trials take about three years, which delays the product launch even further as during this time, more research is completed and new evidence will have been published to improve the product. As the digital world moves at an extremely fast rate, this type of regulation de-incentivises the creation of innovative new products. The FDA has recognised some of the issues and reformed this process to a degree in December 2017.  They clarified that many types of digital therapeutics will no longer be deemed as medical devices, meaning the regulatory process will be cut down. The new guidelines also outlined the kinds of changes to existing products that will require fresh approval.  The FDA also introduced a pilot scheme for pre-certification for digital companies rather than just products. These are given to those who have demonstrated excellence in software development in lower-risk devices to help streamline the process of approval.The UK is another country that has followed suit in attempting to streamline regulations. The National Institute for Health and Care Excellence (NICE) is working with the NHS to increase their use of digital innovations. They have published new guidelines on what evidence they need to approve a digital product according to its function. It outlines what are the minimal and ideal types of evidence needed as well as appropriate economic data, as NICE, unlike the FDA, takes cost of a product into heavy consideration. Digital therapeutics that follow the steps to be regulated by these bodies will be far more expensive than the cost of releasing an app on a mobile app store without approval or clinical backing. Lisa Suennen, leader of Manatt Phelps & Phillips digital and technology businesses, as well as the firm’s venture capital fund, believes distribution plays a role in the general expense of developing these types of products. She said that: “The biggest financial risk is in riding out the period from launch to adoption, which can be literally years.  There are very few ways to efficiently distribute these products.  At least traditional therapeutics companies have sales forces that know how to sell pills and injectables. So far these entities have struggled to distribute software.”This distribution also ties into exposure. Due to the rapidly changing face of the industry, it is hard to make patients and doctors aware of new beneficial digital therapies for either physical or neurological afflictions. Suennen feels advertising is especially expensive because: “You have to market to them the old-fashioned way. But you have to do it with people who are familiar with selling software and can help the practice understand how to prescribe it. More important is a way for physicians and nurses to ensure patients download it, learn how to use it and get customer support.”It is often difficult to get doctors to properly convey how the technology works and for patients to understand it, especially if they are not tech savvy. Developers that are part of large pharmaceutical companies, like Pear Therapeutics, have service centres to help these groups implement the technology properly. Maricich says that reSET has been “designed to be easy and effectively used by patients with basic technological knowledge. The patient only needs to know how to go to the app store, download the software, and follow the instructions from both the software and their healthcare provider.”However, Suennen feels that due to most companies not having this type of service, they fail to get exposure and get their product implemented properly. She believes that: “Those who think they can sell digital therapeutics without a service program for this are sorely mistaken. And before all that, there needs to be solid clinical evidence of efficacy and, for most of the payers, also financial evidence that the outcomes and economic gain are worth the hassle.”Many financial experts, like Andrew Hendin from Bessemer Venture Partners, believe a solution to the successful marketing of digital therapeutics is a closer collaboration between companies with tech backgrounds, like Apple, with companies who have a medical background. Suennen feels this is an essential combination but it is not as simple as getting the two to work together. “Consumer tech backgrounds are great for improving user experience of medical products, provided those tech people understand the work flows and payment streams and regulatory requirements enough to build something that will be usable by the provider/payer. But these individuals are not well-suited to building distribution models in healthcare, by and large, and often do not understand enough about reimbursement and FDA.” It is clear that digital therapeutics hold the future of treatment in many areas of healthcare. Digital health data is already making clinical trials far easier to conduct, while digital therapeutics are helping to make patient adherence stronger in and out of trials. New technology like VR and AI assistances and companions are treating neurological conditions in ways they have never been treated before. However, it is clear more is needed in building on the steps the FDA have taken in approaching digital therapeutics in a different way compared to traditional drugs, and companies must learn how to market their tech in a clear fashion if they want it to be adopted by the masses. 

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