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Prescription Digital Therapy Now A Reality

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The pursuit of offering ‘prescription digital therapeutics’ or ‘digiceuticals’ by Big Pharma, to ensure better clinical outcomes for patients, has apparently come to fruition now.

On April 18, 2018, by a media release, Novartis announced that the Sandoz Division of the Company has entered into collaboration with Pear Therapeutics to commercialize and continued development of digital therapeutics, designed to effectively treat disease and improve clinical outcomes for patients.

The collaboration brings on to the table, a synergy between Sandoz expertise in launching and commercializing various disease treatments, with Pear’s leading experience in digital therapeutics design and implementation. This deal has attracted attention of many. Mainly because, any pharma player will, for the first-time, detail a digital therapy treatment directly to the medical profession, and seek their prescription support.

It is worth noting that Pear’s flagship digital therapeutic – reSET is the first USFDA-cleared mobile medical application with both a safety and efficacy label to help treat patients with Substance Use Disorder, in September 2017. According to published reports, several studies have established that it is two-times more effective than conventional in person therapy sessions. Interestingly, the rate of treatment efficacy increases even up to tenfold, in refractory patients.

Just the beginning of a long run: 

The above market launch of a digital therapy by Novartis signals just the beginning of a long run in changing in the disease treatment archetype for better outcomes. Incidentally, prior to this announcement, on March 1, 2018, the same Company had announced, “Novartis and Pear Therapeutics to collaborate on prescription software applications aimed to treat patients with schizophrenia and multiple sclerosis.”

The media release underscored:“Psychiatric and neurodegenerative diseases place a heavy physical, mental and economic burden on patients and their families. With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need”.

The scope and potential:

An article titled – ‘Digital therapeutics: Preparing for takeoff’,published by McKinsey & Company in February 2018, captures its scope succinctly. It says, “digital therapeutics tend to target conditions that are poorly addressed by the healthcare system today, such as chronic diseases or neurological disorders. In addition, they can often deliver treatment more cheaply than traditional therapy by reducing demands on clinicians’ time.”

A separate McKinsey interview article, titled ‘Exploring the potential of digital therapeutics’, published in the same month, elucidated the potential of digital therapy equally well.  It highlighted:“A digital therapeutic is an intervention based on software as the key ingredient, which has a direct impact on a disease. This is what distinguishes this category from the broader term digital health. We will see digital therapeutics and digital diagnostics integrate into the health system…”

‘Prescription digital therapy’ are not just ‘Fitness and Well-being’ Apps:

Prescription digital therapy are not just to monitor a person’s general fitness level against pre-identified parameters, and overall well-being. Whereas, digital therapeutics help patients to regularly and consistently monitor relevant and tailor-made disease related data - in real-time to detect behavioral, lifestyle and requisite biological changes on a daily basis. However, this is not ‘a so well-realized necessity’ today, especially, in the treatment of certain serious disease conditions, to ensure significantly better clinical outcomes for patients.

Digital therapeutics can ensure making a favorable change in patient behavior, which is not merely as efficient as administering medicines, but could also ensure greater effectiveness than conventional medications. Further, it assists patients to better understand, manage and control several disease conditions, and more importantly, sans any untoward side-effects.

Besides, with digital therapy, the required treatment interventions will reach patients faster than traditional treatment processes. Both the patient request and the medical response for the same can be quickly exchanged, together with relevant data support, through smartphones or other wearable digital interfaces – either in the form of voice or text or both. I shall dwell on this later in the article. Thus, digital therapy may not require patients to meet the doctor every time a need arises.

Moreover, fitness and wellbeing Apps do not require marketing approval from a country’s drug regulator. Mostly because, they help monitoring general and generic fitness parameters, capturing some low-risk changes. Whereas, a custom-made prescription digital therapy would necessarily require such regulatory nod.

In tandem, various studies are also being conducted on wearables, such as an Apple Watch, as an interface. The following are examples of some of these studies:

Digital therapy study with Apple Watch as an interface:

In February 2017, Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited, announced a collaboration to pilot the use of a specially designed app on an Apple Watch wearable to monitor and assess cognitive function in patients with Major Depressive Disorder (MDD).

In November 2017, they presented results from ‘Digital Wearable Technology Study’ in patients with MDD. The observational study involved 30 participants, aged 18-65, with a clinical diagnosis of mild to moderate depression who have been prescribed antidepressant monotherapy for MDD.

The study also evaluated feasibility and participant compliance with measures of mood and cognition on wearable technology; and compared measures of mood and cognition on wearable technology using traditional neuropsychological testing and patient reported outcomes on depression symptoms at 6 weeks. Participants were provided with an Apple Watch on which brief cognitive and mood tests were administered daily.

The researchers observed that patients were compliant with the wearable Apple Watch device on a daily basis to evaluate mood (95 percent) and cognition (96 percent). The study also demonstrated that abbreviated daily assessments delivered through the wearable Apple Watch device corresponded with objective Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests and full-length patient reported outcomes, PHQ-9 and PDQ-D, assessed during weeks 1, 3 and 6. No adverse events were reported in the study.

According to another report, this user interface with Apple’s smart-watch versions 2 and 3 is now being used in a number of studies for chronic conditions, such as Parkinson’s disease – combining biometric data with user input. Again, in February 2017, Johns Hopkins University announced a project to use the smart-watch for research on possible triggers of epileptic seizures.

When used as an interface with prescription digital therapy, the provision of e-SIM and GPS in Apple Watch Series 3, I reckon, would also help patients to immediately communicate with the remote therapy centers using the same device, anytime – as and when the patients want.

Digital therapy initiatives in India:

Initiative on digital therapy has already started rolling in India, as well. Its pace is also quite encouraging. For example, Wellthy Therapeutics is building a patient centric solution for diabetes through digital intervention and management. On February 20, 2018, the Company, reportedly, shared the interim results of an ongoing real-world pilot to evaluate the effectiveness of the Wellthy Diabetes Smartphone App (WD). The results were shared at the 11th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2018) in Vienna, Austria.

The data demonstrated how the use of WD improved glycemic control. On completion of 16 weeks, participants showed a reduction in their HbA1c by (-0.61%) on average, with 61.5% of participants having showed significant reduction in their HbA1c with an average of (-1.17%) reduction.

Conclusion:

As indicated in my article titled, ‘Digiceuticals: A Force Multiplier to Contain Chronic Diseases’, published in this blog on October 23, 2017,prescription digital therapies are primarily of two types – one for “medication augmentation” and the other for “medication replacement.”

Be that as it may, prescription digital therapyimproves clinical outcomes for patients by manifold. It also shows potential to take over from traditional treatment with medicines in several serious and virtually crippling ailments, mostly related to human behavior and lifestyle, such as a host of chronic diseases, and without causing any side-effects.

Thus, prescription digital therapy is now a reality. It has come to stay for long – can’t be wished away, any longer.

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.

Dawns A New Era: Regenerative Medicine For Degenerative Disease

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Could breakthrough innovation in ‘Regenerative Medicine’ significantly reduce the need of expensive lifelong medications, or even make the use of some important medical devices less relevant, or even help avoiding expensive and risky surgical interventions? The common answer to these critical questions is now getting clearer, in tandem with the rapid progress of the science of ‘Regenerative Medicine.’

On June 13, 2017, Nature Biomedical Engineering published an interesting an article titled, “3D-printed vascular networks direct therapeutic angiogenesis in ischemia.” In simple words, these 3D-Printed patches are going to usher in a highly innovative way to treat ischemic diseases, in the future. As the researchers highlighted, arterial bypass grafts are currently considered as the gold standard for the treatment of end-stage ischemic disease, though many patients are unable to tolerate the cardiovascular stress of arterial surgery. The researchers found that implantation of 3D-printed grafts containing endothelial-cell-lined lumens, induces spontaneous and geometrically guided generation of collateral circulation in ischemic settings.

In rodent models of hind limb ischemia and myocardial infarction, these scientists successfully demonstrated that the vascular patches rescue perfusion of distal tissues, preventing capillary loss, muscle atrophy and loss of function.

In this article, I shall deliberate on the importance of this discovery, and its overall future implications on a broader perspective.

Regenerative medicine:

Here comes the basic question – What is ‘Regenerative Medicine’?

It is defined as a highly innovative branch of medicine that develops implementable methods to regrow, repair or replace damaged or diseased cells, organs or tissues. According to RegerativeMedicine.net following are illustrations of some conditions or diseases that regenerative medicine has the potential to cure, and what their current state of treatment looks like in in the American perspective:

  • Heart valves- 250,000 patients receive heart valves, at a cost of US$27 billion annually
  • Heart disease and Stroke- 950,00 people die of heart disease or stroke, at a cost of US$ 351 billion annually
  • Diabetes- 17 million patients have diabetes, at a cost of US$ 132 billion annually

I discussed in this blog, the subject of ‘3D Printing in health care’ on January 11, 2016. Hence, won’t dwell on that subject here

Ischemia, and the relevance of the above discovery:

Ischemia, as many would know, is a condition that restricts adequate flow of blood in some parts of our body, which over a period, may narrow, harden or even block the important blood vessels, much often resulting in stroke, heart attack or other related life-threatening vascular disorders.

Currently, ischemic heart conditions are usually treated either with blood thinning drugs, or blood vessel relaxants. In more serious stages of this condition, doctors prefer angioplasty or other surgical interventions, such as coronary artery bypass.

In this broad perspective, the relevance of the above discovery in addressing various debilitating or life- threatening ischemic conditions, is profound. Its novelty lies in the ability of the scientists making a 3D-printed patch that can be infused with cells to help grow healthy new blood vessels.

An emerging medical space:

The science of ‘Regenerative Medicine’ is increasingly being considered as an emerging medical space aimed at the treatment of those diseases that are usually classified as degenerative, incurable and irreversible. As it appears today, this science has the potential to unfold a new paradigm in this space, where patients can expect cure for many serious ailments, such as, spinal injuries, heart disease, Parkinson’s, Alzheimer’s disease and even diabetes, besides many others.

One more recent pursuit in this much uncharted frontier was reported in the British news daily – ‘The Telegraph’ on February 21, 2017, revealing the outcome of a path-breaking medical study for freezing the progression of a crippling ailment called Multiple Sclerosis (MS). This research followed a unique Stem Cell (SC) transplantation process, and is regarded as the largest long-term follow-up of SC transplantation treatment study of MS in regenerative medicine.

This study, spearheaded by Imperial College London, established that 46 per cent of patients who underwent the treatment did not suffer a worsening of their condition for five years. The process works by destroying the immune cells responsible for attacking the nervous system. This is indeed a very significant development in the space of medical research.

The treatment, called autologous hematopoietic stem cell transplantation (AHSCT), was given to patients with advanced forms of MS who had failed to respond to other medications. However, the researchers noted that the nature of the treatment, which involves aggressive chemotherapy, carried “significant risks”.

As many would know, MS is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord, leading to problems with movement, vision, balance and speech. It’s a lifelong condition and often causes serious disability, with no cure still in sight. The disease is most commonly diagnosed in people in their 20s and 30s, although it can develop at any age.

A potential game changer:

According to California Institute for Regenerative Medicine (CIRM), this procedure has a game changing potential for successful use:

  • To replace neurons damaged by spinal cord injury, stroke, Alzheimer’s disease, Parkinson’s disease or other neurological problems
  • To produce insulin that could treat people with diabetes, and heart muscle cells that could repair damage after a heart attack, or
  • To replace virtually any tissue or organ that is injured or diseased

Research on “Regenerative Medicine’ signals a new hope:

Following are examples of just a few more promising developments, indicating that research in ‘Regenerative Medicine’ is taking rapid strides, signaling a new hope:

- A cure for Type 1 diabetes:

According to an international report on October 9, 2014, for the first time after 23 years of research, Harvard University has been able to manufacture millions of beta cells required for transplantation. It could mean a cure for diabetes, and the end of daily insulin injections for patients living with Type 1 diabetes. Although, just around 10 per cent of all diabetes is Type 1, it is the most common type of childhood diabetes.

The report indicated, the stem cell-derived beta cells are presently undergoing trials in animal models, including non-human primates, where they are still producing insulin after several months.

Another report of April 2014 indicates that for the first time, scientists have successfully replaced the damaged DNA of a type 1 diabetes sufferer with the healthy genetic material of an infant donor. When these cells are injected back into the diabetic patient, it is expected that they will begin to produce insulin on their own.

- Restoring vision in macular degeneration:

Yet another study published in ‘The Lancet’ in October 2014 stated that scientists in the United States have announced that single transplant of stem cells has helped restore the sight of patients suffering from incurable forms of blindness due to Age-related Macular Degeneration (AMD). Currently no effective treatments exist for this eye disorder, which can cause complete blindness due to the loss of light-receiving photoreceptor cells in the retina.

To recreate a type of cell in the retina that supports those photoreceptors, the new treatment uses stem cells derived from embryos that are only a few days old and have the ability to develop into any kind of tissue in the body. However, the transplants have proved controversial because they use stem cells derived from spare human embryos left over from IVF treatment.

- A cure for heart failure:

One more international report of May 01, 2014 states, by injecting human stem cells into the organs of macaque monkeys, scientists have been able to regenerate their damaged hearts by up to 40 per cent in just a few weeks. Thus, it appears now that a cure for heart failure could be just a few years away and would mean that even people who are “bed-bound” with heart failure could be “up and about” again within a few weeks.

As on date, the heart muscle cannot be repaired, making people with severe heart failure necessarily wait for a heart transplant, provided the patients are willing, and can afford so.

Conclusion:

There is a host of diseases, including several chronic ailments, such as diabetes, heart conditions, rheumatoid arthritis, or some types of cancer, which can’t be reversed, however, could be managed with a lifelong treatment. For most of these diseases, ‘Regenerative Medicine’ has the potential to be a game changer by transforming many lives.

Moreover, ‘Regenerative Medicine’ is expected not just to bring down the cost of health care and the disease burden significantly, but would also help increasing the economic productivity of a nation considerably.

Currently, medical research of the highest order in this area, has mostly been conducted by various academia of global repute, along with a few in the industry. It should soon involve, besides patients, several industries, including pharmaceuticals and biotech sectors, in a big way.

Nevertheless, this emerging trend sends a clear signal that to treat various chronic, incurable, irreversible and seriously debilitating degenerative diseases ‘Regenerative Medicine’ is now poised to take a giant leap in the health care space.  In that process, it would possibly help healing various ailments in a more meaningful, providing a cure for many chronic diseases that was a badly missing piece in the medical science, so far.

Thus, ‘Regenerative Medicines’ to treat many ‘Degenerative Diseases’ signal a great potential to give an altogether new shape and dimension to the future of global health care. It is also expected to ensure lesser lifelong usage of expensive drugs, setting a new normal to bring back the patients’ lives back to the pre-disease state.

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.