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Covid-19 Pushes Pharma To Walk The Talk of ‘Patient-Centricity’

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Echoing many other industries, such as, Fast-Moving Consumer Goods (FMCG), pharmaceutical industry leaders, as well, have been talking about putting their customer at the center stage of strategic decision-making processes. In other businesses this grand intent is generally expressed as, ‘customer oriented’ or ‘customer-focused’, or ‘customer-driven’, besides several other similar expressions.

However, in the pharma industry this popular expression is widely talked about as ‘patient-centricity.’ Nonetheless, it is also generally believed that pharma leaders, weren’t hugely inclined to ‘walk this talk’ – until Covid-19 pandemic struck the world – very hard. In this article, I shall delve into this area, focusing on several aspects of it. Let me begin with, what COVID-19 has taught about pharma’s ‘patient-centricity’ efforts.

What COVID-19 has taught about pharma’s patient-centricity efforts:

A recent study, titled, ‘What COVID-19 has taught us about pharma’s patient centricity efforts,’ published by ZS on July 05, 2020, unravels some interesting findings in this area. Some of those points are as follows:

  • ZS’ mid-2019 ‘Patient Centricity Industry Study’ had found nearly universal agreement about the importance and significance of being patient-centric.
  • But the investment for the same did not match the intent, creating an “optimism gap” where senior leaders think more progress than middle the management.
  • At that time, while 73 percent of participants agreed that ‘patient centricity’ is fundamental to their organization, only 16 percent said they understood their individual role in the organization’s ‘patient centricity’ initiatives.
  • Whereas, during the past few months as the industry responds to Covid-19 pandemic, ‘pharma has demonstrated that it can quickly mobilize to surround and support patients, making the workforce focus on the patient priorities.
  • Over the past three months, organizations were found to look at new ways to engage with patients. For example, patient panels to continually check in and monitor the impact on the patient experience, connecting with patient advocacy groups – to get a pulse on critical needs and leveraging the field force to hear from physicians where their patients need the most help.
  • These companies are also investing now to understand the impact of Coronavirus on the patient and partner with others in the ecosystem.

Some interesting industry initiatives during Covid-19 pandemic:

This  ZS study noted, several pharma companies are showing great flexibility and creativity in tapping into their combined expertise and skills to support patients and the healthcare community, in a time of need. Some of the interesting examples cited in the paper include:

  • Pfizer rolled out a five-point plan, including an R&D SWAT team to support vaccine development.
  • Lilly, Merck and others banded together to help employees with relevant skills, volunteer on the front lines of treatment
  • Several other pharma companies have also joined with the Bill and Melinda Gates Foundation to share data.

I hasten to add, according to this study, some industry leaders did agree that COVID-19 has proven that it’s possible to actually be more patient centric in business operations for better outcomes. However, many pharma players would still need to ‘walk this talk’ and put in hard work with adequate resources in getting there – the study noted.

Could ‘patient-centric pathway lead to post Covid-19 business recovery?

Just lip service on ‘patient-centricity’, as witnessed earlier, is unlikely cut any ice in the new normal, as people start living with the new Coronavirus, in everyday life. Making this more touted, but less practiced concept work on ground in pharma, is expected to be one of the effective pathways for early business recovery, as we move on.

The McKinsey article of May 12, 2020, titled ‘Pharma operations: The path to recovery and the next normal’ has also flagged this issue, alongside a few more. Similar to the findings of the above ZS study, this paper also noted that ‘leaders of operations in the pharmaceutical industry have been historically slow to respond to changing times. Interestingly, during COVID-19 pandemic, many of those leaders were found highly responsive to the new demand of time. They ‘rallied to enable the supply of key medicines across borders, manage workforce safety, and handle evolving government restrictions, while beginning to prepare for new vaccines and therapeutics, it noted.

More importantly, several companies have now put in place crisis-response command centers. These hubs play critical roles to appropriately manage and bring stability in an otherwise unstable time. From this experience, in my view, ‘patient-centricity’ could be an effective pathway to follow for post Covid-19 business recovery. Having said that, let me try to tighten some loose knots of understanding in this specific area, as below. To start with, let us together recapitulate a brief background of evolution of ‘patient-centricity’ concept in the drug industry.

“No decision about me, without me”:

Not so long ago, the National Health Service (NHS) of U.K realized that every patient should be as actively involved in making decisions about their health and health care as they wish to be. Accordingly, in 2012 it released the White Paper - ‘Equity and Excellence: Liberating the NHS,’ setting out the U.K Government’s vision of an NHS that puts patients and the public first, where “no decision about me, without me” is the norm.

The concept of ‘patient centricity’ in the pharma industry is believed to have grown from the above concept. The core idea of the concept, as defined in a BMJ article is, “Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family”.

The authors envisage, effective implementation of the same would provide an opportunity for drug companies to adopt and use its core facets as reference points for patient engagement, throughout a product life cycle. In tandem, this also flags an important point: Why the concept of ‘patient-centricity’ is mostly talked so ‘passionately’ by almost all drug companies, while very few of them seem keen to ‘walk the talk?’

The key barriers to achieving ‘patient-centricity’:

The key puzzle on ‘Patient centricity: everyone wants it; not everyone gets it’, was well-deliberated by Reuters Events (Pharma), published on December 14, 2024. It pointed out – as an aim ‘patient-centricity’ is all too often overlooked, despite the fact that even several top pharma companies often express their desire to be patient centric organizations; such as:

  • “Inspired by patients, driven by science” (UCB);
  • “Science and patients…the heart of everything we do” (AstraZeneca);
  • “A global integrated healthcare leader focused on patients’ needs” (Sanofi).

Analyzing the overall reasons for the same, the paper articulated: ‘Difficulties in communication with patients, skepticism about their input, and unwillingness to relinquish control are some of the barriers to achieving patient centricity.’ Interestingly, this situation remains generally unchanged even today.

Conclusion:

Meanwhile, as recorded in the morning of September 06, 2020, total Coronavirus cases in India have reached a staggering figure of 4,113,811 with 70,679 deaths, despite every effort taken by the Government. As PTI reported on September 05, 2020: At the current pace, India will overtake Brazil early next week to become the country that has seen the second highest number of cases.’ With this perspective, let us now look at the concept of ‘patient-centricity’ for better treatment outcomes.

As deliberated earlier, just as providing affordable care for all – making ‘patent-centricity’ the centerpiece of the core business strategy for pharma, had remained akin to chasing the ‘Holy Grail’. This happened, despite last so many years one could easily spot inclusion ‘patient-centricity’ even in the corporate vision and mission statements of many drug companies.

As it appears today, the term ‘patient centricity’ remained another cliche, till Covid-19 disrupted the status quo of the old normal? But, will it last long? Only another robust study in the future, I reckon, will be able to confirm it. However, this would mostly depend on whether patients continue sending signals of: “No decision about me, without me,” for better health outcomes.

It’s not a terribly disputed fact, either that various stringent norms in the Covid lockdown period, have prompted many health care consumers switching from their good old health care practices, to the digital or online mode to meet with similar needs. Consequently, they are now becoming more digitally empowered than ever before. In this situation, leveraging AI with expert help, would help implement ‘patient-centricity’ more productively to meet challenges of the new normal.

If done with precision, it would help move even beyond ‘patient-centricity’ in the new normal, with better disease prevention or management and ‘connected healthcare,’ leading to better quality of lives for many. Thus, Covid-19 pandemic – pushing pharma to ‘Walk the Talk’ of ‘patient-centricity,’ if lasts long, could usher in a fundamental change in the health care space. It has demonstrated its huge potential during the ongoing pandemic to ensure patient-friendly, high quality, affordable and universal health care value delivery – for patients’ sake.

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.

Shift from Disease Centered Care To Patient-Goals Directed Care In The New Normal

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In the initial days of the first quarter of 2020, no one could fathom that just within the next 4 months over two million fellow citizens will get infected by an unknown virus, recording over 45,500 deaths. Many authorities may wish to project or analyze these Covid-19 numbers in so many different ways. Nevertheless, the fact remains, currently, in passing each day India is recording the highest count of fresh Covid-19 cases in the world, alongside the most daily deaths from the virus.

In the early days of Covid19 in India, many expected a remedial pathway to emerge soon – conventional or unconventional. Accordingly, Indian citizens across the country responded to the call of some national leaders by observing some – even unconventional measures, such as:

  • On March 22, 2014, to “boost morale” of doctors and public workers, as urged by the Indian Prime Minister, many people banged pots and pans on balconies across India.
  • On April 05, 2020, again responding to the Prime Minister’s passionate call, a large number of Indians turned off lights, lighted candles and Diyas hoping to dispel COVID-19 darkness.
  • On May 02, 2020, as organized by the Government, the country’s armed forces engaged in a nationwide exercise to express gratitude to doctors, paramedics, sanitation staff and other front-line workers involved in fighting the Coronavirus pandemic.

Gradually, the stark reality sank in, as the old normal faded out in the horizon. Public expectations arguably started shifting from heavenly interventions, as it were, to science-based measures. It has now been generally accepted that there is no alternative to social distancing and wearing a mask at the public places. These should continue, till the ‘silver bullet’ – vaccines arrive. More so, when going for herd immunity “cannot be a strategic choice or option,” given the size of India’s population, as the Government said.

Billions of people have now started hoping for the ‘silver bullet’ to come soon. This sky-high expectation continues to be fueled by media hype – based primarily by the Press Releases of the concerned companies. In the midst of these, comes a word of caution from the apex health body of the world. As recent as August 03, 2020, the World Health Organization (W.H.O) announced, ‘despite strong hopes for a vaccine, there might never be a “silver bullet” for COVID-19, and the road to normality would be long.’

To add some degree of certainty in this humongous – primarily scientific and logistical challenge to save lives, – pharma and biotech industry, as usual, are coming to the forefront. Billions of eyeballs are now glued on to them – following every bit of what they are saying – as the devastating impact of this health catastrophe is profound. Besides individual health, the fall-out of the pandemic is intimately intertwined with livelihoods, nation’s economy, social fabric and adjusting to the new way of living, including new mechanisms for most transactions.

Obviously, this would create a new normal – quite different from the old one – and naturally would include pharma business, as well. In this scenario, patients will assume a much different status, especially in the disease treatment process. More patients would likely to prefer their individual health-goals directed holistic care, which calls for a holistic disease treatment solution. The process needs to be contactless as far as practicable, less time intensive and above all cost effective

In this article, let me focus on this area. I reckon, many pharma players are also evaluating the impact of this shift to achieve business excellence in the new normal.

The current treatment approach and the pharma focus:

A recent paper, published in the JAMA Cardiology on the April 2016, made some interesting observations in this area. Citing cardiology disease area as an example, the authors noted the following, among other points:

  • Physicians’ decision-making process generally ‘concentrates on disease-specific outcomes, following practice guidelines for specific conditions.’
  • Value-based purchasing also largely focus on individual diseases.
  • However, disease-centered framework is ill-suited for persons with multiple chronic conditions, including older adults and the majority of adult health care users of all ages.
  • Disease-centered decision-making results in treatment burden when patients must adhere to multiple guidelines and harm when guideline recommendations conflict.
  • Furthermore, disease-centered recommendations may not address what matters most to these patients – varying health priorities.

The shortcomings of this approach from the patients’ perspectives, besides adding greater value for patients, prompt a need for change. From the current disease-oriented treatment approach, and pharma’s business-related focus in sync with this system.

Habit of visiting specialists at the very beginning complicates the process:

The disease-oriented treatment approach, as it is today, isn’t a legacy issue. In the good old days, General Practitioners (GP) used to examine their patients thoroughly – covering the entire body. Thereafter, depending on the specific areas of need, expert interventions used to be recommended.

However, todays well-informed people, equipped with health information of all kinds, can possibly figure out the broad outline of their health problems. Accordingly, many of them directly arrange appointment with specialists. As most of them are generally not terribly wrong in figuring out the problem areas, specialists’ treatment progresses in the same direction. Other existing health issues, not being of high priority treatment areas for persons concerned, could remain ignored, till these also flare up.

Undoubtedly this approach, even if is made ‘patient-centric’, in a broader sense, by pharma players, would cost more time, more money to patients. Besides, loss of income and increase in morbidity. This is certainly an avoidable situation for all – patients, doctors and pharma companies.

Go beyond ‘patient-centricity’ encompassing ‘patient-goals directed care’:  

The new focus should be directed towards ‘patient-goals directed care.’ This approach, which flows from a very old and a classic concept of  Sir William Osler articulated in the 19th century. This remains as relevant today for any holistic - ‘patient-goals directed care.’ It goes way beyond much hyped ‘patient-centric’ approach.

Sir William Osler once said, “The good physician treats the disease; the great physician treats the patient who has the disease.” The great physician understands the patient and the context of that patient’s illness. Accordingly, I reckon, pharma players new focus needs to be in conformance to this concept. It fits in so well with changing patients’ expectations in the new normal.

As has been evaluated in many studies, although, patient-goals directed care may appear to be particularly useful for persons with multiple chronic conditions, ‘this approach works across the age and health span, making it a compelling path toward value-based care from the patient’s perspective.’

‘Each patient represents a story’ which needs to be carefully deciphered: 

The article – ‘To Be a Great Physician, You Must Understand the Whole Story,’ published in the Medscape General Medicine on March 26, 2007, elucidated the point nicely. It said, each patient represents a story, which includes their diseases, their new problem, their social situation, and their beliefs. A physician needs to understand this story. Accordingly, perform a targeted physical examination based on the historical clues, order the correct diagnostic tests, and interpret them in the context of the history and physical exam. Once the appropriate data are collected, the patient’s story needs to be revisited, based on scientific data.

Revisiting process of the patients’ story includes making the correct diagnosis or diagnoses. The story must reveal the patient’s context – Who is this patient? – What is the patient’s goal? – How might the patient’s personal situation impact the treatment options? And more – as the above article highlights.

Each patient’s story’ is important for pharma companies, as well:

Patients’ disease related stories are of crucial importance to the pharma players, as well, for strategic reasons. Not just to gain insights on the disease manifestation process, but more importantly to facilitate a company’s engagement with them.

Another interesting article has brought out some more important issues in this area. The paper is titled, ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’ It was published by the SAGE Journals on March 28, 2017, where the authors underscored, engagement with patients can only be possible, if there is credibility. Elaborating this point, the paper cited two GSK examples aimed at building trust with patients and physicians, as follows:

  • Change in marketing practices: In 2011, GSK eliminated prescription sales targets in the US and introduced a new incentive model for sales and marketing practices based on value and feedback from prescribers; external speakers/ convention travel support was discontinued (2016).
  • Clinical transparency: Since 2013 GSK has committed to promote transparency of clinical research and is a leading example in the pharmaceutical industry—it was the first company to grant access to anonymized patient data. The ‘All trial campaign (2013)’ commits to publishing all trial data; the GSK patient-level data access site has become a multi-sponsored portal (2014).

Conclusion:

As of August 09, 2020 morning, the recorded Coronavirus cases in India have crossed a staggering 2 billion mark, reaching 2,153,10 with 43,452 deaths. The figure keeps climbing – faster than expected, unabated.

The business relevance for a shift from the conventional disease centered care to patient-goals directed care, require deep understanding of the top pharma leadership along with its very purpose, in the new normal. Patients deserve this now, more than ever before, as explained above.

In my view, a changing mindset to align pharma business strategy – from providing a disease-oriented care to patient-goals directed care, is expected to improve patient outcomes manifold. Nevertheless, like what the above SAGE article emphasized, the organization at its end would require defining collectively and with clarity – why is this change now? How it is to be done – step by step?  And what are the results the company aims to achieve?

Consequently, it would help create a large pool of delighted and company loyal customers having strong ‘word of mouth’ advantages. Top pharma leadership’s ‘buying in’ this concept, with an appropriate organizational structure in place, would herald a new dawn of ‘Patient Value-Based Care’ – Convid-19 pandemic notwithstanding.

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.

 

New Digital Tools To Protect From Infection, Neutralize Covid-19

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There seems to be some light at the end of the dark tunnel of a serious biological threat that the world is passing through, since the nightmarish last seven months. The COVID-19 pandemic has spread to 213 countries and territories, and the number of new cases is continuously rising. According to reports, the severity of the situation has already re-shaped our society, more than ever before.

In tandem, reports are arriving from most countries, testifying the tremendous commitment of the governmental, scientific and clinical communities, to help local populations dealing with the pandemic. Scientists are still far from having a complete picture of the pathophysiology of this dangerous disease, including its long-term implications on individuals.

Amid this challenge, round the clock search for a life-saving and long-term pathway to outmatch the fast-spreading Covid-19, seems to be coming to fruition, soon. If everything materializes as expected, Covid-19 vaccines may be available by the end of this year or at the beginning of the next year. If it happens, this will be a record in the history of any vaccine development process, as the normal ‘mind to market’ period to deliver a scientifically proven, safe and effective vaccine is normally around 10 years. That said, there always exists a gap between the cup and the lip, as the saying goes.

No doubt, vaccines will be the best way to bring the new Coronavirus under a tight leash to help normalize life, restore livelihoods, and putting a nation’s economy back to the growth trajectory. The good news is, alongside this magic bullet, the power of technology is exploring other technological measures to keep the virus at bay, wherever possible. In this article, I shall focus on this interesting area.

Let me hasten to add, the value offerings of these devices can’t be compared with the long-term benefits that vaccines will offer in containing this global pandemic. Nevertheless, the questions still remain, when will a well-documented, safe, effective and affordable vaccine hit the market?

W.H.O expects to deliver 2 billion doses of vaccines by end 2021:

According to a News Release of July 15, 2020, by the World Trade Organization (W.H.O): ‘Seventy-five countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility, which aims to:

  • Accelerate the development and manufacture of COVID-19 vaccines.
  • Guarantee fair and equitable access for every country in the world.

The goal of COVAX is to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO pre-qualification, by the end of 2021. Besides W.H.O, other experts are also cautiously optimistic about the availability of Coronavirus vaccines ‘soon’. Here also the question may crop up: how soon is ‘soon’?

How soon is ‘soon’ – for sooner availability of Covid-19 vaccines?

Experts have opined, a vaccine would normally take years, if not decades, to develop. However, in this unprecedented global health crisis, researchers hope to achieve the same amount of work in only a few months, following the ‘fast track’ regulatory pathway. Let me give a sense of the prevailing buzz around the availability of some of these vaccines.

Going by what the Chief Executive Officer (CEO) of Serum Institute of India said about Oxford-AstraZeneca developed vaccine, many expect their availability by the end of the current year in India. The Company CEO, reportedly, said on July 22, 2020: “By November, we hope to launch the vaccine if the trials are positive and if the Drug Controller of India blesses it and says it is safe and effective.”

Further, on July 28, 2020, Moderna Inc. and Pfizer Inc. also launched two 30,000-subject trials of Covid-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, as the companies announced. Notably, both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods, but does not have an extensive track record.

According to another report of July 30, 2020, Russia said, the world’s first COVID19 vaccine to be ready by August 12, 2020. The vaccine is being developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology.

India’s indigenous experimental Coronavirus covid19 vaccine candidate, developed by Bharat Biotech, is also undergoing phase 1 and Phase 2 trials at 12 sites spanning across India. The initial results are positive. Earlier, ICMR had announced its launch on August 15, 2020. However, specialists in this area feel, ‘the August 15 timeline seems totally unrealistic, if not entirely impossible.’

Be that as it may, most experts still think a vaccine is likely to become widely available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged. Bringing to the market a Covid-19 vaccine, no doubt, will be considered as a ‘huge scientific feat,’ but ‘there are no guarantees it will work’ for all. It’s also a point to ponder that ‘Coronaviruses already circulate in human beings. They cause common cold symptoms and we don’t have vaccines for any of them’ just yet, as the report highlights.

It’s, therefore, a clear possibility that a well-documented, safe and effective Covid-19 vaccine may not be available, at least, in the next 6 months. Moreover, access to an affordable Coronavirus vaccine by the global population will also not happen in a jiffy. In that case, it is encouraging to note that other cutting-edge technological initiatives are also moving ahead with a great speed, to bring the rapid transmission of the new Coronavirus under a tight leash.

Novel, non-medical tech initiatives to contain the Covid-19 spread:

As potentially lethal Covid-19 is overwhelming the world, besides search for new drugs, faster diagnosis to fight the infection – and most effective preventive measure – vaccines, several non-medical tech initiatives are also underway. Many of these are quietly heading forward in search of user-friendly solutions, not just to ‘take the pressure off overworked health care workers’, but also ‘to stop the spread of the disease.’ These are all running parallel to offer technology driven disease treatment-options during this global health crisis.

An interesting paper from the European Parliamentary Research Sevice (EPRS), also vindicates some critical developments in this area. It focuses on technology-based solutions for various pressing pandemic-related problems. Let me illustrate this point with one example each, in the areas of ‘taking the pressure off overworked health care workers’, and in ‘stopping the spread of the disease.’

Technology to ‘take the pressure off overworked health care workers’:

Even in India, one hears quite a lot about the hardship of overworked health care workers. Various unconventional ways were also prescribed for the nation to encourage them. Some of these aren’t inexpensive, either. From this perspective, one such application is robotics technology. It can be effectively used as an intelligent solution to reduce the risk of person-to-person transmission − especially in pandemic hotspots. As the above EPRS article highlighted, many countries are now deploying robots in other areas also to ‘take the pressure off overworked health care workers,’ such as:

  • To disinfect whole hospitals,
  • Decontaminate public and private sites,
  • Handle biohazardous waste,
  • Deliver food and medication to infected patients,
  • Taking patients ‘ temperatures and act as medical assistants.

For example, an Israeli-made AI-powered robot assistant is, reportedly, being used in hundreds of hospitals, medical centers, nursing homes, and corporate buildings in Asia. This is to help minimize human-to-human contact as millions of people take precautions due to the novel Coronavirus outbreak worldwide. By the way, Israel is now a good friend of India, too.

Technology ‘to stop the spread of the disease’:

On June 01, 2020, Science Daily reported, the researchers at Penn State, the University of Minnesota and two Japanese universities, have found that a personal, handheld device emitting high-intensity ultraviolet light to disinfect areas by killing the novel Coronavirus, is now feasible.

Another report of July 10, 2020 also brought to the fore that the researchers from the University of Houston have created a new air filter that virus tests at the Galveston National Laboratory found can kill 99.8 percent of COVID-19 instantly. The filter could be useful for killing COVID-19 in public places, such as, in airports and airplanes, in office buildings, schools and cruise ships, besides other closed spaces such as schools, hospitals and health care facilities. Thus, the ability of this “catch and kill” air filter to control the spread of the virus could be very useful for society,” confirmed another report.

On July 29, 2020, an Indian business news daily wrote, ‘Bengaluru-based Organization De Scalene has received clearance from the US Food and Drug Administration (USFDA) and the European Union to license and manufacture Scalene Hypercharge Corona Canon (Shycocan).’ The device disables the virus’ capability to infect, by flooding electrons in closed areas. It is claimed that Shycocan ‘has the ability to neutralize 99.9% of the Coronavirus that might be floating in the air in closed spaces.’

Although, it is not an alternative to medicines that can cure infected people or preventive vaccines, the device can be used to keep Covid-19 at bay, at least, till vaccines arrive. Thus, going by these developments, one gets a sense of various non-medical technological activities post Covid-19 pandemic outbreak. Especially about, how today’s technological whiz kids are working alongside the medical scientists to take the sting out of Covid-19 onslaught.

Conclusion:

The Lancet article – ‘Applications of digital technology in COVID-19 pandemic planning and response,’ published on June 29, 2020, also made similar observations. It said: ‘With high transmissibility and no effective vaccine or therapy, COVID-19 is now a global pandemic.’ In this scenario, to contain the spread of a highly transmissible virus, countries that have quickly deployed digital technologies in various critical areas to contain the spread of the infection, may emerge as front-runners in managing disease burden, the paper concluded.

As of August 02, 2020 morning, the recorded Coronavirus cases in India reached a staggering 1,751,919 with 37,403 deaths. Recent Sero-surveys also show COVID-19 peaks in the country is still far away. It is very likely that a vast majority of the population will survive the Covid-19 catastrophe, even if only the existing systems are followed. But, just surviving is neither the reason nor the purpose of life. What most people want today is finding out a comprehensive way for – ‘jaan bhi and jahan bhi’ (life also, the world also).

Understandably, on July 31, 2020, W.H.O has also reiterated: “The pandemic is a once-in-a-century health crisis, the effects of which will be felt for decades to come.” Under this backdrop, unleashing the potential of new non-medical digital tools, as illustrated above, seem to be of immense benefit – not just to protect many more people from the infection, but also to neutralize Covid-19 effectively, especially in India.

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.

Covid-19 Drugs: Accessibility, Affordability And Availability

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Covid-19 continues refusing to unravel the key to neutralize its destructive power – for bringing human life and the socioeconomic fabric of a country back to the old normal again. Just as India, all other countries are, apparently, awaiting a ‘magic bullet’ to come, breaking the shackles of this labyrinth, so to speak.

General expectation is, all concerned will understand that coming out of the new Coronavirus maze, sooner, at any cost – is the only way to bring back life, livelihoods, social fabric and the national economy on to the rail, again. Consequently, every entity in the world would require making moderate sacrifices in this unprecedented endeavor.

Right at this time, accessibility, affordability and availability of emergency use Covid-19 drugs, for various reasons, are going beyond the reach of a large number of the population who need those the most. This is happening not just beyond the shores of India, but in the country, as well, perhaps much more than expected. Interestingly, the issue pertains more to Covid-10 repurposed older drugs, and not so much for vaccines – just yet, as I shall deliberate below.

In this article, I shall focus on this issue, hoping for a reversal of the current trend through active involvement of the both the drug company leadership, and also the national decision makers to safeguard public health interest. Interestingly, the drug pricing issue, mostly with repurposed older drugs, is both global and local. Thus, let me first dwell on the subject of drug price increases during this global public health emergency.

Drug price increases during a global public health emergency: 

According to the July 08, 2020 report of IHS Markit, prices of critical drugs are increasing at a time when they are needed the most, as the governments and individual patients potentially struggle to pay for them.

The findings brought to the fore, prices for the 10 most critical drugs to treat COVID-19 have risen a highly unusual 4 percent globally, during the crisis. The cost for over half of these essential COVID-19 medicines rose across 80 countries between February and June 2020. Let me illustrate this point with one example each of Covid-19 emergency treatment options, starting with the global outcry for the same.

Global skepticism on remdesivir pricing:

As the world anxiously awaits a Covid-19 vaccine to hit the market, an experimental repurposed older drug – remdesivir of Gilead Sciences Inc. was introduced as an emergency treatment option for this infection. Pending detail clinical trial results, currently the drug has received only emergency regulatory approvals with an expectation that it may shorten the recovery period in some severely ill Covid-19 patients.

Gilead Sciences, on June 29, 2020, announced its price of $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries.However, it will cost $3,120 for patients with private insurance. This price was swiftly and widely criticized, because the drug has received at least $70 million in public funding toward its development - the report highlighted.

Elaborating what would be affordable pricing for this drug in the developed world, another reportquoted the watchdog group – Public Citizen. This group maintains $1 per day is fair. It points to a cost-recovery model developed by the University of Liverpool, which calculated that the cost of manufacturing remdesivir at scale would be 93 cents per dose, leaving the remainder as, in its view, “a reasonable profit to Gilead,” as the report underscored.

Interestingly, analysts expect Gilead to make $525 million on remdesivir sales this year and $2.1 billion next year. This isn’t the first time Gilead is facing public criticism on life saving drug pricing. Just to recap, in 2013, the company also received ‘brickbats’ for its $84,000 price tag for groundbreaking hepatitis C treatment Sovaldi—followed up by its combo pill Harvoni, priced at $94,500. But those were first in class new and innovative drugs. Nevertheless, the remdesivir pricing issue is viewed differently, because it is not just a repurposed older drug, but indicated to combat a global public health crisis.

Let me now give an Indian example on a similar issue, but with a different anti-Covid-19 drug.

Criticism in India with Covid- 19 drug pricing: 

The Drug Controller General of India (DCGI) had on June19, 2020 approved anti-viral drug favipiravir, manufactured in India by Glenmark Pharmaceuticals Ltd. This approval was for “restricted emergency use” of the drug in mild to moderate cases of COVID-19 in the country, in view of the urgent medical need during the pandemic. Favipiravir is made under the brand name Avigan by Japan’s Fujifilm Holdings Corp and was approved for use as an anti-flu drug there in 2014.

According to media reports, Glenmark launched the drug on June 20, 2020 with the brand name FabiFlu at a price of Rs 103 per tablet. On this pricing issue, a member of the Indian Parliament, reportedly, made a representation to the DCGI stating, as a patient has to take 122 tablets of the drug in 14 days, the total cost of the treatment will come to around Rs 12,500. The M.P argued, “price quoted for this drug is definitely not affordable to the common people,” and ‘is definitely not in the interest of the poor, lower middle class and middle-class people of India.’ Additionally, the submission mentioned that ‘Glenmark has also claimed that this drug is effective in co-morbid conditions like hypertension, diabetes, whereas in reality, as per protocol summary, this trial was not designed to assess the FabiFlu in comorbid condition,’ as the letter read.

However, on July 13, 2020, Glenmark reportedly said that it had reduced Favipiravir price from Rs103 to Rs75 per tablet. The Company said, “The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API (Active Pharmaceutical Ingredient) and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country.”

Thereafter, as reported on July 19, 2020, after receiving a complaint from a member of Parliament, the DCGI sought a clarification from Glenmark over its alleged “false claims” about the use of FabiFlu on Covid-19 patients with comorbidities, including the “pricing” of the drug.

In response Glenmark stated, “Compared to other therapies approved for emergency use in Covid-19, FabiFlu is much more economical and an effective treatment option.” The comparing argued, the estimated total cost for the full course of Favipiravir is Rs 9,150. Whereas, the same for Remdesivir, Tocilizumab and Itolizumab will come to Rs 24,000-30,000, Rs 44,000 and Rs 32,000, respectively.

Importantly, seriously ill Covid-19 patients will often be given many of these drugs, such as, tocilizumab, remdesivir and favipiravir, either one after the other, or simultaneously, making the overall price of treatment hefty for many. From this perspective, the bottom line is, Covid-19 drug treatment in India – where the out of pocket drug expenses is one of the highest in the world, won’t be affordable to many. Besides, there are other critical issues related to Covid-19 drug access and availability to Indian patients. The question that surfaces in this situation, are Covid-19 drug prices are high where there is no or less competition. If, so this is an avoidable situation.

Could this be due to less or no competition?

Continuing with the example of Favipiravir against the above backdrop, Cipla also, reportedly, received the DCGI approval for the launch of experimental Covid-19 drug Favipiravir in India on July 24, 2020. The brand will be marketed under the brand name Ciplenza in the first week of August and is priced much less than Glenmark’s Favipiravir – at Rs 68 per tablet. Could this be due to market competition?

Possibly so, because another report of July 25, 2020 indicated, nearly 10 other Favipiravir formulations will be launched shortly, despite inconclusive scientific clinical evidence as on date. Favipiravir price is expected to fall further due to competition. In that case, what could be the takeaway message, when this price trend is viewed against the response of Glenmark to the DCGI letter, justifying FabiFlu pricing?

Other issues of Covid-19 drug availability and access to Indian patients:

Other critical issues related to Covid-19 drug availability and access to Indian patients include, prices of Covid-19 drugs shooting up in short supply. There have been reports of difficulty in accessing remdesivir in India, too, although, Gilead Sciences has licensed this drug out to a few Indian generic pharmaceutical companies such as Hetero Healthcare, which has announced that it would manufacture and sell it at Rs 5,400 per vial. According to the latest protocol of the health ministry, the dosage of remdesivir should be 200 mg IV on day 1 followed by 100 mg IV daily for 4 days (5 days in total). From this one can easily work out the treatment cost with remdesivir for each patient.

Moreover, a BBC investigation has found that two life-saving drugs used to treat Covid-19 patients in India – remdesivir and tocilizumab – are in short supply and being sold for excessive rates on a thriving black market. Yet another recent investigation has unraveled a growing black-market for plasma therapy, ‘born out of the desperation of families willing to do anything to save their loved ones infected with Covid-19.’

I am citing these examples to give a sense of the plight of common Covid-19 patients from the drug availability, affordability and accessibility perspective – to save lives. However, the good news is, in this otherwise gloomy scenario, as perceived by many, a more empathetic scenario has been reported from many Covid-19 vaccine manufacturers.

More empathetic scenario with Covid-19 vaccine manufacturers: 

According to the World Health Organization (W.H.O), over 160 groups are working on COVID-19 vaccines, and 24 candidates have already reached human testing, Some are, reportedly gearing up for phase 3. It is widely expected, vaccines might be ready later this year or early next year. Vaccine developers are racing ahead at record speed, supported by Governments and facilitated by the drug regulators, to translate billion dreams coming true amid a public health catastrophe.

For the world population to acquire immunity against the Covid-19 onslaught, the key question remains: ‘At what price’, when vaccines are available? According to reports, the encouraging news is, some major vaccine makers, such as:

  • AstraZeneca (with Oxford University) plans to price at “no profit” during the pandemic “to support broad and equitable access around the world.” The company has entered several agreements with governments and other groups to provide about 2 billion doses around the world, at no profit.
  • Similarly, J&J has also “committed to bringing a safe and effective vaccine to the public on a not-for-profit basis for emergency pandemic use.”
  • Pfizer CEO has also said the company “will make a very, very marginal profit at this stage.” He pointed out that the company hasn’t taken any governmental funding, unlike other players. The company and its partner BioNTech have entered a deal with the U.K. government for 30 million doses. Moreover, Pfizer and BioNTech will get $1.95 billion from the US government to produce and deliver 100 million doses of their Covid-19 vaccine candidate.
  • Moderna CEO said, there’s “no world, I think, where we would contemplate to price this higher than other respiratory virus vaccines.”
  • Sanofi, which has separate COVID-19 vaccine partnerships with GlaxoSmithKline and Translate Bio, has “been committed to working with governments, partners and payers to ensure that when new vaccines are approved, we will make them available and affordable,”
  • Merck CEO also said the company has committed to “broad, equitable, affordable access.”
  • Nearer home, Serum Institute of India, has pledged to make 1 billion doses of the Oxford-AstraZeneca jointly formed COVID-19 vaccine at under Rs1000 per shot. The production could start as early as first quarter next year. Company CEO said this is not the time to make money from a vaccine against the novel Coronavirus, which has caused a global pandemic.

These pledges do give a comfort to many. Because, unlike Covid-19 repurposed older drug manufacturers, Covid-19 vaccine makers seem to be more empathetic to make these accessible and available to the world population at an affordable price.

Conclusion:

Well past a million mark, as on July 26, 2020 morning, the recorded Coronavirus cases in the country reached 1,339,176 with 31,425 deaths. With the number of daily cases being more than Brazil, India is poised to bridge its gap with the South American country. The steep unenviable climb continues.

The July 21, 2020 article – ‘Drug Pricing Back in the Spotlight,’ published in the PharmaExec.com, quoted the ICER Executive Vice-President saying,’ the drug pricing conversation is different in a pandemic.’ The system needs to ensure public access to drugs and vaccines in this global health crisis. If it does not happen, I reckon, appropriate authorities must step in with specific remedial measures.

Otherwise, the kudos showered on the drug industry for promptly offering a number of repurposed older drugs for emergency use against Covid-19 may not last long, if these treatments are not affordable and accessible to a vast majority. From this perspective, the questions being raised on accessibility, affordability and availability of many Covid-19 drugs, need to be addressed and resolved – soon.

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.

Pharma To Leverage The Art of Turning Challenges Into Opportunities, Now

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Since, the dawn of the year 2020, the human population living in different countries, across the world are facing ‘lockdowns in different forms. Although essential, it severely restricts normal daily essential and other important activities of all. A large number of populations in India, is also experiencing the same – for nearly 4 months, almost at a trot, as on date.

The fear of getting infected by COVID-19, fueled by uncertainty about a comprehensive way to surely avert infection and apprehension about what happens if someone gets infected, have been haunting many for several months. Moreover, the possible impact of several related essential measures, such as, social distancing and wearing a mask mostly while being outdoors, on both life and livelihood, is profound. It has already started causing an unprecedented – both physical and mental stress on many individuals, besides the economy of the nation.

Living amid ‘lockdown’ conditions is not just an unpleasant experience for all, it’s almost a ‘prison like’, experience for a vast number of people – particularly, both young and old with comorbidly. “It’s very similar to being trapped in a bunker with no access outside,” as expressed by a person with similar issues, which, may be construed as a universal feeling of common individuals. Interestingly, this was quoted in an article -  ‘What patients need right now’, published in the Reuters Events Pharmaon July 07, 2020. The article also highlighted that many other fellow sufferers, especially non-Covid-19 patients, are enduring pandemic enforced isolation without much hope. “They are staying in limbo until help is available and adapting to the worsening of their health conditions,” the article added.

Further, as captured in the McKinsey article – ‘COVID-19 and commercial pharma: Navigating an uneven recovery,’ published on April 21, 2020 – not just patients, health care professionals including doctors, are also facing unprecedented challenges. Especially, because of the need to address fundamental changes in the treatment of patients with conditions other than COVID-19. This is happening across medical specialties and therapeutic areas, besides of course in advising and treating patients with suspected and confirmed cases of COVID-19.

In some instances, some doctors do also worry about their financial security, as practices and health systems face unprecedented financial issues, the above article emphasized. However, at the same time, many of them are now rapidly adjusting how they deliver care, such as through increased use of telemedicine in different forms and ways, the survey found. Which is why, the support they need from pharma companies is also changing.

Taking cognizance of these critical developments, pharma players would require rewriting their playbook for business operations and for its urgent implementation. This article will focus on this important area of pharma business, by leveraging the art of turning a problem or a challenge into an opportunity.

Leveraging the art of turning a challenge into an opportunity:

Turning a problem or challenge into an opportunity in managing business operations, isn’t a cup of tea of all managers, across domains. More so, when it’s caused by an unprecedented disruptive change, such as the Covid-19 pandemic.

The first and the foremost prerequisite from a manager is a mindset to make it happen – driven by uncluttered thinking, with a clear focus on what needs to be achieved, how and when – step by step. Each element of a change has to be analyzed in-depth – supported by credible data, with possible barriers envisaged on the way. In tandem, weighing the chances of success in these initiatives based on data – and not gut feeling, within a predetermined timeframe will be critical. The net outcome of this process will help pharma players acquire a differentiated competitive edge for excellence, amid today’s all-pervasive quandary.

Under this backdrop, leveraging the art of turning a problem or challenge into an opportunity – in an organized manner, for a successful outcome of the present and future pharma business, appears to be a crying need.

The points to ponder:

Effectively moving in this direction will call for – at its very onset, a careful and unbiased data-based assessment of several critical areas, which will include:

  • Whether customer engagement platforms, medium, processes and also the core content of communication of pre Covid-19 days remain equally relevant today, and will remain so in the foreseeable future, for productive business outcomes.
  • Mapping changes with the extent for each, in all touchpoints of disease treatment processes is important – involving both patients and doctors, and simultaneously capturing their new preferences in those areas.
  • Arriving at what strategic and tactical changes the new normal calls for, to effectively engage with especially, non-Covid patient treating doctors and non-Covid infected patients, for other disease areas.
  • How doctors are delivering care, particularly to these patients today?

Accordingly, the pathway for required changes has to be charted out in detail, specifying the end point of each, on a time-bound and ongoing basis. The good news is, several pharma players have already taken several praiseworthy initiatives to combat this crisis.

What pharma companies have done so far:

So far, many pharma companies – both global and local, have taken some commendable steps to address the immediate fallouts of the crisis. These include,

  • Repurposing old medicines – starting from hydroxychloroquine, remdesivir to dexamethasoneand probably beyond. All these drugs are currently being used for the treatment of Covide-19, although conclusive scientific evidences are still awaited – for most of such repurposed drugs.
  • Covid-19 vaccine development started almost immediately, including the homegrown ones.

As the above McKinsey article – ‘COVID-19 and commercial pharma: Navigating an uneven recovery,’ also reconfirms, now most pharma companies are largely focusing on ‘the immediate crisis, including by facilitating access to medicine; supporting HCP, institution, and patient needs in new ways; safeguarding employees; and enabling employees to operate in a new environment.’

The areas where pharma needs to focus more amid immediate crisis:

Another, responsibility of pharma to help tide over the immediate crisis, is to ensure that critical drugs, such as remdesivir, do not go in short supply. And also, avoiding unnecessary hype on a COVID-19 vaccine, which a global CEO termed as a grave disservice‘ to the public.

Nearer home, it also happened – not by any pharma company, but by the country’s premier, state-run medical research organization – the Indian Council of Medical Research (ICMR). The head of the ICMR has announced that India is planning to launch the Covid-19 vaccine by August 15, 2020. This was later retracted under heavy adverse criticism.

Future focus areas need to be in sync with the changing customer behavior:  

While converting several challenges into opportunities in sync with the future requirements of their business operations, drug companies should try to derive the first mover advantages. For this purpose, creative use of almost real-time data will be vital. In this endeavor, I reiterate, one of the top priorities will be to ensure that all touchpoints of the consumer engagement process take into account the changing customer behavior, as captured by data.

To have a productive value delivery system in the new normal, cerebral use of modern technology-based tools and platforms could provide a sharp cutting edge. A similar process may be adopted – even a stage earlier – during the differential value creation process of the business. Nevertheless, the name of the game for the future, would still remain delighting the customers at all the touch points, especially while navigating through strong headwinds.

Another major impact area of pharma business:

The onslaught of Covid-19 pandemic has also resulted in some significant behavioral changes among many health care consumers. These spans across several areas, as I wrote earlier. For example, a number of surveys have revealed that fewer number of non-Covid-19 patients are now visiting doctors’ clinics.

The study quoted by the above McKinsey article highlights some important points in this regard, such as:

  • Among surveyed HCPs, 82 percent report declines in patient volumes, with more than half describing the declines as “significant”.
  • 40 percent of the surveyed patients reported having a doctor cancel an appointment, while an additional 30 percent or so canceled the appointments themselves.
  • Half of surveyed physicians worry that their patients will not be able to receive timely care for new or existing conditions, particularly those that are not COVID-19 related.
  • The overall reduction in volume is widespread, but variation exists. For example, the number of oncology-related visits have declined far less than those related to cardiology or dermatology, perhaps reflecting patient or physician perceptions of urgency.
  • Such data represent a snapshot of a time still early in the trajectory of this crisis, but the HCPs surveyed expect the trends to continue—and to accelerate, potentially.

Another challenge is surfacing, the talent gap to squarely deal with the crisis.

The problem of talent gap, an opportunity? 

While preparing a company to succeed amid new challenges of the new normal, pharma leadership will notice some critical talent gaps in important areas of business. This is indeed a problem or a challenge. But can this also be converted into a new opportunity? … I guess, this is an opportunity of reskilling the company to meet with the future challenges, to move ahead at a faster pace.

In pursuit of this goal, top pharma decision makers may wish to evaluate a well-balanced mix of two approaches:

  • Reskilling competent existing employees for the new world.
  • Hiring new and ready – suitable talents, for immediate results.

Conclusion:

Reuters reported last Friday, with over 1 million Covid-19 cases, ‘India joins U.S., Brazil in the grim Coronavirus club.’ As on July 19, 2020 morning, the recorded Coronavirus cases in the country reached 10,77,874 with 26,828 deaths. According to the Indian Medical Association (IMA), the spike in the number of Covid-19 cases in India has resulted in the community spread of the Coronavirus disease. It further added: “This is now an exponential growth. Every day the number of cases is increasing by more than around 30,000. This is really a bad situation for the country.” The pace of climb continues going north.

Meanwhile, the Prime Minister of India has also urged all concerned to convert Covid-19 related challenges into opportunities. He said, it’s time to initiate reforms in several areas of governance by all the Indian State Governments.

Call it, the Prime Minister’s advice, or a basic management tool – most appropriate to leverage at this hour, the concept is worth considering by pharma players, as well, instead of getting overwhelmed by the crisis. Thus, in my view, it’s about time for pharma companies to identify critical Covid-19 related challenges, both immediate and also of the future – and convert those into opportunities – powered by technology-based cerebral inputs, in the new world order.
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

 

In Pharma’s Moment of Truth “What You Do is Who You Are”

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It’s a time when pharma industry will be tested, both by its external and internal customers – more than ever before. Looking back, in search of footprints on the sand is no answer either, as there isn’t any. But, a decision on moving ahead has to be made by each drug company in any case – charting a strategic pathway, in search of business excellence, if not for survival. A possibility looms large that the crisis may even overwhelm a company, if any, ill-conceived or ill-thought through steps are taken.

In that sense, the moment of truth has arrived for the industry – a time when ‘what different you do’ in the value delivery process of the business, will decide ‘who you are.’ One’s ability to lead the company or even follow the leadership, to navigate through this crisis, would determine the present and future success of the corporation. This isn’t an easy task. The evolving processes would be challenging to implement, and the traditional mindset may often act as a retarding force, as it were. In this article, I shall explore this critical area with recent examples, as far as possible.

Ability to fathom its most critical component is the bedrock for next steps:

The most critical component in this situation is the ability to make a careful and unbiased assessment of – how different would the ‘new normal’ be from the ‘old normal.’ The focus should not be on the barriers in making the necessary strategic changes, which I hear too often – but how to steer the business through this unprecedented crisis, regardless tough barriers on the way.

Covid-19 threat isn’t going to go away anytime soon:

However, one thing is for sure – no one knows, not just in India, but globally how big the crisis is, and will assume what form, when and how long. Let me give just three illustrations in this area that will be easily understood by all:

  • Initially, experts used to say, face masks are required only for those having symptoms and people close to them. “Masks are not required for those who doesn’t have symptoms. Whereas, the same experts are saying these days, “data now emerging about asymptomatic patients spreading the infection across the country, masks play an important role in containing the spread.” Thus, one is required to wear a face mask always while going outdoors.
  • Explaining the mode of disease spread, earlier, many experts, including the W.H.O, said that COVID-19 virus is primarily transmitted between people through respiratory droplets and contact routes. Thus, a mask is needed when one goes outdoors. Whereas, now the same experts, including the W.H.O, have confirmed that Coronavirus can be airborne indoors. In that case, one may need to wear a mask even indoors.
  • On April 23, 2020 the Director-General of Indian Council of Medical Research (ICMR), reportedly, claimed that the situation is stable, and the country has been able to ‘flatten the curve.’ But on May 09, 2020, Director, AIIMS, reportedly, said, “Currently, the cases are continuing to grow at a flat rate, sometimes even more. So, it is very difficult to predict when the peak will come; but it is likely to peak around June or July…” Whereas, an MIT study, which has also been reported in the press reveals, “India might see 2.87 lakh Covid cases per day by February 2021.”

These instances drive home the point – although a serious threat of Covid-19 infection will continue in the foreseeable future, but the way it will manifest itself, and the fresh precautionary measures that will deem necessary, may change with time. Let me give one more example of increasing threat of getting re-infected by Coronavirus by already infected individuals has heightened today than in the past.

The battle tactics need to be updated:

Strategy for war against Covid-19 onslaught may broadly remain similar. But the battle tactics in the multiple fronts need to be updated on an ongoing basis. This needs to be based on increasing or narrowing of the spectrum of threat and other critical factors, as scientific evidences will reveal from time to time.

For example, as is unfolding today, a large number of already infected people, particularly living in areas with high population density, may not necessarily develop any long-term immunity against the Coronavirus infection. Such a possibility will have a wide impact on any business strategy in the new normal that an organization may contemplate.

The rationale for constantly updating battle tactics:

Let me now focus on the rationale for constantly updating battle tactics based on scientific evidences with a few contemporary examples. The study, published in the Nature Medicine on June 18, 2020, found that individuals recovering from Covid-19 infection may have immunity only for 2-3 months. Although, it may not necessarily be construed that a recovered person can get re-infected, but any vaccine that may eventually come may need to address such issues, which seems to be a tough call.

Alongside, findings of another large research – Spain’s Coronavirus antibody study, published in The Lancet on July 06, 2020, has also cast doubt on the feasibility of herd immunity as a way of tackling the Coronavirus pandemic. As the BBC News reported on July 07, 2020 - based on these findings, Prof. Danny Altmann, British Society for Immunology spokesperson and Professor of Immunology at Imperial College London has made similar comments on effective vaccine development initiatives.

He said, the study would, “reinforce the idea that faced with a lethal infection that induces rather short-lived immunity, the challenge is to identify the best vaccine strategies able to overcome these problems and stimulate a large, sustained, optimal, immune response in the way the virus failed to do.”

“What You Do is Who You Are”: 

As the saying goes: “What You Do is Who You Are.” With this fast-evolving scenario, pharma leadership will need to effectively address a dual strategic game plan to outmaneuver the barriers of the Covid-19 pandemic:

  • Putting in place a robust operating strategy for customer value delivery process of the business.
  • Capturing the details of new Covid19 related ongoing developments to constantly hone the battle tactics in several different fronts.

Both the above processes will involve picking up all such validated research findings, mostly on the run. Mostly because, such issues may impact both internal and external customers of the organization, besides competition. Therefore, factoring-in each of those new developments, while constantly sharpening the war strategy and battle tactics in the fast-evolving scenario, will be of crucial. And, what you think or do in this situation will determine who you are – what type leadership traits you exhibit to face the challenges of the new normal, effectively.

Two types of leadership in the new normal:

Amid challenges of the present crisis, I reckon, top leadership will find two broad types of domain leaders – ‘pro-tradition’ and ‘pro-change’ – both will have successful past track records. They need to be identified for appropriate strategic tasks.

As is known to many, a good number of successful leaders are operating through decades around the concept of physical presence of patients while consulting a doctor or other health care providers. Several of them seem to be still unsure about the extent of organizational and operational changes required to face this unprecedented crisis, head-on. Even today, some of them keep trying to impress others by citing instances of what they did so well in the past.

There is nothing wrong in that. But, the business environment and requirements of those days were different – quite different from today’s demand. Curiously, many of such good leaders, with impeccable past success records, seem to be more bothered about seemingly insurmountable barriers on the way. They are afraid of migrating away or jettisoning the traditional pathway of success. Probably, the fear of failure – after achieving success for a long time, is the reason. I consider these successful professionals as ‘pro-tradition’ leaders.

There are also examples of another type of leaders. They are generally younger, looking forward with a contemporary mindset, nurture a can-do spirit with a resilience to bounce back, even in difficult times. Which is why, any transient fear of failure doesn’t usually overwhelm them. And, these leaders, I reckon, may be broadly termed as ‘pro-change’ leaders.

Keeping aside, past success records or future success potential of pharma leaders, in the current scenario – what they actually think or do in the changing environment to steer the organization out of this never-before crisis, will indeed determine ‘who they are.’

A contemporary initiative sets an example:

Top leadership of several drug companies, such as those at Novartis, is leading the way for a change management as the new situation will demand – by setting examples for others. These leaders seem to be taking note of all changes, as discussed above, while giving shape to a strategy, and reshaping the same based on data, as and when required. Interestingly, more technology professionals are getting attracted to pharma operations during Covid-19 pandemic than ever before, as a recent research report unfolds. This is a good omen for pharma and needs to be leveraged, effectively.

The findings of a new research report:

A new research report from Novartis -  A Powerful Pairing,  emphasizes: “The global COVID-19 pandemic sparked a seismic shift in the adoption and scaling of digital technologies across the healthcare sector at a pace never before seen. Almost overnight, organizations had to dial-up their efforts to develop, manufacture and ultimately bring medicines to patients in a socially distant world.” The survey brings out some interesting points, such as:

  • 86 percent of respondents believe the time has come for digital healthcare, and many of them are interested in taking part.
  • Regardless of the sector they currently work in, the two industries that technology professionals would consider switching to, are technology and healthcare and pharma (49 percent for each). This interest rises to 58 percent for workers based in India and 55 percent for those based in China. They feel, Covid-19 pandemic has made them more aware of medical causes around the world and how important they are. Through work in this sector, they can save countless human lives.
  • 52 percent of technology talent sees innovation potential in the healthcare and pharma sector, with the top reason to apply for a job being the opportunity to innovate through technology.
  • 89 percent technology professionals say that data science is important to the development and delivery of healthcare industry solutions and services.

Conclusion:

Surging ahead to reach a million mark, as on July 12, 2020 morning, the recorded Coronavirus cases in the country reached 850,358 with 22,687 deaths. With a record high of 27,755 daily cases yesterday, the pace of climb continues.

It’s now virtually a writing on the wall that India will have to sail through the unprecedented Covid-19 pandemic for quite some time, where unprecedented leadership interventions will be of critical importance – even in pharma. This endeavor will also call for selective induction of competent technology professionals in all pharma business domains, as required. The challenge involves not just carving out the ‘war strategy’, as it were, against Covid-19, but also continually honing the ‘battle tactics’ in multiple fronts – mostly on the run, for desired outcomes.

The situation calls for taking an in-depth inventory of an organization’s existing human resources, based on success ingredients required to turn the tide, which, I reckon, should also be the starting point in this venture. In this moment of truth – standing at the cross-roads of the drug industry, there is no further room for top pharma leadership to procrastinate the decision-making process. All competent professionals should be taken on board. In tandem, both – seemingly ‘pro-tradition’ and ‘pro-change’ leaders, should be encouraged to realize that in the new normal “What You Do is Who You Are” in the future pharma business.

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.

Time For Pharma To Leverage ‘The Break In The Clouds’

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A ‘break in the clouds’ is now clearly visible in the dark and overcast sky – witnessing a global havoc caused by the Coronavirus pandemic in the healthcare space – with its severe socioeconomic consequences. The name of the game to combat this gargantuan crisis in a heavily restricted environment with success, is adding ‘error-free speed’ in all aspects of the planned countermeasures.

This isn’t a very easy task, either. And certainly, is possible with well-integrated digital interventions. From this perspective, one can construe this situation as ‘break in the clouds’ that can be leveraged by pharma companies for digital transformation of their respective business operations.

It may also be interpreted as a blessing in disguise, because such transformation will empower the companies to take appropriate effective measures with speed. When effectively leveraged, such strategic steps will help pharma players in two ways. One, to contain the virus spread while ensuring access to care through business operations. And the second, will help propel the organization to move ahead, even within such a crisis. However, the ‘Digitalization’ process is multifaceted, having, at least two fundamental prerequisites. In this article, I shall focus on this strategic space.

Alternative ways to provide health care is fast gaining ground:

The product and service delivery models of pharma companies are generally built around the concept of physical presence of patients while consulting a doctor or other health care providers. However, Coronavirus pandemic has triggered some significant changes in this area. Let me illustrate this point with some contemporary references.

As the recent L.E.K paper – ‘COVID-19 and the Acceleration of Digital Health in APAC’ emphasized – ‘by sheer necessity, governments and regulators have also reduced the barriers to participation and uptake for remote engagement of consumers, enabling access to care despite social distancing measures,’ during the pandemic. Moreover, a technical guidance paper, published by the World Health Organization (W.H.O) on April 1, 2020 on strengthening health systems against COVID-19, also recognizes ‘telemedicine’ as an alternative model for delivery of care to ensure the continuous running of essential health care.

COVID-19 will take health system digitalization to a new level:

The above L.E.K paper also pointed out – in the days and months ahead, COVID-19 will accelerate the ‘digitalization’ of health systems to a new level. Especially when, healthcare stakeholders adopt a more urgent, no-holds-barred strategy to stem the rising tide of infections. L.E.K article predicted, the new ways of working and behaviors, forged and refined in the heat of battle against COVID-19, will not be easily put “back in the box.” Consequently, this increasingly digitalized reality will force a paradigm shift in the healthcare ecosystem, the paper concluded.

‘A virtually perfect solution’ to neutralize Covid-19 impact: 

Another paper - ‘Virtually Perfect? Telemedicine for Covid-19,’ published in the NEJM on April 30, 2020 wrote, disasters and pandemics pose unique challenges to health care delivery. It underscored, ‘Though telehealth will not solve them all, it’s well suited for scenarios in which infrastructure remains intact and clinicians are available to see patients.’ It also indicated, telemedicine may be a virtually perfect solution, particularly where such infrastructure is available.

‘Governments must reimagine healthcare delivery’:

That ‘Telemedicine can be a COVID-19 game-changer’ - both now, and in a post-pandemic world, was also articulated by another article, published by the World Economic Forum on May 13, 2020. It suggested: ‘Governments must reimagine healthcare delivery in the face of COVID-19.’

This is mainly because, hospitals and several other places where the COVID-19 battle is raging – have become risky places for both patients and healthcare workers. Although, several measures are being taken to limit transmission from such places, those are still ‘insufficient to stop overstretching of healthcare systems that were already overwhelmed before COVID-19,’ the article observed.

The good news is, in sync with the recommendation of the World Health Organization (W.H.O) for the use of telemedicine as an alternative model to boost clinical performance and optimize service delivery, India has also recognized its telemedicine facility. The Government finds it as ‘a blessing in disguise in time of Covid-19’ and has urged - ‘it’s already high time to recognize telemedicine as a mandatory technology for responding to the current pandemic.’

Health consumers started utilizing digital platforms during lockdown:

hanger, As I wrote in my article of April 27, 2020, being literally locked down at home, a good number of healthcare consumers in India, are utilizing innovative digital platforms, mostly for common illnesses or follow-up consultations, such as:

  • For medical consultation on digital platforms, e.g., Skype, Facetime etc.
  • Getting diagnostic tests done at home by requesting through digital apps,
  • Sending test reports to doctors digitally,
  • Getting doctor’s prescription through digital mode,
  • Ordering medicines through e-pharmacy apps by uploading prescriptions,
  • Getting medicines delivered at home after e-payment,
  • Repeating the same process whenever required.

I also mentioned there, the use of telemedicine in several different, unconventional formats, is also gaining momentum, signaling its greater potential in the years ahead. It seems a reality today, as strict compliance with ‘social distancing’ guidelines is one of the basic requirements of health safety for all.

Does pharma have any other prudent choice now to be effective?

Traditionally, health care industry almost in all countries, is structured on the model of in-person interactions between patients and their clinicians. As the article – ‘Covid-19 and Health Care’s Digital Revolution,’ published in the NEJM on June 04, 2020 wrote, ‘clinical workflows and economic incentives have largely been developed to support and reinforce a face-to-face model of care, resulting in the congregation of patients in emergency departments and waiting areas during this crisis.’

Realizing that this model of care contributes to the spread of the virus to uninfected individuals who are seeking evaluation, many health care consumers are now postponing the needed care or looking for a digital solution for common ailments, to begin with.

In this environment to be effective – pharma players don’t seem to have any other choice but to transform their business operations and scaling up operating systems with the power of digital technologies, as the article indicated. Although, some digital technologies, including telemedicine, have existed for decades, they have had poor penetration into the market for different considerations. But, it’s a transformed situation today, exhibiting a groundswell for the same.

Groundswell for digital transformation in pharma?

COVID-19 pandemic is creating a groundswell for an early digital transformation in the health care space where pharma industry plays a very critical role. If one observes carefully, it is not difficult to fathom the change in behavior and practices of health care consumers. Thus, it calls for commensurate changes in the operating models of the drug players, to keep the kettle boiling, at the very least.

Consequently, the need for integrated digital interventions, quite akin to ‘Zoom’ – replacing many long in-person meetings. Changes of such nature and significance won’t just come and go. These are here to stay to add speed, convenience and cost-effectiveness in business operations, even if Coronavirus disappears, eventually.

The shape and talent need of future organizations will be prompted by such changes, facilitated by digital technologies and Artificial Intelligence (AI). However, digital transformation isn’t just a ‘switch-on’ operation of drug companies, as and when they would wish. Moving towards this direction will call for an unbiased assessment of, at least two prerequisites, for each player.

Two important prerequisites:

As both personal lives and also the work lives of almost all professionals and entrepreneurs, along with the customer behavior, have metamorphosed significantly, commensurate changes need to be implemented in all these areas, urgently. One area where a quantum change has taken place almost unknowingly – mainly driven by the human instinct of survival in a crisis, is the use of various state-of-the-art digital platforms. These include, the way businesses and professionals interact with each other for productive engagements.

Many studies have unraveled this process, such as the one – ‘Seizing the moment in digital’, published in the eye for pharma on May 28, 2020. It underscores two critical prerequisites for any digital transformation of businesses. These are to assess – first, how compatible will this transformation be with the existing organization culture and the same of its top leadership.

If any barrier surfaces, the organization would need to ask, whether its business is ready for a commensurate cultural transformation to make it work productively. The second one is, the capability – it may not be just the technical capability – internal or outsourced to go digital, but more importantly, the capability to run the transformed business to fetch desired results.

Conclusion:

The world is still in the midst of a global crisis, triggered by the Coronavirus pandemic. It is quite far from even plateauing in India. As on July 5, 2020 morning, crossing half a million mark, the recorded Coronavirus cases in the country have reached 673,904 with 19,279 deaths. And its climb continues.

Thus, amid a virtually unfathomable Covid-19 crisis, it will be foolhardy to predict what will happen next. However, as one joins the dots of some significant development, a perceptible trend emerges through the break in the clouds. This is unlikely to vanish anytime soon, and is very likely to be a new normal. Many articles from various thought leaders, such as one of McKinsey Digital - ‘The COVID-19 recovery will be digital’, published on May 14, 2020, vindicated a ground swell for the same. Yet another interesting article of May 11, 2020, termed the Covid-19 pandemic as a black swan event – ‘pushing towards a digital future.’

That said, digital transformation for a drug player will call for an unbiased assessment of two critical prerequisites – culture and capability, to deliver a meaningful outcome. Be that as it may, all indicators confirm that this is undoubtedly a critical time for pharma to leverage the ‘break in the clouds’ in pursuit of excellence – in the new normal.

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.

Pharma’s Dual Challenge – To Save Lives And Livelihood

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“Jaan hai to jahan hai” (If you have life, you have the world). Prime Minister Modi - with a skillful tweak, used the couplet of the 18th century poet - Mir Taqi Mir, while announcing the criticality of 21-day national lockdown from March 24, 2020 due to Covid-19 global pandemic. Many Indians lapped up this concept, considering it as a short haul sacrifice to save lives. Possibly, because the Prime Minister had said at that time, ‘Mahabharata battle won in 18 days, war against Coronavirus will take 21 days.’

As the Covid-19 went on a rampage despite the national lockdown, the Prime Minister, on April 11, 2020, changed it to ‘jaan bhi and jahan bhi’ (life also, the world also). This slogan seems to be more relevant in the emerging scenario.

After over a couple of months stringent national lockdown, the necessity and urgency of restarting active life started assuming a priority status for all concerned. But, the restarting process won’t be a piece of cake either – for anybody. As it would not only involve saving lives, but also – ensuring proper means of livelihood, making the industries gradually return to normal, and thereby revival of the country’s economy.

Dr. Ashish Jha, Director of the Harvard Global Health Institute, has summarized the nature of this challenge concisely, as quoted by the article – ‘Five key questions about India’s rising Covid-19 infections.’ This was published by BBC News on June 15, 2020. Acknowledging that India is in a very difficult situation, Dr. Jha said, “We are still early in the pandemic and we have a good year or so to go before we turn the corner. The question is what is the plan to get India through the next 12 to 16 months?”

Like many other industries, this is an arduous task to accomplish even for the drug industry, and for that matter – by any country. From the pharma industry perspective, I reckon, the commencement of the ‘restarting’ process, would pose a tough and dual challenge for many players – for different reasons. The current expectations require them going much beyond developing and delivering effective drugs and vaccine to win the Covid-19 war, and include the following, as well:

  • The population needs to develop either a vaccine-induced or a herd immunity, for a long-term protection against Covid-19. Pharma companies can facilitate the former one.
  • The entire population should have access to scientific evidence-based Coronavirus drugs and vaccine – at a price that most people can afford, to achieve the goal of vaccine-induced immunity.

In this article, I shall explore the ground issues in this area while confronting this dual challenge by the pharmaceutical industry, in general.

Developing herd immunity not an option for India: 

As it is known to many, even without an effective vaccine, it is possible for the population to develop a herd immunity. However, in this situation, a very large population will need to get infected, with its consequent impact on healthcare infrastructure and people’s lives. But, it will possibly be foolhardy to even think about this option, particularly for any country, such as India.

Dr. Ashish Jha in the above article on the BBC News, has also captured this challenge, aptly. He articulated, ‘India cannot wait for 60% of its people to get infected to achieve herd immunity and stop the virus. ‘That would mean millions of people dead. And that is not an acceptable outcome.’ Moreover, India’s Covid-19 infection curve has not started flattening – there is no consistent and steady decline, just yet. Thus, a vaccine-induced immunity seems to be the only prudent choice for the country.

Other reasons why an early intervention is necessary:

A national lockdown in India was certainly necessary to save lives. However, its prolonged duration of over 3 months, has caused a widespread confusion, anxiety, and fear among the public regarding the disease. Consequently, it has created several unintended social consequences, such as disease related stigma, discrimination, besides triggering several serious health hazards. The World Health Organization (W.H.O) also recognizes this problem.

Instances of stigma and discrimination against medical personnel – doctors and health care workers are common and have already been reported. Similarly, those working in aviation, especially on flights that were sent to bring the Indians back from COVID-19 affected foreign land, also met the same fate. Interestingly, such instances are not uncommon even within various housing societies for high income groups and communities. The stigma associated with COVID-19 is real and here to stay, at least for some time.

Serious health hazards like, panic, depression and anxiety have also gone viral as the nation was observing lockdown. Experts, reportedly, have opined that the fear of contracting viruses, compulsorily going to institutional quarantine centers and rising number of deaths, among others, are big triggers for all. Many believe, various communications – formal and informal – to keep people indoors, have given rise to such unintended consequences involving average Indians.

These developments further reinforce the critical need for an early therapeutic intervention in the disease treatment and prevention areas, such as an effective vaccine, where pharma can deliver what it does the best, and sooner.

Green shoots of overcoming the first challenge are visible:

Although, the world has not reached there, just yet, some green shoots of overcoming the first challenge with scientific-evidence-based drugs and vaccine, are now in sight. Treating Covid-19 effectively with the old warhorse – dexamethasone at a very affordable price, is almost a reality today. W.H.O has also called to ramp up dexamethasone production for Covid-19 patients.

Meanwhile, a few other drugs, such as remdesivir and favipiravir have also received marketing authorization of DCGI for treatment of Coronavirus in India. Similarly, Oxford University and AstraZeneca’s experimental Covid-19 vaccine have, reportedly, entered the final stages of clinical trials. Scientists are now in the final assessment of how well the vaccine works in protecting people from becoming infected by the virus.

A shift in the most vulnerable population poses another tough challenge:

As the need to restart the economy of the country becomes paramount, alongside the urgency of saving lives and livelihood, a shift in the most vulnerable population for Covid-19 infection is clearly visible.

As many would know, Coronavirus pandemic started with the more affluent class of the society who mainly travel abroad for work or studies. However, it is now spreading fast in the lesser privileged social strata, including poor migrant labors and other marginalized population. The spread now spans across from affluent communities, right through densely populated slum areas. The trend keeps going north, as each day passes, as of now.

In such a situation, to contain the disease effectively, Covid-19 drugs and vaccine must be accessible and affordable to all. Making this requirement another tough challenge for the pharma industry – as and when the therapies receive marketing approval of drug regulators.

Recently available drugs are expensive, even in India:

From the recent trend it appears, unlike hydroxychloroquine or dexamethasone, most of these emergency use Covid-19 drugs, such as remdesivir or favipiravir may not be accessible and affordable to a vast majority of the population, as discussed below.

Like remdesivir, favipiravir is also, reportedly, the subject of at least 18 clinical trials involving more than 3,000 patients across India, USA, Canada, Italy, China, France, UK and other countries. Encouragingly, for the Oxford University developed Coronavirus vaccine, Serum Institute is expected to price it at Rs.1,000 per vaccine. Thus, for a family of 4 persons, it would cost around Rs. 4000. Be that as it may, lets have a look at the comparative clinical efficacy of cheaper and relatively expensive repurposed older drugs, against their respective costs.

Comparative efficacy and cost of a cheaper and expensive repurposed drugs: 

While comparing the relative clinical efficacy of cheaper and relatively expensive repurposed drugs – against their respective costs, some interesting facts surface, as follows:

According to the reported results, published by FiercePharma in an article on June 24, 2020, dexamethasone treatment led to a 35 percent reduction in death rate among patients on invasive mechanical ventilation and 20 percent for those receiving oxygen without invasive ventilation. The dose used was, 6 mg of dexamethasone in a single dose per day – either orally or via intravenous injection – for ten days at a stretch. Whereas, the cost of Dexamethasone (0.5mg) in India, for a strip of 30 Tablets, is around Rs.6.00.

Similarly, the same article reported, remdesivir has been found to reduce the death rate among severe patients to 7.7 percent from 13 percent for placebo, a difference that was not statistically significant.Whereas, remdesivir in India, will cost around Rs 5,000-6,000/dose. And its recommended dose for adults and pediatric patients weighing 40 kg and higher, is a single loading dose of 200 mg on Day 1 followed by once daily maintenance doses of 100 mg from day 2 up to 5 to 10 days.

Similarly, favipiravir will be available in India as a 200 mg tablet at a Maximum Retail Price (MRP) of Rs 3,500 for a strip of 34 tablets. Whereas, its recommended dose is 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14, according to its manufacturer.

An interesting fallout of Dexamethasone study:

An interesting fallout of the dexamethasone study on arriving at a fair price for remdesivir for treating Covid-19 patients, is worth noting. The Institute for Clinical and Economic Review (ICER) had earlier highlighted the “cost-effectiveness” benchmark price of remdesivir ranges from $4,580 to $5,080. However, ‘a new scenario analysis assuming the likely incorporation of dexamethasone as standard of care, produces a lower benchmark price range for remdesivir of $2,520 to $2,800.’

Conclusion:

As on June 28, 2020 morning, crossing half a million mark, the recorded Coronavirus cases in the country have reached 529,577 with 16,103 deaths. And the climb continues. In the context of the same disease, a publication of the London School of Economics and Political Science (LSE) had recently articulated: ‘In less than 3 months, COVID-19 has become a global pandemic of proportions we have not experienced this century. This has led to some of the largest economies in the world racing to develop a vaccine to combat the disease. However, in this time of urgency, patent laws may conflict with the equal provision of these future medicines worldwide.’

In sync with this sentiment, apprehensions of profiteering on drugs, tests, or vaccines used for the COVID-19 pandemic are mounting in almost all countries. Governments are now being encouraged to suspend and override patents and take other measures, such as price controls, to ensure availability, reduce prices and save more lives.

According to reports, Canada, Chile, Ecuador and Germany have already taken steps to make it easier to override patents by issuing ‘compulsory licenses’ for COVID-19 medicines, vaccines and other medical tools. Similarly, the government of Israel issued a compulsory license for patents on a medicine they were investigating for use for COVID-19.

From the industry, a strong demand for fiscal stimulus, such as the removal of the Health Cess and Customs Duty, to support patient access to critical medical products, is also gaining momentum, alongside the early release of Government payment to providers.

Thus, while exploring the dual challenge lying ahead for many pharma companies – to save both lives and livelihood – delivering effective drugs and vaccine may probably be an easier task than improving access to those – for all, in a meaningful way.

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.