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More Challenges For Brand Launch Success In The New Normal

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The drug manufacturers’ life blood to drive business growth has always been successful new product launch. However, this task has always remained a tough challenge to crack, since last so many years for various reasons. According to McKinsey & Company: “About two-thirds of drug launches don’t meet expectations. Improving that record requires pharmaceutical companies to recognize the world has changed and adjust their marketing accordingly.” Several research studies have been carried out by now to gain actionable insight on this issue.

Existing challenges for successful drug launch got further amplified, as Covid-19 pandemic added a novel dimension in this space. It involves disruptive changes in many facets of customers’ new product-value expectations. Similar changes are witnessed in the product value delivery process, doctor-patient engagement, content development and delivery platforms, among others. This article will explore this area from successful new product launch perspective, in the days ahead.

Dismal outcome of many new drug launches – more for primary care:

According to a recent study, published by L.E.K Consulting on December 18, 2020: ‘About half of all products launched over the past 15 years have underperformed pre-launch consensus forecasts by more than 20%.’ This is quite in line with what McKinsey & Company found in 2014, as quoted in the beginning of this article.

However, in a relative yardstick, the primary care market has been the most vulnerable, which continues even during the ongoing pandemic. For example, according to an April 2020 Evaluate Vantage analysis, ‘Covid-19 adds a new danger to drug launches.’ The study emphasized, new drug launches, especially those targeting the primary care market, are particularly vulnerable as the pandemic continues. The key reason being, besides widespread disruptions in the health care system, sales teams will be physically unable to reach frontline physicians, as much as, and also the way they could do the same in the old normal. The studies underscore that a strong launch is critical to achieving maximum commercial potential, despite odds.

Some pivotal factors demand a greater focus than ever before:

After in-depth analysis of various studies in this area, some pivotal marketing factors appeared critical to me, in order to reduce success uncertainty while launching new products.

Alongside, unbreachable and agile supply chain alternatives also assumed a never before-frontline-importance in the new normal, unlike pre-Covid days. Another recent study, titled ‘Competitiveness During Covid-19 Pandemic: New Product Development and Supply Chain Agility’, published by ResearchGate in October 2020, vindicated the point.

As the title indicates, the above study examined the effect of new product development and supply chain agility to gain competitiveness during the Covid-19 pandemic and probably beyond. Thus, while developing and launching new products in the new normal, some pivotal factors, such as the following, appeared critical to me, in order to reduce success-uncertainty while launching new products:

  • Early planning for launch with a robust market access strategy, better sales forecasting with stretch goals – supported by state-of-the art forecasting tools and relevant learnings from the past.
  • Gaining actionable insight on changing customer needs, market dynamics and competitive threats in the new normal – by generating credible and contemporary data and leveraging the power of analytics – to offer differentiated stakeholder value.
  • Driving home patient-centric coeval product values that will delight customers – through flawless execution of stakeholder engagement strategies.
  • Working out virtual, innovative, personalized and impactful alternatives to some critical launch related physical events, such as, conferences, seminars, webinars and the likes, for doctors and other customers.
  • Developing creative and contemporary content and other marketing assets for significant online or omnichannel presence of new brands – supported by video clips and other tools, aiming at the target audience.
  • Differentiating the launch product clearly from those of the nearest competitors, where a focus on price-value relationship of the brand – from the patients’ perspective, could play a game changing role. As McKinsey & Company also highlighted, launching an undifferentiated product in an unestablished disease area carries a greater risk of failure.
  • Creating a robust and agile supply chain to navigate through unexpected market changes – as all experienced recently.

Delivering ‘patient-centric’ real value of the brand together, is critical:

Interestingly, L.E.K Consulting has also emphasized in its recent study that to drive and effectively deliver ‘patient-centric’ real value of new products, it is imperative for drug companies to execute the launch process flawlessly.

To make it happen on the ground – at the moment of truth, careful selection of a team of self-motivated people is necessary. This needs to be followed by intense training in all aspects of the specific launch, including effective use of modern digital tools and platforms – and above all – by creating a ‘can do’ team spirit to deliver the deliverables.

This requirement has been epitomized in the recent article, titled ‘Beyond the Storm: Launch excellence in the new normal,’ published by McKinsey & Company. Therein, the authors articulated, ‘Intangible though it may sound, great launches have a different feel from normal launches. There is a real sense that – we’re all in this together.’

Pharma’s current way of using digital platforms doesn’t satisfy many doctors: 

Over the last one year, as the pandemic brought all human activities virtually to a grinding halt, there has been a significant shift towards digital tools and online platforms, including in the way medical practitioners interact with drug companies. As recent surveys indicate, pharma customers don’t seem to be quite satisfied with the way many pharma players are currently making use of this technology.

This is happening even with those doctors who are open to virtual engagement and in favor of remote patient consultations. The issue needs to be resolved soon, particularly for new product launch successfully – using digital platforms, as reported in recent surveys.

The survey reports retraining of ‘sales reps to become digital orchestrators’:

One such recent survey, conducted by Indegene, which was also reported by Fierce Pharma on February 01, 2021, digital dissatisfaction of doctors with pharma companies, has jumped during the pandemic. The rates of dissatisfaction with pharma digital interactions, across media channels, ranged from 23% to almost 50% of physicians. Some of the key findings of the study include:

  • 49% of physicians are not happy with pharma’s social media engagements – perceived as less sophisticated when compared to expectations set by consumer companies.
  • Pharma is far from providing a satisfactory digital experience, as compared to other industries. The current dissatisfaction level where a higher percentage of doctors were dissatisfied, include marketing emails – 46%, telephone sales calls with sales reps – 42% and both webinars and websites – each at 39%.
  • In-person meetings dropped from 78% to 15% during the pandemic, but even now only 48% of doctors surveyed expect in-person engagements to continue in the post-COVID world.
  • Attendance at medical conferences also dropped from 66% to only 16% during the shutdowns and travel restrictions, but only 50% of HCPs now expect to resume in-person congresses after it’s safe to hold them.
  • The number of physicians engaged in remote sales visits increased from 11% to 47% during the pandemic, probably because there weren’t other alternatives available. Interestingly, one-third of physicians still plan to continue with virtual sales meetings even after the pandemic.
  • Most stakeholders are realizing, this is going to be the new normal, with senior pharma leadership also saying, ‘it’s never going to be the same as before.’
  • About 5 of the top 15 global pharma players are retraining their sales reps to become “digital orchestrators” and working to help them create clear and comprehensive digital communications for doctors.

Speedy resolution of these issues is likely making a substantial difference in improving pharma-to-physician interactions, particularly during new drug launches, in the days ahead.

Conclusion:

Success uncertainties in new product launches have always been a cause of concern for the drug industry, especially after having invested a substantial resource towards innovation and clinical developments. Interestingly, pharma players were mostly following ‘stick to the knitting’ dogma, as it were, in their launch planning. Despite the availability of sophisticated digital tools and analytics over the last several years, particularly in generating and accurate analysis of contemporary and credible data to gain insights, not much had changed radically. Suddenly Covid pandemic disrupted most market traditions, business processes, and the general belief on decision makers’ ‘gut feelings’ on customer behavior, market dynamics. Besides, the mindset of ‘doing better that what you have been always doing’, prevailed in many cases. In India, market research for most companies remained within the ambit of syndicated retail and prescription audit, despite frequent grumbling of many marketers on some critical findings of these reports.

The last one year has created more challenges in this area, although with a silver lining. A large number of drug companies have now stepped into the area of digital marketing – in varying degree, scale and resource deployment. This shift is expected to help reduce launch success uncertainties of new drugs. It will again, depend on how effectively the technology is leveraged by the cerebral power of astute markers.

Another article on pharma product launch, published by McKinsey & Company on December 15, 2020, also vindicated this point. It underlined: ‘As pharmaceutical companies reshape their commercial model to prepare for the uncertainties ahead, personalization and digital enablement will be crucial to launch success in the new environment.’

Amid these, as some surveys highlight, many doctors are not satisfied with the way digital technology is being currently used by pharma companies – to interact with them and cater to their information needs. With these ‘teething troubles’ being properly and promptly addressed, many drug companies, I reckon, will be able to remarkably reduce success uncertainties of new drug launches 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.

 

A Rare Strategic Acrobatic Feat in Covid Time

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‘Keep nose to the grindstone while lifting eyes to the hills.’ Quite a while ago, all-time global management guru – Peter Drucker used this essential acrobatic feat as an example, for the business strategists. This illustration signifies the criticality of harmonizing decisions affecting both the short and the long-term goals of an organization, for a sustainable business excellence.

In most recent times, the pharma major AstraZeneca that has virtually become one of the household names, for developing a Covid-19 vaccine candidate with the University of Oxford, has performed the above acrobatic feat – with precision. During the prevailing unprecedented health crisis, the Company has unequivocally proven that it remains on course – in achieving its dual objectives, as Drucker had prescribed in his management classic – ‘The Practice of Management.’

It happened in tandem – without getting overwhelmed by the disruptive forced of Covid pandemic, unlike most others. Immediately, the Company focused on an urgent objective of saving the humanity – by developing, manufacturing and delivering a Covid vaccine to the world, in a record time. This was possibly a relatively short-term goal. And closely followed the other – a critical strategic decision for the organization’s long-term sustainable business excellence.

I have discussed before, the Company’s first initiative – developing a Covid vaccine candidate with the University of Oxford. Hence, in this article, I shall focus on two other related areas:

  • Deadly impact of rare diseases in some Covid infected young patients.
  • Why not some large Indian companies also explore similar strategies as demonstrated by AstraZeneca – and the reasons behind the same?

Before going into those areas up front, let me start with a brief description of AstraZeneca’s intent to expand its footprint in the of area of rare diseases, besides immunology area to help treat rare types of cancer.

The acquisition:

On December 12, 2020 AstraZeneca announced that to accelerate its strategic and financial development, the company will acquire Alexion valuing $39 billion. Subject to all statutory approvals, the deal is expected to close in the third quarter of 2021. Interestingly, Alexion’s top brand – Soliris, is the world’s one of the most expensive drugs in the world. It is prescribed to treat a rare – life-threatening blood disease paroxysmal nocturnal hemoglobinuria (PNH). Incidentally, rare diseases have also some significant relevance for Covid infected patients. Let me now recapitulate, some key aspects of rare diseases.

Some key aspects of rare diseases: 

Rare Diseases (RD) – also referred to as Orphan Disease (OD), are diseases affecting a small percentage of the population, and include genetic diseases, rare cancers, infectious tropical diseases and degenerative diseases. There is no universally accepted definition of a rare disease, yet. Different countries define these differently. However, the common considerations in the definitions are, primarily, disease prevalence and to a varying extent – severity and existence of alternative therapeutic options.

Impact of some rare diseases in Covid infected patients: 

Since the beginning of the Covid pandemic, people with underlying diseases, such as, hypertension, diabetes, cardiovascular and kidney disorders, are considered to fall in the high-risk group. They are more likely to have severe disease and complications and need to be extra cautious of the infection. Importantly, it has been recently reported that some rare diseases also increase risk of dying during Covid-19 pandemic at a younger age.

For example, as reported on December 07, 2020, recent studies indicate, rare autoimmune rheumatic diseases increase risk of dying during Covid-19 pandemic for younger patients. The researchers also found that women with rare autoimmune rheumatological diseases (RAIRD) had a greater increase in all-cause mortality rates during the pandemic when compared to men with RAIRD. However, there seems to be an India specific issue also in this situation, as well.

India specific issue for Covid infected patients with some rare diseases:

Some India specific issues on RD, could have a significant adverse impact on Covid infected patients in the country. One such critical issues is the ‘Baseline Knowledge of Rare Diseases in India.’ This fact was well captured in an important survey that was published with the same name, as an original article, in the ‘International Journal of Rare Diseases & Disorders,’ on November 06, 2019.

The study noted, among others:

  • Although, rare diseases have recently received worldwide attention, the developing countries are seriously behind in regard to awareness, drug development, diagnosis, and social services, in this area. India, which has one-third of the world’s rare disease population, has no accurate assessment of the problem.
  • The drugs for ‘Rare Diseases (RD), also called Orphan Drugs (OD)’, often cost exorbitant with difficulties in diagnosis and treatments.
  • Indian policymakers want to find out the number of RD and the extent of the population suffering from them and help provide treatment for them, which is a challenging task with 1.45% GDP health care budget for 1.3 billion people.
  • The health care professionals appear to have some awareness as compared with non-healthcare professionals, but even among health care professionals, only one third had a rudimentary understanding of RD and OD, whereas three-fourths have virtually no knowledge of RD.
  • Forty-three percent of health professionals had not seen rare disease patients, and a large percent of practicing physicians had not seen even one rare disease patient in their entire professional practice.

Thus, it is clear from this survey that the most important issues are awareness and diagnosis, as many rare diseases are not diagnosed or possibly misdiagnosed. Besides, the survey also observed, since 1983, many global companies started developing orphan drugs after the Orphan Drug Act implementation. There is none at this time in India, although in 2017, the Drugs & Cosmetic Act. 1945 has been amended to include “rare diseases and orphan drugs”.

The National Policy on Rare Diseases flagged some of these facts:

The ‘National Policy on Rare Diseases 2020,’ for India, released by the Union Ministry of Health on February 07, 2020, acknowledged many of these important facts. It also said, ‘Considering the limited data available on rare diseases, and in the light of competing health priorities, the focus of the draft policy is on prevention of rare diseases as a priority as identified by experts.’

Interestingly, the first of such policy was prepared by India in 2017 and a committee was appointed to review it in 2028. However, recently published the National Policy on Rare diseases, has also noted one more important point. It noted: ‘Paradoxically, though rare diseases are of low prevalence and individually rare, collectively they affect a considerable proportion of the population in any country, which according to generally accepted international research is – between 6% and 8%.’ Currently, India, reportedly, doesn’t have any registry of rare disease, which has now been entrusted to the Indian Council of Medical Research (ICMR) in the National policy.

Common symptoms can hide underlying rare diseases, leading to misdiagnosis:

The above policy has also noted, rare diseases are characterized by a wide diversity of signs and symptoms that not only, reportedly, vary from disease to disease, but also from patient-to-patient suffering from the same disease. Importantly, relatively common symptoms can hide underlying rare diseases, leading to misdiagnosis.

During Covid treatment, similar circumstances could lead to a serious life-threatening situation. The 2020 RD Policy also reiterates: “Early diagnosis of rare diseases is a challenge owing to multiple factors that include lack of awareness among primary care physicians, lack of adequate screening and diagnostic facilities etc.” That said, yet another key question arises – will developing and marketing such drugs be profitable for the pharma industry?

Will developing such drugs be profitable for the pharma industry?

It is worth noting that the National Policy on Rare Diseases 2020, aims more at lowering the incidence and prevalence of rare diseases based on an integrated and comprehensive prevention strategy, rather than ensuring patient access to affordable treatments. Nonetheless, it also says, within the constraints on resources and competing health care priorities, India will try to enable access to affordable health care to patients of rare diseases which are amenable to one-time treatment. In general, the policy suggests, ‘voluntary crowdfunding for treatment’ of rare diseases.

With this being the prevailing situation in India, even during Covid pandemic, an interesting article – ‘How Orphan Drugs Became a Highly Profitable Industry,’ published in The Scientist, noted some important facts in this area. It highlighted: ‘Government incentives, advances in technology, and an army of patient advocates have spun a successful market—but abuses of the system and exorbitant prices could cause a backlash.’

It also articulated, despite higher costs and less-certain returns, investments in drug development on the rare diseases side appear to ‘be bucking the trend.’ The result of the global focus on RD nowadays is: ‘Firms with marketing authorization for orphan products, are now more profitable than those without.’

This also partly explains the financial rationale behind AstraZeneca’s recent acquisition of Alexion Pharmaceuticals, valuing $39 billion.

Conclusion: 

As of December 20, 2020 morning, India recorded a staggering figure of 10,031,659 of new Coronavirus cases with 145,513 deaths. The country has already crossed 10 million in Covid cases as the vaccine approval remains pending. The threat of subsequent waves for further spread of Covid infection continues to loom large in many states. Meanwhile, many studies indicate that comorbidity should now include rare diseases, as well, especially to prevent deaths in younger patients. From this perspective effective diagnosis and treatment of RD are also coming under spotlights. Curiously, the National Policy on Rare Diseases 2020 focuses more on awareness and prevention of RD rather than access to affordable treatment, particularly in Covid infected patients to save precious younger lives. As I wrote previously and still believe, the ‘National Policy on Rare Diseases’ becomes more meaningful with ‘Orphan Drugs Act.’

Vaccines to prevent Covid infections are also expected to get emergency approval in India, shortly. At lease, some of these being available at affordable prices, including AstraZeneca-Oxford vaccine, according to reports. As recent reports indicate the same company, is also entering into RD therapy areas, through a key acquisition, yet another hope looms large. A hope for availability of relevant RD drugs at an affordable price for Covid infected patients, despite other apprehension, as I wrote before.

That apart, purely from the business management perspective, as well, this rare strategic acrobatic feat of AstraZeneca - ‘Keep nose to the grindstone while lifting eyes to the hills,’ during the Covid crisis, I reckon, is exemplary for the practicing managers.

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.

 

Creative Pharma Marketers To Unshackle Covid Fetters

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Pharma industry, just as most others, has started recognizing that the business needs to be brought back to normal, despite Covid fetters. Some early evidences suggest, a new breed of pharma marketers is refusing to get confined to Covid triggered operational limits, without breaching any prescribed safety norms.

These pacesetters no longer grapple with finding right answers to the question – when and how the brand building activities can be brought back to the old normal? Truly speaking, none has its answer, as yet. Covid has the power to strike back, anytime – anywhere, in waves, when the guards are even slightly down. Moreover, as and when vaccines will come, these may not be ‘silver bullets’ for many – throughout a lifetime, at least, in the foreseeable future.

Accordingly, these forerunners are effectively leveraging the art of turning challenges into opportunities. They are conceptualizing new business models for making path-breaking progress in contemporary purpose driven branding exercises. For all pharma marketers, I reckon, this is the moment of truth, when what you do reflects what you really are, in this area. Thus, in this article. I shall deliberate, with examples, how these creative new age pharma marketers are trying to unshackle Covid fetters.

Today’s reality on the ground: 

A number of global surveys on how patients’ have reacted to Covid-19 pandemic with reasons behind the same, are now available. One such study was conducted by Medisafe, during March and April, 2020. Some of its key findings are as follows:

  • More than half of the respondents, especially those with comorbidities, worry about getting Covid infected while accessing to in-person treatments.
  • Over 9 out of 10 respondents were practicing social distancing, as a remedial measure.
  • Consequently, they are missing doctors’ appointments, and many are opting for telehealth wherever appropriate and necessary.

In many situations, such as,  common and repetitive health issues, including some mental health conditions, virtual health care are more convenient. It has also been established during the pandemic that telehealth can deliver similar outcomes at a lower cost, than in-person visits. In addition, remote monitoring of some key health parameters, like heart rhythm, blood sugar, weight, respiratory rate, also help people control their chronic conditions better, and assist clinicians with diagnosis and treatment.

More doctors prefer telehealth, but the majority wants some in-person visits too: 

An interesting study – ‘Want Both In-Person and Virtual Visits with Sales Reps,’ published by Bain & Company on June 02, 2020, ferreted out today’s reality, in this space. It found, prior to Covid, about three-fourths of physicians preferred face-to-face engagement with sales reps. In contrast, today more of them are asking for a reduction in Rep visit frequency and more remote support or virtual approaches. Curiously, a majority still prefers, at least some in-person interaction ‘once the pandemic passes.’

Interestingly, no one seems to know, just yet, when exactly will this pandemic get over. Besides, whether or not Covid will keep coming back in waves, for an indefinite period. Or, any similar or even worse global health crisis, in future, could bring greater disruption for the industry.

Driven by such apprehensions, it is possible that more and more patients will prefer telehealth, expanding access to health care for an increasing number of people. Nonetheless, one should also take into consideration that virtual health care has also some significant limitations, especially those which may lead to serious or life-threatening conditions.

Some key limitations to overcome:

Alongside multiple advantages of telehealth, it has some significant limitations, which can’t be wished away, either. This point was also well articulated in the article – ‘Where Telemedicine Falls Short,’ published in the Harvard Business Review (HBR) on June 30, 2020. The author, who is also a primary care physician gave a number of examples in this regard. For example, in one place he wrote:

‘I have found treatable cancers multiple times in routine exams that would be impossible to replicate in the virtual world. Could a Zoom visit detect a lymph node too firm, a spleen or liver too large, or an unexpected prostate nodule (with a normal PSA)?’ The paper also emphasized: ‘Trust and face-to-face encounters are even more important for patients with complex and intertwined problems.’

Be that as it may, the task to encourage patients, even with serious ailments, for in-person consultation and examination by doctors’ in their clinics, won’t be ‘a piece of cake’ too. On the contrary, it will be rather a colossal exercise.

Why will this task be colossal?

One can get a sense of tough challenges involved in this effort from the IQVIA report titled, ‘COVID-19 Pandemic and the Impact on SEA Healthcare Market.’ Along with other areas, the study captured several details of the above area, specifically for the South East Asia (SEA), as follows:

  • Decrease in patient visits (Out-Patient): 2 out of 3 hospital doctors are experiencing >60% decrease in patient visits.
  • Extended period of time before patient load resumes to normal: ~50% of doctors think that it will take 4 to 6 months to resume normal operations.
  • Increase in prescription duration: ~25% of doctors have 2x their standard prescription duration to reduce patient visits.

The study also observed, ‘in order to reduce the risk of getting infected, patients are reducing their visits to the HCPs.’ Such an unusual situation is unlikely to be mitigated, soon, with any traditional or ‘one size-fits all’ type strategy. Particularly when Covid threat still looms large on the population. As is happening today, even after signs of waning, Covid may return in waves – for an indefinite period. Thus, innovative marketing interventions, backed by actionable insights, are essential to help overcome the fear of getting Covid infected, by both patients and doctors.

How to respond to this situation in a creative way?

The creative marketing response to overcoming the possible barriers on the way, would call for predictive rather than reactive pharma strategies. The game plan not only needs to be purpose drivenfor the marketers, but should also be perceived that way by all concerned. For example, the core purpose of marketing in this scenario, will be to provide a life-saving patient ‘service’, with win-win outcomes.

And the additional ‘service’ in this case is encouragement in-person physician visits during early symptoms of life-threatening health conditions – taking all safety precautions and overcoming ‘paranoia’ of getting infected. The win-win outcomes will include – saving lives, preventing deterioration of the disease condition, and of course, facilitation of the brand demand. The good news is some global pharma majors have already started making progress in this direction.

Promoting doctor visits during the pandemic – an example:

Leaving footprints to follow, some pharma marketers have already started creatively working on it. Let me cite a recent example of this unique initiative. This was reported by Fierce Pharma in its November 02, 2020 issue. The marketing process carries all the required ingredients for excellence, as mentioned above.

It wrote, ‘Pfizer and Bristol Myers Squibb are the latest drugmakers to join the swell of campaigns promoting doctor visits during the pandemic.’ This decision was based on data, showing many people haven’t been going to their primary care appointments for symptoms that may lead to potentially serious conditions.

This initiative is focused on three critical health conditions, namely, atrial fibrillation, deep vein thrombosis and pulmonary embolism. The rationale for selecting these three indications is, these are all treated by the partners’ anticoagulant Eliquis.

Accordingly, the BMS-Pfizer Alliance launched a campaign to raise awareness and encourage people to seek prompt medical attention. The American campaign was built around the theme – ‘Your symptoms could mean something serious, so this is no time to wait.’ In tandem, the companies also widely communicated through multiple channels that ‘Decreases in Americans’ Primary Care Visits May Lead to Late Diagnoses of Potentially Serious Conditions.’

According to reports, the net result of this creative marketing, so far, is no less than outstanding, as compared to many other pharma players operating in similar situations. ‘Eliquis’ brand sales for the first six months of 2020 topped $4.8 billion, a 21% increase over the same time period last year. Doesn’t this initiative demonstrate that creative pharma marketers can unshackle even Covid fetters?

Conclusion:

Meanwhile, as on November 08, 2020 morning, India recorded a staggering figure of 8,507,754 of Coronavirus cases with 126,162 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks. But, the threat of further spread of Covid infection, in waves, still looms large in the country.

Most scientists agree – while effective vaccines offer the best chance of reaching zero COVID-19 – eliminating the virus across much of the world, while not unthinkable, could take a significant number of years. Thus, it may be realistic for some time to focus on flattening the curve with stringent control measures, involving efficient contact tracing, testing and isolation, together with social distancing and mask wearing – till it happens, ultimately.

Meanwhile, the business must flourish, even amid a new normal. And this is, in no way, a pipe dream, but a proven reality, as we have seen above. No doubt, this calls for most pharma marketers wearing a fresh thinking cap, equipped with more cerebral power, as it were, to unshackle Covid fetters on their way – effectively.

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.

 

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.

Changing Doctors’ Practice Dynamics With Covid-19 And Beyond

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Unexpectedly, the answer to an onerous question surfaced just around a year’s time. In my article on this blog, written on April 08, 2019, I raised a question – “Would ‘Connected Healthcare’ Catch Pharma Players Off-Guard?” Interestingly, an unexpected and abrupt turn of events in the global healthcare space, including India, triggered by Covid-19 pandemic, signals an early dawn of an evolving reality, related to ‘Connected Healthcare’, in India.

Never ever, I reckon, the Government realized so well that continuation with a fragile public healthcare infrastructure is self-defeating for the country. Allocation of financial resources, at least 2.5 percent of the country’s GDP, for its rejuvenation – powered by AI-based modern digital technology, would help avoid overburden on the healthcare system. This will mean, saving more lives and also a significant reduction of morbidity, especially in a situation, like Covid-19 pandemic. Good health can propel good economy, more effectively.

That’s why, ‘connected healthcare’ – by effectively linking requisite ingredients of all health-related information that medical professionals and the patients would need, appears to be the new reality. This process is being facilitated by rapid acceleration of usage of various digital platforms, by both healthcare consumers and providers. Thus, it is becoming increasing clear now that leveraging digital technology with innovative mindset and a fresh pair of eyes, will be the way forward, in India, as well. It seems very likely, when considered from two angles:

  • What several research data reveals about an increase in usage of digital platforms by healthcare consumers and providers, before and during Covid-19 pandemic. Especially because, this struggle appears to be for a long haul.
  • Most countries are currently struggling to navigate through highly contagious Covid-19 outbreak and simultaneously trying to chart a workable pathway for avoiding similar eventualities in the future.

In this article, I shall try to focus on Covid-19 induced changes in doctors’ practice dynamics – based on research studies, while revisiting the subject on ‘connected healthcare,’ and its relevance now – also in the years ahead.

Research studies capture a new and growing awareness: 

The recent findings from the “Digital Doctor 2020” survey, which is a ‘21-country study of Doctors’ perspectives on digital and connected health, highlight some interesting points. This study was conducted just before the global outbreak of Coronavirus. Some of its findings were also deliberated inan article published in the PharmExec.com on April 23, 2020. The paper is titled, ‘How Prepared Were Physicians for the COVID-19 Digital Upswing? Some of the key points, as reported, are worth noting:

  • Although, the awareness of drug prescribers of different digital technologies related to healthcare is high, how these technologies work in healthcare was unknown to many doctors at the time of the Digital Doctor 2020 survey. It came out that clear benefit statements, will be welcomed when there is such a steep learning curve.
  • Regardless of face-to-face interactions still remaining preferred choice before the pandemic, online channels are on the rise and accelerating with COVID-19 lockdown.
  • Benefits of using connected health devices for patient management and treatment are widely recognized and is believed to play a key role in the future. The respondents agree, even their patients are now more interested in their own health data, as they are gaining control over their weight, diet and physical activities.

Highlighting that their research data over the last few weeks showing increasing usage of digital solution to respond and adapt to the new realities of Covid-19 pandemic, the author of the article concluded: ‘For a long time, digital solutions have often been considered an option; now they have become a necessity.’ To understand the emerging scenario, let us now look at the preferred communication channels of the doctors – pre-Covid-19 outbreak. 

Preferred channels of doctors pre-Covid-19 outbreak:

According to the Ipsos survey of pre-Covid-19 outbreak, face-to-face communication with Medical Representatives (MR) used to be the most favored channel of the doctors, as follows:

Channel Med. Rep Speaker Program Conf. E-detail Journal Ads Med. Liaison E-mail Direct mail Pharma website
Pref. % 35.2 11.7 10.0 8.4 8.4 8.8 8.4 5.0 4.1

However, on April 14, 2020, Ipsos shared the results of their interim research conducted, together with M360, among doctors, conducted during Coronavirus outbreak. The preliminary findings indicate, Covid-19 will permanently alter physician practice dynamics. A clear shift in the engagement model with them – away from in-person detailing, throws several significant questions on the traditional physician engagement template of the pharma players.

It also signals another fundamental change in the physicians’ practice dynamics, as Covid-19 seems to have changed practicality of having face-to-face communication between the representatives and doctors, as before. This situation makes ‘connected healthcare’ a reality – as we move deeper into the everyday- evolving scenario.

Some unexpected and significant changes surfaced in a month: 

The above research also flagged, the following two important changes, among several others, triggered by the Coronavirus outbreak:

  • The mean number of sales representative visits dropped from 15.7 before the Coronavirus outbreak to 1.3 in just the following month, during the pandemic 
  • Overall preference and effectiveness of e-detailing also improved, significantly, where any non-personal communication and interaction with drug companies, either through sales representatives or by others, were considered as e-detailing. 

This brings me back to the question, how are doctors feeling about this never before shift in their practice dynamics?

How are doctors feeling about a never before shift in their practice dynamics?

The ongoing research on this critical area captures a new reality, where many doctors, especially those who are not directly engaged in combating the Covid-19 pandemic, are clearly feeling a shift in their practice dynamics. Curiously, the new feeling of a shift also includes, the way these doctors interact with different drug companies, mostly through their Medical Representatives.

These inklings of the doctors are expected to get translated into some fundamental changes in the real-life situation, as we all sail through the life-changing time caused by Covid-19. Especially, considering the requirements of a new normal – social distancing, wearing a mask always while on outdoor, and several other norms as prescribed from time to time.

‘Connected healthcare,’ is expected to take its place on the center stage:

In this situation, ‘connected healthcare,’ which used to be more discussed than practiced, is expected to take its place on the center stage. It is necessary in the present situation for remote consultations, primarily for chronic ailments – for effective disease management and treatment. More so, as in the current situation individual health awareness of a large population, even in India, is increasing with an accelerated speed, perhaps more than ever before.

Thus, this is the right time to focus on ‘connected healthcare’, powered by AI-based digital technology. It has immense potential to help the Indian population getting immediate medical attention at a lower cost, with an improved access, for all. Though these are early days, it appears the ball has started rolling in the right direction, as the recent draft guidelines of the Indian Council of Medical Research (ICMR) indicates: ‘Patient can WhatsApp, SMS or email consent for Covid-19 clinical trials.’

Conclusion:

Still today, there is no sign of even temporary flattening the disease progression curve in India. As on May 10, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 62,939 with 2,109 deaths, which is rising in India faster than most other countries. On May 07, 2020, AIIMS director again warned that Covid-19 pandemic is yet to peak in the country. “According to modeling data and the way our cases are increasing, it is likely that peak can come in June and July,” he added.

But is it getting worse? Despite stringent lockdown, there has been a surge in cases, which can also be attributed to higher levels of testing. However, from a doubling rate of 11.5 days on May 3, it has shortened to 10.3 days, which means that cases are doubling in quicker time. Each set of 10,000 cases is now increasing at a more rapid pace than the preceding set, highlighted an editorial of a leading news daily.

With a vaccine still elusive, the government had been banking mostly on the lockdown to break the chain of transmission of the virus. Meanwhile, the World Health Organization (WHO) has said: ‘Deliberately infecting healthy people with Coronavirus may speed Covid vaccine studies,’ reflecting more uncertainties in this area. It is also not likely that the country will cease to have any problems with its fragile public healthcare infrastructure and delivery system, even after flattening the disease progression curve.

Along with many other Covid-19 induced life-impacting changes, doctors’ practice dynamics are also expected to undergo a metamorphosis, lasting for an indefinite period. Consequently, I reckon, it’s about time, even for the pharma industry to voluntarily adopt ‘connected healthcare’ as a future way of life. One can get a glimpse of it in the Covid-19 clinical trial draft guidelines of the ICMR. Nonetheless, ‘connected healthcare’ comes with a clear signal of reducing the cost of healthcare and improved patient access, having the potential to effectively mitigate a sizeable part of the precipitated healthcare crisis, caused by Coronavirus.

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 Sales Post Covid-19 Lockdown

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Disruptions from Covid-19 pandemic have caused limited access to physicians for Pfizer’s marketing and sales teams have had. If ‘the novel Coronavirus pandemic hamstringing the company’s sales team,’ there could be a slowdown in new prescriptions and a sales hit in the second quarter, said the global CEO of Pfizer, on April 28, 2020. He further said, ‘new prescriptions for a range of its products will decline as patients continue avoiding in-office physician visits.’

Pfizer is not only the company facing such situation. In fact, the entire pharma industry is encountering a tough headwind for the same reason. However, being very specific on the quantum of sales hit – on the same day, ‘Merck, with a heavy presence in physician-administered drugs’, predicted an adverse impact of US$ 2.1Billion on sales, from COVID-19.

Physical absence of, virtually the entire pharma field force in the field for strict compliance of social distancing during the lockdown period, causing a crippling effect on the new prescription demand generation activity. This possibility was hardly imagined by anyone in the industry. Which is why, the current situation is too challenging for pharma sales and marketing leadership teams to respond, with a sustainable strategic approach. Moreover, most of them don’t yet seem to be accustomed with charting any pivotal demand generation activity, sans field force.

Further, the meaning of ‘Patient-Centricity’ in the post lockdown period – still maintaining ‘social distancing’ norms, is expected to undergo considerable changes. This may include development of newer health care practices for many customers, which they started practicing during the lockdown period. However, no one can exactly predict, as on date, whether such changes will continue for a long term, as we move on. In this article, I shall deliberate on a likely scenario in the pharma selling space post Covid-19 outbreak, based on research studies. This is primarily because Covid-19 could be with us for a long time.

Covid-19 could be with us for a long time:

As reported, on the day 35 into the world’s largest lockdown, India, reportedly, was failing to see an easing of new cases similar to what hot spots such as Spain and Italy have recently experienced with more intensive Covid-19 outbreaks. Even today, the scale and duration of the pandemic are very uncertain, so will be the necessity of maintaining social or physical distancing guidelines. This possibility gets vindicated by what the Director General of the World Organization said on April 22, 2020: ‘Make no mistake: we have a long way to go. This virus will be with us for a long time.’ Thus, shutdowns in different forms, is expected to continue for some time in India.

‘Covid-19 pandemic to last for minimum two years’ with its consequent fallout also on the pharma industry:I

Interestingly, ‘India began its containment measures on March 25, when its outbreak showed only 564 cases.’ As on May 03, 2020, the recorded Coronavirus cases in India have sharply climbed to 39,980 and 1,323 deaths. India is now expected to prepare exiting the 54-day lockdown in phases from May 17, 2020, with a few limited relaxations even before that date. However, as the BBC news of April 9, 2020 also points out, the country may not afford to lift the lockdown totally – everywhere, for everyone and for all the time, anytime soon, for obvious reasons.

The April 30, 2020 report from the Center for Infectious Disease Research and Policy at the University of Minnesota, confirms this situation. It says: ‘The Coronavirus pandemic is likely to last as long as two years and won’t be controlled until about two-thirds of the world’s population is immune.’ This is because of the ability to spread from asymptomatic people, which is harder to control than influenza, the cause of most pandemics in recent history. Thus, the Coronavirus pandemic is likely to continue in waves that could last beyond 2022, the authors said.

Many countries around the world are already facing similar issues for exiting Covid-19 lockdown. It has been observed that easing the lockdown is a tricky policy choice, as it triggers a fresh wave of infection, as recently happened in advanced countries, such as, Singapore and several other nations.

It is, therefore, clear now that shutdowns need to continue in different forms in India as different waves of Covid-19 infections strike, in tandem with scaling up of requisite testing and health infrastructure to manage those outbreaks, effectively.  Consequently, its impact on the pharma industry is likely to continue with its unforeseen fallout, prompting the same old question, yet again, why the oldest commercial model remains pivotal in the pharma industry.

The oldest commercial model remains pivotal in the pharma industry:

About a couple of years ago from now, an interesting article of IQVIA, titled, ‘Channel Preference Versus Promotional Reality,’ highlighted an important fact. It said, one of the oldest commercial models of using medical or sales representatives to generate product demand through personal communication with each doctor, and other key stakeholders, is still practiced in the pharma industry, both as a primary medium and also to communicate the message.

The same model continues in the pharma industry, regardless of several fundamental challenges in the business environment. Curiously, erosion of similar models in many other industries, such as financial and other services, in favor of various highly effective contemporary platforms, is clearly visible. Some of these fundamental challenges involve an increasing number of both, the healthcare professionals and also patients they treat, moving online.

This has been happening since some time – long before Covid-19 outbreak. Today, many patients want contemporary information on the disease-treatment process, available alternatives and the cost involved with each. These patients also want to communicate with their peers on the disease for the same reasons, before they take a final decision on what exactly they would like to follow. A similar trend is visible, at a much larger scale, with medical professionals, including top drug prescribers.

Healthcare customers’ increasing digital preference was captured well before the Covid-19 outbreak:

The rise of digital communication as a global phenomenon, was deliberated in the June 04, 2019 ‘Whitepaper’ of IQVIA, titled ‘The Power of Remote Personal Interactions.’ It captured an increasing digital preference of healthcare customers much before Covid-19 outbreak. For example, according to IQVIA Channel Dynamics data1, there was a 26 percent decline in total contact minutes for face-to-face detailing in Europe, since 2011.

Another 2018 IQVIA survey reported, 65 percent to 85 percent of representatives were saying that access to physicians is becoming harder. The paper also indicated that the rise of digital and multichannel communication with healthcare professionals has been far from uniform across countries, with Japan leading the world, followed by the United States.

India is an emerging power in the digital space, today. Thus, I reckon, it has immense opportunity to leverage digital platforms in healthcare, especially to effectively address the current void in the demand generation activity of drug companies. The key question that needs to be answered: Are pharma customers developing new habits during, at least, the 54-day national lockdown period?

‘It takes about 18 days to 254 days for people to form a new habit’:

According to a study, titled ‘How are habits formed: Modelling habit formation in the real world,’ published on July 16, 2009, in the European Journal of Social Psychology, it takes anywhere from 18 days to 254 days for people to form a new habit. Thus, changing preferences of many healthcare consumers, including doctors and patients, at least, in the 40-day period of national lockdown in India, may trigger a change in habits of many patients. This change may further evolve over a period a time.

Such changes would demand a new and comprehensive ‘Patient-Centric’ approach from pharma players, as well, having a clear insight on the dynamics of the changes. Gaining data-based insight on the same, pharma sales and marketing leadership would need to develop a grand strategy to deliver ‘patient-group’ specific desired outcomes. One of these approaches could be, triggering non-personal sales promotion on digital platforms.

Triggering non-personal sales promotion on digital platforms:

Dealing with future uncertainty calls for non-conventional and innovative strategies, such as, generating brand prescription effectively even without personal promotion. Thus, to tide over the current crisis, triggering non-personal sales promotion on digital platforms, appears to be the name of the game. In a 2018 IQVIA survey, looking at the multi-channel landscape in life sciences, 54 percent of the 250 respondents from pharma and biotech were found already using virtual interactions, such as e-Detailing, or were planning to assess the approach.

What is required now is to rejuvenate the initiative, with a sense of great urgency. Covid-19 pandemic has the possibility and potential to expedite a strong pull in this direction, responding to a new ‘customer-centric’ approach, as prompted by the evolving scenario, triggered during the 54-day long stringent lockdown period. This is especially considering the fact that it takes about 18 days to 254 days for people to form a new habit.

Further, as Bloomberg reported on May 02, 2020, “coming up with a vaccine to halt Covid-19, in a matter of months isn’t the only colossal challenge. The next big test: getting billions of doses to every corner of the world at a time when countries increasingly are putting their own interests first,” which may take quite time.

Conclusion:

One thing for sure, the sudden outbreak of Covid-19 pandemic has made all ongoing and robust strategic business plans somewhat topsy-turvy. Most pharma companies were compelled to floor the break-pedal of several business operations, including prescription demand generation activity of field sales forces, during the lockdown period.

At this time, many healthcare consumers, including patients, tried various remote access digital platforms to continue with their treatment or for a new treatment of common ailments, besides procurement of medicines. Two primary drivers, in combination with each other, prompted those individuals to try out the digital mode. One, of course, the stringent lockdown norms, and the other being the fear of contracting Covid-19 infection, if the prescribed personal distancing standards are breached – just in case.

This position may lead to two possibilities – one, involving the patients and the doctors and the other, involving field staff/doctors/hospitals/retailers, etc. During, at least, the 54-day long lockdown period, if not even beyond May 17, 2020 – those patients may develop a sense of convenience with the digital platforms. This may lead to a new habit forming, which has the potential to create a snowballing effect on others – through word-of-mouth communication. The process may signal a shift on what ‘Patient-Centricity’ currently means to the pharma players.

The other one, I reckon, involves with the continuation of strict social or physical distancing norms for an indefinite period. This could seriously limit field-staff movement and meeting with the doctors, hospitals/retailers, besides many others, and more importantly would lead to a significant escalation of cost per call. The question, therefore, is: Will pharma selling remain as before, post Covid-19 lockdown? Most probably not. If so, a new task is cut out, especially for the Indian pharma leadership team, to chart a new ‘Patient-Centric’ digital pathway, in pursuit of sustainable business excellence.

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.

Setting A Cost Of Time That Patients May Gain From A New Therapy

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Since quite some, an intense ongoing debate about setting a cost of time, often by a few months, that patients could possibly gain from a new therapy for complex diseases. The answer still remains elusive.  Meanwhile, newer therapies for treating cancer, such as, Kymriah, priced at US$ 475,000, alongside several rare diseases, hit the market with jaw-dropping prices. The latest being - Zolgensma of Novartis, carrying a price tag of US$ 2.12 million – the most expensive treatment ever. This trend assumes greater significance as Bio – claimed as the world’s largest trade association representing biotechnology companies, and related organizations, across the United States and in more than 30 other nations, also makes some interesting points in this area.

This article will dwell on the relevance of this important issue, both in today’s and also in the future perspective. It will try to explore, why pharma and biotech companies are not keen to use a ‘transparent multi-factorial life-value calculator’, especially for prolonging life or curing an incurable disease, with a high-priced novel therapy.

Emotional ads to justify the trend, against tough practical questions: 

A part of a sleek looking advertisement from Bio, depicting the power of new therapies to prolong life, carries a headline – ‘Time. The Currency of Life,” followed by three emotive lines and two equally emotive questions: “Another decade with a spouse. A few more years with your best friend. A rich, fuller life rather than one cut short. How do we place value on these?” It then asks: “What is more precious? What is more priceless?”

Turning this emotive question on its head to a rational one, an article published in the Stat News on February 25, 2016 questioned: “How much is an extra month of life worth?” It asked the drug makers to calculate the same. The same article also quoted a Yale University economist and practicing radiologist asking: “It’s all well and good to just say life is priceless, but the reality is we are paying for it.”

Emotive ads try to justify funding towards innovation for such drugs:

The same advertisement, as above, while trying to indirectly justify such exorbitant drug costs, used yet another emotive note in its playbook. It emphasized: “By continuing to fund the innovation pipeline that has served us so well, we will be able to reduce the costs associated with modern-day health care.”

Such claims are being scientifically challenged – head on, by many important studies. To illustrate this point, I shall quote the following two, both were published in the JAMA Network. The first one in the JAMA Otolaryngology-Head & Neck Surgery and the next one in JAMA Oncology.

The first article is the ‘John Conley Lecture’, carrying a title, ‘Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity,’ appeared on December 2014. On innovative drugs of such genre, the paper concluded: “The use of expensive therapies with marginal benefits for their approved indications and for unproven indications is contributing to the rising cost of cancer care. We believe that expensive therapies are stifling progress, by:

  • Encouraging enormous expenditures of time, money, and resources on marginal therapeutic indications and
  • Promoting a me-too mentality that is stifling innovation and creativity.

The second article is an ‘original investigation, titled ‘Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated with New Cancer Medicines.’ It also underscored: ‘Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.’

Here again, the emotional appeal is being made by creating a ‘perfect World’ scenario. Whereas, scientific analysis of the innovative and high-priced drugs, reveals the reality for other stakeholders to take note of. Different pharma trade associations, although being a part of the same orchestrated effort, try differently to take the eyes off the humongous prices of new life-saving drugs. But many continue to believe that new cancer drug prices have long gone beyond control.

90 percent Biopharma companies do not earn a profit – A bizarre claim?

As is well-known, besides justifying high drug prices by highlighting ‘high R&D cost,’ drug manufacturers often say, as the Bio ad campaign makes an eyebrow raising claim – “Of the approximately 1,200 Biopharma companies in the United States, more than 90 percent do not earn a profit.”

Citing the example of the US market where drug prices are very high, it justifies, the general focus on list prices of the drugs is misplaced. This is because, the ‘manufacturers provide billions of dollars in rebates and discounts on their innovative therapies annually, to federal, state and private payors, in addition to offering direct assistance through patient assistance programs.’ It further added, these discounts vary but can result into a significant total of as much as 50 percent or greater depending on the program.

Experts have challenged even this claim that the list prices do matter, even in the US, for many, including uninsured population and those with co-payment arrangement, which are not based on the discounted prices. Leaving aside America, what happens in those countries, such as India, where out-of-pocket expenses on health care are considered the highest in the world?

With new cancer drug prices going beyond control, the price of postponing death is growing:

That the new cancer drug prices have long gone beyond control, isn’t a new realization. A research paper, published in the Journal of Clinical Oncology on May 06, 2013, also noted emphatically: ‘Allowing the producer-dominated market to set drug prices has spiraled the cost of cancer drugs out of control.’  So did another 2015 study, published in the Journal of Economic Perspective.

According to various studies, such as the one published in the JAMA Otolaryngology-Head & Neck Surgery, as quoted above, also found after studying over 70 of such new drugs that the median improvement in survival was around 2.1months. Some other reports indicated this number to be around 3.5 months on an average.

Interestingly, the 2015 study, published in the Journal of Economic Perspective found that ‘the price of postponing death is growing. In 2013, one extra year of life for cancer patients costs US$ 207,000, on average, nearly quadruple what it did in 1995.

Is it quality of life over the quantity of life, or vice versa?

The above findings may lead one to the critical question – what type of treatment choice would create the most desirable net impact on individual cancer patients? This evaluation should include all the three parameters – the extent of prolongation of the ‘Length of Life (LoL)’, the ‘Quality of Life (QoL)’ the patients experience during this period – and the additional drug cost that needs to be incurred.

It should ideally be up to patients whether they will choose quality over quantity of life or vice versa. To facilitate this process, an informed briefing by the doctor on the most likely scenario, vis-à-vis other available treatment alternatives, is expected to help individual cancer patient exercise the best affordable individual option.

This point was scientifically addressed in a research article - ‘Quality of life versus length of life considerations in cancer patients: A systematic literature review,’ published in the Journal of Psycho-Oncology on May 15, 2019. The study noted, ‘Patients with cancer face difficult decisions regarding treatment and also the possibility of trading the Quality of Life (QoL) for Length of Life (LoL).’ Little information is available on patients’ preferences in this regard, including ‘the personal costs they are prepared to exchange to extend their life.’

Another related question that also remains equally elusive, is the relationship between the cost of a medication and the amount of quality-time that it offers to patients. Quantifiable assessment of such nature could bring more transparency in drug pricing, especially for those that help treat life-threatening ailments, such as cancer.

Similar questions are raised on pricey therapy for rare diseases:

The cost of drugs for rare diseases is threatening the health care system – articulated an article, published in the Harvard Business Review (HBR) on April 07, 2017. The paper stated, in December 2016, US-FDA announced the market approval of nusinersen (sold as “Spinraza”), an effective Spinal Muscular Atrophy (SMA) treatment licensed to Biogen by Ionis Pharmaceuticals. SMA is considered the most common genetic cause of infant mortality.

As the author penned, “Patients and providers greeted the approval with near ecstasy, but the celebration was bittersweet. Five days after the FDA approved, the drug, Biogen announced each dose would cost US$ 125,000. Given that patients need six doses in the first year and three per year after that, it means the drug costs US$ 750,000 per patient in the first year and US$ 375,000 annually thereafter.”

A desperate father’s reaction for the price – and the economics behind it:

The HBR article captured the reaction of the father of an infant on this price, who is desperate to save the baby – in the following words – “Then there’s Will’s heartbreaking reaction, which I’m sure echoes the sentiments of many touched by SMA. – “The Biogen announcement of the cost of nusinersen floored me in every way possible,” he says. “Words cannot describe the sickening feeling I get when I think about it.” If this could be a father’s reaction in America, one can well imagine what happens in a similar situation to people in the developing world.

At that time, Zolgensma of Novartis, wearing a price tag of US$ 2.12 million for treatment of the same disease, was also shaping up for market launch. On this drug, the author of this HBR article who also happened to be a professor, vice chair of research, and chief of the Division of Neuromuscular Medicine at the University of Utah School of Medicine, wrote: “A very promising gene therapy for SMA is on the horizon, which would require only one dose and potentially render nusinersen obsolete. Did such mercenary economics influence Biogen’s pricing decision? We may never know; drug companies are not required to justify their prices.” On the contrary, as many believe, the concerned global CEOs, reportedly, get a hefty financial reward, for the same.

Conclusion:

It is not difficult to understand either, that some drugs, especially for rare diseases, will be used for treating a smaller number of patients. Hence, the optimal economies of scale in manufacturing can’t be attained. At the same time, the cost of R&D of the therapy needs to be recouped along with a reasonable profit, for investment towards future drugs. This is in addition to market exclusivity the drug will enjoy through patent thicket.

Nevertheless, despite the existence of several methods of a human life value calculation, such as in the insurance industry the use of a transparent and drug industry specific, multi-factorial live-value calculator is still not in vogue. As the drug industry often highlights, the ‘value of human life is priceless’ – regardless of the costs of drugs. In this situation, many industry experts, academics and patient groups advocate that the ongoing uncontrolled pricing mechanism for such medicines should be brought under a leash. This could come in the form of a tough price negotiation’ before the drug marketing approval, as was promised by the Government, or putting in place a stringent price regulatory system.

Be that as it may, the bottom line is to understand and find an answer to: ‘Why Does Medicine Cost So Much?’ This issue was analyzed by the Time Magazine in its April 09, 2019 edition. Quoting Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, it emphasized: It all starts with the manufacturers. There are essentially no regulations governing how new drugs are priced – drug companies select a price what they “believe the market will bear.” Blockbuster first-in-class treatments, therefore, command a stratospheric price, like what happened with Gilead’s hepatitis medication – Sovaldi, way back in 2013. It was priced at US$ 1,000 a pill, or US $84,000 for the full course of treatment. From this perspective, although, setting a cost of time that patients may gain from a new therapy has a moral and ethical relevance – but actually, it doesn’t seem to be business-friendly in the drug industry.

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.