Tag Archives: Leveraging

Covid Prompts Pharma To Move Away From Competition Driven Business Model

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As deliberated in my just previous article in this blog, Covid has been a watershed in several areas of pharma business. One such key area is its competition driven strategic business model. It aims to deliver significant value for a longer time than the competition, protected by a patent thicket driven TINA factor – and only for those who can afford such patented drugs. It didn’t matter, if a vast majority of patients are denied access to these medicines, with a dangerous pricing trend acting as an insurmountable barrier. Flying solo has been the motto of most players in this ball game, to delight the stock markets.

Interestingly, Covid pandemic seems to be changing this model. Pharma industry, by and large, is now trying to demonstrate its core value for the society – moving away from displaying competition driven one-upmanship. In this article, I shall deliberate on this area.

Covid poses both – a humongous challenge and a great opportunity:

As the article, published in the MIT Sloan Management Review on April 16, 2020 highlights: ‘The COVID-19 pandemic may well prove to be the biggest challenge for humankind since World War II.’ The same holds good for the pharma industry, as well. The drug companies are now expected by all, to play a pivotal role in the fight against the pandemic ‘that is bringing health care systems to their knees and sending shock waves through economies across the globe.’

This is generally because, pharma industry possesses wherewithal to develop effective drugs and vaccines to combat this health crisis – if not alone, but certainly collectively. It also offers a great opportunity for pharma to ‘walk the talk,’ by demonstrating upfront that meeting all patients’ unmet needs lie at the core of the pharma business. As I quoted a global CEO in one of my articles articulating, this crisis also comes as ‘a Shot at Redemption in Pharma Industry.’

Thus, if the industry reacts quickly and responsibly, it may have the chance to also redeem a reputation that’s been tarnished for years. Some of these instances are, illegal marketing practices, corruption scandals, and obscene pricing of vital drugs, the MIT Sloan article underscored. Flying solo in this situation may not be just enough, if not foolhardy.

Flying solo in this situation may not be enough:

Taking this initiative won’t be a piece of cake, either, if pharma companies prefer to do it alone during this unprecedented health crisis.  The drug players will need to be willing and able to successfully collaborate with other players in the race to develop treatments and vaccines. Otherwise, their legitimacy will be fundamentally questioned, especially when the entire world is running against time.

The rationale of two top drug companies entering into collaborative arrangements is obvious – the realization that pooling of all resources together is the best way of delivering effective Covid related solutions to the society at the shortest possible time. The good news is, pharma has already taken the first step in this direction, even when some of them are competitors, in several areas – moving away from their competition driven business models, as of now.

Once strange bedfellows – now partners:

The article published in the Bloomberg Law on June 05, 2020 very aptly observed: ‘The race to address the pandemic has brought together strange bedfellows as big-name companies’ partner with their rivals.’ The Scientist also wrote on July 13, 2020: ‘The urgent need for tests and therapeutics has brought companies together and pushed researchers to work at breakneck speeds.’

One can find this happening on the  ground now, as some major pharma and biotech companies, including Eli Lilly, Novartis, Gilead, and AstraZeneca, formed a group called COVID R&D to share resources and expertise to try to accelerate the development of effective therapies and vaccines for COVID-19. Besides, Roche Holding AG and Gilead Sciences Inc. have teamed up on trials for a drug combination to treat Covid-19.

There are several instances of such collaboration also in the Covid vaccine area. For example, GlaxoSmithKline plc struck a deal with Sanofi to produce 1 billion doses of a coronavirus vaccine booster. Besides, Pfizer from the US and BioNTech from Germany are joining hands to co-develop and distribute a potential Coronavirus vaccine, aimed at preventing COVID-19 infection.

It’s a reality today that Covid-19 has brought not just the strange bedfellows within pharma and biotech companies together. Academia and governments have also moved on to the same collaborative platforms, to save people from a deadly and super contagious infection, in the shortest possible time. We have witnessed this

in India, as well. For example, the Council of Scientific and Industrial Research (CSIR) and Aurobindo Pharma Limited have also announced a collaboration to develop vaccines to protect against SARS-CoV-2 or COVID-19.

The rationale and some possible issues: 

Each of these players is bringing some expertise and intellectual property to the table. “As they work together, they’re going to create more, so you have the ‘yours,’ the ‘mine,’ and the ‘ours’ of collaboration,” as the Bloomberg Law points out. That said, any collaboration of such nature and scale will have its own share of legal issues, such as, patents, trademarks, trade secrets, revenue sharing models, and more.

The collaborators, in pursuit of saving mankind from Covid-19, are expected to find enough alternatives to resolve these glitches for a win-win outcome – not just for now, but much beyond – with the dawn of a new collaborative model. The rapid general acceptance of this collaborative model by more and more drug companies to meet unmet medical needs in many other areas – much faster, in all probability, will delight the health care consumers and also be appropriately rewarded.

Leveraging the collaborative business model beyond pandemic:

E that as it may, it still remains an open question to many, whether such collaborative model will be leveraged for an accelerated rate of drug, vaccine and diagnostics development beyond the pandemic.

The good news is, as The Scientist article reported, some pharma players are seriously pondering how to continue working in this new way – with the same sense of urgency and purpose, for other disease areas too. They believe, the lessons being learned with the collaborative models, may help expedite development of therapeutics in other serious conditions, such as, Alzheimer’s, intractable cancers and autoimmune diseases.

If and when it happens as a predominant business model, suffering patients and the society, in general, would lap it up and the innovators would be suitably rewarded. However, the paper also says, there are still some drug companies who prefer to continue working in a more insular fashion, as was happening in the old normal. But, experts also feel, that should not cause any worry, as long as majority prefers to continue following the collaborative models, in the new normal, as well.

Pharma would make a good profit from collaborative business models too:

For those who say that drug companies won’t make good profit from Covid drugs and vaccines, Pfizer CEO has an answer. Albert Bourla, Pfizer’s CEO, reportedly, has no patience for the argument that pharmaceutical companies should not be making a profit on the drugs and vaccines they introduce to fight Covid-19. This article highlights, at $19.50 per dose, the 1.3 billion doses of Pfizer BioNTech Covid vaccine that the Pfizer plans to make by the end of next year, could translate to nearly $13 billion in sales, after the company splits its revenue with its partner BioNTech. It is roughly the same as Pfizer’s all-time best-selling drug Lipitor sold in its best year.

Adding to it, another article on the same issue, published by Fierce Pharma on August 13, 2020, further reinforced the above expectation. It wrote, the longtime Evercore ISI pharma analyst haspredicted the total market for COVID-19 vaccines would be worth $100 billion in sales and $40 billion in post-tax profits. It assumed frontrunner Moderna would supply about 40 percent of the market, Novavax would take 20 percent and the other vaccine developers would split the rest. “One could look at the field under this base scenario and conclude it is reasonably valued in total,” the analyst concluded.

Nonetheless, there could still be several points that remained unanswered in this analysis. But the bottom line is, the collaborative model is not just profitable, it starts generating profit earlier and faster – virtually eliminating the cost of possible delays when a company flies solo.

Conclusion:

With a seemingly flattening curve, the Covid pandemic still continues, alarmingly. As of October 25, 2020 morning, India recorded a staggering figure of 7,864,811 of Coronavirus cases with 118,567 deaths.

With this backdrop, COVID-19 has provided the pharma industry a new opportunity to demonstrate its true value to the society – not the self-serving ones. It’s now clear that no one can rule out, there won’t be a similar unprecedented health catastrophe in the future too. It may come in various different forms, or may even be from a rapid and complex mutation of the same lethal virus.

Moreover, such crisis may not come and go in just a few months – may even linger for a long time. In any case, these may again be equally disruptive – or even more disruptive to lives, livelihoods and the economic growth engine. In such a scenario, putting the brightest scientific brains of the world together will be critical, and adding top speed to the process being the essence to come out of the crisis with least possible damages.

Covid pandemic has also demonstrated that the competition-based model of the drug could be a serious retarding force in that endeavor. What will matter, is a well-structured collaborative model that can create a win-win situation – both for patients and the business. I reckon, it’s about time to move into this model to find most effective drugs and treatment solutions for many other unmet needs related to a host of intractable diseases, much sooner.

There could, of course, be some business issues with this model. But those can be resolved amicably for an all-weather greater success in business, along with protecting the society – for all. From this overall perspective, it appears, Covid pandemic now sends a strong signal to pharma companies to move away from predominantly competition driven business models, expanding more into collaborative ones.

By: Tapan J. Ray    

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

 

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

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

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

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

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

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

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

Leveraging the art of turning a challenge into an opportunity:

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

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

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

The points to ponder:

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

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

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

What pharma companies have done so far:

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

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

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

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

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

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

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

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

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

Another major impact area of pharma business:

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

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

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

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

The problem of talent gap, an opportunity? 

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

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

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

Conclusion:

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

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

Call it, the Prime Minister’s advice, or a basic management tool – most appropriate to leverage at this hour, the concept is worth considering by pharma players, as well, instead of getting overwhelmed by the crisis. Thus, in my view, it’s about time for pharma companies to identify critical Covid-19 related challenges, both immediate and also of the future – and convert those into opportunities – powered by technology-based cerebral inputs, in the new world order.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this

 

The Game is Changing: Ensure Better Treatment Outcomes: Leverage Technology

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Today, several pharma players, mostly ‘encouraged’ by many non-pharma tech companies, are trying to gain, at least, a toehold in the digital health care space. It is visible even within the generic drug industry. Such initiatives, as they gain a critical mass, will remold the process of doing – almost everything in the pharma business, catapulting the concerned drug companies to a much higher growth trajectory, as many believe.

This is quite evident from an interview of Fierce Pharma with the senior management of Sandoz – the generic drug arm of Novartis, that was published on May 14, 2019. The honchos said: “We’re looking across the whole value chain to make sure we’re embracing digital and technology wherever we can. So that means from the way that we innovate, to the way that we sell and the way that we operate and do day-to-day business.” The process covers “a whole range of activities from how you use AI and automation, all the way through to prescription digital therapies.”

I discussed about leveraging technology in the pharma space to address many burning issues – both for patients and the pharma industry. One such article, “Focus on Patient Compliance To Boost Sales…And More…”, was published in this blog on May 20, 2019. It establishes that even world-class sales and marketing programs can, at best, ensure higher prescription generations, but can’t prevent over 50 percent revenue loss from those prescriptions, due to patient non-compliance.

Interestingly, the issue of ‘nonadherence to treatment’ is being debated, since several decades. Various conventional measures were suggested and also taken. But the problem still persists in a huge scale, with probably an increasing trend. Thus, fresh measures, preferably by leveraging modern technology, are of high relevance in this area.

In this article, I shall illustrate the above point, with one of the most exciting areas in the digital space – the digital therapeutics. This is a reality today and marching ahead at a much faster pace than many would have anticipated.

Unfolding another disruptive innovation in healthcare:

One of the articles that I wrote on this subject is ‘Unfolding A Disruptive Innovation in Healthcare,’ which highlights a different facet of the same subject. Thus, let me begin today’s discussion with a recapitulation of some important aspects of a drug, particularly the following ones:

  • A large number of patients don’t find many drugs accessible and affordable during the entire course of treatment.
  • Drugs have to be administered orally, systemically or through any other route
  • Alongside effective disease prevention or treatment, many drugs may bother patients with long and short-term side-effects, including serious ones.
  • Treatment outcomes can’t often be easily measured by patients.

These are, of course, known to many, but several questions come up in this area, which also deserve serious answers, such as:

  • Are drugs indispensable for the treatment of all types of disease?
  • Can a holistic disease treatment be made more accessible and affordable with radically different measures?
  • Can the same effectiveness of a drug, if not more, be achieved with no side-effects with a non-drug therapy?
  • Can outcomes be significantly improved following this process, as compared to drugs?

In search of answers to these questions – arrive digital therapeutics:

In search of answers to the above questions, a number of tech savvy whiz kids. dared to chart an uncharted frontier by asking themselves: Is it possible to treat a disease with a software – having no side-effects, but providing better cost effectiveness and treatment outcomes to patients?

Today, with the signs of healthy growth of the seed – sown with the above thoughts, ushers in – yet another game changing pathway for disease treatment. The quest for success of these pathfinders can benefit both – the drug innovators and also the generic players, in equal measure, besides patients. Digital therapeutics is an upshot of this pursuit.

Its ‘purpose’ outlines – why it’s one of the most exciting areas in digital space: 

The Digital Therapeutics Alliance well captures the purpose of digital therapeutics, as, “Improving healthcare quality, outcomes, and value through optimizing the use and integration of digital therapeutics.”

What do digital therapeutics actually do?

There are several, but quite similar descriptions of digital therapeutics. For example, Deloitte described digital therapeutics as software products used in the treatment of medical conditions, enabling patients to take greater control over their care and are focused on delivering clinical outcomes. It also highlights, ‘digital therapeutics are poised to shift medicine’s emphasis from physically dosed treatment regimens to end-to-end disease management based on behavioral change.’

Digital therapeutics offers all positives of a drug and more:

In indications where digital therapy is approved and available, the new approach offers all positive attributes of an equivalent drug, with no side-effect. There isn’t any need of its physical administration to patients, either. Deloitte elucidated this point very aptly: “As software and health care converge to create digital therapeutics, this new breed of life sciences technology is helping to transform patient care and deliver better clinical outcomes.” More importantly, all this can be made available for better compliance and at a cheaper cost in many cases.

For example, according to the article published in the MIT Technology Review on April 07, 2017, carrying the title ‘Can Digital Therapeutics Be as Good as Drugs?’: “Some digital therapeutics are already much cheaper than average drug. At Big Health, people are charged $ 400 a year, or about $ 33 a month to use the insomnia software. The sleeping pill Ambien, by contrast, costs $ 73 for six tablets of shut-eye.”

Two basic types of digital therapeutics:

The Digital Therapeutics Alliance also underscores: “Digital therapeutics rely on high quality software to deliver evidence-based interventions to patients to prevent, manage, or treat disease.” It further elaborates: “They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.” In line with this description, the above MIT Technology Review article, as well, classifies digital therapy into two basic categories:

  • For medication replacement
  • For medication augmentation

It also says that the digital therapy for sleep (sleep.io), belongs to the first category, making sleeping pill most often unnecessary and with outcomes better than those of tablets. Whereas, the second category includes various disease specific software apps that improve patient compliance with better self-monitoring, just as co-prescription of drugs.

Nonetheless, the same MIT article gave a nice example of ‘medication augmentation’ with digital therapy. The paper mentioned, Propeller Health – a digital company, has inked a deal with GlaxoSmithKline for a ‘digitally guided therapy’ platform. The technology combines GSK’s asthma medications with Propeller Health made sensors that patients attach with their inhalers to monitor when these are used. Patients who get feedback from the app, end up using medication less often, the study reported.

The first USFDA approved digital therapy:

Let me give one example each of the launch of ‘medication replacement’ and ‘medication augmentation’ digital therapy, although there were other similar announcements.

  • On November 20, 2018, by a media release, Sandoz (Novartis) and Pear Therapeutics announced the commercial availability of reSET – a substance use disorder treatment that was the first software-only digital therapeutic cleared by the US-FDA, for medical prescriptions.
  • Closely followed by the above, on December 21, 2019, Teva Pharmaceutical announced US-FDA approval for its ProAir Digihaler for treatment and prevention of bronchospasm. Scheduled for launch in 2019, it is the first and only digital inhaler with built-in sensors that connects and transmit inhaler usage data to a companion mobile application, providing insights on inhaler use to asthma and COPD patients – for prevention and better treatment of the disease.

Many other projects on digital therapeutics are fast progressing.

Conclusion:

Stressing a key importance of digital therapeutics in chronic disease conditions, McKinsey article of February 2018, titled ‘Digital therapeutics: Preparing for takeoff’, also underlines: ‘Digital therapeutics tend to target conditions that are poorly addressed by the healthcare system today, such as chronic diseases or neurological disorders.’

It also, further, emphasized that digital therapeutics can often deliver treatment more cheaply than traditional therapy, by demonstrating their value in clinical terms. It illustrated the point with US-FDA’s approval for a mobile application that helps treat alcohol, marijuana, and cocaine addiction, well-supported by clinical trial data. The results showed 40 percent of patients using the app abstained for a three-month period, compared with 17.6 percent of those who used standard therapy alone.

I now come back to where I started from. The pharma ball game is changing, and that too at a faster pace.Ensuring and demonstrating better treatment outcomes for patients – both for patented drugs and the generic ones, will increasingly be the cutting-edge to gain market share and grow the business. Thus, leveraging technology to its fullest is no longer just an option for pharma companies. The evolution of digital therapeutics as a game changer, vindicates the point.

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.

Focus On Patient Compliance To Boost Pharma Sales…And More…

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One high-impact area in the healthcare space that often finds its place in the backseat is – patient noncompliance. A term that is commonly used in regard to ‘a patient who does not take a prescribed medication or follow a prescribed course of treatment.’ It comes with a steep price, for causing serious adverse impact not just on human health and health system, but also in the pharma business. Intriguingly, such incidents are still not scientifically monitored enough and vigorously acted upon, both globally and locally.

The World Health Organization (W.H.O) has also flagged it as a huge problem, as it reports, 10 percent to 25 percent of hospital and nursing home admissions result from patient noncompliance. Furthermore, about 50 percent of prescriptions filled for chronic diseases are not taken correctly, with 40 percent of patients not adhering to the treatment regimen.

In this article, just after giving a flavor to its financial cost to patients, I shall dwell mostly on its impact on the pharma players, as overcoming this important problem doesn’t generally fall in the area of strategic focus for most of them. Finally, I shall explore how drug manufacturers can translate this problem into an opportunity – as the third growth driver for business, creating a win-win situation for all.

Economic and health impact on patients:

Noncompliant patients suffering from both acute and chronic ailments, pay a heavy price, not just in terms of longer suffering arising out of complications, but also incurring significantly more health expenditure for treatment of the same diseases. According to IMS Institute for Healthcare Informatics, on average, less than 40 percent of patients around the world are fully complying with their treatment instructions.

Even in the Indian context, the problem is no different. Let me illustrate the point with the example of a chronic disease, such as Asthma. The article published on June 26, 2018 in ‘Lung India’ – the official publication of Indian Chest Society reported: “The mean annual direct costs among compliant and non-compliant patients were ₹14, 401 and ₹24, 407, respectively. Percentage of hospitalization was less among the compliant group (6 percent) when compared with noncompliant group (17 percent).”

The study concluded, asthma is not only associated with patient-specific impairment, but also creates a significant economic burden for the family and society. The major contributors to the burden are the medication cost and hospital admissions. Patient compliance with prescribed drugs can help keep asthma under control, thereby decreasing the economic burden and emergency hospital admissions – avoiding the economic risk from ill health with high out of pocket payments.  Productivity loss is another under-appreciated source of economic loss contributing to indirect cost. The rising costs of investigations, interventions, and treatment of chronic diseases further complicate the problem.

Economic impact on pharma business:

According to November 16, 2016 report, published by Capgemini and HealthPrize Technologies, globally, annual pharmaceutical revenue losses had increased from USD 564 billion in 2012 to USD 637 billion due to non-adherence to medications for chronic conditions. This works out to 59 percent of the USD 1.1 trillion in total global pharmaceutical revenue in 2015.

The report highlights, besides medication nonadherence being a serious global health issue that needs to be addressed immediately, it also happens to be a critical business issue for pharmaceutical companies. Thus, it is the only area of their business where a sharp strategic focus “can generate significant top – and bottom-line growth, improve outcomes, and create substantial savings for the healthcare system – all at the same time.”

Major reasons for patient noncompliance:

Several reasons are commonly attributed to patient-noncompliance to medicines, such as:

  • Lack of knowledge of its health and economic impact
  • Importance of completing the full-course of the drug and dosage regimen for long-term remission, following immediate relief
  • Untoward side-effects and other inconvenience
  • Forgetting therapy because of preoccupation
  • Financial inability to complete the prescribed treatment regimen due to the high cost of drugs.

Nevertheless, the 9th Edition of Global Research Report by Capgemini Consulting underscores that reality is more complex. Patient adherence initiatives, if any, when undertaken, even by pharma companies, often lack a thorough understanding of the root causes of discontinuing treatment and failure to effectively engage patients with a holistic approach to the issue. It also emphasizes: “Individual tactics are tried by different brands and then discontinued as budgets and priorities shift, before their impact is known. Successes are seldom pulled through and expanded across the organization.”

Using it as the third major growth drivers for pharma:

The two primary factors that drug manufacturers are leveraging to boost growth of the organization are:

A.  New product introduction – gradually extending to line extensions and new indications. One such illustration is the cholesterol-fighting drugLipitor of Pfizer. The lifetime sales of this brand as of the end third quarter 2017 generated a stunning USD 150.1 billion of business for the company. Incidentally, Lipitor patent expired in 2011. There are many similar examples, including Humira of AbbVie.

B.  Regular and hefty price increases for already marketed products, for various reasons, but almost regularly. According to this 2019 report, percentage price increases, on a huge base, of some of the world’s top pharma brands were as follows:

  • AbbVie: Humira, a blockbuster drug with USD 15 billion in sales in the first 9 months of 2018: +6.2%
  • Allergan: Many of its brand-name drugs, including dry-eye medication Restasis: +9.5%
  • Biogen: Multiple sclerosis drug Tecfidera: + 6%
  • Bristol-Myers Squibb: Eliquis, a drug that prevents blood clots and is on pace for USD 6 billion in sales in 2018: + 6%
  • Eli Lilly: Type 2 diabetes medication Jardiance: + 6%

Many studies have captured the importance of regular price increase, as a key pharma strategy, not only to drive the internal growth, but also to keep their investors, as well as, the stock market on the right side. There are examples that for some of the top global pharma players, this strategy was directly responsible for 100 percent of earnings-per-share growth in 2016, and more than 20 percent of the revenue made in the first three quarters of 2018.

On the other hand, some top analysts’ findings highlight that drug companies serious strategic focus just on the issue of patient noncompliance with novel tactical measures, could fetch as much as a 30 percent increase in annual earnings per share for many players, even in India.

This brings up to the point – can strategic focus to minimize patient’s non-compliance, supported by adequate resources, be the third growth driver for drug companies?

Can focus on patient noncompliance be the third growth driver for pharma?

For a moment, leaving aside the above two primary growth drivers, if we look at the estimates, as quoted above, well over 50 percent to 60 percent of a brand’s potential sales is wasted due to patient noncompliance. Isn’t it huge? Can this be ignored? Obviously not. Instead, why not pharma converts this problem into an opportunity, with a sharp strategic focus, leveraging technology.

Translating this potential opportunity into reality is neither very easy nor is every company’s cup of tea. But the reward for the winners is indeed phenomenal. To chart on this frontier, one of the toughest barriers, besides a winner’s mindset, is getting access to credible and meaningful patient-data, for various reasons. On the other hand, it isn’t an insurmountable problem, either – especially, with today’s rapidly progressing technology.

Some companies have started the long march:

According to the review article, published in the New England Journal of Medicine: ‘The ability of physicians, to recognize non-adherence is poor, and interventions to improve adherence have had mixed results. Furthermore, successful interventions generally are substantially complex and costly.’

Realizing that it as a potential opportunity – disguised as a problem, several pharma players have started thinking about exploring this not much charted territory, confirm reports coming from different countries of the world. To give an illustration, November 22, 2016 edition of Fierce Pharma reported: ‘Pharma companies have more recently joined the conversation with partnerships and programs that include adherence aims.’

It is generally believed today that rapid ascendency of modern technology, and its strong influence on people, will help create a new awareness of its current adverse impact both on patients and the drug companies.

What else could be done in a much wider scale?

Digital interventions, such as smartphone apps, are becoming an increasingly common way to support medication adherence and self-management of chronic conditions. In this regard, the May 14, 2018 study titled, ‘Smartphone apps for improving medication adherence in hypertension: patients’ perspectives’, published in the journal of Patient Preference and Adherence, concluded as follows:

‘These data showed that patients can identify the benefits of a medication reminder and recognize that self-monitoring their blood pressure could be empowering, in terms of their understanding of the condition and interactions with their general practitioners.’ But some loose knots are still to be tightened.

Tightening the loose knots:

Having leveraged the state of the part digital technologies to tighten the loose knots in this area,a host of AI-enabled smartphone health and diagnostic apps, capturing patient compliance details, especially in chronic disease areas, are fast coming up. Most of these are being developed by large, small and medium sized non-pharma pure tech companies, including startups. For example, according to reports: ‘With the release of the Apple Health Record and Apple Watch with a single-lead ECG, it’s evident that Apple has officially entered the healthcare space.’

A good number of these apps have received even the US-FDA approval, such as: MyDose Coach - a reliable dose calculating app for type 2 diabetic patients who take insulin once-daily in concert with physician guided insulin recommendations. Or, GoSpiro – a home spirometer, to measure air output from the lungs for COPD patients and connects wirelessly to provide hospital-quality data regarding breathing.

That many non-pharma entities are trying to create a space for themselves in a high-tech, but non-drug treatment segment within the pharma space, has prompted, several drug manufacturers to rewrite their marketing playbook, incorporating this ‘new notation’.

It’s real now…for some:

As the above Fierce Pharma article reported: ‘Pharma companies have more recently joined the conversation with partnerships and programs that include adherence aims; efforts from Verily and Sanofi and IBM and Novo Nordisk have recently made the news.’Further, on November 07, 2018, in another report it brings to the fore that Geisinger Health System has developed mobile apps to manage asthma with AstraZeneca, and a wearable app to manage pain with Purdue. It also joined forces with Merck to develop tools for patients and caregivers to improve care coordination and medication adherence.

Moreover, on February 09, 2019, Japanese drug major Astellas and WiserCare - a company that develops healthcare decision support solutions, announced a collaboration that includes improving patient adherence to care plans, and improve the overall care experience.

In tandem, concern on patients’ data privacy, may also now be addressed, possibly by making use of blockchain or similar technology for such initiatives, as I discussed earlier in this blog.

Conclusion:

‘Acquiring new customers is important, but retaining them accelerates profitable growth,’ is the theme of an article, published in Forbes on June 08, 2016. Therefore, just as any other business, this dictum applies to the pharma industry, as well, especially in context of patient noncompliance to medicines, with a clear strategic focus to minimize its impact on performance.

The major reasons for patient noncompliance ranges from ignorance of its adverse impact on health to side effects, forgetfulness and right up to inability to afford full-course of the prescribed drug treatment. Despite its continuity over decades, adversely impacting patients, health system and the pharma players, it won’t be prudent to infer that no attempt was being made in the past, to address this critical issue. Nevertheless, those measures have not worked, for many reasons, as we see today from various research studies in this area, even in the Indian context.

Once again, intervention of technology to make patients compliant to medicine, is showing promise for following it up more vigorously. That some global drug majors are entering into collaborative arrangements with non-pharma, technology companies of various sizes, sends a signal of the emergence of a third major growth driver for pharma, as discussed above.

This issue is so important, especially considering that the low hanging fruits of R&D have mostly been plucked, just as regular hefty increases of drug prices are meeting with tough resistance, squarely. In this scenario, a robust strategic focus on patient compliance would not only boost pharma sales but would also reduce the disease burden of a large section of people significantly. This will benefit all and harm – none.

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.

SCM: Embracing Technology For Patients’ Safety

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Supply Chain Management (SCM) in the pharma industry is generally perceived as a logistic function, just in most other industries, involving the distribution of medicines from manufacturing plants, right up to pharma distributors. Thereafter, it becomes the responsibility of the respective distributors to reach these to the wholesalers, who cater to the needs and demand of retail chemists.

In tandem, pharma SCM is also playing a key role in reducing overall cost of drugs, improving the profit margin, and to some extent their affordability to a larger number of patients. This process involves efficient procurement of right products of the right quality, transporting them in the right condition, delivering them at the right location in right time, with optimal inventory carrying cost.

That said, today’s reality demands the SCM to cover much larger space. This calls for taking in its fold even those critical parameters that go beyond the realm of business performance – protecting the health and safety interests of patients, effectively. In that sense, SCM plays a pivotal role pharma business operation, having a potential to make a profound impact in the lives of many, quietly.

Coming out of the cocoon of narrowly defined distribution or logistic functions, pharma SCM, in many countries, has started rediscovering itself, as a multi-dimensional and multi-factorial business necessity, keeping patients within its core focus area, always.

I wrote on ‘The importance of Supply Chain Integrity’ and ‘Maximizing value of a new product launch with an innovative Supply Chain Management System’ in this blog on November 29, 2010 and August 30, 2010, respectively. Thus, in this article, I shall dwell on the role of pharma SCM in ensuring patients’ health and safety, embracing modern technology.

Current concerns:

Gradual transformation of SCM with high-tech interventions is visible now, but in a sporadic way. Speedy development initiatives in this area need to be more inclusive, everywhere. This is a paramount requirement of the pharma business, that has been prompted by serious breaches in the SCM process, affecting patients’ health, safety and security, besides impacting the brand image.

Manifestations of these get reflected in the instances like, availability of substandard and counterfeit drugs, or large product recalls, or quality issues with APIs and excipients escaping SCM scrutiny.

W.H.O says, it’s now all-pervasive:

The availability of substandard and falsified medical products, although is a menace to the society, seems to be all pervasive. The November 2017, Fact Sheet of the World Health Organization (W.H.O) recognizes this fact. The paper categorically states that no country has remained untouched by this issue – from North America and Europe to sub-Saharan Africa, South East Asia, and Latin America. Thus, this hazard, once considered a problem limited to developing and low-income countries, is no longer so.

The leading factors: ‘poor governance and weak technical capacity’:

The W.H.O study titled “Public health and socioeconomic impact of substandard and falsified medical products” released in November 2017 invited rather embarrassing media headlines, such as “India among countries where 10% of drugs are substandard.” Some of the most common medicines consumed in India, such as Combiflam and D-Cold were also found as sub-standard by Central Drugs Standard Control Organization (CDSCO) – as this news item reports.

Commenting on the possible reasons for this menace, W.H.O underscored that such substandard and falsified medical products are most likely to reach patients in 3 important situations. These are, constrained access to high quality and safe medical products, poor governance, and weak technical capacity.

The most important and viable option to effectively address this drug-safety threats is innovative applications of state of the art technology platforms. Many pharma players, are gradually realizing it through experience. Quite in unison, various Governments, India included, are also contemplating to follow the same path. Some nations are enacting robust laws for strict compliance of the remedial measures, as charted out by the respective drug authorities.

Harnessing technology as an enabler:

I reckon, harnessing modern technology will facilitate putting in place a robust ‘Track and Trace’ in the SCM, through product ‘serialization’, to effectively address this menace. As many would know, pharma serialization broadly means that each medicinal product pack will carry a Unique Identifier (UID), that can be tracked and traced till the same reaches the end-user.

The process may start with the key ‘touch points’ of a drug before it reaches the patients, such as suppliers, formulators, carrying and forwarding agents (C&FA) or distributors, wholesalers and retailers. This can be extended backwards, as well, to make the drug-sourcing process safer, which is also of crucial importance.

Leveraging technology for patient safety:

Realizing the importance of drug-safety needs of patients, many drug regulators, even in the developed markets, are leveraging technology as a key enabler in the SCM value chain to effectively address this issue. There are several recent global examples of achieving this specific objective. One such example comes from the top pharma market in the world – the United States.

Where the ‘Track and Trace System’ came as a law:

To ensure greater drug-safety for patients in the country, the oldest democracy of the world decided to introduce the ‘Track and Trace System’ in the SCM process by enacting a robust law. Accordingly, in December 2016, the US-FDA released the final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA).

Under this law an electronic ‘Track and Trace System’, through product ‘serialization’, will be put in place in the United States. As reported in the ‘Pharmacy Times’, DSCSA comes into force to regulate transactions between dispensers, pharmacies, and also among manufacturers, repackagers, wholesale distributors, third-party logistics providers, and trading partners, from November 24, 2017.

Following DSCSA, on June 30, 2017, the agency issued a draft guidance for the industry, titled Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. It informed the manufacturers and other supply chain stakeholders that “although manufacturers are to begin including a ‘product identifier’ on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions.”

The US-FDA explains ‘product identifier’, as follows:

  • A unique identity for individual prescription drug packages and cases, which will allow trading partners to easily trace drug packages as they move through the supply chain.
  • Includes the product’s lot number, expiration date, a national drug code (or NDC), and a serial number. The serial number is different for each package or case. This creates a unique identifier – human and machine readable – to enable product tracing throughout the supply chain and enable all trading partners to better detect illegitimate products within the supply chain.

The US drug regulator clarified that the compliance policy outlined in the draft guidance applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017 and November 26, 2018.

Several other countries also realizing its criticality:

Besides the United States, several other countries are harnessing high technology to make the SCM system more robust to ensure patient safety. Some of these include, EU, South Korea, Brazil and China, South Korea and Argentina. India too has initiated action in this area, but only for exports, as on date. Intriguingly, drug-safety for patients within the country doesn’t seem to be on the ‘must do’ list of the law and policy makers of the country, just yet.

‘Track and Trace’ system in India:

As stated above, the ‘Track and Trace’ system in India for drugs is currently applicable only to pharma exports. By a notification dated January 05, 2016, the Directorate General of Foreign Trade (DGFT) made encoding and printing of unique numbers and bar codes as per GSI Global Standard mandatory. This would cover tertiary, secondary and primary packaging for all pharmaceuticals manufactured in India and exported out of the country to facilitate tracking and tracing.

However, for drugs in the domestic market, although a draft proposal was circulated to the stakeholders in June 2015, but no significant progress has yet been made on its implementation in India.

Conclusion:

Availability of potentially harmful substandard and counterfeit drugs is posing a threat to public health and safety, almost in all countries across the world, with a varying degree, though. The November 2017, Fact Sheet of the World Health Organization (W.H.O) also highlighted this issue with a great concern.

A robust SCM systems, built on modern technological platforms are now receiving encouragement from the Governments in many countries, to contain this menace. Accordingly, lawmakers are formulating tough laws, and the drug regulators are specifying the requirements that need to be built into the pharma SCM mechanism.

Some pharma players, on their own, are further raising this bar, while framing their internal compliance norms for SCM. They realize that besides responding to patients’ health and safety needs, it is necessary for the commercial consideration too, alongside the company’s reputation.

Although, India is included among those countries where 10 percent of drugs are substandard, as the W.H.O reports, no such regulatory mechanism has been made mandatory within the Supply Chain to cover drugs in the domestic market, as yet. Interestingly, the DGFT has made the ‘Track and Trace’ mechanism only for the exporters, probably for patients’ health safety of the importing countries! Neither has the majority of domestic pharma manufacturers voluntarily implemented it, demonstrating ‘Patient-Centricity’.

Making SCM robust, weaving into it the drug-safety needs of patients, is a necessity in India too. When a large number of countries, including BRICS nations, are embracing modern technology to achieve this goal, why isn’t India doing so – intriguing…No…?

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.

 

Leveraging Artificial Intelligence For Greater Patient-Centricity

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‘Artificial Intelligence (AI)’ – the science of simulation of intelligent behavior in computers, has the potential to leave a transformational impact on virtually everything that we see and feel around us. As many will know, the modern definition of AI is “the study and design of intelligent agents where an intelligent agent is a system that perceives its environment and takes actions which maximizes its chances of success.”

Let me begin with a couple of exciting examples on the application of AI for general use. One such is Siri the voice-activated computer in the iPhone that one can interact with as a personal assistant, every day. The other is the self-driving features with the predictive capabilities of Tesla cars; or even the well-hyped Google driver-less car. Alongside, Google is also in pursuit of creating AI with ‘imagination’ through its ‘DeepMind’. It develops algorithms that simulate the human ability to construct plans.

Pharma’s emergence in the AI space:

The unfathomable potential of AI is being slowly recognized in the healthcare arena, as well, including pharma industry. It’s gradual emergence in the space of ‘intelligent learning’, often called ‘machine learning’, ushers in a new paradigm of learning from a vast pool of highly credible real-time data. Innovative applications of this process can fetch a game changing business performance. Its scope spans right across the pharma value chain – from Drug Discovery, including Precision Medicine; Clinical Trials; Pharmacovigilance; Supply Chain Management, and right up-to Sales and Marketing.

Pharma’s emergence in the AI space is quite evident from Reuters report of July 3, 2017. It wrote that GlaxoSmithKline (GSK) has inked a new USD 43 million deal with Exscientia to help streamline the company’s drug discovery process by leveraging AI. With this deal in place, Exscientia will allow GSK to search for drug candidates for up to 10 disease-related targets. GSK will provide research funding and make this payment, if pre-clinical milestones are met.

Again, on July 27, 2017, Insilico Medicine – a Baltimore-based leader in AI, focusing on drug discovery and biomarker development, announced a similar agreement with the biotechnology player Juvenescence AI Limited. According to this agreement, Juvenescence AI will develop the first compounds generated by Insilico’s AI techniques, such as Generative Adversarial Networks in order to generate novel compounds with desired pharmacokinetic and pharmacodynamic properties.

Several other pharmaceutical giants, including Merck & Co, Johnson & Johnson and Sanofi are also exploring the potential of AI for streamlining the drug discovery process. It would help them to significantly improving upon the hit-and-miss business of finding new medicines, as Reuters highlighted.  Eventually, these applications of AI may be placed right at the front-line of pharma business – in search of new drugs.

I have already discussed in this blog – the ‘Relevance of AI in creative pharma marketing’ on October 31, 2016. In this article, I shall mainly focus on leveraging AI in health care for greater patient-centricity, which is emerging as one of the prime requirements for excellence in the pharma business.

Imbibing patient-centricity is no longer an option:

In an article published in this blog on the above subject, I wrote that: ‘providing adequate knowledge, skills and related services to people effectively, making them understand various disease management and alternative treatment measures, thereby facilitating them to be an integral part of their health care related interventions, for better health outcomes, are no longer options for pharma companies.’

The craft of being ‘patient-centric’, therefore, assumes the importance of a cutting-edge  of pharma business for sustainable performance.

What exactly is ‘patient-centricity’?

BMJ Innovations – a peer reviewed online journal, in an article titled, ‘Defining patient centricity with patients for patients and caregivers: a collaborative endeavor’, published on March 24, 2017, defines ‘patient-centricity’ as: “Putting the patient first in an open and sustained engagement of patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.”

Thus, to deliver the best experience, and treatment outcomes to patients, their participation and engagement, especially with the doctors, hospitals and the drug companies assume significant importance.

The June 2017 ‘Discussion Paper’ of McKinsey Global Institute, titled ‘Artificial Intelligence the Next Digital Frontier’ also captured this emerging scenario, succinctly. Recognizing that health care is a promising market for AI, the paper highlighted the enormous potential in its ability. The power of which can draw inferences by recognizing patterns in large volumes of patient histories, medical images, epidemiological statistics, and other data.

Thus, AI has the potential to help doctors improve their diagnoses, forecast the spread of diseases, and customize treatments. Combined with health care digitization, AI can also allow providers to monitor or diagnose patients remotely, as well as transform the way we treat the chronic diseases that account for a large share of health care budgets, the paper underscored. This poses the obvious question: what exactly AI can possibly do in the space of health care?

What can AI do for health care?

In a nutshell, the application of AI or ‘machine learning’ system in health care generally uses algorithms and software to approximate human cognition in the analysis of relevant, yet complex scientific and medical data. In-depth study and interpretation of these in a holistic way would be of immense use in many areas. For example, to understand the relationships between prevention or treatment processes and outcomes, or various debilitating conditions affecting people with the advancement of age, to name just a few.

This necessitates the generation of a huge pool of relevant and credible data from multiple sources, storing and analyzing them meaningfully, and then garnering the capabilities of ‘machine learning’ with the application of AI. Such a process helps in zeroing-in to a series of complex, interdependent strategic actions to go for the gold, in terms of business results. Using conventional methods, as exist today, other than imbibing AI or ‘machine learning’, may indeed be a Herculean task, as it were, to achieve the same.

Invaluable business insights thus acquired need to be shared, across the various different functions of a company, for greater patient-centricity within the organization.

Moving from ‘patient-engagement’ to ‘patient-centricity’:

While making a significant move from just ‘patient engagement’ to being ‘patient centric’, one-size-fits-all strategy is unlikely to yield the desired results. The process of gathering adequate knowledge and understanding of any individual’s disease management skills, which mostly depend on complex multi-factorial, interrelated and combinatorial algorithms, will be a challenging task, otherwise.

Thereafter, comes the need to deliver such knowledge-based value offerings to target patients for better health outcomes, which won’t be easy, either, in the prevailing environment.

Considering these, AI seems to have an immense potential in this area. Some global pharma players are also realizing it. For example, GSK is reportedly engaged with IBM’s Watson in the development of AI-enabled interactive digital Apps for its cold and flu medication to provide relevant information to patients.

Conclusion:

Patient-centricity would soon be the name of the game for pharma business excellence. However, to be truly patient-centric, especially in the sales and marketing operations, pharma players would require to source, process and analyze a huge volume of relevant data in several important areas. These include, target patients, target doctors, environmental dynamics, demographic variations, regulatory requirements, current practices, competitive activities, to name a few.

In this strategic business process, AI or ‘machine learning’ will help accurately mapping the ongoing dynamics and trends in virtually all critical areas. It will help ferret out the nuances of turning around the competitive tide, if any, and that too with immaculate precision. In that sense, AI is likely to emerge as a game changer in imbibing patient-centricity, in the real sense. Consequently, it carries a promise of delivering significantly better outcomes, yielding higher financial returns, alongside.

Although, some concerns on AI are being expressed by several eminent experts, it is generally believed that on the balance of probability, it’s crucial potential benefits far outweigh the anticipated risks. In my view, this holds good even for the pharma industry, especially while leveraging AI for greater patient-centricity, better disease prevention, and more desirable treatment outcomes – improving the quality of life of many, significantly.

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.

 

Multi-channel Engagement: A New Normal In Pharma Marketing

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The 2015 Report of AffinityMonitor reconfirms that access to important doctors for pharma Medical Representatives (MRs) continues to decline. Now, fewer than half of all doctors are truly accessible to the MRs, down from nearly 80 percent in 2008. In other words, though MRs continue to be the best way to engage the average physician, this “best way” is steadily getting worse.

However, for physician engagement, all digital channels put together to rank the second highest. These include both digital “push”, such as, email or alerts sent to a physician’s smart phone – followed by telemarketing, direct mail; and digital “pull”, such as content that doctors can access on their own from the Internet, and peer interactions, like webinars.

With the new digital channels emerging, pharma companies will have a wider range of promotional and engagement channels to reach out to not just the doctors, but also other important stakeholders. Additionally, various non-personal marketing channels could also help pharma companies overcome the declining trend of restricted access to physicians for MR.

No single channel works for all physicians:

Although, no single channel works for all physicians, as each doctor has a unique preference for how he or she wants to receive information across various channels, most doctors will engage with pharma players in some way. The findings of this report are based on data compiled from more than 100 pharma brands, including engagements with 632,000 physicians across a wide range of specialty areas, and more than 123 million individual physician interactions.

The report suggests that by understanding those channels on a physician level, and targeting their marketing and promotion accordingly, pharma companies can hone the effectiveness of each physician engagement, and thereby improve sales and marketing productivity considerably, for excellence in business.

Similar trend in India with varying degree of difficulty:

Similar trend, though with varying degree of difficulty, can be noticed in India, as well. Over the past several years, many top pharma companies have been already experiencing the steadily declining quality of access of pharma MRs to many important doctors.

This is primarily due to the number of patients coming to these busy practitioners is fast increasing, and as the doctors are trying to see all these patients within the same limited time that was available to them, as in the earlier days. In tandem, their other obligations of various kinds, personal or otherwise, are also overcrowding the same highly squeezed time space.

Thus, an increasing number of MRs, which has more than doubled in the past decade, is now fiercely competing to get a share of lesser and lesser available time of the busy medical practitioners. Added to this, a gross mismatch between the inflow of doctors with similar prescription potential and ever increasing inflow of patients, is making the situation worse.

Reevaluating traditional marketing and sales communication models:

In this complex scenario, the key challenge before the pharma players is how to make sales communication with the busy medical practitioners more productive?

Consequently, many pharma companies, across the globe, have started reevaluating their traditional sales communication models, which are becoming increasingly expensive with diminishing returns from the MR calls.

As I discussed in some other article, a few drug companies have commenced using various interesting multi-channel digital platforms, though mostly fall under the traditional pharma sales communication process.

I shall now briefly glance over the trend of responses of the Indian pharma companies over a couple decades, to meet these challenges of change.

MR based Experimentations:

With a strong intent to squarely overcome this challenge, many Indian pharma players initially tried to experiment with several different MR based approaches, in various permutations and combinations. It was initially directed to make the prescription generation process more productive, by equipping the MR with a wide range of soft skills.

Some pharma players also tried to push up the overall sales productivity through additional rural market coverage to Tier IV cities and below. Quite a few of them succeeded in their endeavor to create profitable business models around the needs of hinterland and rural geographies.

These pharma players, though quickly realized that extra-urban geographies require different tactical approaches, broadly remained stuck to the traditional marketing and sales communication models. These approaches include, differentiated product portfolio, distribution-mix, pricing/packaging and promotional tools, considering most the doctors are not as busy as their counterparts in the metro cities and large towns.

Strategic marketing based experimentations:

Several changes were also made in the strategic marketing areas of pharma business, though most of these, if not all, were imbibed from the global marketing practices of that time. These were well captured in an IMS report of 2012. Some of these strategic marketing shifts were as follows:

  • Strategic Business Unit Structure (SBU): To bring more accountability, manage evolving business needs and use the equity of organization for reaching to the middle of the accessible pyramid.
  • Therapy Focus Promotion: Generally seen where a portfolio is specialized, therapy focused, and scripts are driven through chosen few doctors; generally, in chronic segment.
  • Channel Management: Mostly adopted in OTC /OTX business; mature products with wider portfolio width.
  • Hospital Task Force: Exclusively to manage the hospital business.
  • Specialty Driven Sales Model: Applicable in scenarios where portfolio is built around 2 or 3 specialties.
  • Special Task Force: Generally adopted for niche products in urban areas, such as fertility clinics or for new launches where the focus is on select top rung physicians only.
  • Outsourced Sales Force: Generally used for expansion in extra-urban geographies or with companies for whom medico marketing is secondary (such as OTC or Consumer Healthcare companies).

Pharma MNCs did more:

In addition, to increase sales revenue further, many pharma MNCs engaged themselves in co-promotion of their patented products with large local or global pharma companies operating in India, besides out-licensing. A few of them pushed further ahead by adopting newer innovative promotional models like, Patient Activation Teams, Therapy Specialists, or creating patient awareness through mass media.

Realizing quickly that patients are increasingly becoming important stakeholders in the business, some of the pharma MNCs started engaging them by extending disease management services, along with a clever mix of well-differentiated tangible and intangible product related value offerings, such as, Counseling, Starter kits, Diagnostic tests, Medical insurance, Emergency help, Physiotherapy sessions, and Call centers for chronic disease management, to name a few. Concerned doctors used to be reported about the status of the patients, who were not required to pay anything extra for availing these services from the MNC pharma companies.

Nevertheless, despite all these, declining productivity of the traditional pharma sales communication models continued, predominantly from the extremely busy and very high value medical practitioners/experts/specialists, as mentioned above.

The critical point that remained unaddressed:

At that time, pharma sales communication kept focusing on customer/market types and characteristics. Most companies missed the emerging order of unique customer preferences towards the medium of sales communication, and differentiated message requirements for each doctor. Not many pharma players could probably realize that MR’s quality of access to doctors for productive sales communication would emerge as one of the most critical issues, and become increasingly complex.

Leveraging technology for an effective response:

Amid all these experimentations with pharma sales and marketing models, a few companies did ponder over leveraging technology to chart a novel pathway for effectively addressing this emerging challenge. They tried to ascertain:

  • Whether the traditional sales approach would continue to be as relevant as opposed to digitally customized sales applications?
  • Whether MRs would continue to remain as relevant in all areas of pharma prescription generation process, in the years ahead?

First major venture in e-marketing:

Towards this direction, in 2013, Pfizer reportedly started using digital drug representatives to market medicines, leaving the decision in doctors’ hands as to whether they would want to see them.

Prior to that, in 2011, a paper published in the WSJ titled, “Drug Makers Replace Reps With Digital Tools” stated that pharmaceutical companies in the United States are downsizing their sales force with increasing usage of iPad applications and other digital tools for interacting with doctors.

Lot many other fascinating experimentations with pharma e-marketing have now commenced in several places of the world, many with considerable initial success. However, most of these efforts seem to be swinging from one end of ‘face-to-face’ sales communication with doctors, to the other end of ‘cyber space driven’ need-based product value sharing with customers through digital tool kits.

Blending the right communication-mix is critical:

Coming back to the AffinityMonitor 2015 Research Report, today pharmaceutical and biotech companies have at their disposal more than a dozen of promotional channels to include in their strategy, spanning across, from traditional methods to digital ones.

Some physicians still want to interact with MRs, others restrict MR detailing, as they prefer to get the required information from various credible websites, directly, and from their peers. One doctor may prefer to regularly use a mobile application for product information, while another similar physician may rarely wish to surf the Web for information to achieve the same purpose. Some others may simply not engage with any sales communication no matter what the channels are. Although overall accessibility to MRs is getting more restricted, some doctors are still more accessible than others, the report finds.

Segmenting doctors by their accessibility to personal promotion, such as, MRs and by non-personal promotion like other channels, including digital, allows pharma companies to identify potential gaps in their marketing approach.

For example, of the 54 percent of doctors who are less accessible to MRs, 15 percent show good accessibility to other channels. In other words, those doctors haven’t closed the door for good, just yet. Pharma companies can still reach them, provided they use the right approach, the report suggests. Drug companies would, therefore, require gathering specific information doctor-wise, and customizing both the medium and the message for effective brand value delivery, accordingly.

Sales and marketing avalanche too isn’t working:

This study revealed that a pharma company’s top 100 doctors receive as high as 423 contacts a year, and the top 10 doctors receive more than 600 each year. Given such volume, it’s easy to imagine how doctors can start to get buried under an avalanche of sales and marketing. It’s also easy to see how even the right message, in the right channel, to the right doctor, could get lost in all the noise, and may even create a bad customer experience for many physicians, the report concludes.

Conclusion:

The decline in pharma MR’s quality of access to physicians for brand communication is now well documented. Moreover, ‘one size fits all’ type of message, delivered even by the best of MRs, is unlikely to be productive in the changing macro environment.

Therefore, the right knowledge of whether a doctor would prefer to engage through traditional marketing and sales communication methods by meeting with an MR, or would just prefer to get his/her required information through any digital medium, is critical for success in the new ball game. This in turn will help generate the desired level of prescription support for any pharma brand.

Still, a majority the doctors’ choices in India would, possibly, involve MRs, while a good number of other important doctors’ choices may probably be independent of them. Nevertheless, from this emerging trend, it’s clear now that multi-channel engagement would be a new normal in pharma sales and marketing, sooner than later.

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.

Leveraging 3D Printing In Pharma, For Cost Containment And Patient-Centricity

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Today, although a number of new and state of the art drugs is regularly being developed, and brought to the market at a reasonably rapid pace, their access to the majority of the global population has still remained a huge challenge. One of the key access barriers continue to remain exorbitant prices of these drugs.   

Keeping commensurate pace with gradual improvement in the pinpointed diagnosis of various diseases with modern diagnostics, processes, devices and techniques, fueled by increasing health awareness within a sizeable section of the population, more patients are now aspiring for access to a better quality of life, and greater productivity at work. This is happening all over the world, though with varying degree and magnitude. 

Consequently, there has been a sharp increase in the demand for healthcare, which has caused a huge bottleneck in the overall healthcare delivery process, for various reasons. The huge gap between the availability of high-tech drugs/healthcare services, and their access to the general population, mostly due to affordability reasons, is going north at a rapid pace. 

Two-pronged cost containment pressure:

This unfettered ascending trend is creating primarily the following two types of cost containment pressure: 

  • Being driven purely by the economical reasons, the Governments and other payers have started taking stringent cost-containment measures, bringing huge pricing pressure, especially on the drugs and medical device manufacturers.
  • In countries, such as, India, where the ‘Out of Pocket’ expenditure on healthcare in general, and the medicines in particular, is hovering around 70 percent, the patients, several Governments have started announcing drug price control policy to protect the health interest of patients. 

However, currently, only some piecemeal measures are being initiated, including in India, where a holistic approach for all, such as, Universal Health Care (UHC) and several other similar options, are long overdue.

Three different remedial measures:

In my view, consideration of either of these three following approaches, or an innovative blend of these, would enable the Governments to address this pressing issue, remove the existing bottle neck, and thereby bridge the healthcare access gap, holistically:

A. Fast implementation of Universal Health Care (UHC).

B. Closer look at the entire Pharmaceutical Value Chain with a resolve to work out innovative, game-changing solutions to reduce cost of each of its critical components, significantly.

C. Effectively addressing the emerging need of Patient-Centricity.

A. Fast implementation of Universal Health Care (UHC):  

I have already discussed UHC in one of my articles titled, “Universal Health Coverage: The Only Alternative To Drug Price Control in India?”, published in this Blog on November 9, 2015.

B. Cost containment with 3D printing:

A report of IMS Health, published on November 18, 2015, forecasts the increase of  total global spend for pharmaceuticals by US$ 349 billion on a constant-dollar basis, compared with US$182 billion during the past five years. It also indicated, more than half of the world’s population will live in countries where the use of medicine will exceed one dose per person per day by 2020, up from 31 percent in 2005, as the “medicine use gap” between the developed and the emerging markets narrows. 

This steep ascending trend would eventually affect the pharma ‘Value Chain’ in a significant way, throwing open several path-breaking high-technology based options, with impressive favorable impact on the general costs of medicines. 3D-printing technology is expected to play a significant role in this initiative.

Before proceeding further, let me zero-in on a few critical components, as follows, of the pharma ‘Value Chain’, as I see visualize these: 

  • Drug innovation (R&D)
  • Manufacturing
  • Marketing
  • Supply Chain

According to my understanding, at least in 3 of the above 4 ‘Value Chain’ components, there is an immense potential of leveraging 3D printing technology effectively, and in a big way.

In my article of January 11, 2016, published in this Blog, titled “3D Printing: An Emerging Game Changer in Pharma  Business”, I have already discussed the game changing impact of 3D Printing technology on the drug discovery process, drug manufacturing strategy, and supply Chain effectiveness in the pharma business. 

Hence, I prefer not to dwell on those areas, yet again, here. Instead, I shall briefly deliberate on the application of 3D Printing technology to effectively address the emerging need of ‘Patient-Centricity’ with an interesting and a very recent example. 

C. Improving ‘Patient-Centricity’ with 3D printing: 

At this stage, there is a need to understand what exactly is the ‘’Patient-Centricity’. It seems to be a popular buzzword now with the health care related companies, primarily to give an impression that they are really focusing on ‘Patient-Centricity’.

However, there does not seem to exist any universally accepted definition of this terminology, just yet. Nevertheless, one appropriate definition could well be: “A focused and transparent approach to providing maximum possible benefits to a patient from a drug, device, technology, or health care services.” 

I briefly focused on a part of this basic issue in my article titled, “‘Disease Oriented Treatment’ to ‘Patient Oriented Treatment’- An evolving trend’, published in this Blog on January 7, 2013.

As I said before, in this article, to explain ‘Patient-Centric’ approaches with 3D printing, I would quote from a very recent, and a path-breaking work in this area.

On May 25, 2016, ‘The Straits Times’ reported, the researchers at the National University of Singapore have found a way to use 3D printers to create low-cost tablets. With the help of this technology a tablet can be so personalized to respond to individual patient’s needs that the drug can be customized to take on different release profiles, such as, constant release, pulsed release, increasing or decreasing release, and any arbitrary interval as required by the patient. However, the most striking is, different drugs with different release profiles can also be combined in a single pill.

Once administered, the tablet dissolves layer by layer over a period of time, releasing the drug at a controlled rate. The duration can be altered by changing the chemical composition of the liquid.

It is worth noting here that the conventional tablets are only capable of a constant rate of release, requiring the patient to manually control the dosage and release rate, by taking doses according to a prescribed schedule, given by the doctor. In this scenario, if a patient requires different drugs with different dosages and intervals, it can become inconvenient to keep track and potentially dangerous, especially when the patient misses a dose, the report highlighted. 

The commercially available printer used in the project costs just S$2,000.

The Assistant Professor Soh Siow Ling, who leads the project, reportedly, expects that the low cost will allow it to be used in hospitals and neighborhood clinics. He further explained, “Every single person is different, based on many factors such as genetics, age, body mass and so on. Different people also have different activity levels and consumption habits, which affect their needs. It is, (therefore), not desirable to use the same drug to treat different illnesses which have similar apparent symptoms.”

The report indicated that in October, 2015, these findings were published in an issue of Advanced Materials, which is a peer-reviewed materials science journal.

A patent for the tablets was filed last year, and they are currently in talks with multinational corporations, and medical professionals to identify potential applications, the article highlighted. 

Changing role of doctors:

From the above developments, it appears that unleashing the full potential of 3D printing technology in the pharma industry, would also enable the medical profession to move further towards ‘Patient-Centricity’, in its true sense.

This technology would empower them offering to each patient, the right drug or drug combinations, with most suitable drug delivery system, and exactly the way individual patients would prefer, with a very high degree of precision.

Thus, from overall disease treatment perspective, especially with medicines, this approach offers a great potential to be significantly more effective, and convenient to individual patients, as compared to the conventional approaches. 

I reckon, over a period of time, professional competitiveness would drive the doctors further honing their effectiveness in the disease treatment process, and that too with a high degree of precision. In that situation, many doctors may decide to setup on-demand 3D drug-printing facilities even at their clinics.

The gradual embodiment of this brilliant technology by the doctors, is expected to throw open new vistas of opportunity, also to personalize the shapes, colors and flavors of any medicine, according to individual patient’s choice. This, in turn, would improve patient compliance, ensure a predictable relief from the disease, and demonstrate ‘Patient-Centricity’ of a high order by the medical profession, in general. 

Conclusion:

For the first time ever, with Aprecia Pharmaceuticals in the United States getting approval of the US-FDA on August 3, 2015 for the market launch of a 3D printed prescription drug for oral use by the epilepsy patients, dawns a new paradigm in the global pharma business horizon.

Effective application of this ‘disruptive innovation’ could well be a game changer not just in the ‘value chain’ of conventional pharma business models, across the world, but also for taking a giant leap towards ‘Patient-Centricity’. The doctors are also expected to be very much an integral part of this process. 

Besides all the above benefits, 3D printing can also encourage low-volume production, whenever required, and a wide variety of Active Pharmaceutical Ingredients, to meet any immediate demand, mostly for use in research and developmental work. 

Thus, noting the ongoing significant progress in this area, I reckon, leveraging 3D printing technology in pharma, not just to address the cost containment pressure, effectively, but also to ensure a tangible and visible move towards ‘Patient-Centricity’, in true sense. All-round success in the innovative application of this cutting-edge technology in the global pharma industry, would eventually separate men from boys in pursuit of 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.