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With More Patients Preferring Telehealth Pharma Marketing Needs Retooling

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Even after six months of COVID-19 pandemic, the omnipresent chaos, general unease and apprehensions about a yet unpredictable future continues in all countries, including India. In absence of vaccines and proven medicines to address the disease, wearing face mask, maintaining social distancing and frequent hand sanitizing, remain the primary measures for all to combat this unprecedented health crisis.

The rapid spread of the lethal Coronavirus has not only impacted lives and livelihoods, besides changing the health care ecosystem – with a silver lining, though. The pandemic has instilled a sense of urgency – an accelerated speed – in the entire value chain of the health care systems, including the pharma industry.

To contain the rapid spread of the disease – many physicians, Governments and even patients themselves, are being encouraged to leverage technological platforms, for various non-Covid related medical needs. Realizing that there no other working alternatives in this situation, even most skeptical doctors and patients are now resorting to video consultations.

Consequently, ‘Telemedicine’, in different forms, has started growing in leaps and bounce. Its spin-off benefits favor the patients – better care at lower costs, sans any further strain on the existing health care systems. Along with many others, the Bloomberg article of April 10, 2020 – ‘Coronavirus Should Finally Smash the Barriers to Telemedicine,’ also expects it to grow, not just during the pandemic, but much beyond.

Echoing the World Health Organization (W.H.O) on the need to promote telemedicine in this health crisis, Niti Aayog of India also acknowledged, ‘‘Telemedicine: A Blessing In Disguise In Time Of COVID-19.’ It further added, ‘With the arrival of the COVID-19 pandemic, telemedicine has finally gained momentum. Telemedicine providers reported an overnight increase in demand, acceptance among doctors, paramedics, and consumers.’

As patient-doctor interactions are now expanding – from personal visits to physicians to remote telehealth, is there a need for recomposing notes of the pharma marketing playbook - to excel in the new world order?  This article would focus on this specific area of leveraging ‘The Break in The Clouds’.

Telemedicine and its key primary driver: 

‘Telemedicine’– often called telehealth or e-medicine, in simple term, involves the remote delivery of health care services, when both doctors and patients are not physically present at the same place. It includes, patient examination, doctor consultations, diagnosis, treatment and remote monitoring, over the technology enabled modern communication infrastructure.

Although, telemedicine is not a new concept, it was not very popular for various reasons, till Covid pandemic offered no other viable alternatives to non-Covid patients. The article – ‘COVID-19: The rise and rise of telemedicine,’ published in the MobileHealthNews on May 27, 2020, also vindicates this point. It reconfirmed: ‘Telemedicine has experienced a huge surge in adoption over the past few months, during the coronavirus pandemic.’

Even Frost & Sullivan’s recent analysis, ‘Telehealth – A Technology-Based Weapon in the War Against the Coronavirus’ of May 13, 2020, found the demand for telehealth technology rising dramatically, as the COVID-19 pandemic continues to disrupt the delivery of healthcare worldwide. Thus, ongoing stringent requirements of wearing face masks and maintaining social distancing to contain the virus spread, will continue to drive the growth telemedicine as the preferred way of accessing healthcare.

Indian perspective of increased online access to health care:

Practo’s Insight Report of June 20, 2020, titled, ‘How India accessed health care in the last three months,’ has revealed some interesting India-specific data in this area. This study was based on transactions of 500 million Indians accessing health care online, during March 1, 2020 to May 31, 2020 period. It found, while COVID-19 continued to remain India’s topmost concern, ‘telemedicine has helped doctors – patients stay connected, as people practiced physical/social distancing.’ This resulted into a ‘500 percent increase in online doctor consultations,’ in that time frame. Other important findings of this report include:

  • 80 percent of all telemedicine users experienced it for the first time.
  • 44 percent of the teleconsultations were from non-metro cities.
  • In-person doctor visits dropped by 67 percent.
  • Indians consulted their doctors 2 times per month, using telemedicine.

The surge in teleconsultations in India, reportedly, follows the long-pending telemedicine guidelines which were finally issued by the Ministry of Health and Family Welfare, in collaboration with NITI Aayog and Board of Governors, Medical Council of India (MCI).

Could ‘Telehealth’ be a game changer even beyond Covid time?

Many experts in this area believe so. For example, the article – ‘Telehealth could be a game-changer in the fight against COVID-19. Here’s why,’ published the World Economic Forum on May 01, 2020, makes some important observations. It suggests: ‘Beyond the pandemic, governments, insurers and healthcare providers need to work together to ensure that the innovation sparked by this crisis endures and accelerates. Post-crisis, telehealth can still help alleviate the pressures posed by healthcare resource shortages, the growing elderly population and issues with healthcare accessibility.’

The article, published in the Invest in India website of the Government of India, on April 10, 2020, emphasized the relevance and benefits of ‘Telemedicine’ in India – even after Covid Time. Conceding, in-person health care delivery in the country is challenging, given the large geographical distances and limited resources, it enumerated all-time relevance and the key advantages of ‘Telemedicine,’ as hereunder:

  • Saves cost, effort and other related inconveniences, especially of rural patients, as they need not travel long distances for obtaining consultation and treatment, also limiting burden on the secondary hospitals.
  • Ensures higher likelihood of maintenance of records and documentation, minimizing the possibility of missing out advice from the doctor and other health care staff.
  • Provides safety to patients and health workers’, especially where there is a risk of contagious infections.
  • The doctor has an exact document of the advice provided via tele-consultation. Written documentation increases the legal protection of both the parties.
  • Enables the availability of vital parameters of the patient available to the physician with the help of medical devices such as blood pressure, blood glucose, managing.
  • Provides equal access to quality care to all, minimizing inequity and barriers to access.

The official guidelines for telemedicine practices in the country are aimed at allowing registered medical practitioners to providing remote consultation. Under this backdrop, Telemedicine is expected to remain in a growth trajectory, even in India. Accordingly, there arises a need for recomposing notes of the pharma marketing playbook - to excel in the new world order. 

Increasing telehealth preference prompts marketing strategy retooling:

As I wrote on July 10, 2020, pharma leaders need to leverage the art of turning challenges into opportunities, now – especially when telehealth is at the threshold of playing a pivotal role in the health care delivery systems. In this scenario, traditional pharma brand-demand generation strategies are unlikely to deliver expected business results, anymore. Pharma players would need to work out fresh and effective marketing models, in-sync with patients changing health care related needs. Conceiving, strategizing, and delivering changing patient-value based content, effectively, using modern omnichannel platforms, would be the new ballgame.

‘Telehealth is more than a channel for delivering care’:

As the ZS Insights article – ‘While telehealth continues to evolve, pharma needs to keep an eye on the future,’ published on August 03, 2020 reiterated: ‘Telehealth is more than a channel for delivering care, it reflects a fundamental shift in how brands reach patients and physicians.’ Following are some key points worth noting:

  • Until now, in-person delivery of care has anchored brand marketing in the sales territory-based geographic perspective. Whereas, telehealth platforms are free of sales territory-based geographic distinction.
  • Physicians now provide telehealth services to patients in two ways, having different implications for pharma players:
  1. Vertically integrated virtual practices, such as, Practo, Lybrate and others in India.
  2. Brick-and-mortar offices, where physicians provide telehealth visits through     FaceTime, WhatsApp, Zoom and other teleconference platforms.

It is envisaged, alongside patients avoiding the risk of contracting Covid, tangible benefits of lower treatment cost and escaping long waiting time to meet the doctors physically, will encourage people switching to Telemedicine, for an indefinite period.

Collaborative, not standalone pharma marketing may not work better:

In the era of telehealth or Telemedicine, the common ground where patients, doctors and drug companies can meet, would be the telemedicine platforms. These may well be some popular telemedicine apps for e-consultation, such as, Meddo, Practo, mFine and others in India. Besides, there lies an opportunity for pharma companies also to develop custom-made ones, for installation by doctors.

These platforms can be effectively leveraged with collaborative approaches – for content delivery to physicians, patients and other stakeholders, at the appropriate time and places. There are various innovative ways to prepare a grand strategy for this purpose – ‘tailor-made’ for each company. And astute pharma marketers should play the role of ‘master tailors.’

Conclusion:

Meanwhile, as on October 11, 2020 morning, India recorded a staggering figure of 7,051,413 of Coronavirus cases with 108,371 deaths. The daily number of new cases appeared to have slowed down during the last week.

Nonetheless, the unprecedented and savage onslaught of the new Coronavirus has unsettled the pharma industry, as it disrupted the old normal of the world. At the same time, many people have also demonstrated high resilience, grit and innovative mind to keep moving, in a relatively orderly manner – amid an omnipresent chaos, as it were. In the health care space, the need for responding to non-Covid related health emergencies, pushed people to experiment with not much used before – telehealth or  Telemedicine.

It worked and continues receiving support from all concerned. Its other major benefits also surfaced – as a breath of fresh air. It’s unlikely that people will let it go, in the foreseeable future, which has a great implication to pharma industry. With more patients and doctors increasingly preferringTelemedicine, in various ways, pharma marketing needs retooling its strategy kit – by expanding into collaborative approaches with Telemedicine providers.

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.

 

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.

‘Digiceuticals’: A Force Multiplier to Contain Chronic Diseases

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There is a growing need for more effective prevention, treatment or management of many serious Noninfectious Chronic Diseases (NCDs), with greater safety and at a lesser cost. As a major step in this direction, ‘digiceuticals’ or ‘digital therapeutics’ are now drawing heightened interest from the medical and scientific communities.

‘Digiceuticals’ are basically custom made digital software working as drugs. These are presented mostly in the form of user-friendly smartphone apps for various disease conditions –  both as stand-alone therapy, or to augment other treatment processes for better outcomes.

Increasing usage of digital technology enabled therapy for a gamut NCDs, prompts me to discuss in this article the relevance, scope, promise, and of course, the rationale behind the same. Its importance swells manifold when the risks of lifelong health hazards that such chronic disorders may pose are factored-in, alongside their overall socioeconomic impact.

Chronic diseases – the invisible global epidemic:

Chronic diseases, such as heart disease, stroke, chronic respiratory disorders and diabetes, including cancer, are by far the leading causes of death and disability worldwide. The World Health Organization (W.H.O) also reiterates that this invisible epidemic is spreading out globally – across every region and pervading all socioeconomic classes.

The mortality, morbidity and disability attributed to chronic diseases, as estimated by the W.H.O, is expected to rise to 73 percent of all deaths and 60 percent of the global burden of disease by 2020. Interestingly, 79 percent of the deaths attributed to chronic disorders occur in the developing countries, such as India.

Can chronic diseases be prevented?

W.H.O also emphasizes that four of the most prominent chronic disorders, namely cardiovascular (CVD), cancer, Chronic Obstructive Pulmonary Diseases (COPD), and Type 2 diabetes – are linked by common and preventable biological risk factors, notably high blood pressure, high blood cholesterol and overweight. Most importantly, these relate to major behavioral risk factors, like unhealthy diet, physical inactivity and tobacco use, among several others.

Awaits a radical change – from “Suppliers Push” to “Consumer Pull”:

In the above perspective, a series of well-integrated action related to several human behavioral factors, could help prevent many NCDs, effectively. A fundamental change in mindset of all concerned is critical to avert the merciless onslaught of this epidemic. This calls for a radical change in the existing process of addressing these disorders – from “Suppliers Push” to “Consumer Pull.”

The January 2017 White Paper titled, “Human-Centric Health: Behavior Change and the Prevention of Non- Communicable Diseases”, published by the World Economic Forum (WEF), drives home this point succinctly, as follows:

“Decreasing the burden of NCDs will require a transformation through which the threat of disease is recognized and addressed. The transformation should move us away from the present state of ‘supplier push’, which emphasizes expensive, capital-intensive, hospital-centric interventions that have so far produced disappointing results, to a system that relies on ‘consumer pull’. A consumer-focused system would recognize the principles of behavioral economics to encourage and enable people to adopt healthier behavior across all aspects of their lives. Individuals would be supported in this effort by a network of critical stakeholders ranging from government to private enterprise, from healthcare providers to payers, from the technology developers to local communities.”

NCDs are triggered by behavioral pattern and lifestyle:

Picking up the thread from here, I shall deliberate now, how the state of the art digital technology-developers are playing a stellar role in this space, with greater precision and more cost-effective way. This is because, many NCDs are triggered by consistent behavioral and lifestyle pattern of an individual. Consequently, continuously monitoring of desired changes in individual behavior, are expected to gradually become the first-line treatment to effectively address these conditions. Several published studies indicate that the process has started rolling, aided by smartphone based sophisticated digital tools – in many cases even without any expensive and lifelong medications.

The May 26, 2016 paper titled, “Clustering of Five Health-Related Behaviors for Chronic Disease Prevention Among Adults, United States, 2013”, captures a cluster of five health-related behaviors for chronic disease prevention as – never smoking, getting regular physical activity, consuming no alcohol or only moderate amounts, maintaining a normal body weight, and obtaining daily sufficient sleep. This article was published by the Centers of disease Control and Prevention of the United States.

Preventing chronic diseases with ‘digiceuticals’:

The April 7, 2017 article captioned, “Can ‘Digital Therapeutics’ Be as Good as Drugs?”, published by the MIT Technology Review, dwells on this area. The paper indicates an emerging belief among technology geeks that ‘digiceuticals’, or digital drugs will become ‘the third phase’ of medicine for many disease conditions, being the successor to the chemical and protein drugs that we have today, but without the billion-dollar cost of bringing one such drug to market. The core idea behind this new concept is to develop software that can improve a person’s health as much as a drug can, but without the same cost and side-effects, the author says.

An innovative new class of medicine:

The term digital therapeutics or ‘digiceuticals’, as many calls these, is considered as an innovative new class of medicine that gives participants access to the world’s most effective behavior therapies, enhanced with smart digital technology, and delivered directly to their front door. These can be used both as a replacing medicine, and also for enhancing efficacy of a medical treatment, as a situation would necessitate.

There doesn’t seem to be any clear-cut difference between these two – digital therapeutics and ‘digiceuticals’. Nonetheless, some do believe that there is a difference – quite akin to prescription medication versus nutritional supplements, with consequential differences in regulatory and other areas. Be that as it may, ‘digiceuticals’ when used for prevention, treatment or effective management of any chronic ailments would require to be scientifically evaluated just as any other drugs, devices and treatment processes.

The future of health care will be App-based:

Another article titled “Digital Therapeutics: The Future of Health Care Will Be App-Based”, published in Forbes on July 24, 2017, highlights how several digital technology companies are now focusing on the development of state of art smartphone app-based digital treatment programs that can be delivered at a massive scale and with a low cost to prevent progression of many debilitating NCDs, for a large population across the world, including India.

‘Digiceuticals’ versus other mobile wellness apps:

Unlike many smartphone based wellness apps to keep a regular tab on daily exercises, heart rates, calorie intakes, breathing, sleep pattern among several others; treatment processes with ‘digiceuticals’ are quite different. These softwares are tailor-made to prevent or treat specific chronic disorders, like diabetes, cardiovascular conditions, COPD, insomnia and chronic depression, to name a few. The trend is fast catching up along with an increasing general realization that the influence of individual behavior and lifestyle pattern is so crucial in the prevention, and also in arresting the progression of many debilitating NCDs.

The current status:

The latest scenario in this area has been well captured in several research studies. One such is the 2017 Report of Grand View Research, Inc., which articulated the following key findings:

  • The global ‘digiceuticals’ or digital therapeutics market size was estimated at USD1.7 Billion in 2016, which is expected to grow at 21.0 percent CAGR from 2017 to 2025.Diabetes is expected to gain the largest market share due to the increasing global prevalence, fueled by the preventive steps taken to reduce them.
  • The adoption of digital therapeutics offers a reduction in healthcare cost associated with many NCDs, and are thus being used on an increasing scale. Digital tracking, continuous monitoring of various health parameters, management of physical activity and controlling eating habits are some of the important factors expected to propel the market growth.
  • Ascending trend of its usage for prevention of a wide range of NCDs would further add to the growth momentum. Patients accounted for the largest market share in the end-user segment owing to user-friendly interface and cost-effective management of many NCDs.
  • The North American region accounted for the highest revenue owing to technological advancement and health care expenditure to curb rise in a number of chronic diseases.
  • The Asia Pacific region is expected to garner considerable growth during the forecast period owing to increasing adoption of advanced healthcare technologies and rise in the number of NCDs.

The latest development in India:

A similar initiative, though, as augmentation of physician intervention in patients with Type 2 diabetes for better treatment outcomes, has recently been reported by the Press Trust of India (PTI) on June 13, 2017.

The abstract of the report, among other points, says that an Indian digital diabetes leader has announced “the results from a pilot designed to evaluate the feasibility and scalability of an artificial intelligence-led lifestyle intervention to improve self-management of people living with type 2 diabetes as a supporting tool to existing care in India…. The pilot results suggest that continuity of care between physician appointments for people with type 2 diabetes can be achieved with positive outcomes in a clinically significant, scalable and affordable way through this program. Participants that completed the pilot on average dropped their average blood sugar levels (HbA1c) by 0.59%. Amongst the participants that completed and dropped their HbA1c, the average observed was even higher at 1.04%. In addition, the participants showed a daily active usage of 78% for the duration of the 16-week program.”

This is indeed a laudable initiative by an Indian digital tech company. More such ventures are expected to be forthcoming, taking rapid strides in India. Keeping pace with these developments, “digiceuticals,” I reckon, will spread its wings faster to play a crucial role in preventing, if not treating and managing several serious NCDs – and in most cases without even swallowing any pill.

Conclusion:

The key concept behind ‘digiceuticals’ or digital therapeutics is to exert a strong influence on individual behavior and lifestyle pattern, which are crucial both in prevention, and in controlling the progression of many NCDs.  The desired level of change in behavior and lifestyle of individuals can be achieved through custom-made digital software. These are expected to deliver the same, or even better results in such disease conditions, at a much lesser cost, sans any serious side effects.

The ball has already started rolling with considerable success and a discernible promise in this direction. However, accelerating its speed further, and ultimately flooring the gas pedal, would depend on how all concerned stakeholders’, especially the technology experts, doctors, pharma industry, and other health care providers work in-sync with each other, leveraging the true potential of ‘digiceuticals’.

The rapid pace of progress in this endeavor will be a force multiplier in arresting the fast spreading ‘invisible epidemic’, as it were, of many serious chronic diseases or disorders, in a much better and cost-effective way than ever before.

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.

On Serious Healthcare, Some Bizarre Decisions

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On August 04, 2016, it was widely reported by the media that the Union Minister of Chemicals and Fertilizers – Mr. Anant Kumar, would launch a new digital initiative of the National Pharmaceutical Pricing Authority (NPPA), named, “Search Medicine Price”, on August 29, 2016.

This is an app developed by the National Informatics Centre, for android smartphones ‘that will enable patients to check the prices of essential medicines on-the-go’. It will be an extension of NPPA’s “Pharma Jan Samadhan” web-portal facility. The Indian price regulator believes that wide use of this app would successfully reduce the instances of overcharging the consumers by the pharma companies and retail chemists, especially for lifesaving, and other expensive medicines. 

India’s drug pricing watchdog is planning to introduce this app to enable the patients check the prices of essential medicines on-the-go, and expects that this measure will hold drug companies and medicine retail outlets more accountable to patients.

In the test version of the app, which has since been released for stakeholder feedback, patients can search for the ceiling price of all medicines under the National List of Essential Medicines (NLEM), on the basis of its generic name and the state they’re buying it from.

The Chairman of NPPA, reportedly, further said, “Consumers can use the app before paying for a medicine to ensure that they get the right price. At present, whatever action we take against the companies, including recoveries, the consumer does not get back the overcharged amount he or she has paid.”

Good intent with a basic flaw:

The intent of the Government in this regard is indeed laudable. However, the initiative seems to underscore the blissful ignorance of the prevailing ground realities in India.

The media report highlights that with this app, the patients can search for the ceiling price of all medicines featuring in the NLEM on the basis of their generic names.

Whereas, the ground reality to make any meaningful use of this app is quite different. This is primarily because, in the Indian Pharmaceutical Market (IPM), over 90 percent of drugs are branded generics. An overwhelming majority of the doctors, as well, follow this trend while writing prescriptions for their patients, in general. For any single ingredients or Fixed Dose Combination (FDC) formulation, there are as many as even 30 to 40 brands, if not more. 

In that case, when the prescriptions given to patients are mostly for branded generic drugs, how would that person possibly get to know their generic names, to be able to check their ceiling prices with the help of the new “Search Medicine Price” app?

Not just a solitary example: 

This is just not a solitary instance of ignorance of the Government decision makers on the realities prevailing in the country.

With an admirable intent of making drugs more affordable for increased access, especially, to all those patients incurring out-of-pocket health expenditure, the Government has been taking several such measures, and is also trying to create a hype around these. Unfortunately, most of these efforts, miss the core objective of increasing access to drugs at the right price, by miles. 

Another recent example: 

This particular example, in my view, is even more bizarre.

It happened on February 29, 2016, the day when the Union Budget proposal for the financial year 2016-17 was presented before the Parliament of India.

In this budget proposal, the Union Finance Minister announced the launch of ‘Pradhan Mantri Jan-Aushadhi Yojana (PMJAY)’. 3,000 Stores under PMJAY will be opened during 2016-17.

Many consider this scheme as a repackaged old health care initiative, only adding the new words ‘Pradhan Mantri’ to it.

Just to recapitulate, Jan-Aushadhi is an ongoing campaign launched by the Department of Pharmaceuticals in 2008, in association with Central Pharma Public Sector Undertakings (PSU), to provide quality medicines at affordable prices to the masses.

Under this scheme, Jan Aushadhi Stores (JAS) are being set up to provide generic drugs, which are available at lesser prices, but are equivalent in quality and efficacy as expensive branded drugs.

The Department of Pharmaceuticals had initially proposed to open at least one JAS in each of the 630 districts of the country, so that the benefit of “quality medicines at affordable prices” is available to at least one place in each district of India.

If the initiative becomes successful, based on its inherent merit and the cooperation of all stakeholders, the scheme was to be extended to sub divisional levels as well as major towns and village centers by 2012. However, after 5 years, i.e. up to February, 2013, only 147 JAS were opened, and out of those only 84 JASs are functional. 

More recently, according to a June 02, 2015 report, “under the new business plan approved in August 2013, a target of opening 3,000 Jan Aushadhi stores during the 12th plan period i.e. from 2013-14 to 2016-17 was fixed. As per the Standing Committee on Chemicals and Fertilizers report in March 2015, till date only 170 JAS have been opened, of which only 99 are functional.”

Tardy progress:

The tardy progress of the scheme was largely attributed to:

  • A lackluster approach of State governments
  • Poor adherence to prescription of generic drugs by doctors,
  • Managerial/ implementation failures of CPSU/ BPPI.
  • Only 85 medicines spread across 11 therapeutic categories were supplied to the stores and the mean availability of these drugs was found to be 33.45 percent, with wide variations across therapeutic categories. 

There is no doubt, however, the intent of ‘Pradhan Mantri Jan-Aushadhi Scheme’ of 2016 is as laudable as the earlier “Jan-Aushadhi Scheme”, launched by the Department of Pharmaceuticals in 2008, was at that time. But, the moot question that comes at the top of mind:  Is it robust enough to work effectively in the present situation? 

Why it may not fetch the desired outcome?

Besides strong support from the State Governments, and other factors as enlisted above, making the doctors prescribe drugs in generic names would be a critical issue to make the “Pradhan Mantri Jan-Aushadhi scheme’ a success, primarily to extend desirable benefits to a sizeable section of both the urban and rural poor. Another relevant question that comes up now, how would the Government ensure that the doctors prescribe drugs in the generic names?

A critical challenge:  

Since, the generic drugs available from ‘Jan Aushadhi’ retail outlets are predominantly prescription medicines, patients would necessarily require a doctor’s physical prescription to buy those products.

Despite some State Government’s circulars to the Government doctors for generic prescription, and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, that states: “Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs”, the doctors, in India, prescribe mostly branded generics. It includes even many of those prescriptions, generated from a large number of the Government hospitals.

The legal hurdle for generic substitution:

In a situation such as this, the only way the JAS can sell more for greater patient access to essential drugs, if the store pharmacists are allowed to substitute a high price branded generic with exactly the same generic molecule that is available in the JAS, without carrying any brand name, but in the same dosage form and strength, just as the branded ones. 

However, this type of substitution would be grossly illegal in India. This is because, the section 65(11)(c) in the Drugs and Cosmetics Rules, 1945 states as follows:

“At the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed. 20[(11A) No person dispensing a prescription containing substances specified in 21[Schedule H or X] may supply any other preparation, whether containing the same substances or not in lieu thereof.]” 

Thus, I reckon, the most important way to make ‘Jan Aushadhi’ drugs available to patients for greater access, is to legally allow the retailers substituting the higher priced branded generic molecules with their lower priced equivalents, sans any brand name.

A move that did not work:

Moving towards this direction, the Ministry of Health had reportedly submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration.

In this proposal, the Health Ministry reportedly suggested an amendment of Rule 65 of the Drugs and Cosmetics Rules, 1945 to enable the retail chemists substituting a branded drug formulation with its cheaper equivalent, containing the same generic ingredient, in the same strength and the dosage form, with or without a brand name.

However, in the 71st meeting of the DTAB held on May 13, 2016, its members reportedly turned down that proposal of the ministry. DTAB apparently felt that given the structure of the Indian retail pharmaceutical market, the practical impact of this recommendation may be limited.

Conclusion:

Considering all this, just as ‘Pradhan Mantri Jan Aushadhi Yojana’, the likes of ‘Search Medicine Price app’, apparently, are not potentially productive health care related initiatives, if not just one-offs, ‘feel good’ type of schemes for the general population. 

These are not robust enough either, to survive the grueling of reality, impractical for effective implementation, and thus, seriously handicapped to fetch any meaningful benefits for the patients, on the ground.

It is, therefore, still unclear to me, how would the needy patients, and the Indian population at large, could derive any benefit from such bizarre decisions, on so serious a subject as health care.

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.