HIV LANDSCAPE IN TUNISIA

Tunisia, formally the Republic of Tunisia, has a population of 11.69 Mn people, making it the smallest country on the North African coast. Tunis is Tunisia’s capital and most populous city. This smallest African country is regarded as having the most diverse economy in the region, and it is possibly best known for its wide range of historic sites. Tunisia has one of the greatest living standards on the continent with a GDP of $38.3 Bn and a per capita income of $3,317.5. According to government estimations, the growth rate increased from 1.5% in 2015 to 2.5% in 2018, and this trend is expected to continue, reaching 2.7% in 2020.

Tunisia’s healthcare system in a nutshell

Tunisia’s public health care system is overseen by the Ministry of Health (Ministére de la Santé, MoS), which is assisted by numerous public institutions. According to MoS data, Tunisia’s health care system is divided into three levels: primary, with 81 clinics and 2091 basic health centers; secondary, with 109 district hospitals; and tertiary, with 33 regional hospitals and 24 modern teaching hospitals or CHUs (centre hospitalier universitaires). As a result, the public sector continues to be Tunisia’s principal healthcare provider, accounting for 87% of hospital bed capacity, with 31,936 beds. In terms of doctors, 51% work for the public sector and 49% for the private sector. In addition, public health infrastructure continues to expand, with numerous projects underway.

Even though private medicine has always existed, private clinics are a more recent development (except for the Clinique Saint Augustin, which was founded in 1933). According to MoS data, there are approximately 81 private clinics and medical centers. As a result, the private clinic building is predicted to pick up, with 75 new clinics slated to open by 2025.

Speaking of disease prevalence, currently, non-communicable diseases (NCDs), including diabetes, chronic respiratory conditions, vascular diseases, and cancer, have become the main health concern for the Tunisian population, accounting for 72% of deaths, according to figures from the World Health Organisation (WHO).

According to World Bank data, an important decline in communicable diseases has been observed. Thanks to vaccination campaigns, strategic plans, and improved access to clean drinking water and sanitation facilities. However, a low but significant increase in the prevalence of HIV is estimated in the coming years. There are several reasons for this expected increase in prevalence. Some of them include an increase in the number of key populations (homosexuals, drug abusers), disparities in the availability of ARTs, and others.

HIV Infection Prevalence

According to the WHO, the African region accounts for almost two-thirds of the global total of new HIV infections. The countries in sub-Saharan Africa like Eswatini, Lesotho, and Botswana have the highest rates of HIV. In 2019, Eswatini had the highest prevalence of HIV with a rate of 27%. The HIV prevalence in Tunisia is considered to be among the lowest in Africa, about 0.03%of the entire population. This could be attributed to the healthcare system of Tunisia.

Tunisia has a city-centric healthcare system, meaning, the healthcare facilities and accessibility are better in the major cities than in the rural areas. Many hospitals we find in the major cities are of an international standard, and about 67.1% of the Tunisian population is situated in the urban region. Eventually, a large part of the population receives a better quality of healthcare. However, in addition to this, the government is also focussing on means to offset lingering inequalities in access to medical treatment in urban and rural areas. All these factors could contribute to the low prevalence of HIV in Tunisia.

However, the prevalent population in Tunisia expected to increase in the next 5 years, given the growing incidence among key populations such as homosexual men (9.1% prevalence) where condom use is 50% and PWDs (People Who Inject Drugs-6% prevalence), where the knowledge of HIV status is approximately 29% and condom use is 47%. The growth in incidence in key populations could be due to the fact of being surrounded by stigma and social norms which can lead to disparities in access to healthcare.

Efforts made by the healthcare system to combat HIV

In recent years, Tunisia has prioritized interventions for key populations under its National Strategic Plan and has committed to increasing domestic investment in the fight against HIV by creating more awareness and educating people. It also plans to invest more in healthcare workers and NGOs. As of now, they have established screening via over 25 diagnostic and counseling centers, and also, people affected with HIV receive free healthcare, transportation, and monthly allowance for those in need. Even after humongous efforts put in by the government and NGOs, in 2016, only 31% of the population are taking ART medication and only 15% of people receiving ART have received viral suppression which was way behind the WHO 90-90-90 target.

90–90–90: progress is being made, but the world is falling short of the 2020 goals

In 2016, the United Nations General Assembly adopted the 90–90–90 target, which sought to provide HIV testing and treatment to the great majority of individuals living with HIV by the end of 2020, as well as reduce the quantity of HIV in their systems to undetectable levels, so they can stay healthy and prevent the virus from spreading further.

Globally, considerable progress has been made in the HIV testing and treatment continuum. At the end of 2019, 81% of persons with HIV were aware of their HIV status, and more than two-thirds (67%) were receiving antiretroviral medication, amounting to an estimated 25.4 Mn of the 38 Mn individuals living with HIV- a figure that has more than tripled since 2010.

However, meeting the 90–90–90 goal requires a minimum of 73 percent of HIV-positive people to have suppressed viral levels, making the global objective by the end of 2020 unlikely to be achieved. The COVID-19 pandemic may have affected the viral load as well. Current goals aim to eliminate AIDS as a public health threat by 2030.

Overview of the pharmaceutical market in Tunisia

a.  Market size

Due to the national strategic plan for HIV, it is assumed that significant progress will be made towards the WHO 90-90-90 target by 2024. The price per patient per year is forecasted to decrease ( a 4% decline yearly). This enables the government to treat a larger pool and the market size is almost estimated to double due to the increase in diagnosis and rate of treatment. The estimated market size is $0.5M to $1.8M by 2024.

b.  Growth rate

The Ministry of Health of Tunisia had a budget of $1M (3M Tunisian Dirhams) for drug procurement in 2016, out of which approximately 40%-50% was allocated for procurement of ARTs. Tunisia has a higher demand for branded drugs than most of the other African markets, which is expected to grow at a rate of 10%. In addition, with the scale-up towards the 90-90-90 target, the growth is expected to be driven by the number of patients increasing from ~854 in 2016 to ~2200 in 2024. However, volume growth will be offset by some price declines (~10% decline by 2024), which will impact the growth of the market.

c.  Market competition

Branded products capture over 90% share by value in Tunisia with top brand competitors being Gilead and GSK. In 2018, Gilead generated revenues in the range of $230K, driven by its 2 brands Atripla and Truvada. Its sales have further increased over the last 3-4 years. Another mighty brand is GSK with an estimated sales of $220K (2018) through its Lamivudine/ Zidovudine drugs used in the first line. Mylan has a reasonable share of the market and captures approximately 30%-40% (2018) patient share.

d.  Top Pharma companies

The market has a large number of branded products in line with the preference of physicians. Gilead, GSK, Merck are some of the top pharmaceutical companies. Atripla (Gilead), Truvada (Gilead), Epivir (GSK), Retrove (GSK), Strocin (Merck) are among the top-selling ART drugs. The Central Pharmacy of Tunisia plays a key role in the procurement of drugs in Tunisia through tenders. There is no other private market.

e.  Performance

As of now, the government initiatives have been yielding good results, but not good enough. The rate of diagnosis and treatment as of now is suboptimal. This could be one of the causes of patient attrition. The screening for co-infections, as of now, is also suboptimal. Only 10% of patients starting on ARVs were tested for HBV/ HCV, resulting in lower diagnosis rates of co-infections. In addition, the accessibility to healthcare in key populations is low. To tackle these discrepancies, the government has launched high impact initiatives like the HIV Elimination Plans, aiming to target key populations and the AIDS out of isolation plans, aiming to increase the rate of diagnosis of co-infection in HIV patients.

Conclusion

Despite relatively high government expenditures on health, Tunisia’s out-of-pocket (OOP) expenditures remain high (about 40%), indicating that health is a priority. Healthcare is a top priority for both the public and the government. With its own set of minor shortcomings, this advanced healthcare system model presents itself as a promising market for future investors.

References:

  • UNAIDS
  • UNAIDS – Tunisia – 2018 Progress reports submitted by countries
  • Global HIV Targets, avert.org
  • Central Pharmacy of Tunisia
  • World bank Data
  • WHO document on Tunisia
  • HIV Market Report – Clinton Health Access Initiative

Digital Therapeutics – Landscape assessment and potential market entry strategies

Healthcare is shifting from Hospital to Home

The evolution of healthcare has been remarkable to observe: whereas before the patient would have to go to a hospital or clinic to avail their services, now these services come to the patient’s doorstep. Earlier there would be long calls and waiting times to get an appointment with a doctor, medical records were lost or not up to date as patients didn’t make frequent visits to the doctor or hospital, there could be mistakes in data entry and maintenance of paper records, and it was cumbersome for patients to travel such long distances to go to the healthcare center. Now however, there is technology in place that can monitor vital signs round the clock, wearable devices that record a patient’s SPO2, heart rate, breathing and blood pressure as well. This data is seamlessly transferred via Bluetooth or cloud to the physician and is accurate and up to date. It is prudent to invest in electronic health records and big data, as organization of this information is vital in healthcare.

Some examples of smart tech used in medicine include the Abilify MyCite – a Smart Pill: it is a small pill which contains a sensor that can transmit information directly to a mobile phone of the patient and the physician, and helps monitor if the patient is compliant with their medications. This is necessary in patients who cannot be expected to take their drugs regularly, such as those with schizophrenia, acute manic and bipolar disorder patients. In general, about 50% of patients are non-compliant with their medicines which are prescribed, and around 30% of all prescribed meds are never picked up from the pharmacy. This smart pill can thus reduce the disease burden by timely treatment and notification of medication compliance. It has been approved for use by the Food and Drug Administration. Another great mention here is the Bluestar software which is focused on diabetes type 1 and 2 management of patients and takes a holistic approach to it, by syncing with glucose meters, pharmacies, activity and fitness bands and trackers. All this data and insights are delivered to the consumer’s healthcare team and makes it easier to have the data related to their disease stored in the cloud and in one place. It can be tailored to the user’s specific needs and is helpful in getting help 24/7 should it be required. There are contact lenses created by Korean scientists which can detect the level of glucose in tears and give a reading of the body’s sugar levels in diabetics. This eliminates the need for invasive finger prick blood tests. There are also wearable patches which can take your electrocardiogram by detecting the heartbeat and pulse. With such convenience available, more than 80% of consumers are ready to try such wearable devices that can monitor their health, and over 44% of them feel they have more control over their health through these. Health has become an on demand service, with 77% of appointments with doctors being booked online. With everyone owning a smartphone, it is no surprise that around 47% people will research their doctor before a visit, and 38% patients will read up about the hospital they want to go to. AI startups in healthcare have increased manyfold, as much as fourteen times their market share in 2000. Not just with patients, even doctors find tech and AI makes them perform better. Those surgeons who trained virtually have been shown to do 29% faster in surgery and with 7 times fewer mistakes. This is possible through Virtual Reality software enabling them to simulate an operative environment. VR also finds uses in allowing children with autism to find their way in the world and gives them confidence. Not only this, but VR is also being used in chronic pain management. By 2016, 50 million people in the US alone had some form of chronic pain. The use of VR will alleviate the need for opioid medications and subsequent opioid epidemic.

Technological advancements and increased awareness are driving adoption of Digital Health Solutions

Digital Health is a broader field which includes the consumer more actively on a regular basis through providing articles online, platforms for healthcare discussions and queries, lifestyle and wellness apps, storing of health records and data, and transmission of the same. It doesn’t require clinical evidence support. As these are not considered to be medical devices, they don’t require any oversight or review. This is more generally what comes to mind when a person thinks of digital healthcare.

Compared to the market size of $106 billion in 2019 for digital health, by 2026, it is expected to grow by 6.03 times, with a whopping $639 billion. Wearable health devices will grow in the market for a share of $22 billion by the year 2025, a mighty leap of 80 times from 2015. With sedentary lifestyle trends on the rise and a larger population slipping into obesity and consumption of adulterated foods leading to more diabetes cases, the chronic disease burden by 2020 will have risen by 57%. With this, however, people are also becoming more aware of the importance of preventive care and its long term benefits in saving money in healthcare costs in the future. People are becoming more aware about taking preventive measures by reading and sharing such information through the internet. The pandemic has also brought forth to light mental health issues, and many younger people are seeking help before it gets too late: this market of mental health services and software will reach an estimated $2.31 billion by the year 2022. There are various causes for such rising trends in online healthcare systems: smartphones have become the norm and make information easy to access. Advanced technologies such as IoT and AI can be applied to various sectors of patient care to develop products. People are using mobile health technologies to monitor their chronic diseases by themselves, and keep them in check, E.g. for diabetics.

Investing in healthcare has become very lucrative, with investors pouring in $13.7 billion, and it was seen as the second highest funded year ever. The most focused on sector is Telemedicine, which saw a funding of $1.7 billion, followed by Analytics and mobile health. Other categories which were also well funded in 2019 are booking apps, clinical decision support portals etc.

Digital health solution companies do not need clinical evidence or regulatory oversight to launch their product in the market. But there is a subset of Digital health – Digital Therapeutics which is regulated, requires clinical evidence and real-world outcomes in order to launch their product / services to improve people lives.

Digital Therapeutics are software products that deliver evidence-based interventions to improve / manage / treat a medical disease

Dtx are narrow spectrum and tightly regulated interventions that can manage or cure a disease. These need to be evidence-based with extensive research to show their efficacy. Proof of their success in clinical trials and in everyday practice has to be shown in order to decide their indications, contraindications, risk and benefits.

The market for digital therapeutics was 2.9 billion USD in 2019, and is expected to grow to 13.8 billion USD by 2027. Some of the largest investments were seen in diseases such as diabetes management, cardiovascular disorders and obesity.

The key players in this sector are Voluntis and ScientificMed for cancer management; metaMe, mahana, and Bold Health for digestive health; kaia, BehaVR, jogo and lucine in pain and musculoskeletal disease management; for diabetes, it is omada, welldoc, glooko, Dario Health and amalgam Rx. In the management of sleep disorders we see Big Health and SusMed dominate the market. In the treatment and management of addictive disorders, the big names are Pear Therapeutics, Lief Therapeutics, BehaVR, and Click Therapeutics. For anxiety and depression, the main companies are Gaia, appliedVR, Palo Alto Health Sciences, happify Health and Limbix. In the management of respiratory disorders, the key players are Propeller, Nuvoair, and Sound Life Sciences.

Active investors in the digital therapeutics market include Specrum Health Ventures, Lead Edge Capital, Providence Ventures, RRE Ventures, US Venture Partners, Bronze Venture Capital and M2. Some of the biggest deals observed in venture capital in 2020 were as follows: a 100 million USD Mindstrong deal, $93.1 million deal of Virta Health, Omada’s 57 million USD deal, and a $51 million deal by Mojo Vision. Investments in digital therapeutics have increased ninefold from 2015 – 2019. Till august 2020, investments into DTx were at a record $709.7 million with 32 deals in place. In 2019, $1.2 billion were invested across 52 deals, up from $134.3 million in 2015 for 22 deals.

a)  Diseases in DTx

The disease which takes up a large chunk of the market in digital therapeutics is diabetes, especially in regions such as the Middle East, North America and North Africa. And in Asia, it is pretty common in India – which is known as the ‘diabetes capital of the world’. Through 2020-2027, the share of diabetes in digital healthcare will increase by a CAGR of 20.5%. The compound annual growth rate of obesity will be 23.5% in the same time period, with USA having the lion’s share of the market. Obesity will contribute $1.01 billion by 2027 and will grow at a rate of 22.7% from 2020-2027. Next comes cardiovascular disease, which is one of the leading causes of death worldwide. It has been shown that 90% of cardio related deaths are preventable by monitoring health related data through wearable devices and platforms for the same. Here also, North America dominates the market of cardiac disease burden. Apart from this, North America has the highest cases of gastrointestinal and central nervous system disease share in the digital therapeutics market. The central nervous system disorders digital therapeutics market is expected to grow at a CAGR of 19.7% during 2020-2027, and GI disorders digital therapeutics at 16.6% during the same period. The burden of respiratory disease digital therapeutics is also highest in North America, valuing at $161 million in 2019, and is expected to grow at a CAGR of 20.5% between this seven year period.

b)  Challenges and Risks

All these minefields of data will also have threats and risks posed to them: data breaches can cost companies billions of dollars of revenue losses, and their stakeholders have suffered as a consequence. Cybercrime will try and steal patients’ data, and this is a serious breach of trust in these healthcare companies too. Another challenge is the changing nature of oversight and review boards, new laws and regulations coming into place that need to be accepted by healthcare startups in order to stay afloat and relevant in the market. Apart from this, the basic requirement of an online healthcare service is that the patient is tech savvy and understands the platform, the platform itself must be able to handle large traffic and run without glitches, and a trained medical staff that can handle this new form of patient care.

There are many examples of real-world diseases that show the efficiency of digital health and therapeutics in detection and management of illnesses: heart disease can be prevented by checking activity, food intake and weight management through wearable smartwatches that keep a track of these parameters. The most prevalent chronic disease is cardiovascular diseases, and according to the CDC, 6/10 people die of chronic illness. Along with this, ADHD, asthma, diabetes and breast cancer can also be tracked and managed through smart devices and platforms. This strategy lowers the cost of treatments as well.

Managing chronic conditions is tricky, as it causes a drain on the money required to manage them, and earlier detection and monitoring through digital therapeutics can bring down costs of insurance companies for management of acute problems. This infrastructure is growing rapidly because of a boom in the smartphones market, which in 2019 was at 82.9% people in the UK using them, 79.9% in Germany, 79.1% in the USA, and worldwide, 55%. However, a different picture comes to light in underdeveloped nations where people set more store in traditional therapies and there is a lack of information, implementation of such digital schemes, and lack of promotion of these platforms. Also, a general concern of 1/3 of patients using digital therapeutics fear that their information might be sold to third parties by tracking their behavior in invasive ways. This research was done by Savvy Cooperative in 2016. However, there is a scope for growth and investment in this sector in Asia-Pacific and LAMEA as more people adopt smartphones, become aware of the benefits of digital health, and the lucrative side of availing treatments online rather than a pricey hospital set up.

c)  DTx Market business models

Along with wearable devices, there need to be software to backup, store and analyze the data being received from patients. This software market holds 68.7% of digital therapeutics. These solutions include mobile and web applications, and other devices to track patient data. The companies in this software solutions market are: Proteus Digital Health, WellDoc, Noom and Twine Health. This software digital market is expected to reach a value of $9760 million by the year 2027.

There are two models of work in digital therapeutics: one is Business-to-business (B2B), and Business-to-Consumer (B2C). In B2B, we see manufacturers supplying their products to healthcare facilities, wellness centers, gyms etc. In B2C, products are sold directly to the consumer. The B2B model is projected to reach $5.61 billion by 2027, and B2C at $8.9 billion by the same year. In the digital therapeutics overall market, the strongest region coming into play is N. America. This is due to a steadily rising ageing population, an increased burden of chronic illnesses, and better awareness programs adopted by the government. Canada and USA together took up 91.9% of the digital health market space in 2019. Mexico is catching up with an expected CAGR of 19.5% during 2020-2027. Other key countries showing promising growth here are Asia-Pacific, with India estimated to grow at the fastest CAGR here at 26.1% from 2020-2027, in Europe, UK dominates with an expected CAGR of 18% for the same seven years, and in LAMEA, Saudi Arabia will grow fastest at a CAGR of 23.8% in this time period.

d)  Top Companies in the Digital Tx market by large have collaborated or partnered with Big Pharma to launch new products in the market

  • Voluntis

Coming to some of the top companies that are key players in the digital health and therapeutics market, the first one is Voluntis: it was founded in 2001, and focuses on patients with diabetes and oncology related issues. They manage chronic conditions and try to improve treatment outcomes, and have collaborated with Biocon Biologics to innovate on digital therapeutics for insulin. They also have a software called Oleena which remotely monitors cancer patients for related symptoms, and has successfully completed the FDA regulatory review for it. Oleena gives personalized recommendations to cancer patients based on the symptoms they enter into the app, and patient can self-manage their symptoms. However, when the severity of the condition becomes too much for the patient to handle by themselves, the app connects them to the medical assistance team, and the app continues monitoring the patient till the symptom has resolved. Apart from this, Voluntis have created other products such as Insulia, Diabeo, CoacguCheck, Theraxium Oncology etc.

  • Omada Health Inc.

It was founded in 2011 and creates online digital programs which oversee individuals at risk of chronic illness. It combines behavioral data and data science for type 2 diabetics.

  • ResMed Inc.

It is a big presence in the respiratory disease market. It uses cloud computing and medical devices to manage and treat sleep related breathing disorders such as sleep apnea. They have a wide variety of products and services, such as Propeller Health, which is a software program attached to inhalers that detects pattern of usage of inhaler, how often, compliance and breathing patterns of the patient through sensors placed here. It is used in the management of asthma and chronic obstructive pulmonary disease. Other products include ‘myAir’ which tracks sleep therapy progress, AirView, for Obstructive Sleep Apnea patients.

  • Pear Therapeutics, Inc.

The company was started in 2008, which aims to provide clinically validated software solutions which are therapeutic for patients and help them improve their prognosis, allow more engagement and compliance from them, and also give room to clinicians to track the patients’ status. They have made products such as ‘reSET’: it is the first Prescription Drug Therapeutic (PDT), which has received FDA authorization to help enhance disease prognoses, and is a 90-day PDT for patients suffering from Substance Use Disorder. It is indicated for provision of Cognitive Behavioral Therapy (CBT), along with the usual contingency plans and drug regimens prescribed to manage the condition in an outpatient setting. The ‘reSET’ system has a portal where the patient can record the lessons completed, get rewards for compliance, keep a record of their cravings or triggers and the storage of simultaneous data such as in clinic drug test reports.

Along with such revolutionary products, Pear Therapeutics has also come up with solutions like Pear – 003 (for Insomnia and Depression), Pear – 006, for Multiple Sclerosis and ‘reSET-O’ for Opioid Use Disorder. It has collaborated with Novartis to launch ‘reSET’ and ‘reSET-O’.

  • Livongo Health, Inc.

It was founded in 2014, and is focused on diabetes management by providing patients with tools and coaching. The Livongo Diabetes Meter is a pretty nifty device that logs your blood glucose levels directly into the meter through pre-ready strips that come in the packaging. The device stores your glucose readings, and gets you in touch with a certified diabetes management expert should your reading go too low or high, or if you’re feeling under the weather. They provide tips and advice on how best to manage your blood sugar levels day to day, and spare the hassle of unnecessary doctor’s visits and wastage of time. The data is uploaded and synced on cloud. The company has been acquired by myStrength, Inc.

e)  Strategies adopted in the Digital Therapeutics market – Partnership emerging as the top strategy among all the stakeholders

There are many more such big names in the industry, and they partner up or collaborate on numerous products to access the chunk of market that the other company caters to. For example, ResMed has a wider distribution network and a bigger variety of products, more investment and greater geographical presence. The company Fitbit has access to more than 87 countries, with its wearable devices being popular for fitness. Livongo Health also dominates the market as a key player in terms of market penetration, R & D, and capital investment. It has a formidable presence in computer platform as well as smartphone applications. Some successful partnerships in recent years have been as follows: Noom and Eversana partnered up to better cater to patients with chronic conditions and rare diseases, to check patient adherence and engagement for long drawn out therapies. Another great joint initiative was done by Walmart and 2Morrow, and they came up with a digital therapeutics program to curb smoking and vaping via walmart’s website. There are many such companies which have created joint programs for digital therapeutics space. Voluntis and Bristol Myers Squibb partnered up in 2020 to create and investigate digital therapeutics solutions that could support cancer patients by leveraging Voluntis’ platform of Theraxium Oncology, which allows for the creation of a web portal for the patient’s healthcare teams to work seamlessly in one digital space, and also gives prescriptions via the same. Patients are supposed to update any new or severe symptoms of disease and they will immediately receive actionable information to manage it, or have instructions from their healthcare provider, tailored to that specific need.

Propeller and Orion also partnered up in 2019 to bring new digital therapies for patients with COPD and asthma. It connects Orion’s already existing Easyhaler line of inhalers with Propeller’s digital medicine platform via a small sensor. Happify health and Sanofi also teamed up in 2019 to explore digital therapies for people with depression and multiple sclerosis. The company Biofourmis moved to acquire Gaido Health, which places them in a strong position to venture into the Oncology space of DTx. Their joint ventures aim to monitor post-discharge cancer patients and manage their symptoms after leaving hospital. The company Virgin Pulse also acquired Blue Mesa, which is best known for its diabetes prevention program called Transform.

The Swiss pharmaceutical company Novartis acquired digital therapeutics firm of Amblyotech that provides their novel digital therapy for treatment of amblyopia. This acquisition moves Novartis further into the refractive disorder line in ophthalmology. The software utilizes video gaming with 3D glasses, which trains the patient with lazy eye to use both eyes simultaneously to view the images as a whole. The software uses something called ‘dichoptic display’ where an algorithm presents each eye with different images. Recently, CVS health also announced that they had added five new companies to their digital health platform for PBM clients, including Hinge Health, Livongo, Hello Heart, Torchlight and Whil.

Akili launched a product in 2020, EndeavorTM, which is aimed for children with ADHD, and is an action based video game shown to improve concentration and attention. MedRhythms in 2020 announced that they were developing a Patent Advisory Board, which is the first of its kind in the industry. This will bring a patient’s perspective into decisions that motivate the company’s goals, vision and products, through the lens of living with the effects of Parkinson’s, MS and strokes. Pear Therapeutics also announced a limited distribution program for its product, Pear – 004, for management of people living with schizophrenia. Big Health launched a CBT based app called DaylightTM, which focuses on combating and reducing feelings of anxiety.

Partnership by far remains the best strategy for growth, closely followed by collaboration, product launch, product approval, acquisition, agreement, and business expansion.

f)  Regulation

Devices related to digital therapeutics are divided into three classes, namely Class 1: which are subjected to general controls like establishment registration and device listing , labelling, medical device reporting and prohibitions against adulteration and misbranding. Class 2 devices: Subjected to general controls, performance standards and other special controls. Requires prior 510(k) clearance before commercially marketing in US. And Class 3: Devices that pose the greatest risk (such as life sustaining, life-supporting, or implantable devices. Such devices require PMA permission supported by clinical trial data. To get FDA approval and clearance, there are two pathways as well: the 510k Clearance Pathway: any device which doesn’t require Premarket Approval Pathway or PMA, and if any modification is done to it prior to getting the 501k approval, which can be any change in its design, intended use, will need a new clearance. The same applies for PMA.

The FDA in 2017 announced a new policy which would provide better guidelines for digital health, and launched a software precertification pilot program for the same, called Pre-Cert. Some successful FDA approvals that have come this way are as follows: Pear is a digital therapeutics startup which received FDA approval for its app Somryst, to manage older patients with chronic insomnia.

When it comes to defining the digital therapeutics solutions, there is the example of Apple Inc, which is a multinational organisation that produce wearable devices among other things, and there are services and software apps available to improve patient costs. These apps and the sotware itself are used by a number of healthcare professionals. This is known as Full-scale Market Attributes. When it comes to Pure Play Attributes, these are done through pharmaceutical partners, which will augment current pharmaceutical solution through addition of a software component or becoming part of pharma-based platform. It will need a digital subscription and is reimbursable. A great example of this is Pear Therapeutics, which integrates clinically validated software apps with previously approved treatment modules.

Current Disease Trends & Investing in Them

Healthark internal analysis has identified two conditions as the top investment pockets: diabetes and obesity. With the rise of diabetes, it takes up a market share of 24% in 2020, and will be the highest revenue generator in digital therapeutics by 2027. Obesity too, will take up a market share of 24% by 2027, and will see a growth of 23.2% between 2019-2027. This data has shown us that diabetes is a chronic and highly costly disease to manage along with having such high prevalence rates. There is great opportunity here for manufacturers of R and D in digital therapeutic products. Some big names already in the diabetes management sector are Noom, WellDoc, Glooko, and Omada Health. They are providing customers with software apps and programs to handle and monitor their diabetes.

This trend is observed as in 2018, 10.5% of the American population was suffering from diabetes and was the 7th leading cause of death. Currently, there are 425 million diabetics around the world, and this number will reach 625 million by 2045. In 2016, 1.6 million people had lost their lives due to diabetes, according to data put forth by WHO. Along with all these, the cost of treating diabetes has also gone up by 26% since 2012.

Coming to obesity, its prevalence has increased to 42.4% from 2017 to 2018 and it is the second most prevalent chronic disease after diabetes. Also, in 2018 it was shown that among adults aged 20-39, obesity was 40%, and 44.4% in adults aged 40-59 years, and at a whopping 42.8% among adults aged 60 and older. This condition also provides opportunities for prevention by usage of digital therapeutics, by tracking and monitoring lifestyle, and daily exercise along with intake of healthy food. In a 2017 analysis by Noom, it was found that 78% of the users would download it for losing weight (Noom Weight Loss Coach).

North America will dominate the DTx for the next decade

It contributes to 49% share of the digital therapeutics market as of 2020, and will be growing at a CAGR of 19.2% during 2019-2027. Even through Asia-Pacific is expected to grow at the highest rate, North America will still hold the majority of market share in the forecasted period. By 2027, North American markets will take up 6.28 billion USD in digital therapeutics. Europe and Asia will take up 3.27 and 2.96 billion USD respectively. These trends are observed because the US led FDA has put in place strong guidelines to oversee the digital therapeutics market, establishing standards for the product quality before it hits the market. This increases the product reliability and efficacy. There has also been a rise in chronic diseases burden in North America, with 6 in 10 adults having 2 or more chronic disease in the USA. It is estimated that by 2023, 49% of the American population will be having some form of chronic illness.

There is also a need to bring down healthcare costs as 84% of the management money is directed towards treatment of chronic diseases, making up 19.9% of the country’s GDP. This price will only rise in the future with increasing burdens of chronic disease. There is also a positive shift towards reimbursement for digital therapies, showing that 25% of organisations already cover digital Tx, and 45% more are interested in covering for this in the future. The two major PBMs which are CVS Caremark and Express Scripts, together make up 53% of the reimbursement market, and have made adaptations to include DTx in their plans.

Strategic steps for building a digital therapeutics solution

In order to better allow the digital therapeutics to flourish, awareness of this service must be made clear to both the patient and the provider, through social media, word of mouth, research and more. Development of a business model is necessary which can be tailor made for the specific client, along with investments needed in specific areas: in order to expedite your product launch, it is important to get into partnerships and joint ventures, acquisition. Also, a company may need to license and integrate multiple digital therapeutics products to complement an existing treatment by developing its own platform.

Partnerships are useful in fulfilling unmet patient needs that have already been identified along with pairing of technical capabilities and digital skillset of a technology company with regulatory expertise. A great example of this is seen with HARMAN, which is a subsidiary of Samsung electronics, and it entered into a long-term partnership with Roche, in order to develop a digital therapy solution for people with autism.

Another strategy that can lead the way forward is acquisition: identification of a specific company to leverage its therapeutics area, then investing in scaling the digital capability. An example for this is Apple acquiring asthma monitoring company called Tueo Health, to collect relevant data, alert users of changes in condition and set up a live consultation should the need arise, via the Tueo Health asthma educator.

A third tip for growth in DTx is licensing: a company can easily license and integrate multiple digital therapeutics products to complement existing treatment, by developing its own platform. It can also create an app store to integrate multiple digital offerings. A thriving example of this is the integration of Amazon’s Alexa services with Livongo’s blood glucose monitoring services. Users may use the voice service feature of Alexa to ask on their blood glucose status and health tips.

Tackling the entry barriers for your DTx solution

They present many challenges as well which can be addressed to make use of their full potential. It’s an opportunity for software based technology companies where they can leverage their technical knowledge and venture into the healthcare market, and capitalise on the growth potential in digital therapeutics. A key challenge here is creating awareness that DTx can provide patients: this can be tackled by using social media and holding seminars and conferences, where patient success stories can be narrated, and using messaging that promotes knowledge about digital health on social media. Getting approval from regulatory bodies such as the FDA is also a challenge, which can be overcome by collaboration of software and pharmaceutical companies, to leverage their understanding of the regulatory bodies in healthcare industry.

Launching new products can be a herculean task as well, whereby companies will need to work across multiple industries to ensure they mark unchartered territories with expertise. This can be achieved by developing a reimbursement model that provides significantly more benefits than existing models.

Digital therapeutics does present challenges that need to be overcome, by creating awareness of the products on offer, launching the product by wise collaborations, and getting timely approvals from regulatory bodies. It presents growth potential that can be capitalised with the right investment and research.

Sources

  1. Difference between digital health, digital medicine, and DTx products – Journal of family medicine and primary care
  2. Digital Health, Digital Medicine, Digital Therapeutics (DTx): What’s the difference? – Healthxl
  3. Digital Health Whitepaper – Capgemini
  4. Digital Transformation in Healthcare in 2021 – Digital Authority Partners
  5. Digital Health – Allied market research
  6. Digital therapeutics Funding – FCA Ventures
  7. Top DTx moments 2020, 2019 – DTx East
  8. The Digital Therapeutics Revolution – Pitchbook
  9. Digital Health Software Precertification – FDA
  10. Startups in Digital Therapeutics – Tracxn
  11. Digital therapeutics still have a long road ahead of them – MobiHealthnews

GLOBAL COVID VACCINE-DEPLOYMENT RISK AND CHALLENGES

The COVID-19 pandemic has resulted in significantly excess mortality and has thrown national economies into a tailspin. Although the spread of the virus can be slowed with physical separation, face coverings, testing and tracing, and possibly therapeutics, the risk of outbreaks and economic and social disruption will likely persist until effective vaccines are provided to large segments of the global population to prevent hospitalization and severe disease, and preferably achieve herd immunity. Even in the face of variants, data from vaccine clinical trials and real-world evidence reveal that coronavirus vaccines can avoid infection and greatly reduce the risk of serious disease and hospitalization.

Several COVID-19 vaccines have now been licensed for human use, and several more are in the final stages of clinical trials. In several nations, the BioNTech and Pfizer partnerships (Pfizer-BioNTech) and Moderna vaccines have obtained Emergency Use Authorization. Vaccines from other multinational players, such as AstraZeneca, Johnson & Johnson, Russia (Sputnik V), and others, are now arriving and being distributed for administration around the world.

Four dimensions of an effective global immunization strategy against COVID-19

We have all witnessed that having approved vaccines is not enough to eradicate COVID-19 worldwide. They must also be mass-produced at a low cost, distributed internationally so that they are accessible where they are required, and widely used in local communities. A recently published Health Policy paper in Lancet outlines the following four-dimensional strategy for effective global immunization against COVID-19:

1. Development & production

• Vaccines that have been approved by strict regulatory bodies or WHO
• Large-scale production

2. Affordability

• Processes that represent public investment and risk-sharing when accounting for large purchase volumes
• Long-term financial support for COVID-19 vaccinations & vaccination campaigns

3. Deployment

• Infrastructure to allow efficient regional and local distribution and administration of doses
• Public trust in vaccines and vaccination programs to achieve widespread uptake

4. Allocation

• Vaccines are available where required
• Multilateral efforts to ensure global access on time

Each of these four dimensions come with their own set of challenges that are closely related, and the development and production steps have important implications for pricing, allocation, and public confidence.

Risk and challenges

As production ramps up and rollouts are designed and implemented, we will face a set of complex challenges. The following risks and challenges are highlighted as important emerging risks and challenges:

A.   Limitations in production scaling due to raw materials

Expanding access to raw materials and increasing production levels can present logistical, contractual, and even diplomatic problems, necessitating new forms of collaboration. Early signs indicate that global syringe and fill-finish material manufacturing ability is adequate. For example, the top two US manufacturers can produce 280 million vials per year with a capacity of 2.8 billion doses. However, several niche chemical and biological vaccine components are available from a variety of sources, and countries will have to compete for scarce resources.

At the same time, many vaccine manufacturers have pursued highly specialized contract manufacturing partners to load mRNA onto lipid nanoparticles and purify the resulting therapeutic on a large scale while adhering to strict regulations. For example, Moderna’s COVID-19 vaccine was developed in collaboration with Catalent and Lonza. Such collaborations will almost certainly become more important as global vaccine demand grows, and they will be a key factor in the campaign’s overall success.

B.   Quality-assurance challenges in manufacturing

Quality-assurance challenges include generating yields while maintaining the safety and effectiveness of each dosage. Makers have required vast amounts of inputs, a greater technological workforce, and a much-expanded ecosystem of manufacturing facilities to produce a new class of vaccines, such as those focused on mRNA or viral vectors, at an unparalleled scale (1.8 billion to 2.3 billion doses by mid-2021). At the same time, national regulators such as the US FDA continue to establish requirements for these new therapeutics, even as large-scale development continues. In this context, quality assurance will continue to be critical.

C.   Challenges in cold-chain logistics and storage management

Manufacturers and distributors in North America plan to keep mRNA-based vaccines cold-chain compliant for delivery and long-term storage. Before administration, large quantities of dry ice can be needed at different locations. This is an especially pressing issue in developing countries, where cold storage and dry ice are scarce. The current high demand for vaccine doses may alleviate initial storage issues at points of care, but expected high-volume delivery later in 2021 may temporarily outstrip vaccine consumption, necessitating a greater focus on storage management.

D.   Increased labor demand

Complex procedures for managing and processing COVID-19 vaccines, as well as the extra precautionary monitoring time after patients are vaccinated, have the potential to put a strain on labor capacity or divert staff away from other vital positions. According to estimates, one administrator could vaccinate seven to ten patients every hour with the assistance of two support staff at a reasonably streamlined vaccination location. This rate is slower and requires 3.5 times more effort than the annual flu vaccine. The US CDC estimates that if retail pharmacies were solely responsible for public administration of the COVID-19 vaccine, 15 to 20% of their skilled workforce would be needed.

E.   Wastage at points of care

Errors in the storage, preparation, or scheduling of doses at the point of service can have serious implications. Failure to ensure that recipients keep their appointments, for example, will not only prevent individual immunity but will also result in product waste since all vaccine doses in multidose vials must be administered within a limited period of time after the vial is opened. It’s also crucial to have proper on-site storage conditions. Because of the temperature specifications, existing mRNA vaccines would be more difficult to store on-site.

F.   IT challenges

For allocating, transmitting, documenting, and controlling vaccine deployment, IT systems such as vaccine-tracking systems (like CDC’s VTrckS) and immunization information systems (IIS) will be critical. In the US, over 50 different IIS (one for each state and territory) must communicate with VTrckS. It’s been a major software creation, data hosting, and organizational challenge to ensure that these can run at unparalleled scale and are optimized for a two-dose vaccine schedule. Given the potential for hackers and criminals to inflict damage, it will also be critical that these systems protect patient privacy and are protected against cyber threats. In addition, COVID-19 vaccine developers and regulators have already been targeted by cyberattacks.

Collaborative approaches to mitigate emerging risks

There are several ways of mitigating above mentioned risks and challenges:-

A. Creating resiliency in raw-materials supplies

• A wide array of global suppliers is needed to meet the specific requirements of each vaccine seeking regulatory approval
• Sustainability readiness
• Industry-government collaboration

B. Scaling manufacturing within quality guidelines

• Increase the scale of production in both new and existing facilities
• Create predictable supplier plans in current facilities to ensure quality and yield

C. Cold-chain optimization

• Have redundancy in the delivery system
• Take advantage of feedback loops
• Make use of point-of-care inventory management

D. Resolving labor shortages

• Make use of various forms of point-of-care services.
• Simplify administration across sites

E. Curbing spoilage at points of care

• Keep track of and report spoilage at care points
• Pace the administration of the first dose and make second doses a top               priority
• Establish recipient commitment
• Certificate management

F. Taking on IT obstacles

• Maintain a balance between IT updates and resilience
• Circulate cyberthreat information
• Create a method for demonstrating immunity

Conclusion

The Covid 19 pandemic has reshaped the world in unprecedented ways. This has openly questioned the global current capacities, and several nations, including developed ones, have failed miserably in combating the pandemic. Following a valiant research endeavor that resulted in the creation of a vaccine in record time, production is ramping up now, and rollouts are being designed and implemented. We are at the forefront of emerging vital threats and challenges, a few of which have been highlighted in this report. The only way to control current and upcoming pandemics is through global collaborative research and distribution channels.

References:-

  1. https://www.mckinsey.com/business-functions/risk/our-insights/the-risks-and-challenges-of-the-global-covid-19-vaccine-rollout
  2. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00306-8/fulltext
  3. https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00129-6/fulltext
  4. https://www.sciencedirect.com/science/article/pii/S0168851021000853
  5. https://www.who.int/bulletin/volumes/99/3/21-020321/en/

The potential for artificial intelligence in healthcare

Artificial intelligence has come a long way since it was first established as a field in 1956. Over 60 years ago at Dartmouth College, a group of scholars organized by computer scientist John McCarthy coined the term. The Dartmouth group wanted to explore the possibilities of having machines solve problems that humans typically solved using their natural intelligence. Today, AI has evolved past that early research and development stage.

In recent years, there has been an amplified focus on the use of artificial intelligence (AI) in business and society to resolve complex issues. Likewise, the adoption of artificial intelligence (AI) in healthcare is growing while radically changing the face of healthcare delivery. AI is being employed in a myriad of settings including hospitals, clinical laboratories, and research facilities. AI approaches employing machines to sense and comprehend data like humans has opened up previously unavailable or unrecognised opportunities for clinical practitioners and health service organisations. Some examples include utilising AI approaches to analyse unstructured data such as photos, videos, physician notes to enable clinical decision making; use of intelligence interfaces to enhance patient engagement and compliance with treatment; and predictive modelling to manage patient flow and hospital capacity/resource allocation. These technologies have the potential to transform many aspects of patient care, as well as administrative processes within provider, payer and pharmaceutical organizations.

The complexity and rise of data in healthcare means that artificial intelligence (AI) will increasingly be applied within the field. Several types of AI are already being employed by payers and providers of care, and life sciences companies. The key categories of applications involve diagnosis and treatment recommendations, patient engagement and adherence, and administrative activities.

There are already a number of research studies suggesting that AI can perform as well as or better than humans at key healthcare tasks, such as diagnosing disease. Today, algorithms are already outperforming radiologists at spotting malignant tumours, and guiding researchers in how to construct cohorts for costly clinical trials. However, for a variety of reasons, we believe that it will be many years before AI replaces humans for broad medical process domains.

Rather than robotics, AI in health care mainly refers to doctors and hospitals accessing vast data sets of potentially life-saving information. This includes treatment methods and their outcomes, survival rates, and speed of care gathered across millions of patients, geographical locations, and innumerable and sometimes interconnected health conditions. New computing power can detect and analyze large and small trends from the data and even make predictions through machine learning that’s designed to identify potential health outcomes.

Machine learning uses statistical techniques to give computer systems the ability to “learn” with incoming data and to identify patterns and make decisions with minimal human direction. Armed with such targeted analytics, doctors may be better able to assess risk, make correct diagnoses, and offer patients more effective treatments.

Healthcare delivery has over years become complex and challenging. A large part of the complexity in delivering healthcare is because of the voluminous data that is generated in the process of healthcare, which has to be interpreted in an intelligent fashion. AI systems with their problem solving approach can address this need. Their intelligent architecture, which incorporates learning and reasoning and ability to act autonomously without requiring constant human attention, is alluring. Thus the medical domain has provided a fertile ground for AI researchers to test their techniques and in many instances; AI applications have successfully solved problems with outcomes comparable to that of human clinicians. As healthcare delivery becomes more expensive, stakeholders will increasingly look to solutions that can replace the expensive elements in patient care and AI solutions will be sought after in these situations. However, cold technology cannot totally replace the human elements in patient care and a model that incorporates both technological innovations and human care has to be investigated.

Clinical Applications of AI Today and in the Future

There are numerous applications of AI on the market today or awaiting approval that can improve patient care and potentially save lives.

Those applications involve pattern recognition, robotics and natural language processing, which includes speech recognition and translation. Machine learning, a “technique that trains software algorithms to learn from and act upon new data to continuously improve performance,” is also increasingly used today,

Here are a few examples of the latest tools that leverage AI and its subsets to augment various areas of medicine and healthcare, such as:

  • Virtual assistants: This AI-driven technology can help people with Alzheimer’s disease with their daily activities. For example, 59-year-old Brian Leblanc, who was diagnosed with early onset Alzheimer’s disease in 2014, started using Alexa on his Amazon Echo Dot for reminders to eat, bathe and take medication. What it enables him to do is to have more control over his life.
  • MelaFind: This technology uses infrared light to evaluate pigmented lesions. Using algorithms, dermatologists can analyze irregular moles and diagnose serious skin cancers such as melanoma. Although this technology should not replace a biopsy, it helps with giving an early identification.
  • Robotic assisted therapy: Bionik Laboratories in Toronto and Watertown, Mass., use robotics and AI to assist patients in their stroke recovery. A robotic arm and hand use digital algorithms to detect motions that patients can’t execute during therapy and guides them through it. It can help patients perform more recorded movements per hour than they would have if working with a physical therapist alone.
  • Caption Guidance: The Food and Drug Administration just approved this AI-powered software, which can help medical professionals capture, without any specialized training, echocardiographic images of a patient’s heart that are of acceptable diagnostic quality. Machine learning trains the software to spot high-quality 2D ultrasound images of the heart and even record video clips of it, changing the way heart disease is diagnosed.

Is your solution truly patient-centric?

We live in a world of consumerism and companies are ever-increasingly focused on doing more to satisfy their customers. However, healthcare is different as a customer is not a typical value or experience seeker, but a patient in need of care. Healthcare in most countries is a fundamental right of an individual, and one of the core tenets of evolution and progress. And hence, every year all the stakeholders including the government, academic and research institutes, pharma and medical device companies, hospitals and the public pour crores into research and identification of solutions for better care.

As all these stakeholders focus on innovation and the next-best thing in healthcare, one must ask if the problem of improving patient care and health outcomes is truly being solved. Every year India sees innovative solutions either driven indigenously or imported from other countries and contextualized for the local healthcare system. However, most of these solutions providers given the siloed nature of the industry take a very microscopic view of the disease, trying to solve for one pain point through their product or service. We have identified a couple of simple yet commonly observed case-studies to highlight the problem and share a patient-perspective as they interact with these innovative solutions, developed to help improve their condition and quality of life.

Case-study I:  An elderly patient on regular dialysis

Let’s take a case of an elderly patient having diabetes and related kidney failure and requiring dialysis on a regular basis. The doctor will do everything he or she can by prescribing the right care, regular procedures and follow-ups. However, there are other facets to the disease management and things that a patient can do himself or herself as well such learning more about the disease, precautions, side-effects, adhering to a regular medicine schedule, regularly measure hemoglobin levels as they tend to deteriorate over time, work with a dietitian on an adequate meal plan and so on.

As we look at these challenges, there are multiple solutions that are presented to the patient including reminder apps for improving compliance, lifestyle management application for diabetes management, diary to maintain a regular log of hemoglobin control, or a home-based hemoglobin measurement device (like the home-based glucometer). As we look at these many great solutions from a patient perspective, a few natural questions that emerge are: (a) how many applications and devices can a single patient manage? (b) how does all the data come together from these multiple solutions, and (c) what if the patient has other disease which hasn’t been covered as part of these disease management solutions?

Case-study II: A child suffering from Juvenile Idiopathic Arthritis

Juvenile or childhood arthritis is a condition where a child undergoes bouts of painful swelling inflammation of joints. While the course of treatment is relatively well-established including physical therapy, pain-killers, corticosteroids, DMARD’s and surgery in some rare cases, given the young age of the patient there are multiple open questions that remain to be answered: (a) how do you motivate the child to get regular physical therapy, (b) how do you alleviate the pain during treatment and, (c) also how do you support the education of the patient during this journey?

With today’s technology evolution such as introduction of gamification in healthcare, digital patient education platforms, and virtual reality to help combat pain, the future of this treatment looks promising. Stakeholders will have to however work on building a holistic ecosystem and not siloed solutions using the foresaid technologies, ensure that the experience for the child remains personalized and more importantly humanized, and continuously ensure that all this eventually leads to improvement of clinical outcomes.

During past few years of my experience in studying the patient journey for various diseases, evolution and deployment of various innovative solutions and the unmet needs, I have realized that there are four key elements that define any patient-centric solution:

  1. Information / Engagement: Quality of information shared, and the degree of engagement achieved with the patient
  2. Channels: Select the most appropriate and effective channel for each activity
  3. Patient Journey: Ability to engage at each stage of patient journey and bring the right value proposition
  4. Personalization: Personalization or customization of the services to the extent possible and in the right context

Below map indicates a reference framework for identifying different pain-points and areas of considerations as we design a solution for any disease area.

Stakeholders need to consider the following factors and answer related questions such as:

  1. Information / Engagement: Are we enabling the patient with all the information and engagement aspects across the spectrum? A pharma company might be more inclined to share prescription guidance and a dietitian might be more inclined to share only a meal plan, but then such an approach would mean that the patient must shop around the ecosystem to for information
  2. Channels: What are the right channels for disseminating the information amongst the available options? Each provider might not have all the channels, but there are ample opportunities to collaborate and ensure the right channel partner is involved
  3. Patient Journey: What stage of the disease journey is the patient going through, and based on that are we addressing the right needs of the patient and the care-giver?
  4. Personalization: Does the solution require personalization, humanization and contextualization based on the various outlined parameters?

During introduction of the recent healthcare reforms in US, one of the most emphasized roles was that of a ‘care coordinator’, someone who can stitch a holistic experience for the patient. We seeing some interesting solutions being introduced in India as well for 360-degree management of diabetes and a few other chronic diseases, which include delivering the medication to the patient on time, timely reminders, education on using the insulin pen correctly, diet advice, answering any other queries the patient has, lifestyle guidance and counseling. While most stakeholders do not have all the capabilities internally, the most encouraging sign is that they are collaborating with each-other with one common goal of helping the patient. Are you working towards the same?

Digital Therapeutics: Is the mobile app ready to replace your pill?

Imagine the future, it’s year 2050 and Mrs. Gupta is sitting on her couch talking to her friends about this amazing new treatment she is using to alleviateherknee pain. She talks about a new mobile app that her physician has prescribed, which has a combination of videos and games guiding her to perform targeted exercises or joint movements. The app comes along with a Bluetooth enabled band to be placed on her joints to measure the joint movement during exercise and ensure precision. Moreover, the app measured her joint movements and suggested that her knee can go without a surgery for almost 5-years based on the degree of movement and a few other parameters. No pills, no side-effects or physical therapy visits, the entire treatment can be accessed from the app store through a prescription given by her doctor.

Sounds like a byte from astar-trek episode, butgiven the pace at which Digital Therapeutics is evolving, these treatment modalities might be accessible to all of us way sooner than 2050. So, the first question that arises for many of us is, what is “Digital Therapeutics”? Digital Therapeutics is a health discipline and treatment option that utilizes a digital and often online health technologies to treat a medical or psychological condition.

Usually the treatment relies on behavioral and lifestyle changes usually spurred by a collection of digital impetuses. While the initial application of such solutions started mainly with cognitive and psychological disorders, with expanding advent of technology now companies are targeting a wide variety of diseases including diabetes, heart failure, obesity, Alzheimer’s disease, dementia, asthma, substance abuse, ADHD, panic attacks, anxiety, depression, and several others.

United States is currently leading the way in terms of development and adoption of Digital Therapeutics (also known as Digital Medicine). They define it as clinically-validated, FDA approved, prescription disease management and treatment technologies that can enhance or replace current medical treatments. It is classified into two broad categories:

  • Digital Companions: Digital solutions clinically proven to support patients and enable them to self-manage / coordinate with providers while on a medical treatment for a specific disease
  • Replacement Therapies: Digital solutions that can be used to treat a specific disease instead of a pharmaceutical product (essentially replacing the need for the pharmaceutical product)

Big Health, a San Francisco based start-up recently launched Sleepio, a digital sleep improvement program featuring Cognitive Behavioral Therapy (CBT) techniques, to help overcome even long-term poor sleep. Sleepio has been scientifically designed and clinically validated for improving sleep quality. The application is already accessible to over a million people through their insurers.

 

Pear Therapeutics, another Boston-based company, considered a pioneer in this area is working on treatment for ten diseases ranging from psychiatric disorders to autoimmune conditions and cancers. Now they are partnering with pharma companies such as Novartis to commercially distribute these products to patients at scale. Extending their commitment they established Pear Connect, a first of a kind patient service center helping with relevant patient guidance, physician monitoring of patient condition and timely insurance reimbursements.

Wellthy Therapeutics, a Mumbai based company recently became the first Indian company in this category. Wellthy has an application to manage diabetes, that has clinically proven results across multiple studies and was well received by diabetologist and endocrinologists recently at RSSSDI, Asia’s largest diabetes conference.

But are all mobile and desktop health applications considered Digital Therapeutics? NO, it is only those digital solutions that are focused on treatment, have evidence proving their outcomes and that require to be prescribed by a physician form this niche category. A regular fitness app that connects to your pedometer or measures calories is not a digital therapeutic. We see the internet loaded thousands of such solutions that claim to improve health, but it only leaves the patient with a problem of plenty and makes it difficult to choose the right solution.

Digital Thereapeutics is an evidence-based solution where clinical studies have been conducted to measure the safety and efficacy of the solution. It allows clear data to make an informed selection of the right solution, overcoming the problem faced by patients in selecting the right solution. Moreover, the selection here is made by the physician and not the patient, adding a layer of right expertise during selection.

With such rapid evolution in the area of Digital Therapeutics, the question lies around why is it better as compared to traditional medicine? There a numerous aspects making these treatments highly desirable including ease of access, lower cost, fewer side-effects, non-invasive nature, ease of monitoring and personalization. It has to be created once and can be accessed by millions of patients with almost no incremental cost. With mobile and internet penetration spreading rapidly to remote parts of India, it is also much easier to distribute. Given the digital nature, data is continuously generated and tracked, helping overcome the issue of non-adherence in chronic diseases, helping improve treatment outcomes.

With all its advantages, can Digital Therapeutics replace conventional medicines? NO, Digital Therapeutics by design work only in certain situations, usually ones that are chronic in nature requiring a long-term treatment and where lifestyle changes, physical therapy, dose alteration, continuous monitoring, etc. have a considerable role. For example, Digital Therapeutic might not be as effective in relieving acute pain in a joint or splitting headache that a migraine patient is having. But it can help with a structured posture and exercise program for relieving joint pain in the longer run, or a meditation program that can prevent migraine episodes over time.

As our understanding of various diseases evolves, digital solutions will start becoming more and more relevant in terms of either supplementing or complimenting current treatment. Moreover, wider development and adoption of digital solutions will also require maturity and evolution by the industry as a whole. Doctors and hospitals will have to evolve in understanding and prescribing these treatments, regulators will need to develop sophistication to evaluate digital solutions and insurers will have to learn to model reimbursement and risk-benefit ratio.

While there is more work to be done to get Digital Therapeutics in the hands of every other patient, the future is not as distant as it may seem.

Internet of Health: Defining the Future of Personalized Medicine by Connecting the Dots

Internet of Things has been the potboiler of innovation, technology and deep analytics for few years now. But has its promise yet delivered? Well, the jury is still out but it does have the potential to transform the health care and medication as we know it today. Internet of Health (IoH) has incredibly high value if realized and guess what – its already happing!! Smart medical devices (diagnostic, wearable, in-hospital and many more) are playing a leading role in driving the future of healthcare. What actually will drive IoHs promise of personalized medicine is disruptive innovation and comprehensive integration with the other health information technology elements both within and outside the hospital ecosystem.

IOT enabled ecosystem will allow physicians:

  • In making the right treatment decisions at the right time,
  • Sharing of right information
  • Analyzing the outcomes of their decisions.

This will enable healthcare democracy in true nature to collectively unearth the real-world outcomes of treatment protocols and move towards personalized medicine enabled healthier world.

Smart Medical devices

  • Medical devices will not only conduct a diagnostic test (e.g., imaging, blood test), but will team up amongst themselves to create a complete profile of the patient at the most granular level based on the phenotypic and genotypic information of the individual based on information shared in the electronic medical record systems and results of the diagnostics tests conducted.
  • Once the patient has been characterized at the most possible granular level, these systems will help present the physicians with best possible options for further care, based on outcomes from the past data.
  • Multiple historical theories and quantified studies have proven that when the physician are presented with this information at the right time and in an easy to interpret format, it will lead to improved patient outcomes.

So what are we really talking about an Internet of Health driven Information and Insight ecosystem!

The IoH driven information and insights ecosystem will share with physicians, clinical insights from similar patients across the world. In particular, in case of rare variants and/or orphan diseases, it will share insights related to treatment options and their outcomes, and relevant supporting medical literature at the point of making a treatment decision.

uch comprehensive information and insights ecosystem focuses on dissemination of right information at point-of-care include three key components:

  • Anonymized patient directly from the source, either within or outside the distributed health network- to point of care
  • Aggregated insights from aggregated central analyses to the physician, and
  • Additional excerpts from literature to compliment insights from the above two

Physician information and insights systems are typically configured based on disease areas, treatments, procedures, physician specialties and on the patients phenotypic and genotypic characteristics.

As we are all familiar, healthcare presents the thorny challenge of data privacy, security, ownership, and interoperability. Given these challenges, meeting the above vision will mean development of a two-tiered capability by medical devices organizations:

(1) Aggregating and analyzing data, and

(2) Disseminating the information to the point-of-care.

As these two tiers are developed, it will result in a system where patient outcomes related insights are available centrally based on an aggregated analysis, and yet the overall patient data resides where it should at the source in a federated model, resulting in a highly efficient distributed health network.

The first tier will focus towards aggregating and analyzing clinical information, to generate insights that can help providers and physicians to improve clinical efficiencies both at population and patient level.

Data once aggregated and analyzed at a central level will enable the following:

  • Better understanding of disease patterns and trends at a granular level
  • uating patient outcomes for different treatment options, and outlining the potential side effects of treatments for specific patients
  • Correlating phenotype and genotype information to help precision treatment

The foundation of a distributed health network lies in the common data exchange framework, used at each node such as physician and provider networks, diagnostic facilities, bio banks, etc. allowing for data profiling, sharing and related governance through appropriate frameworks (e.g., SHRINE and PopMedNet). The right data exchange framework is an essential foundational step for various source systems to interact without the need to pool in all the information at a single source. The framework ensures the core data at each site remains undisturbed and its integrity not being compromised. Only the relevant data elements will be accessed over a secured network for analyzing patient information and deriving clinical insights.

The second tier which focuses on information dissemination, references all the three components, as stated above, to pull in relevant clinical insights and analysis viz.:

  • System derives relevant information and clinical insights from the entire distributed health network and share that information with the concerned physician
  • System looks into the central repository and share relevant analyses results, such as best treatment options, expected outcomes, biomarkers, side effects, etc., and
  • Develop a summary of most recent and relevant medical literature pertaining to the condition to complement the above two pieces of information.

Sharing information in a secure way across a federated network is already a proven technology with multiple Health Information Exchanges and other similar provider and patient networks. To augment, new exciting technologies as block-chain will in timer evolutionize secure exchange of health information.

It is thes electivity and quality of information shared with providers that will define their ability to care. Physicians are anyways burdened with information overload- and diminishing patient access time. Hence, it is important to select the right information be made available to them in the right quantity, not too much and easy to get hold off. Quality determined by the ability to mine signals and analyze information across various formats such as physician notes, imaging, genomic data, etc. predicting outcomes and best treatment options for specific patient phenotypes and genotypes.

Given the complexity of developing such networks it is important to start with a base lining exercise where we identify availability of key components, and areas where collaboration is required. The advised approach is to start small solving a few high value use cases in a small network and eventually expand across a network of providers from different geographies and disease areas.

We have learned over the years how to measure the incremental improvement and value-creation in such long-term endeavours which are achieved over a 3-5 year horizon. This is not a one-time exercise, but rather an ongoing journey towards developing this entire care delivery and support ecosystem in a step-wise manner.

Health-Score: Building a Case for One

Why are numbers important ? When we have things that can be described qualitatively, why quantify stuff ? However, we do require numbers because numbers make us precise, allow to measure things accurately and be more definitive in conveying information and decisions.

Why do we require indices or scores ? When we can describe things in detail, why narrow down the findings to a single score or an index ? However, whether it is sports or business, we do have scores or indices to summarize the nuances of a team performance into a single objective number, and based on that decide a winner.

At the end of a cricket game, one might argue the score line doesn’t reflect the true nature of performance or competition in the game, but, at the end of the day despite all criticism a game will be meaningless if it were not for scores determining a winner.

Health is arguably as nuanced and complex as a game of cricket. It has many aspects to it, multiple nuances, objective and subjective interpretations, and differs from an individual to individual. However, still to make meaning out of it eventually we do need a way to measure and quantify the same. We at Remedy Social have been working for more than past 1.5 years on developing a health-score that reflects an individual’s health status in an accurate manner. While the journey has been very long, interesting and full of learnings, I wanted to share some basic learnings, experiences and practical challenges that I have observed.

First question that one has to ask is what are the characteristics of an ideal health-score or health-index:

  • Measureable: Health-score needs to help measure an individual or a groups state of health, progress or deterioration over time as more information is shared, and should enable measuring health impact of a particular intervention
  • Actionable: Health-score should be actionable in nature, i.e., should be able to capture nuances in an individual’s health and based on that suggest appropriate interventions
  • Comparable: Health-score like any other index has limited meaning on its own. There should be appropriate scale, benchmarks and comparators to make meaning out the scores

Data is the key substrate for developing any health-score or similar indices. In healthcare data is an expensive asset, not always available in a uniform manner. These are the key sources of data that would play a role in determining an individual’s health status:

  • Demographic information (e.g., age, gender)
  • Lifestyle information (e.g., diet, exercise, sleep)
  • Personal information
  • Medical history (current and past medical complains/issues)
  • Family medical history
  • Fitness data (now more easily available and more accurate as compared to survey data)
  • Laboratory test results
  • Clinical / hospital data
  • Medication / treatment data
  • Genomic data, etc.

As you see the list of data elements mentioned above, like any other healthcare geek now you would start imagining the degree of complexity associated with calculating a health-score. Based on experience so far, I have listed a few key challenges that we have observed so far:

  • Data availability: Data is not always available, or typically in healthcare all data is not always available. There is limited availability of data and based on those data-points we have to make sense around an individual or a groups health status
  • Data standards: Data is not always available in the same format. As they say, the challenge with healthcare data standards is that there are too many of them
  • Data consistency: Data is not always available in a consistent manner i.e., for same patients we may get clinical data, for others lab data and for the rest of them we might lifestyle and fitness information
  • Data interpretation: Data is sometimes conflicting, as in multiple data sources are available indicating the same thing. E.g., there are factors indicating risk of diabetes, blood sugar readings, and symptoms reflective of diabetes status and all of them might have conflicting results, creating challenges in which reading to take when and how much weightage to allocate to each source of data
  • Inter-play of various factors: Data is not always about individual elements, but sometimes an inter-play of various readings and sources that come together and create meaningful insights
  • Population bias: Data does not always mean the same thing for different people; normal ranges, cut-off and readings vary based on different demographic factors for a population and hence again create lack of uniformity in the system
  • Need to capture nuances: Just one unique health-score does not always reflect all the nuances of an individual’s health e.g., two people might have same health-score but one of them might have more current health problems, while the other one might seem perfectly healthy but having more long-term risks.

With challenges come opportunities, and here also we see a definitive way forward in terms of solving the health-score mystery:

  • Start somewhere: Golden rule and conventional wisdom to solving any challenge is that one has to start somewhere … at least develop a basic health-scoring engine, which can be improved over a period of time
  • Low entry barrier: Data is scare and people don’t usually have time to share more information, so keep a low entry barrier where you can start an assessment with very limited information
  • Progressive nature: However, we need to have a progressive framework which can keep ingesting more data from multiple sources and refine health-scores as more information is available
  • Adaptable: Develop a scoring framework that can adapt itself to various geographies, industries or any such factors that can impact health in a significant manner
  • Multiple sub-indices: In an ideal state, develop sub-indices that can tease out nuances of the health-score e.g., at Remedy Social we created a ‘Current Health-Score’ & ‘Long-term Wellness Score’ in addition to an ‘Overall Health Score’
  • Disease specific components: Develop sub-indices or risk-models that are able to generate insights and intervention suggestions for specific diseases, in order to make the scoring really actionable
  • Link with actions/interventions: Use data and benchmarks to be able to understand specific cut-off points and link them to specific actions or interventions, to ensure that the health-score has a high utility

Opportunities & Challenges in Healthcare in India

Very recently I had this great opportunity to give a talk regarding “Opportunities & Challenges in Healthcare Sector in India” during one of the Start-up Saturday sessions organized by Headstart Network, at Ahmedabad Management Association. Let me say this upfront that I am not expert on the healthcare sector in India, still trying to find my feet on the ground in past 15 months working on my own preventive health assessment start-up Remedy Social. However, here are a few experiences and observations based on my efforts in the past few months that I had shared during the presentation & wanted to share with a broader audience so that more people can benefit from the same.

t is not secret that healthcare is one of the largest spend drivers in developed countries, responsible for anywhere between 12% to 18% of GDP for various Western countries. However, despite all the major developments and economic progress, India still remains one of the countries with a lower spend on healthcare with the number being somewhere around 5-6% of the overall GDP being spent on healthcare. Pure macro-economic interpretation of these numbers suggest that Indian economy will be growing at 6-10% per annum and on top of it our healthcare budgets will catch-up with Western nations taking the industry CAGR to somewhere around 18-20%, which is highly impressive.

Also, there are a plethora of opportunities in this field as one has an opportunity to play across multiple sub-sectors as covered in various verticals in the below diagram, and an opportunity to develop a niche across various horizontals based on expertise in specific skill-sets that you bring to the table. While I show this framework, I am of course cognizant of the fact that describing the entire sector is less of an article and more of a book writing exercise, and also acknowledge the fact that one can never be 100% comprehensive in covering the breadth and depth of the sector.

Not going through the pain-staking task of describing all the boxes above, I would like to mention a few that excite me the most as we look forward to the progress of this sector:

  1. Marketplaces: One of the key challenges in healthcare has been access to right information. More than anything else, marketplaces start addressing information asymmetry allowing people to access the best information, products and services without having to pay an additional premium for the same
  2. Digitization: We have been a few years behind the other sectors when it comes to IT sophistication, but digitization creates avenues for a lot of user-friendliness, data creation and analytics, improved efficiency, service quality, etc.
  3. Home Care: Most importantly, home care brings healthcare to the patients home, providing care within an environment which is more preferable for the patient and less expensive as well. It generates convenience, improve care, reduced cost and higher satisfaction. This sector had always existed but in a fragmented and unorganized manner. Now it is being organized and structured, creating new avenues in improving care and patient experience.

Moreover, there is a high level of perceived or actual unmet need amongst both consumers and the care providers that I have experienced. Consumers or patients are looking for more: (a) awareness & transparency in the system, (b) improved accessibility to services, (c) cheaper solutions that make care more affordable, (d) improvement in quality of service, and (e) above all an improve experience while getting care.

At the same time, healthcare providers are struggling with: (a) people issues as workforce availability, recruitment and retention continues to be one of the biggest challenges, (b) process issues in terms of ensuring operational efficiency and managing EBITDA’s, (c) performance pressure for ensuring quality and consistency, both in terms of clinical quality and customer service, and (d) publicity as they need to constantly identify appropriate avenues to improve awareness and attract more patients

Despite of all these gaps and growth opportunities in the industry, if only it were that easy to establish and grow a healthcare enterprise … what more could one wish for. This a very nuanced industry, requires a lot of context around the science, the process and the inherent age-old culture that drives this industry. Here are the top six challenges that one should be aware of and build a mitigation strategy around as you venture into this sector:

  1. Business of Trust: Health is always a sensitive area and people don’t trust you very easily with serving them, it takes time to gain trust of doctors & patients in this industry
  2. Set Stakeholder Interactions: Healthcare ecosystem stakeholders have strong connections, set incentive and revenue sharing models, which you need to understand and carefully position your service within that construct
  3. Very Nuanced: Healthcare is not straight-forward like any other industry where one can go ahead and build aggregators, marketplaces, etc. and leave it open to vendors for listing and servicing individuals. Regulations, workflows, service quality levels, etc. are more complex and nuanced.
  4. Talent is Expensive: As a result of the nuanced nature of industry, talent is expensive in this field. It ain’t easy to get people who are knowledgeable, talented and experienced in this industry
  5. People Don’t Spend: Despite of high cost involved in developing capabilities and servicing individuals, people still don’t spend that easily on healthcare. Health is not always a top priority for many individuals unless it becomes an emergency
  6. Competition from Large Incumbents: Above all these is aggressive competition from large incumbents with deep pockets, that are heavily expanding their service portfolio to provide a 360 degree coverage. Whatever service or product innovation you might develop, usually it is very easy for these large players to emulate and provide it across a wide geography

Now all this being said, this list wasn’t meant to scare anyone or discourage from entering this market. However, the idea is to help others like myself be better prepared as you venture into this promising space. It always been my core philosophy that there is no point pondering … the only way to do a start-up is to “get started” … & find a way to just survive long enough, till you succeed …