On November 9, 2015, ‘The Wall Street Journal (WSJ)’ in an interesting article reported, “Your doctor may soon prescribe you a smartphone app in addition to drugs and physical therapy.”

The hospitals in the United States (US) are developing new mobile apps to help patients manage serious medical conditions, record symptoms and communicate back to their doctors between visits, often in real time, besides helping patients adhere to their therapy, WSJ highlighted. The real beauty in these apps is, in addition to sending messages, reminders and instructions, the apps can alert providers to developing clinical problems before they become a crisis.

For example, “a new app from the University of Michigan called ‘Breast Cancer Ally’ is offered to patients to help them manage the onslaught of information and instructions they get throughout their diagnosis and treatment. It allows patients to look up and record their symptoms and provides guidance on when to consult the doctor about complications or concerns.”

Quoting experts, the article states, “this is a technology that is in everyone’s pocket and makes patients feel engaged in their own care.”

The implication of this development is profound. It appears, there could be a near term possibility of the same, for better, comprehensive health monitoring, leading to better quality of life and undergoing lesser hassles, if not hassle-free, as compared to what it is today in doing so.

Immense value in management of chronic diseases:

Besides serious ailments, these customized digital apps for smartphone, could be used to derive therapeutic impact in the early stages of chronic diseases, such as diabetes and hypertension.

As is well-known, in the early onset of most of the non-infectious chronic diseases, self-management plays a critical role to prevent the progression of the disease, saving significant treatment costs, besides other serious and expensive physiological complications in the future.

To achieve this goal, there is a critical need to appropriately educate the patients through doctors, along with the active role of pharmaceutical players. This could well be a win-win situation for the manufacturers of these products to productively engage the patients, not just for disease management, but for the commercial success of their respective brands too, with a well crafted integrated business strategy.

Digital Therapeutics:

Thus, these health apps serve the role of ‘Digital Therapies (DT)’, as well, for patients, especially at the onset of chronic ailments and to prevent any sudden crisis in serious disease conditions.

DT has, therefore, been defined as web, mobile, wearable and other digital technologies combined into an intervention to support healthy behaviors and provide therapeutic impact.

As stated earlier, DT has the potential to offer immense opportunity for patient engagement and to bring in substantial change in their health behavior with remarkable both short and long term cost-effectiveness.

The opportunities:

Offering DT to patients in India may not be very challenging either, on the contrary, it is an area of opportunity for all the interested players, especially when we go by the following facts: 

• According to the latest report from the Telecom Regulatory Authority of India (TRAI) mobile phone subscriber base in India recorded 6.71 percent YoY growth to 980.81 million users in Q2 2015.

• There were approximately 82 million 3G subscribers in India by the end of 2014 and the number is projected to reach 284 million by end of year 2017.

• SMS, email, messaging and social networking apps are the most popular ones.

• The Indian Government has expressed its commitment to setting up a robust digital infrastructure and to promote adoption of mobile Internet and related products and services.

• In 2014-15, the Government budgeted INR 500 crore for building infrastructure as per the National Rural Internet and Technology Mission.

Currently, as the smartphones enable individuals to access various types of information, suggestions and advice from anywhere 24×7, in the above emerging scenario, an increasing number of patients are likely to opt for digital therapeutic tools for self-management of health more effectively. 

This is a win-win situation for all, including the pharma companies, though with a contemporary and honed strategic business model.

In the foreseeable future:

An October 2013 paper of IMS Institute, titled “Patient Apps for Improved Healthcare” expects that over a period of time, the health app maturity model will see apps’ progress from being recommended on an ad hoc basis by individual physicians, to systematic use in healthcare, and ultimately to an end goal of being a fully integrated component of healthcare management.

The study makes the following important observations:

• The patients are unlike to ever have the tools to replace the roles of the physician

• Health apps may encourage patients to take a more active interest in their overall well being and understand the consequences of poor health in later life.

• By having the patients aligned with the importance of wellness programs and sickness prevention, health systems can hope to realize savings, especially from a lower burden of multiple chronic conditions. 

• The Governments may consider making patients aware of the need to take increasing responsibility for their own healthcare, by providing incentives to stay healthy, where health apps could play a major role.

The paper also underscores the following four key steps to move through on this process:

• Recognition by payers and providers of the important role that apps can play in healthcare 

• Security and privacy guidelines and assurances must be in place between providers, patients and app developers

• Systematic curation and evaluation of apps that can provide both physicians and patients with useful summarized content about apps that can aid decision-making regarding their appropriate use 

• Integration of apps with other aspects of patient care

“Underpinning all of this will be the generation of credible evidence of value derived from the use of apps that will demonstrate the nature and magnitude of behavioral changes or improved health outcomes,” the paper comments.

According to available information, currently in the United States, around 100 advanced health apps have been approved by the FDA. However, all these are not for the use of patients. Some of these are for the use of doctors. Other sets of apps are available to patients only against doctors’ prescriptions. The rest is mainly for fitness and general life style related, and are affordable only to a limited number of people.

Key benefits of ‘Digital Therapeutics’:

To summarize, the key benefits of digital therapeutics are as follows:

• More cost-efficient, as compared to conventional alternatives.

• Help doctors managing disease conditions through constant monitoring with digital technology 

• Make patients more aware and even proactive with real time information in preventing many diseases, avoiding disease aggravation and improving quality of life.

• Make sharing of information between doctors and patients easier and effective.

Some concerns:

In many countries, including India, many health apps do not have appropriate health regulatory approval. Hence, a number of key concerns, in general, have been raised in this area for speedy resolution, some of which are as follows:

• Product and data quality
• Reliability in treatment decisions
• Privacy and security for patients

Not many pharma companies are engaged in ‘Digital Therapeutics’:

In my view, there is a solid reason why many global pharma companies are still not adequately engaged with digital therapeutics.

They are generally actively involved in the high voltage advocacy by encouraging innovation, which usually does not go beyond drug discovery. This championing does not talk much either, about charting the broader area of comprehensive disease prevention, treatment and management with the application of disruptive innovation, involving other non drug related digital technologies, which are cost effective to patients.

With the low hanging fruits of drug innovation, resulting into money-churning blockbuster drugs with huge margin and almost in no time, made most of these innovator drug companies comfortable with their current business model of only drug discovery.

This business model is now exhibiting enough signs of fatigue with research pipelines gradually drying out.

Nonetheless, there are some indications now of a few pharma players’ exploring this new area of digital therapeutics, but as an extension of the current business models. It still remains a challenging decision for most of them to shift the gear, moving towards a new horizon of a winning mix of new drugs and path breaking digital therapeutics. 

Conclusion:

These are still early days for the majority of the pharma players looking at commercially leveraging the potential of possible customized offerings of digital health apps as integrated digital therapeutics for patients’ self-care health benefits. What we have seen so far is the drug companies using health apps as a tool to market a drug and not much beyond that.

I discussed this issue in my article in this blog on March 30, 2015, titled, “Quantum Value Addition With Health Apps, Going Beyond Drugs”.

An April 17, 2014 article published in the ‘Forbes/Business’ epitomizes the relevance of digital therapeutics in the modern day healthcare, even in the countries like India, as follows:

“Three out of four Americans will die of a disease that could be avoided—if only they could re-route their unhealthy habits. A new category of medicine, digital therapeutics, wants to change the course of these conditions – and of history.”

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.