Focus On All 3 Areas of Innovation For Affordable Access To Innovative Drugs

Posted on November 29, 2021 by Tapan Ray

Medical treatment has made astonishing advances over the years. But the packaging and delivery of that treatment are often inefficient, ineffective, and consumer unfriendly. This was articulated in an article on innovation in healthcare, published in the Harvard Business Review, way back, in its May 2006 issue.

Highlighting soaring healthcare cost, including ‘out of pocket’ health expenditure, and its impact on public health, the paper recommended innovative solutions for every related aspect of health care. These encompass – healthcare delivery, unleashing the power of technology, and customer-centric business models. Interestingly, despite enormous investment in drug innovation, the access to affordable health care for all, continued over the years.

The consequential scenario was well articulated in another paper on rising consumerism among healthcare consumers, published in the Deloitte Review issue 16, 2015. It noted, the existing business models are increasingly being challenged by all concerned. The aim is to find new sources of value – as expected by patients and deliver them effectively with innovative approaches for better outcomes. This has, initiated a recalibration of the healthcare system, as it were, in many parts of the world, including many -both developed and developing countries, across the globe.

In this article, I shall try to explore this area, especially from the perspective of relevance of innovative business models for affordable access to innovative drugs in the new normal. Let me start with three basic innovation needs in the pharma business that may help chart out a meaningful pathway to attain this goal.

3 innovation areas to make health care better and cheaper:

In pharma industry, people mostly talk about product or treatment innovation. Although, this is of paramount importance to make healthcare more and more effective with time, but may not help save or heal more patients, commensurately.

Going by the ‘health care innovation catalog,’ as charted by the above Harvard Business Reviewarticle, ‘three kinds of innovation can make health care better and cheaper.’ These innovations are primarily related to:

Use of ‘technology’ to develop new products and treatments or to improve care
Bringing in innovative changes the ways ‘consumers’ buy and use healthcare.
Generating new ‘business models’, particularly those that involve the horizontal or vertical integration of separate health care organizations or activities.

As I have deliberated in the past, related to the first two areas, this discourse will deliberate on the third type of innovation to explore the above specified area. Let me hasten to add that several studies published in the later dates, echoed similar approach.

Subsequent studies reinforce the point:

One such example, is the paper titled ‘Innovative Approaches to Increase Access to Medicines in Developing Countries’, published in the Frontiers in Medicine on December 07, 2017. This study also captured: ‘Access to essential medicines is problematic for one third of all persons worldwide. The price of many medicines (i.e., drugs, vaccines, and diagnostics) is unaffordable to the majority of the population in need, especially in least-developed countries, but also increasingly in middle-income countries.’

The paper highlighted, several innovative approaches, based on partnerships, intellectual property, and pricing, can further stimulate innovation, promote healthcare delivery, and reduce global health disparities, significantly. It underscored: ‘No single approach suffices, and therefore stakeholders need to further engage in partnerships promoting knowledge and technology transfer in assuring essential medicines to be manufactured, authorized, and distributed in low- and middle-income countries (LMICs) in an effort of making them available at affordable and acceptable conditions.’

Changing business model concept gaining steam during Covid pandemic:

The issue of affordable access to innovative medicines drew attention of all stakeholders, even the common man, during the Covid pandemic – more than ever before. Several publications raised a flag on this barrier to public health, especially amid a pandemic or epidemic like situation.

One of these papers, titled ‘COVID-19 and the global public health: Tiered pricing of pharmaceutical drugs as a price-reducing policy tool’, was published in the Journal of Generic Medicines, on October 07, 2020. The paper emphasized, COVID-19 has raised serious concerns about affordable and equitable access to critically needed innovative medicines and other health technologies. It pointed out: ‘Patent exclusivities add to the cost of healthcare by allowing supra-competitive prices of protected technologies’, it commented. At the same time, ‘the prices and availability of drugs also depend on certain other factors that are not related to IP protection.’

Here comes the concept of ‘differential pricing’ or ‘tiered pricing’. This is a voluntary price-reducing policy option of the innovator to sell innovative drugs at lower prices in developing countries – compared to developed nations. The study articulated, more and more innovators imbibing this option in the future, could be a way forward to address for the future. Could it be a win-win solution for this critical issue?

Is it a win-win solution to this critical issue?

Since, at least, the last decade, the concept of differential pricing or tiered pricing ‘has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to these life-saving products.’ This was also noted in the paper - ‘A critical analysis of tiered pricing to improve access to medicines in developing countries,’ published in the journal Globalization and Health, on October 12, 2011.

Even at that time, the paper said: ‘International tiered pricing has been proposed as an alternative to high prices when separable high- and low-to-middle-income markets exist for a medicine and when the seller exerts significant power over pricing, such as when there is limited or no competition due to patent protection, data exclusivity, or other market-entry barriers.’

Interestingly, despite above findings, tiered pricing has not been a widely followed concept in the old normal to ensure affordable access to life-saving innovative drugs, for all. One of its reasons could possibly be commercial considerations. Company specific business threshold of tiered pricing may not necessarily be able to offer a price that is equitable or affordable for all. That said, there are a few laudable initiatives of some major innovator companies in the past.

Some laudable past initiatives for affordable access to innovative drugs:

Since the beginning of this millennium, one can witness some laudable pricing initiatives for affordable access to critical, innovative drugs to save lives in developing countries and poorer nations. Let me give a few reported examples below:

Abbott Laboratories – the patent holder of lopinavir and ritonavir had initially announced a tiered price of $650 in 2001 for African countries and 16 non-African least developed countries. In 2002, the Company reduced the price to $500 for these countries and in August 2009 dropped it to $440 – slightly below the lowest generic price.

In 2001, Novartis offered “at-cost” tiered price of $2.40 per adult treatment course for artemether-lumefantrine FDC to WHO for developing countries After 5 years when a generic version of the same was available, Novartis decreased its tiered price to $1.80, thereafter to $1.50.

Eli Lilly’s two key DR-TB drugs, capreomycin and cycloserine were not widely available from other suppliers even after it went off patent. In 2002, Lilly transferred the drug manufacturing technology to several generic drug companies in TB-endemic countries. Eli Lilly’s tiered price has consistently remained below the generic prices for these drugs.

More examples of voluntary licensing during Covid pandemic:

Gilead signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture remdesivir for distribution in 127 countries that face significant obstacles to healthcare access.

Notably, the licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

On May 11, 2021, several media reports revealed that ‘US pharma giant Eli Lilly has issued royalty-free, non-exclusive voluntary licenses to three Indian drug makers – Cipla, Sun Pharmaceuticals and Lupin – to manufacture and distribute Baricitinib, which is being used to treat Covid-19.

As announced on October 27, 2021, the global drug major MSD and Medicines Patent Pool (MPP) entered into a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) including India following appropriate regulatory approvals. The Indian companies, reportedly, include, Sun Pharma, Cipla, Dr Reddy’s, Emcure Pharma and Hetero Labs.

On November 16, 2021, Pfizer Press Release stated: Pfizer and MPP has signed a voluntary license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). Under the terms of the license agreement, qualified generic medicine manufacturers worldwide that are granted sub-licenses, will be able to supply this combination drug to 95 countries, covering up to approximately 53% of the world’s population.

Conclusion:

Covid Pandemic, which apparently, is refusing to vanish anytime soon, makes the issue of making affordable access to critical innovative drugs for all, more intense. Since long, researchers, academicians, practitioners, and the stakeholders involved in addressing this healthcare challenge for the majority of the population have suggested several innovative approaches.

These include, focus on three kinds of innovation simultaneously, and with similar zest, can make health care better and cheaper. One such area is changing pharma business models for critical innovative drugs. The good news is a few pharma players have already charted on this pathway in the past, successfully, by extending royalty-free, voluntary licenses to manufacturers in the developing countries and poorer nations. Some of them even tried to match their tiered pricing with equivalent generic drug prices. But the overall response was rather lukewarm in the old normal. Interestingly, the new normal signals a mindset change in this regard within a larger number of global innovators.

The current trend gives a hope to many that an increasing number of global innovators will sincerely explore – not just one, but all the three areas of innovation for affordable access to innovative drugs. This could possibly reduce, if not eliminate the future need for the grant of compulsory licenses for such drugs, as happened during the peak of Covid pandemic, especially in India.

By: Tapan J. Ray

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

Focus On Core Competencies – Regardless of Generic Or Innovative Drug Business

Posted on February 22, 2021 by Tapan Ray

On February 11, 2021, by two different Press Releases, two global pharma majors – GSK and Novartis simultaneously made interesting announcements. Both were related to three generic cephalosporin antibiotics.

GSK revealed, ‘it has reached an agreement with Sandoz – a division of Novartis, to sell its Cephalosporin antibiotics business. Sandoz will pay GSK USD 350 million at closing, plus additional milestone payments up to USD 150 million, subject to the terms of the transaction.’

While articulating the purpose of hiving of its generic cephalosporin brands, the company reasoned: GSK is now dividing itself into two companies – one with core competencies focused on OTC products, and the other – prescription drugs and vaccines. The company emphasized: ‘The transaction aligns with GSK’s strategy to prioritize and simplify its portfolio and invest in the company’s innovative R&D pipeline and new product launches.’ Other brands in GSK’s antibiotics portfolio, are not impacted by this divestment. In other words, this would possibly mean that the generic drug business doesn’t fall within the core competencies of GSK, any longer.

Whereas, Novartis disclosed, the company’s Sandoz division, ‘has signed an agreement to acquire GSK’s cephalosporin antibiotics business, reinforcing its leading global position in antibiotics.’ Its noteworthy that Sandoz’s core competencies lie in the generic drug business.

While explaining the purpose of this acquisition, Novartis explained, cephalosporins being the largest antibiotic segment by global sales, acquiring these 3 leading brands - Zinnat, Zinacef and Fortum,“will further position Sandoz as a global leader in antibiotics – truly essential medicines that are the backbone of modern healthcare systems.”

The above transactions bring to the fore the criticality of focusing on core competencies for business excellence, regardless of innovative drug business and in multiple situations, such as:

Bringing organizational focus back on core competencies when these tend to get diluted.
Increasing the focus on core competencies as opportunities arise.

In this article, I shall revisit this critical management concept in the current perspective.

A brief recap:

The concept of core competencies of a business organization was introduced by two global pioneers in business management – C.K. Prahalad and Gary Hamel with the article – ‘The Core Competence of the Corporation.’ This was published in the May-June 1990 edition of the Harvard Business Review.

The relevance of focusing on ‘core competencies’:

The quality and quantum of commercial dividend in consistently focusing on ‘core competencies’ in any space, spanning across individual professionals to business organizations, have been profound. This calls for defining these in detail and collectively, at the top rungs of organizational leadership. Then, cultivate, and leverage the core competencies to differentiate an organization from its competition, creating a company’s long-term competitive and sustainable advantage in the marketplace – for business excellence.

What constitutes core competencies to gain strategic strength?

Core competencies – whether for individuals or for businesses, comprise primarily of resources, such as, special skills, capabilities and rewarding experience in those activities as strategic advantages of a business. Garnering financial resources would usually follow, thereafter. Thus, core competencies are always considered as a strategic strength, everywhere. That said, core competencies require continuous monitoring to always be in-sync with changing market dynamics. Otherwise, the strategies are likely to fail.

Broad examples – from pharma perspective:

Broadly speaking, discovering, developing and successfully marketing new drugs, identifying repurposed drugs for new clinical trials, and churning out novel vaccines quickly, may be considered as core competencies for innovative drug makers. They have demonstrated this skill even during Covid-19 pandemic. Similarly, immaculate skills in reverse engineering of existing drug molecules and high efficiency in process research to gain price-competitiveness, may be construed as core competencies of generic drug companies.

Examples of shifting focus on core competencies:

Although, it is desirable that pharma players stick on core competencies for sustainable long-term performance excellence, regardless of being in primarily innovative or generic drug business, we have witnessed this focus shifting on several occasions for both. However, expected success did not generally follow those companies with such tweaking in the strategic business models.

Nevertheless, some drug companies did get tempted to deviate from their core competencies. For example, innovative drug players tried to expand into low-risk generic medicines, which, in the long run, did not deliver expected results for many companies. However, this deviation wasn’t without any compelling reasons.

There were some valid reasons, though:

As is much known, traditionally, global R&D companies prefer to focus only on the business of innovative prescription medicines. Low margin generic business wasn’t their cup of tea. Subsequently, this trend shifted. Especially in those cases, where the pipeline of high potential new drug molecules did not meet the concerned company’s expectations. To stick to the knitting, some companies with deep pockets, explored another model of Mergers and Acquisitions (M&A) of innovative patented products and companies with rich new drug pipelines. Interestingly, in this M&A business model, low risk, low cost and high-volume turnover of generic business also started attracting several R&D based companies, alongside.

Which is why, an increasing number of R&D based companies started planning to expand their business in less risky generic drug business. This appeared to be a quick fix to tide over the crisis, as the generic drug business model won’t require going through lengthy R&D processes. Besides, compliance with ever increasing stringent regulatory approval protocols, particularly in the developed markets of the world.

Examples of why focus on core competencies matter, even in new normal:

There are several examples of large companies to illustrate this point – both from the old and the new normal. Just to give a flavor of the relevance of focusing on core competencies of organizations, I shall draw upon three interesting examples. Each of these, highlight different organizational visions and perspectives at different times, particularly the relevance of focus on core-competencies for a corporation. These are as follows:

The first one is Daiichi Sankyo of Japan’s acquisition of India’s generic drug major of that time – Ranbaxy, in June 2008. The parent company claims: “We provide innovative products and services in more than 20 countries around the world. With more than 100 years of scientific expertise, our company draws upon a rich legacy of innovation and a robust pipeline of promising new medicines to help patients.” It is much known today, what happened to this acquisition, thereafter, for various reasons, including faulty pre-acquisition due diligence. However, later on, the domestic pharma leader – Sun Pharma, acquired Ranbaxy. Nonetheless, at least from Daiichi Sankyo’s narrative, its areas of core competencies, appear closer to any R&D-based drug company.

The second example is US-based Abbott Laboratories acquisition of domestic formulations business of Primal Heath care in India in May 2010. Like Daiichi Sankyo, this acquisition was also a part of Abbott’s strategy to enter into ‘generic drug business’ -dominated emerging markets. Abbott, at that time, apparently decided to expand its strategic focus beyond its core competencies in business, primarily of patented products. However, by the end of 2012, the company separated into two leading healthcare companies. Abbott became a diversified medical products company. The other one – a totally separate company was formed, with the name – AbbVie, as a new researched-based global biopharmaceutical organization. AbbVie now operates in India, as well – with erstwhile Abbott’s innovative brands. In this case, by an innovative restructuring of the parent organization, Abbott brought back its sharp focus on core competencies of both the companies with both doing well in India.

The third example is a recent move of reverting to the original focus of core competencies, when moving beyond these did not yield results. In that sense, this example is different from the second one. On November 16, 2020, Pfizer also announced the creation of ‘the new Pfizer’, as it reverted to its original core competencies of “developing breakthrough treatments and delivering innovative, life-changing medicines to patients around the world.” On that day, Pfizer completed transaction to spin off its Upjohn generic drug business and combined it with Mylan to create a new entity – Viatris Inc. Earlier, the company had sold its veterinary business, a baby formula unit and its consumer products division as part of a deal with GSK – for similar reasons. Earlier, the company’s moving beyond its core competencies to pluck low hanging fruits of generic drug business, did not yield dividend, as Pfizer’s profit in the generic drug sector, reportedly, had gone South.

Conclusion:

According to Pharma Intelligence, several large players, such as, Novartis, Sanofi, AstraZeneca are now focusing on core competencies, as they start recovering from their unsettling patent cliff and other headwinds. Meanwhile, one may expect to witness more of Spin-offs, Carving-out, Splitting-off or further strengthening of core-competencies of organizations – for a sustainable long-term business excellence in the years ahead.

Spin-off and acquisition of Cephalosporin generic business by GSK and Sandoz Division of Novartis, respectively, is a part of the same ball game. Thus, maintaining or reverting focus on core competencies – regardless of generic or innovative drug business, I reckon, are the new imperatives of commercial success, even in the new normal.

By: Tapan J. Ray

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

Posted on August 10, 2020 by Tapan Ray

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 19^th 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.

Drug Pricing: Why Justify On R&D Cost Rather Than Precise ‘Customer Value’?

Posted on December 16, 2019 by Tapan Ray

While looking around, it won’t be difficult to spot many types of steep-priced highly innovative products, where high costs aren’t justified by high R&D expenditure, but for unique ‘customer value’ offerings. Many consumers evaluate those and decide to settle for one, instead of opting for cheaper variants – delivering the basic customer requirements in that product class or category. Although, both pharma and electronic goods belong to high tech-based knowledge industries, similar examples are in plenty of the latter, but hardly any in pharma.

Agreed that pharma is a highly regulated industry, unlike electronic goods. But so are banks, financial services, airlines, telecommunication, among many others. Interestingly, all these industries are building great brands without talking about their investment costs in R&D, while doing so.

In this article, I shall focus on – despite facing a formidable headwind, mostly for the same, pharma industry, in general, continue to lack in two critical areas of brand building. But, before doing that let me quote from some recent research papers wondering, how is this situation continuing unchanged, despite all concerned being aware of it.

Two opposing views:

Just to recap, let me put below, two diametrically opposing views that continue to clash with each one, since long:

New and innovative drug costs being excessive, globally, lowering their prices will not harm the progress of innovation.
Drug industry argues, any restriction of free pricing of innovative drugs, will seriously jeopardize innovation of newer medicines and treatments.

So much of divergence in the views of two key partners within the industry, can’t just continue any longer, without a serious intervention of governments across the world, including the United States.

Pharma does want to talk about ‘Cost & Value of Medicines’. But…

It’s not that pharma doesn’t want to talk about ‘Value of Medicines,’ but not, apparently, to create an ‘emotional connect’ with its stakeholders, including the patients. It appears, more as a general justification for the high cost of new drugs. For example, a pharma trade association’s communication, after acknowledging ‘that many are struggling to access the medicine they need,’ says upfront: ‘Discussions about costs are important.’ It follows a series of much-repeated common justifications, which are no- brainer, such as:

Medicines Help Patients Avoid Expensive Hospital Services,
Developing New Treatments and Cures is a Complex and Risky Undertaking,
Medicines are Transforming the Treatment of Devastating Diseases.

But, the reality is, these justifications are not working on the ground, as these are not quite in sync with ‘customers’ value’ expectations, both from the company as well from the brand. Moreover, instead of establishing an ‘emotional connect’, this approach probably is further alienating many stakeholders, as several governments are now broaching the issue of price control, or some other mechanism to set drug prices.

Pharma marketers need to be eclectic:

Instead of keep following the age-old marketing and communication models, young pharma marketers need to be empowered to be eclectic. They should look around and try to fathom how is ‘marketing,’ as a business domain, changing in other fast-growing industries, and act accordingly. As pharma is a high-tech knowledge industry, let me draw examples from other similar industries, such one that innovates and manufactures electronic products.

Unlike any high-priced, high-tech electronic product companies, such as Google, Apple or Microsoft – pharma marketing communications are more like ‘justification’ centric, for charging high prices for medicines. This approach, apparently, is not just a bit defensive, but virtually negative. Whereas, unlike drug manufacturers, the above tech companies are constantly focusing on the following two areas, for creating a robust ‘corporate brand’ that infuses consumer-trust in each of their products:

Establishing ‘emotional connects’ with customers
Focusing on the total value of unique value offerings, rather than the high cost of innovation to justify high prices

Let me deliberate briefly on each of the above two.

The importance of establishing ‘emotional connects’ with customers:

With the penetration of technology, almost in every household, with a varying degree, though, access to a gamut of information becomes increasingly easy, so are the options available to customers. This is impacting almost every industry, including pharma and healthcare.

Thus, for corporate performance excellence, customers are now creating a space for themselves at the core of the pharma business strategy. Consequently, a need arises for the pharma marketers to enhance end-to-end customer experience. Besides, brand value offerings, this includes both short and long-term customer service offerings to ensure an ongoing emotional connect with customers, for more intense and longer-lasting engagement with trust, both on the ‘corporate brand’ and also on individual products.

Therefore, creating effective ‘emotional connects’ with customers are assuming a cutting-edge strategic importance – in multiple facets of pharma business. More ‘emotionally connected’ customers also act as a force-multiplier to enhance corporate reputation. Although, it mostly happens through word of mouth, in recent days, value added omnichannel communication by respective companies, is playing a crucial role for success in this area.

In the good old days, reaching patients or patient groups directly, would have been a challenging proposition. Most communications on products, diseases and treatments, used to be through healthcare providers. But, this is no longer so, especially in the digital world, that opened a new spectacle of opportunities for crafting patient-centric strategies – as patients become more digital-savvy, too.

Focus on brand value offerings, not on cost of innovation to justify high prices:

To dwell in this area, a series of questions that one may possibly encounter, such as: ‘How do you define value? can you measure it? What are your products and services actually worth to customers?’ Way back, these points were deliberated in the article – ‘Business Marketing: Understand What Customers Value,’ published in the November-December 1998 issue of the Harvard Business Review (HBR). It said: ‘Value in business markets is the worth in monetary terms of the technical, economic, service, and social benefits a customer company receives in exchange for the price it pays for a market offering.’ From this paper let me pick up just two critical components of value, as follows, for better understanding:

Value in monetary terms: Such as, dollars per unit
Value for a customer: What the person gets in exchange for the price it pays

Nevertheless, the important point to note: As ‘market offering has two elemental characteristics: its value and its price, raising or lowering the price of a market offering does not change the value that such an offering provides to a customer. Rather, it changes the customer’s incentive to purchase that market offering.’

When applied in the pharma perspective:

When the above concept of value is applied in the pharma industry perspective, it vindicates an important. Which is, tangible value offerings of an exclusive, high-priced patented products, and the same in its off-patent low-priced avatar remains unchanged, regardless of significant change in its monetary value per unit. However, unlike a patent protected drug, options for generic equivalents will be many, with differing prices.

This brings out another important facet of ‘value’. As the above HBR paper states, considerations of value take place within some context. Even when no comparable market offerings exist, there is always a competitive alternative. For example, in the pharma business, one possible competitive alternative for patented products could well be – when the Government decides to issue a Compulsory License (CL) for make the product available at a cheaper price to patients.

The name of the new game:

Thus, for an exclusive new drug, instead of focusing on cost of innovation to justify high prices, a sharp focus on ‘total value offering’ of the brand would possibly be the name of the new game. It will entail persuading the ‘connected customers’ to realize the total value of both the tangible and intangible cost of each benefit that the product offers, rather than simply the cost of a pill. In doing so, a pharma marketer and his entire team, must have an accurate understanding of what its customers value, and also, would value. This calls for a painstaking research, and a mammoth real time data analysis.

Developing a unique ‘Customer Value’ model:

As the above HBR article reiterates, ‘customer value’ models are not easy to develop. Unfortunately, pharma’s ‘value delivery system’ is still tuned to a self-serving mode and not ‘customer value’ centric.Thus, marketers may wish to note some key points in this regard, as below:

Many customers understand their own requirements, but do not necessarily know what fulfilling those requirements is worth to them.
This leaves an opportunity to demonstrate persuasively, the total ‘customer value’ that the new brand provides, and how it fulfills their requirements.
The strategy makers would have to necessarily generate a comprehensive list of ‘customer value’ elements, based on robust data, on an ongoing basis.
The acquired insight on – what customers value, and would value, to gain marketplace advantages over competitors, would form the core of the business strategy.

The next stage would be a pilot study to validate the model and understand the variations, if any, in the estimates. It is also vital to note that an improvement in some functionality may appear important, but may not necessarily mean that customers are willing to pay for it. The aim should always be delivering superior value, and get an equitable return for it. Thus, enhancing end-to-end customer experience in this effort, becomes a critical ingredient to brand success.

Conclusion:

After the article – ‘Business Marketing: Understand What Customers Value,’ published in the November-December 1998 issue of the Harvard Business Review (HBR), in June 2000, a similar article was published in the ‘McKinsey Quarterly.’ The paper titled, ‘A business is a value delivery system,’ also emphasized the importance of a clear, well-articulated “value proposition” for each targeted market segment.

This means a simple statement of benefits that the company intends to provide to each segment, along with the approximate price the company will charge for each of those. The paper also underlined, the strength of the buying proposition for any customer is a function of the product value minus the price. In other words, the ‘surplus value’ that the customer will enjoy, once that product is paid for.

Over a period of time, high prices of new and innovative drugs are attracting negative headlines, like - ‘High cost of hepatitis drug reflects a broken pricing system.’ This continues, despite high decibel justification of the ‘exorbitant’ cost of innovation. Undaunted, Big Pharma and its large trade associations remain reluctant to jettison their old advocacy toolkit.

They seem to be still on a – ‘Listen and believe what we are saying’ mode. This is vindicated by the December 14, 2019 report that revealed: ‘The Pharmaceutical Research and Manufacturers of America, the drug industry’s top lobbying group, filed a lawsuit this week against the state of Oregon, claiming two laws it passed requiring greater transparency of drug prices are unconstitutional.’

Continuation of such approaches, on the contrary, is further alienating many stakeholders, especially the patients and the governments. Thus, time appears more than ripe today to focus more on delivering measurable ‘surplus value’ of new products, to well engaged and connected patients, both globally and locally.

By: Tapan J. Ray

On The Flip Side of Pharma Industry: A Saga of Perennial Contradictions

Posted on December 9, 2019 by Tapan Ray

Awesome contribution in the battle against multiple diseases, is obviously the primary facet of the pharma industry. However, on its flip side, one would witness a saga of numerous contradictions. Some of these exist perennially in well-protected opaque cocoons, regardless of what recent research data reveal. The consequences of which leaves a detrimental impact on the patient’s health interests, eventually turning into highly contentious issues, in the socio-political milieu of recent times.

While there are many such contradictions involving the pharma industry, this article will endeavor to understand just one inherent dispute. This is related to the impact of high R&D expenditure on drug prices. It assumes importance, especially at a time, when the world’s most influential pharma trade organization continues arguing in favor of the dictum – high new drug prices are driven by mind-boggling cost of drug innovation, as R&D spending keep shooting north. Incidentally, many others challenge this assertion backed by robust data, claiming it’s not so, actually.

Thus, the question that comes up, if high R&D cost prompts high drug prices, what happens when this major cost of new drug innovation comes down, as is, apparently, happening now. A proper resolution of this contradiction by ushering in transparency in this area, is important to safeguard a critical health interest of many patients. A recent research report, followed by several other important developments in this area, exposes this contradiction, probably more than ever before.

Some recent reports revealing the contradictions:

To drive home the point of contradictions, I shall cite a few references below, from a pool of many others. For example, one such report of September 26, 2019 unfolded: ‘The cost to bring a new drug to market has decreased to under US$ 2Billion’. This was announced by Clarivate Analytics plc while releasing the “2019 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook.”

Interestingly, another article had sharply contradicted the above, presenting a different story altogether. Quoting the Tufts University Center for the Study of Drug Development, it highlighted that it costs US$ 2.6 billion growing at 8.5 percent annually. However, adding an estimate of post-approval R&D costs increases, the cost estimate to US$ 2870 million. Many estimated, it would take pharma companies more than 15 years of average sales to reach breakeven.

Curiously, a different research paper, titled ‘Comparison of Sales-Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies,’ published by the JAMA Network Open on January 04, 2019 concluded quite in line with the ‘2019 CMR International Pharmaceutical R&D Factbook.’ It found, ‘Cancer drugs, through high prices, have generated incomes for the companies far in excess of research and development costs; lowering prices of cancer drugs and facilitating greater competition are essential for improving patient access, health system’s financial sustainability, and future innovation.’

Again, contradicting the above, one more article – ‘The Link Between Drug Prices and Research on the Next Generation of Cures,’ published ITIF (Information Technology & Innovation Foundation) on September 09, 2019, touted to: ‘Put simply, drug companies must make significant profits on their best-selling drugs in one generation in order to reinvest in the next generation.’

The saga of contradiction continues.

A glimpse at the current scenario:

While trying to understand the inherent contradiction in the space of cost of drug innovation by analyzing the available data, let us examine the current scenario, of course with reasons. Going by the oft-repeated justification that high R&D expenses drive the drug prices up, the converse scenario would be – a dip in the R&D expenditure should lead to a reduction in medicine prices, commensurately.

But this is unlikely to happen – drug prices won’t possibly come down due to voluntary measures of the drug manufacturers. As various recent developments indicate, it will be clear in the course of this discussion that the same justification won’t be jettisoned anytime soon.

Pharma CEOs do acknowledge that they have some role to play in helping lower drug prices. However, they continue defending prevailing high new drug prices by highlighting, their multibillion-dollar investments in R&D are responsible for advances in treatments of many serious ailments, such as cancer, hepatitis C, schizophrenia and autoimmune diseases.

This was again contradicted by another BMJ Research Study of October 23, 2019, which concludes: ‘A review of the patents associated with new drugs approved over the past decade indicates that publicly supported research had a major role in the late stage developments of at least one in four new drugs, either through direct funding of late stage research or through spin-off companies created from public sector research institutions. These findings could have implications for policy makers in determining fair prices and revenue flows for these products.’ Nevertheless, in the midst of it, signs of a shift in focus of many pharma companies in this area, is clearly discernible.

Signs of a shift in R&D focus are clearly discernible:

This gets well- reflected in the “2019 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook.” As the report unfolds, one of the basic shifts is a change in focus on R&D targets. Until recently, the research focus of most companies was on Noncommunicable Diseases (NCD) such as, Parkinson’s disease, autoimmune diseases, strokes, most heart diseases, most cancers, diabetes, chronic kidney disease, osteoarthritis, osteoporosis, Alzheimer’s disease, and others. Whereas, today there has been an increased focus on rare diseases.

What does it signify?

It obviously signifies, most companies are now trying to launch steeply priced niche products for rare diseases. This includes complex biologic products, gene therapy, personalized medicine and the likes. Which is why, a majority of current new drug approvals, targets smaller patient populations. For example, between 2010 and 2018, the number of addressable patients per drug approval decreased by 15 percent, as the above report revealed.

The bottom-line, therefore, is with the low hanging fruits already been plucked, many pharma players don’t seem to consider targeting innovation of reasonably priced mass market products. It has already happened with antibiotics and would now probably happen with several NCDs.

Two main drivers for this shift:

The two main drivers for this shift, resulting an increase in drug approvals, and significant reduction in cost per new molecular entity (NME), may be summarized as follows:

Increased focus on rare diseases. Of the 57 NMEs launched in 2018, 22 had an orphan drug designation, indicating that they targeted rare disease area.

Increased activity of smaller pharmaceutical companies. In 2018, as high as 74 percent of drug launches were developed by companies with an R&D spend of US$ 700 million to US$2 billion. Major pharma companies (R&D spend of greater than US$2 billion) accounted for just 26 percent of drug launches.

A good news!

The increase in new drug approvals driven by smaller pharma companies is a good news and also encouraging. This suggests, becoming a big company with deep pocket is no longer a prerequisite to bring an innovative drug to the market. On the contrary, making R&D programs more efficient is the name of the game, today.

Changing pharma investment strategies:

As is evident from the CMR International Factbook, drug manufacturers’’ investment strategies are also undergoing a makeover. In the R&D domain, external innovation, in general, is now playing a more critical role. Perhaps, more than ever before. In the first half of 2019 alone, global spend for pharma M&A and licensing activities was, reportedly, around US$140 billion. Interestingly, it outpaced projected 2019 R&D spend by more than 60 percent.

Do high R&D cost impact drug prices and vice versa?

This brings us to the key question: Does the high cost of R&D impact drug prices and vice versa? Or, it is being over-hyped as a tool to justify high drug prices. There are umpteen instances to believe so – for example, the world’s best-selling drug – Humira of AbbVie. According to the Wall Street Journal (WSJ) of September 28, 2017, the initial U.S. patent for Humira expired in December 2016, but the additional patents expire in the 2020s.

Interestingly, according to other reports, AbbVie has collected more than US$115 billion in global Humira sales since 2010. In 2018 alone its sales amounted to US$ 19.9 billion. The report reiterates, ‘AbbVie has made and will continue to make a lot of money from Humira.’ From these facts, one can presume that AbbVie’s R&D expenditure or the product acquisition cost, has long been recovered, but still doesn’t seem to have any significant impact on the drug price.

Pharma CEOs continue to repeat the same argument:

While testifying at a hearing of the Senate Finance Committee, pharma CEOs had to confront with a Senators’ question - “Prescription drugs did not become outrageously expensive by accident, Drug prices are astronomically high because that’s where pharmaceutical companies and their investors want them.” However, acknowledging that their prices are high for many patients for high R&D expenditure, the company chiefs tried to deflect blame onto the insurance industry, government and middlemen known as pharmacy benefit managers.

The CEOs also highlighted the rebates given on list prices to benefit patients. However, the reality is, under the current system, savings from rebates are not consistently passed through to patients in any form. Interestingly, despite such scenario, pharma CEOs don’t want the government negotiating drug prices directly. It’s apparent that none of their reasonings were found to be the genuine reasons for high drug prices, even by the US Senators.

Thus, pharma’s points of justification for high drug prices have not changed, over a long period of time. On the contrary, shifting greater focus on the R&D of rare diseases, where the number of patients is much less, the CEOs seem to be bolstering their same argument on a different ground, despite reducing R&D costs.

Surfaces a glaring contradiction:

Presenting the current situation from the drug industry perspective, the article titled, ‘Drug Prices and Innovation’, published in the Forbes Magazine on June 20, 2019, emphasized on some interesting points.

It said: ‘In 2018 return on investment in drug discovery/development were 1.9 percent, far below the 10.5 percent cost-of-capital - the rate-of-return the industry must provide to compete for capital with similar investments.’ The article also emphasized: ‘Under the current pricing regime, the expected returns from drug discovery do not justify the investment. They have not done so since 2010 and are expected to turn negative by 2020.’ It further added, big pharma, despite one of the highest rates of R&D spending of any industry, chronically fails to fund research sufficient to support adequate growth and returns to the average drug don’t cover the cost of development.

On the other hand, according to a presentation by CVS Health that cited Macrotrends.net as its source,pharmaceutical manufacturers’ profit margins have reportedly exceeded 26 percent for the last three years and 22 percent for the past 10 years.

This brings out again, the glaring contradiction between what is being highlighted and what is actually happening in the pharma business. Lack of transparency in this area of the drug industry, is believed to be the root cause of this confusion among many.

Conclusion:

As it has been recognized the world over, the high new drugs prices are an issue over the contentious argument of ‘high R&D expenditure’ being the ‘root cause’. It is, therefore, imperative for the stakeholders to demand transparency in this area. If finding a solution to this health-related issue is considered critical, without further delay, this needs to be expeditiously addressed.

As the saying goes, once the disease is diagnosed accurately, zeroing in on an effective treatment becomes easier. Let me hasten to add, for new, innovative and patented drugs, the situation in India is generally no different. Thus, there is no scope for any contradiction in this area, whatsoever. As the saying goes, once the disease is diagnosed accurately, zeroing in on an effective treatment becomes easier.

Voluntary implementation of ‘responsible’ drug pricing policies, by pharma manufacturers themselves, has been given a long rope. Time is running out now. If this does not happen soon, government control of drug prices will be essential, just as is being contemplated in the United States – the ‘capital’ of the free-pricing world. Moreover, it has been well documented in several studies that price control won’t jeopardize drug innovation, as pharma manufacturers will have to come out with innovative new products and treatments – event for survival of the business.

Saving lives – more lives, alongside making reasonable profits in the business, remain the primary facet of the pharma industry. However, the flip side of it, revealing a perennial saga of contradictions, such as one we discussed above, raises concerns of their being perceived as profiteering with drug prices, by many. Such practices go not only against patients’ health interest, but also negates the core purpose of existence of the industry – surely, endangering long term survival of this business model – as the modern technology unleashes its mesmerizing power for all.

By: Tapan J. Ray

Disruptive Impact of AI on Pharma Sales And Marketing

Posted on July 15, 2019 by Tapan Ray

Artificial Intelligence (AI) that refers to the ability of machines to perform cognitive tasks like thinking, perceiving, learning, problem solving and decision making, is poised to disrupt our world. Initially conceived as a technology that could mimic human intelligence, AI has evolved in ways that far exceed its original conception. This was articulated in the June 2018 Discussion Paper, titled ‘National Strategy for Artificial Intelligence’ of NITI Aayog, India.

The paper further highlights: With intelligent machines enabling high-level cognitive processes like thinking, perceiving, learning, problem solving and decision making, coupled with advances in data collection and aggregation, analytics and computer processing power, AI’s capability has dramatically expanded. So is its game-changing utility in a growing number of fields to enhance productivity – dramatically.

I also expressed this need in my article, “Indian Pharma To Stay Ahead of The Technology Curve,” published in this Blog on May 22, 2017. Nevertheless, despite galloping progress of AI, a kind of ‘Ostrich Syndrome’ still prevails in some sections of the industry. This attitude, if continues, may catch many drug companies off-guard, with serious repercussions on business. In this article, I shall focus on the possible impact of AI on pharma business, specifically on pharma sales and marketing, instead of being prescriptive in my deliberation.

A disruptive impact on pharma value-chain:

Currently, only a few drug companies have embraced AI-driven technologies to transform pharma value-chain elements, across functional areas of the organization. However, in the next few years, effective adaptation of AI, in the true sense, will be the key success factors for any player – nurturing a burning desire to succeed, consistently. This was, again, an important conclusion of the 2019 FICCI Report titled, ‘Use of Artificial Intelligence and Advanced Analytics in pharmaceuticals.’

While explaining its rationale, the report emphasizes – catalyzed by an exciting range of new, disruptive technologies a paradigm shift is taking place, challenging the status quo with the traditional pharma business model. AI is in the process of disrupting this status quo, especially in the following two areas:

Increasing stakeholder pressure to reduce costs and demonstrate greater value of drugs,
Evolving swing from treatment to prevention, and patient-centric treatments.

Prompts a critical need to re-imagine the future:

These inevitable shifts prompt a critical need to re-imagine the future, for each drug manufacturer. However, the good news is, some of them, predominantly the global ones, have started making sizeable investments on AI. On a deeper scrutiny, the FICCI paper finds that applications of AI are mostly taking place in the new drug discovery and the supply chain area.

Besides individual company initiatives in the R&D area, important collaborative arrangements on AI with academia, have also been announced, such as, ‘Machine Learning for Pharmaceutical Discovery and Synthesis Consortium (MLPDS). This is a collaboration between the pharma/ biotech industries and the departments of Chemical Engineering, Chemistry, and Computer Science at the Massachusetts Institute of Technology (MIT).

MLPDS is expected to facilitate the design of useful software for the automation of small molecule discovery and synthesis. As on July 02, 2019, reportedly, ‘33 Pharma Companies Using Artificial Intelligence in Drug Discovery.’That said,let me hasten to add that some companies are also testing the water, with all seriousness, in pharma sales and marketing functions. So, the AI wave is fast catching up, driving the drug industry to chart uncharted frontiers. In this scenario, would there be any scope of survival for laggards?

Should it happen faster in pharma sales and marketing, as well?

In my view, the answer is an emphatic ‘Yes.’ This is primarily because, the disruptive impact of AI won’t be any less in pharma sales and marketing. It will, therefore, be prudent for these professionals, not just to understand how AI works in their respective functions, but also the ways to effectively use various AI platforms and applications, to transform the traditional processes, fundamentally.

Moreover, when stakeholders, including patients, doctors, hospitals, health insurance companies and even governments, are directly or indirectly using a host of AI-enabled tools and applications for better outcomes, does pharma have any other option?

Areas in which the impact could be transformative:

The recent publication titled, ‘Boosting Pharmaceutical Sales and Marketing with Artificial Intelligence’ of ZS, analyzed this issue quite well. It emphasized, those functions in the drug industry where there exists a significant reliance on human functions, such as expertise and reasoning, the impact of AI can be transformative.

Sales and marketing are two such focus areas, besides other functions. Companies that use AI to orchestrate a cohesive customer experience, will drive stronger differentiation, better customer access and higher sales impact, the report highlighted. Thus, creating specific opportunities and requisite empowerment, are necessary for deserving people, to foster machine learning and human integration in sales and marketing. This, in turn, will help them gain insight into how to unleash the power and value of AI for achieving business excellence.

Some early adopters of AI in sales and marketing:

Recent reports indicate that some global pharma majors have started using AI in sales and marketing. Let me illustrate this point with two examples – Pfizer and Novartis.

In May 2017, Pfizer Australia, reportedly, adopted AI-powered digital analyst tool for sales and marketing decision making.This ‘What-if Simulator’, allows Pfizer to test and optimize a range of scenarios based on internal and external data sets. It helps simulate the impact of sales and marketing strategies, investigate assumptions and hypothesis difficult to test in the real world, and compare the outcome of various what-if scenarios in order to understand what’s contributing to business results. According to Pfizer, ‘the software will also help to understand deterministic and non-deterministic factors presented in its business operations, as well as see how variables within different questions impact one another’.

Another recent media report titled, ‘Novartis puts AI on the job to help reps say the right things to the right doctors,’ appeared in Fierce Pharma on January 09, 2019. It also confirms the keen interest of pharma in this area. Called “virtual assistant,”this application helps salespeople to make sure when they visit a specific doctor that they are talking about exactly what that doctor is absolutely interested in. “When you turn up at the right time with the right things to say, they’re more interested and put more value in it, and our people like the fact that AI is running in the background helping them plan their day,” Novartis official further elaborated.

Accept the dictum – ‘there is always enough room for improvement’:

Following this dictum, is the starting point for pharma marketers to seriously accept AI as a game changer in this industry, regardless of how successful the company is – in doing what they do, following the traditional business models. The core purpose of a drug company is to make sure that patients get what they want, in those disease areas where the company represents.

If a brand strategy is prepared based on research data collected a few months back, there could probably be a flaw in your strategy. This is because any recent offering to patients by a competitor, may have considerably changed what the patients want now. If a strategy is not based on virtually real-time information on what exactly the customers are looking for now, the result could be far from satisfactory.

The elements which are critical in creating ‘great brands,’ were nicely captured in the May 13, 2019 issue of Customer THINK on ‘AI in Digital Marketing.’ It articulated, ‘Great brands will be those that can think creatively, design effectively, and execute flawlessly to deliver seamless experiences woven together by machines and humans. Using this approach, marketers and their marketing machines will stay gainfully employed.’ Thus, creative application of AI by astute pharma marketers will help achieving this goal.

Will AI ultimately replace pharma sales and marketing people?

This is a lurking fear in the minds of many. A related article appeared in the pharmaphorum on July 02, 2019, also wrote about a similar apprehension. The paper is titled, ‘Will AI make pharma marketers obsolete?’ It said: ‘Artificial intelligence, is sometimes seen as either a panacea or a destroyer – the fix for all humanity’s problems, or the apocalyptic scourge that will turn on us.’

I too reckon, AI can never replace people in pharma sales and marketing operations. This is because, there are two distinct elements in both these functions. One, the creative power of a professional that creates, develops, hones, and executes new ideas, strategies. It even decides how effectively AI can be used. The second element is the technological power behind AI. This can carry out a host of different very important, but routine and repetitive tasks – with a great amount of precision and virtually flawless. As the key sales and marketing professionals will need both, the AI can’t completelyreplace people in these two critical operational areas.

Some uses of AI in sales and marketing:

Eularis, in its ‘Blog, Comment & Insight’ of January 15, 2018, deliberated on this area. Just to give a feel of possible use of AI in different very important, but routine and repetitive tasks – with a great amount of precision, I am summarizing some of those points, as follows:

‘Identification and Mapping’ of’ Key Opinion Leader (and up-and-coming Key Opinion Leader), which is constantly changing. Alongside, it can help scan and analyze all relevant journal articles, coming out each week, besides the same for ongoing clinical trials in the chosen field – flagging how changes and new additions can impact the KOL database.

Disease specific patient identification and physician targeting, especially in rare disease areas.

Helps identify individual preferences for content, channels and timing of information, that leads to allowing personalization at scale, and ensuring every customer is receiving what they want, when they want, and in the channel they want.

Facilitates utilizing the power of big data, AI tools and apps to identify which patients will cease adherence and how this can be addressed, thereby minimizing the loss of business for non-adherence.

Helps create custom messaging for sales reps to use for individual physicians based on what that physician needs at that particular moment in time.

Conclusion:

Use of AI-based technology in the pharma industry, basically means automated algorithms with the capability to perform all those tasks that are now being done mostly with heavy dependence on human intelligence. Thus, its possible use spans across almost all functional domains – from drug discovery, clinical development, supply chain and right up to sales and marketing.

Although, it is still challenging to figure out to what extent AI will transform the industry, one gets a strong signal that it is not just another ‘buzz word’ or a new kid on the block. The technology is surely spreading its roots across the health care space, pharma being an integral part of it. Which is why, according to ‘Executive Insight’ (Volume XX, Issue 60) of L.E.K. Consulting, ‘all of the largest 10 pharmaceutical companies are investing in AI, and developments in applications are occurring across the spectrum of pharma business.’

In fine, to fathom the disruptive impact of AI on pharma business, I shall conclude by quoting from March 18, 2019issue of Healthcare Weekly. After a thorough analysis, the paper acknowledged thatAI is already redefining biotech and pharma. It concluded by stating, ‘ten years from now, pharma will simply look at artificial intelligence as a basic, every day, technology. The only question is how long pharma executive will wait till they jump on the wagon and leverage AI to improve their operational efficiency, outcomes and profits.’

By: Tapan J. Ray

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

Posted on May 20, 2019 by Tapan Ray

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

Pharma Marketing: Time For A Disruptive Change with A New Breed of Marketers

Posted on March 11, 2019 by Tapan Ray

In Today’s fast-changing world, as I indicated in several of my previous articles, more and more people first try to understand the causative factors of their ailments, and options available for effective remedial measures. They strive to get such information, either from the cyberspace or by word of mouth from well informed individuals or other sources. This process starts before treatment, and continues, at times, even after remission of the disease.

Even in the developed countries, a scope exists for self-medication for common ailments with OTC drugs, duly approved by respective country’s drug regulators. A point to ponder, most of these were ‘only prescription’ medicines before going off-patent, and after enjoying 20 years of exclusivity with pricing freedom. During their patent life, self-treatment was illegal with any of these molecules, if not dangerous. The same tradition continues today.

The bottom-line is, many patients are now trying to understand their diseases from sources other than the physician. Good or bad, the reality is, such patients generally prefer to visit a doctor as and when they deem it necessary. While visiting a clinic, they already have, not just some idea of the ailment, but also in what way they would prefer to get themselves treated and approximate cost of each. One should not presume, either, that majority of them are unaware of the risks involved with this approach.

Pharma marketers today can’t just wish away this emerging trend of patients and patient groups getting increasingly more informed. Trying to stop this trend will be a Herculean task, similar to swimming against a very strong current. Managing this situation in a win-win way is now a key task of a pharma marketer. In this article, dwelling on this trend, I shall focus on the need for a disruptive change in pharma marketing and the new breed of drug marketers.

Calls for a fundamental shift in pharma ‘marketing focus’:

Achieving this objective warrants a fundamental, if not a disruptive shift, in the ‘marketing focus’ of pharma companies – from traditional ‘product management’ to modern ‘brand management.’

With patented ‘me-too’ drugs, including ‘Fixed Dose Combinations (FDCs)’, as well as generics, now dominating the market, some sort of ‘commoditization’ of drugs are taking place in the pharma industry, whether one likes it or not.

No significant differential advantages oruniqueness exist between such products manufactured by different drug companies. Consequently, doctors or patients have enough choices to prescribe or buy, drugs with comparable efficacy, safety, quality standards and matching price range, from different pharma players.

Shift from product marketing to brand marketing:

One may possibly ask aren’t both quite the same? Is there any meaningful difference between these two? Thus, taking a pause, let us try to understand what’s the difference between these two.

Yes, for many there is not much difference between these two, especially in the pharma industry. Hence, many drug companies name this function as ‘product management’, while others call it ‘brand management’. In fact, these two are often used as interchangeable terminologies in the drug industry. Nonetheless, this understanding is far from being correct.

The key focus in ‘pharma product marketing’ is on the drug itself – its intrinsic value offerings to patients in terms of efficacy, safety, quality and often the cost. Thus, ‘product marketing’ approach may work for breakthrough drugs, but not for ‘me-too’ patented drugs or generic ones to achieve the desired goals of the respective companies, consistently.

Whereas, pharma ‘brand marketing’ in its true form, creates much more value than pharma ‘product marketing.’ The former dovetails intrinsic values of the drug with a set of strong feelings and emotions around the brand, purely based on what patients or consumers would want to experience from it. This process makes even a me-too brand stand out, creating a strong personality around it and differentiating itself head and shoulder above competitors. Importantly, the bedrock of conceptualizing these powerful feelings and emotions, must necessarily be robust, relevant and fresh research data. No doubt, the task is a challenging one– and not every marketer’s cup of tea.

Why building personality for pharma brands and services is necessary?

If we look around the healthcare industry, we shall be able to realize the importance of building personality for a medicine, especially generic drugs with a brand name, in the Indian context.

For example, many hospitals offer similar medical treatment facilities, follow similar treatment guidelines and their cost may also not be very different. But why different people prefer different ones among these, and all hospitals don’t get a similar number of patients? Same thing happens during the patients’ selection of doctors from many, having similar qualification, experience and expertise.

This happens mainly due to the attachment of a persona around each that creates a particular feeling and emotion among patients while choosing one of them. The process and reasons of creation of a persona may be different, but it certainly differentiates one from the other for the consumer. The same thing happens with virtually undifferentiated ‘me-too’ patented drugs or generic medicines.

Time to create a ‘strong pull’ for a drug, instead of ‘push’ by any means:

To create a ‘strong pull’ successfully, specifically for ‘me-too’ patented molecule or generic drugs, there is an urgent need for a fundamental change in the organization’s marketing approach – a shift in focus from ‘product marketing’ to ‘brand marketing’.

Otherwise, current pharma marketing practices for creating a ‘strong push’ for drugs that often involve alleged serious malpractices’ will continue. But continuation of this approach is not sustainable any longer, for scores of reasons.

The benefits of pharma ‘brand marketing’ in bullet points:

To summarize the key benefits of ‘brand marketing’ in pharma, the following points come at the top of mind:

‘Brand marketing’ of drugs helps escaping avoidable and unsustainable heavy expenditure to create a ‘strong product push,’ often resorting to contentious marketing practices.

Proper ‘brand marketing’ of drugs needs high quality cerebral and multi-talented marketing teams, rather than the power of ‘deep pocket’ to buy prescriptions. This creates a snowballing effect of cutting edge talent development within the organization, along with a culture of leading by examples, for a sustainable future success.

‘Brand marketing’ is a better, if not the best way to make a drug most preferred choice in a crowd of similar branded generics or ‘me-too’ patented drugs.

Paying doctors for prescribing a drug does not help developing loyal customers, but creating feelings and emotions for a brand among them, helps foster brand allegiance.

Creative ‘brand marketing’ of drugs will appreciably boost the image of the organization, as well, but ‘pharma product’ marketing in its present form, will not.

Pharma ‘brand marketing’ and ‘patient-centricity’ to work in tandem:

My article, ‘Increasing Consumerism: A Prime Mover For Change in Healthcare’, published in this blog on June 11, 2018, deliberated an important point. It was:

If the pharma strategic marketing process is really effective in every way, why is healthcare consumerism increasing across the world, including India?

The focal point of rising consumerism in the pharma industry is unsatisfied, if not anguished or angry patients and patient groups – in other words consumers. There could be various different reasons for the same. But the core point is, contentious marketing practices that pharma players generally follow, is self-serving in nature. These are not patient-centric, and mostly devoid of efforts to create feelings or emotions for the product, among both prescribers and other consumers.

The pharma marketers to keep pace with changing environmental demands:

As I discussed several times in the past, pharma marketers are often found wanting to meet the changing demands of the business environment. This is important, as the general pharma practices of influencing the prescribing decision of the doctors are facing a strong headwind of increasing consumerism, India included. This is slowly but surely gaining momentum. For example, patients in India are realizing:

That a vast majority of people pay ‘out of pocket’, almost the total cost of health care, without having even a participatory role in their treatment choice, including drugs.

That they no longer should remain unassertive consumers, just as what happens in other industries when a consumer buys a product or service.

That they need to involve themselves more and be assertive when a decision about their health is taken by doctors, hospitals, realizing that pharma and medical device companies often ‘unfairly’ influence doctors’ prescribing decisions.

The role and requisite talent required for pharma marketers have changed:

Keeping aside ‘one size fits all’ type of strategy, even if I look at so called ‘targeted marketing’ in pharma, it appears somewhat baffling. It is somewhat like, ‘empty your machine gun magazine at the target with a hope to win over competition.’ Whereas, today’s environment requires making healthcare product marketing, including drugs and services, more personal, and in some cases even individual, like latest cancer therapy. The wherewithal for technological support to move towards this direction is also available. State of the art marketing and product research tools and analytics should be put to use to facilitate this process.

Increasing usage of digital marketing, in an integrated or holistic way, is going to make traditional pharma marketing less and less productive, whether we like it or not. To maintain a sharp competitive edge in this new ball game, on an ongoing basis, pharma marketers will need to keep raising the bar.

Consequently, the role and requisite talent required for pharma marketers have also changed. The new generation of drug marketers will not just be creative, but their creativity will be guided by a huge pool of credible research-based data, avoiding gut-feel. All guesses in this area must pass the acid test of validation by what the research data reveals. Moreover, pharma marketers will need to possess, at least the working knowledge of various digital platforms and possible usages for each of these.

Conclusion:

There is an urgent need to realize that drug marketing is now at the crossroads, pharma players will have a choice, either to follow the same beaten path or gradually make a course correction to keep pace with changing environmental demands. If a company decides to choose the second one, the role of pharma marketers and the talent required for doing the job effectively, will be significantly different from what it is today.Maintaining the status quo in this area, carries an inherent risk for the future success of pharma companies.

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

Tag Archives: focus

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