Tag Archives: disease

Is Pharma Industry A Late Learner, Always?

Posted on by
Reply

Several upcoming concepts in the pharmaceutical industry are becoming buzzwords today. But, most of these were recommended by stalwarts several decades ago. Interestingly, the prevailing scenario is no different, even related to wide-scale adoption of a number of cutting-edge technologies, to squarely face the ongoing challenge of changing market dynamics. Various studies point out that other industries are making transformative use of these – to be on the same page with their customers, much faster.

Pharma is considered to be a late entrant in the digital space, too. It’s still not quite clear to many, the extent by which ‘Digitalization’ is transforming the way pharma industry functions – aiming at unleashing huge opportunities for value creation – from supply chain to manufacturing – right up to creating a unique customer experience. As this subject was well deliberated in the August 2016 article on McKinsey Digital, I am not going to delve into that area today.

Therefore, the question that comes up: Is pharma industry, in general, a late learner – always, to be in sync with its contemporary customers? For exploring this point, I shall focus mainly on four areas of current hypes in the pharma business, namely - ‘patient empowerment’, ‘patient-centricity’, ‘customer experience’ and ‘E-Patients’.

In this article, I shall dwell on this subject, ferreting out some critical recent findings on the relevance of these not so recent concepts in today’s perspective. Let me start by diving deep into the time capsule.

How old are these concepts?

Industry watchers may know that these are not new concepts, in any way. The relevance of ‘patient empowerment’, ‘patient-centricity’, ‘customer experience’ and ‘E-Patients’ in the drug industry has not unfolded today, neither are these new ideas. The American medical doctor - Thomas William ”Tom” Ferguson (July 8, 1943 – April 14, 2006) was an early advocate for ‘patient empowerment’.

Since 1975: “He urged patients to educate themselves and share knowledge with one another and urged doctors to collaborate with patients rather than command them. Predicting the Internet’s potential for disseminating medical information long before it became a familiar conduit, he was an early proponent of its use, terming laymen who did so – ‘E-Patients‘.”  

Technology follows a concept and not vice versa:

With ‘E-Patient’ terminology, Dr. Thomas Ferguson talked about empowered, engaged, equipped and enabled patients. I reckon, even after close to 45 years, most of the drug industry, is still not quite there – ‘Digitalization’ initiatives notwithstanding. This is because, technology follows a concept and not vice versa.

Why it’s so?

I reckon, this is primarily because, many stakeholders often don’t pay much importance to a critical fact, which is: ‘Patient expectations and needs can differ considerably from the aims and objectives of health care providers, at both the policy and delivery levels,’ and also by many drug companies. Still, most of these entities are yet to lap up this concept.

Is reviving focus on ‘Patient Centricity’ a realistic proposition today?

Several studies in this area have concluded, to be accepted by patients, the patient experience should be the key driver for the development of solutions.’ These include, medicines, devices, information, support programs and even digital apps. Among many others, one such study was published on March 28, 2017, in the SAGE Journals, titled, ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’

The basic question of its feasibility would prompt: ‘Would this approach help pharma players to make enough profit with the drugs?’ While addressing this query, the researchers put across the following points that need to be seriously reflected on:

  • Profit is necessary. But, how drug companies make and use business ‘profit’ is more important for long-term business sustainability.
  • It requires a clear vision at the top of creating and delivering ‘customer value’ as patients will perceive, followed by a robust assertion of ‘Patient Centricity’ across the business domains.
  • This will help break out of the cycle of “recover costs of R&D – make a profit – invest in new drugs – make more profit.” The new ball game will be – profit through customer satisfaction – invest in new drugs for greater ‘customer value and more customer satisfaction’
  • Such commitments, in turn, will help generate not just reasonable profit, but credibility with external stakeholders – such as, patients, regulators, media, etc. – creating an invaluable reputation for the organization, as a future growth booster.

Since old practices have continued for very long, virtually unchanged, a legacy factor has now crept into the system, mostly as a retarding force.

A legacy issue to overcome:

As the above research article underscores: ‘Historically, the pharmaceutical industry’s role has been to develop the science and medicines for prevention or treatment of disease.’ Whereas, ‘Patient Centricity’ involves patients as stakeholders in this scientific process. It calls for an innovative mindset, whereby ‘the industry is challenged to engage and collaborate with patients when deciding the best course of action.’ This need is now palpable within the industry, at the long last. 

Palpable needs for a new focus on designing ‘healthcare solutions’:

With the shift in the environment around the industry and its stakeholders, including patients, are feeling the need to ferret out some old classic concepts for a new focus in designing various ‘healthcare solutions.’ For this purpose, as the above research article reiterated, a better understanding of ‘patient experience’ at critical points, in the course of the diagnosis and treatment of the disease, would help designing more effective ‘health care solutions’ for better patient outcomes.

The commercial necessity for better patient outcomes, merits ‘Patient Centricity’ at the core of the pharma business model, which, in turn, calls for a shift in the cultural mindset within the pharmaceutical industry. Such a shift would involve, among others:

  • Redefining the core strategy, organizational structure, processes and capabilities to focus on transparency and value creation for the patient.
  • A change from a disease-centered to a patient-centered strategy, and from a product-led to a patient-led development process.
  • Listening to and partnering with patients, and understanding the patient perspective, rather than simply inserting patient views into the established process.

Therefore, ‘patient-centric’ initiatives of any company should begin with the basic question: how can the company make a difference for patients?

The new realization: Compete better to win, neutralizing healthcare consumerism:

To better compete and win even in the midst of evolving healthcare consumerism, instead of adding fuel to it around the world, including India, a new book – ‘Making the Healthcare Shift: The Transformation to Consumer-Centricity,’ brings some contemporary ideas where, again, many old ideas seems to have been tested with a new perspective.

Interestingly, the content of this book is based on over 60 executive interviews with the biggest names in healthcare and a quantitative research study. Some of these names include leading academic institutions, such as, the Mayo Clinic, USCF Medical Center; big drug companies like Pfizer, Lilly and Novartis. The book reveals, while healthcare organizations have recognized the need to change to ‘Patient Centricity, they often don’t know where or how to begin.

To help healthcare organizations reinvent how even traditional pharma players engage with consumers in the new paradigm, the authors identify five shifts that pharma players can make to better compete and win in this evolving landscape of healthcare consumerism. 

Need to ‘reinvent the wheel’, is more than ever before!

To ascertain the above point, I shall paraphrase just a few – ‘Patient-Centric’ and ‘Customer Experience’ related areas of the book along with my own views to help you to come to your own logical conclusion:

  • To provide a holistic disease treatment solution, keeping the patients engaged along the entire journey in the disease treatment process, pharma players should bring ‘consumer experience’ at the core of the business model. As I also deliberated in this blog that: ‘Enhancing End-To-End Customer Experience’ is, therefore, considered by many astute pharma marketers, as a vital ingredient of pharma brand building exercise. In that article, I articulated, such initiatives should cover, all the ‘’touchpoints’ and ‘episodes.’ Where ‘touchpoints’ are spots of contact or interaction and ‘episodes’ focus on end-to-end design of a specific customer-need for an organization. Aligning management and the front line around the customer experience, is critical.
  • As things stand today, the entire journey through the disease diagnosis and treatment process, in the current healthcare ecosystem, remains fragmented. Mostly because, it involves many ‘touchpoints’ and ‘episodes,’ comprising of different health care entities. Providers’ inefficiencies, of various types, encountered by patients at different points of this journey often lead to their frustration, causing an unpleasant ‘customer experience.’ To achieve this objective, by effectively addressing the aforesaid common denominator for all – ‘Patient-Centricity,’ is of paramount importance. This entails, as stated before, integrated measures for listening to and partnering with patients, alongside, placing patients’ well-being at the core of all healthcare business initiatives. From this perspective, ‘patient-centricity’ based on customer insights,represents a holistic approach to provide the disease management solutions.
  • With rapid advancement in medical science, culminating into several breakthrough innovations, the world has stepped into a new era of disease treatment solution. Increasingly, ‘one size fits all’ type of population-centric treatment, is giving away a sizeable space for a new ‘patient-centric’ variety of the same. Moving towards this direction would necessitate pharma players, along with all health care organizations to acquire a deep insight on patients. The acquired insights must be based on in-depth analysis of a robust and contemporary sets of data, including demography, attitude towards health, treatment needs and preferred options available to the targeted audience.

This brings me back to where I started from. Dr. Thomas William ”Tom” Ferguson and maybe several others, as well, had recommended similar approaches over four and a half decade ago. We did not learn it then. But, while fighting against all odds, as the industry has been facing over some time, some companies are feeling the need of learning it now. Better late than never!

Conclusion:

It has been universally accepted that market dynamics keep changing in all industries, may be faster in some than others. Looking back, one can sense similar ongoing changes both within the pharma industry and the business and social and cultural environments outside, especially related to its stakeholders. When faster, proactive changes take place within the industry than outside, it delights the customers. Similarly, faster changes in the outside environment that industry fails to keep pace with – deliberately or otherwise, will invite strong headwind impeding growth of the business and even denting its reputation. Although, the former one is desirable, the latter prevails in most areas of pharma business. A Working Paper of the Harvard Business School wanted to understand ‘How do organizations learn?’ It found, among others:

  • Performance outcomes can be augmented, if one deliberately focuses on learning from experience accumulated in the past.
  • The competitive advantage of firms critically depends on the skills of individual contributors. Hence, the centrality of individual and organizational learning is a critical factor for competitiveness of any organization.

This brings us to the question, what is a learning organization. From many similar definitions of the same, let me quote the following one, as it is apt, simple and old enough for all to have learned: “A Learning Organization is the term given to a company that facilitates the learning of its members and continuously transforms itself.” (M. Pedler, J. Burgoyne and T. Boydell, 1997)

Keeping today’s deliberation in perspective, one may possibly conclude, quick individual learners, including the organizations, can offer better performance outcomes than late learners. As the pharma business is encountering a strong headwind for quite some time, it is up to the readers making out, what type of learner the industry, in general, is, and more importantly, why it is so?

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.

Reaping Rich Harvest With Orphan Drugs

Posted on by
Reply

A set of perplexing questions on the drug industry has been haunting many, since long. One such area is intimately associated with the core purpose of this business, as enunciated by each company, often publicly. Just to give a feel of it, let me quote what one of the largest global pharma players – Pfizer articulated in this regard, on April 5, 2019: “Health for All is at the core of our company’s purpose. We advance breakthroughs that change patients’ lives by ensuring they have access to quality health care services and Pfizer’s medicines and vaccines.”

Publicly expressed core purpose of any pharma business being generally similar, it may be construed as the same of the industry, at large. Hence, some baffling questions – not ethical, but purely commercial in nature, float at the top of mind, such as:

  • How the core purpose of business – “Health for All”, gets served when companies bring to the market mostly exorbitantly high-priced drugs, having access only to a minuscule patient population?
  • How are these companies growing at a faster pace and doing better commercially, by focusing more on orphan drugs approved for the treatment of rare diseases, affecting a very small patient population.

At this point, it will be worthwhile to have a quick recap on ‘orphan drug’ and ‘rare disease’. According to MedicineNet, orphan drugs are those which are developed to specifically treat rare medical condition. This rare medical condition is also referred to as an orphan disease. With that preamble, I shall now focus on this knotty area in search of evidence-based answers to – Is it possible to reap a rich harvest in business with orphan drugs for rare disease? And, if so, how?

Is the focus on high priced orphan a strategic business move?

Regardless of an affirmative or negative answer to the above questions, many people are head scratching with anguish while observing this trend in the drug industry. Mainly because, it is possibly the most important industry for most patients, not only while suffering from an ailment, but also before and after it happens, for various reasons.

The anguish increases manifold, when top manufacturers of popular mass-market drugs, such as, the cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin, and rheumatoid arthritis drug Humira, the best-selling medicine in the world, at a later stage seek and receive orphan drug status for these products reaping a rich harvest. The underlying intent being leveraging ‘additional advantages’ for exorbitant pricing and lesser competition. Hence, it is a strategic business move. I shall discuss this point in greater details, as was raised in a Kaiser Health News (KHN) investigation, in this article.

The same feeling gets resonated in several articles and papers, such as the one titled ‘Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up,’ published in The Atlantic on March 23, 2019. It questioned, ‘How is it that pharmaceutical companies can charge patients $100,000, $200,000, or even $500,000 a year for drugs – many of which are not even curative?’ Nonetheless, the strategy is working well, as we shall find below.

More drugs for rare diseases entering the market at a higher price:

Another article, titled ‘Drug Prices for Rare Diseases Skyrocket While Big Pharma Makes Record Profits,’ published by America’s Health Insurance Plans (AHIP) on September 10, 2019 wrote, drugs for rare diseases are now entering the market at higher prices than ever before, ranging from tens-of-thousands to hundreds-of-thousands of dollars per patient. It further wrote, according to a new report by AHIP, ‘out-of-control drug prices mean too many patients are forced to choose between paying for their prescriptions or paying their mortgage. The prices for drugs to treat rare medical conditions are 25 times more expensive than traditional drugs. That is 26-fold increase in two decades.

The rationale behind so high pricing:

To explore the rationale behind the exorbitant pricing of such drugs, let’s examine what the expert organizations, such as the Tufts Center for the Study of Drug Development (CSSD) said in this regard. Quoting a senior research fellow of CSDD, the article - ‘The High Cost of Rare Disease Drugs,’ published by the Genetic Engineering & Biotechnology News (GEN) on March 04, 2014 reported, although biopharma players generally set higher prices for orphan drugs, there is no causal link between cost of development and pricing. Instead, rare-disease drug prices reflect typical supply and demand situation: ‘Few treatment alternatives allow companies to charge what they can, knowing that payers will often ultimately foot the bill.’

It further explained: “The rarity of the disease means that few people are affected. Generally, the fewer disease sufferers there are, the higher the price of the drug. Companies that invest the same amount of money or more in orphan drugs as they would non-orphan drugs, want to recoup their investment.”

The situation in India for such drugs:

The January 05, 2019 issue of The Pharma Letter captures it all in its headline – ‘India lifts price caps on innovative and orphan drugs; major fillip for Big Pharma.’ It said, with the new legislation announced on January 4, 2019, the Indian government has decided to remove price restrictions on new and innovative drugs developed by foreign pharmaceutical companies for the first five years. In a rider, the government notification also states, the provisions of the Drug Price Control Order (DPCO) 2013 will not apply to drugs for treating orphan diseases (rare diseases).

How will it impact Indian patients?

Consequent to the above government decision, as the report indicated: ‘Orphan drugs to treat rare disease, like Myozyme (alglucosidase alfa) and Fabrazyme (agalsidase beta), both from Genzyme, which are used in the treatment of rare genetic diseases, are among a host of medicines that are to be kept out of price control.’

Quoting officials, the paper pointed out, the most challenging part in the fight against rare diseases is access to affordable treatment. As on date, the prices of these drugs tend to vary, e.g., the cost of treatment with enzyme replacement therapies may reach more than $150,000 per treatment per year. Whereas, in some other areas it may even be as much as $400,000 annually. Moreover, most of these drugs are rarely available in India. As a result, Indian patients suffering from rare diseases have to import these drugs directly. This makes affordability of medicines with an orphan drug regulatory status, a major issue for different stakeholders.

Why patient groups are not generally too vocal about this issue?

An interesting paper of 2008-09 brought to the fore the importance of patient organizations to further patient interest in various areas of health care. With the example of rare diseases and orphan drugs, it aptly expressed: ‘by changing the scale of their organizational efforts, patients’ organizations have managed to integrate themselves into the relays of power through which matters of health are thought about and acted upon. Through their formation into coalitions, patients’ organizations have been able to assume a number of important functions in relation to the government of health.’ The paper further added that the orphan drug problem can be thought of as having changed the scale and organizational form of rare disease patients’ groups.

Regrettably, a recent report of October 09, 2019, raised a big question in this area with a startling headline - ‘Big Pharma’s shelling out big-time to patient organizations. Is there any quid pro quo?’ It said, the Senate Finance Committee of the United States, while looking into the drug pricing decisions, ‘is digging into pharma funding for patient advocacy groups, which have been known to speak in tune that are music to the industry’s ears.’ It added, some Big Pharma constituents together contributed more than $ 680 million to hundreds of patient groups and other nonprofits last year.

It’s worth noting, earlier this year, several patient advocacy groups rallied in objection to a Trump-administration plan that would introduce step therapy requiring patients to try cheaper drugs before moving to more costly ones. ‘A Kaiser Health News analysis found that about half of the groups that objected had received funding from the pharmaceutical industry.’ Be that it may, rallying behind high drug prices by patient groups would help the industry only at the cost of patients’ interest. This is beyond an iota of doubt.

The motivation behind marketing more drugs for rare diseases:

There are several motivating factors to market drugs, which also treat rare disease, attaching startling price tags. The top drivers are generally considered, as follows:

  • The company gets seven years of market exclusive rights with the drug marketing approval for a rare or orphan disease. Interestingly, many drugs that now have an orphan status aren’t entirely new, either. Even if, the product patent runs out, USFDA won’t approve another version to treat that rare disease for seven years. This exclusivity is compensation for developing a drug, designed for a small number of patients whose total sales weren’t expected to be that profitable, otherwise.
  • Market exclusivity rights granted by the ‘Orphan Drug Act’ in the United States, can be a vital part of the protective shield that companies create.
  • Leveraging associated free pricing incentive, the concerned company can attach any price tag of its choice to the orphan drug, sans any competition.
  • Interestingly, more than 80 orphan drugs won USFDA approval for more than one rare disease, and in some cases, multiple rare diseases. For each additional approval, the drug manufacturer is qualified for a fresh batch of incentives. 

The system ‘is being manipulated by many drug makers’:

That this system is being manipulated by many drug makers was also established by the Kaiser Health News (KHN) investigation dated January 17, 2017 titled, ‘Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies.’ The analysis brought out that ‘the system intended to help desperate patients, is being manipulated by most drug makers. It reiterated, the key driver is to maximize profits, besides protecting niche markets for even those medicines, which are already being taken by millions. Thus, many orphan drugs, originally developed to treat diseases affecting fewer than 200,000 people, come with astronomical price tags.’

Even some familiar brands were later approved as orphan drugs:

The KHN’s investigation also uncovered that many drugs that now have an orphan status aren’t entirely new. Over 70 were drugs first approved by the USFDA for mass market use. These medicines, some with familiar brand names, were later approved as orphans. ‘In each case, their manufacturers received millions of dollars in government incentives plus seven years of exclusive rights to treat that rare disease, or a monopoly’, the investigation revealed.

The same KHN study also cited the example of AbbVie’s Humira – the best-selling drug in the world. ‘Humira was approved by the USFDA in late 2002 to treat millions of people who suffer from rheumatoid arthritis. Three years later, AbbVie asked the FDA to designate it as an orphan to treat juvenile rheumatoid arthritis, which they told the FDA affects between 30,000 and 50,000 Americans. That pediatric use was approved in 2008, and Humira subsequently was approved for four more rare diseases, including Crohn’s and uveitis, an inflammatory disease affecting the eyes. The ophthalmologic approval would extend the market exclusivity for Humira for that disease until 2023, the report highlighted.

The report also indicated, much touted Gleevec of Novartis, a drug that revolutionized the treatment of chronic myeloid leukemia, has nine orphan approvals. Similarly, Botox, started out as a drug to treat painful muscle spasms of the eye and has three orphan drug approvals. It’s also approved as a drug for mass-market for a variety of ailments, including chronic migraines and wrinkles. Despite humongous pricing, recent reports show that drugs with orphan status are eclipsing many new drugs with outstanding commercial success.

Companies focus on orphan drugs for better financial results:

Many top global companies’ sharp strategic focus on orphan drugs, presumably for the above reasons, is paying a rich dividend. This is evident from a number of recent reports, such as, ‘Orphan Drug Report 2019’ of Evaluate Pharma, released in April. The report says, orphan drugs will make up one-fifth of worldwide prescription sales, amounting to $242bn in spending by 2024 – much of it is going to either big pharma or big biotech players. It also found that the drugs prescribed for the treatment of rare diseases now account for seven of the 10 top-selling drugs of any kind, ranked by annual sales.

Another study of October 2019 by Prime Therapeutics LLC (Prime) shows, with more of ultra-expensive drug treatments coming to market, there is a sharp jump in the number of drug super spenders. While small in number, this group of drug super spenders grew 63 percent, which resulted in $800 million in additional drug costs. In the same period, the number of drug super spenders with drug costs over $750,000 increased 38 percent. This explains, why many companies are focusing on orphan drugs for better financial results.

Conclusion:

As the above quoted report of AHIP articulated, the regulators’ primary intent behind creating lucrative incentives for orphan drugs, was to encourage drug makers to develop treatments for rare diseases by earning a modest profit. ‘Unfortunately, drug makers have responded by building lucrative business models that empower them to achieve a gross profit margin of more than 80 percent – compared to an average gross profit margin of 16 percent for the rest of the pharmaceutical industry,’ the report said.

The AHIP study also finds, from 1998 to 2017, orphan drugs were 25 times more expensive than non-orphan drugs, resulting 26-fold increase in average per-patient annual cost, while the cost of specialty and traditional drugs merely doubled. Today, 88 percent of orphan drugs cost more than $10,000 per year per patient, which will be no different even when Indian patients import the same. The paper also revealed, in 2017, seven out of ten best-selling drugs had orphan indications. And among newly launched drugs, the share of orphan drugs increased more than 4-fold, from 10 percent to 44 percent, over a 20-year period.

Coming back to the core purpose of the pharma and biotech business, as defined by the pharma organizations themselves, one would have expected the situation to be much different. Their stated business purpose – ‘Health for All’, does not seem to recognize: “Every patient deserves to get the medications they need at a cost they can afford,’ as AHIP reiterates. Whereas, “drug makers are gaming well-intentioned legislation to generate outsized profits from drugs intended to treat a small population of patients with rare diseases.” In this scenario, reaping a rich harvest with the orphan drug status seems to have become a new normal.

By: Tapan J. Ray

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

Innovative ‘Medicines Too Damn Expensive’: Health Risk For Billions of People

Posted on by
Reply

Most ‘medicines are too damn expensive. And a key part of the problem is the lack of consistent information about drug pricing. It’s not often that the Trump administration and the anti-poverty NGO Oxfam find themselves singing from the same hymn sheet.’ This was articulated in the article carrying a headline, ‘No One Knows The True Cost Of Medicines, And Blaming Other Countries Won’t Help,’ published by Forbes on March 03, 2019.

In the oldest democracy of the world, on the eve of the last Presidential election, Kaiser Health Tracking Poll, September 2016 captured the public anger on skyrocketing cost of prescription drugs, which they ranked near the top of consumers’ health care concerns. Accordingly, politicians in both parties, including the Presidential candidates, vowed to do something about it.

Ironically, even so close to General Election in the largest democracy of the world, no such data is available, nor it is one of the top priority election issues. Nevertheless, the discontentment of the general public in this area is palpable. The final push of election propaganda of any political party is now unlikely to include health care as one of the key focus areas for them. This is because, many seemingly trivial ones are expected to fetch more votes, as many believe.

In this area, I shall dwell on the ‘mystic’ area of jaw dropping, arbitrary drug pricing, especially for innovative lifesaving drugs – drawing examples from some recent research studies in this area.

High drug prices and associated health risks for billions of people:

New Oxfam research paper, titled: ‘Harmful Side Effects: How drug companies undermine global health,’ published on September 18, 2018, ferreted out some facts, which, in general terms, aren’t a big surprise for many. It highlighted the following:

  • Abbott, Johnson & Johnson, Merck and Pfizer – systematically hide their profits in overseas tax havens.
  • By charging very high prices for their products, they appear to deprive developing countries more than USD 100 million every year – money that is urgently needed to meet health needs of people in these countries.
  • In the UK, these four companies may be underpaying around £125m of tax each year.
  • These corporations also deploy massive lobbying operations to influence trade, tax and health policies in their favor and give their damaging behavior greater apparent legitimacy.
  • Tax dodging, high prices and political influencing by pharmaceutical companies exacerbate the yawning gap between rich and poor, between men and women, and between advanced economies and developing ones.

The impact of this situation is profound and is likely to further escalate, if left unchecked, the reason being self-regulation of pharma industry is far from desirable in this area.

As discussed in the article, titled ‘Why Rising Drug Prices May Be the Biggest Risk to Your Health,’ published in Healthline on July 18, 2018, left unchecked, the rising cost of prescription drugs could cripple healthcare, as well as raise health risks for millions of people. Although this specific article was penned in the American context, it is also relevant in India, especially for lifesaving patented drugs, for treating many serious ailments, such as cancer.

Is pharma pricing arbitrary?

The answer to this question seems to be no less than an emphatic ‘yes’. Vindicating this point, the above Forbes article says: ‘It’s a myth that the costs of medicines need to be high, to cover the research & development costs of pharmaceutical companies.’

Explaining it further, the paper underscored, ‘Prices in the pharma industry aren’t set based on a particular acceptable level of profit, or in relation to the cost of production. They’re established based on a calculation of the absolute maximum that enough people are willing to pay.’

The myth: ‘High R&D cost is the reason for high drug price’: 

Curiously, ample evidences indicate that this often-repeated argument of the drug companies’, is indeed a myth. To illustrate the point, I am quoting below just a few examples, as available from both independent and also the industry sources that would bust this myth:

  • Several research studies show that actual R&D cost to discover and develop a New Molecular Entity (NME) is much less than what the pharma and biotech industry claims. Again, in another article, titled ‘The R&D Factor: One of the Greatest Myths of the Industry,” published in this blog on March 25, 2013, I also quoted the erstwhile CEO of GlaxoSmithKline (GSK) on this subject. He clearly enunciated in an interview with Reuters that: “US $1 billion price tag for R&D was an average figure that includes money spent on drugs that ultimately fail… If you stop failing so often, you massively reduce the cost of drug development… It’s entirely achievable.”
  • In addition, according to the BMJ report: ‘More than four fifths of all funds for basic research to discover new drugs and vaccines come from public sources,’ and not incurred by respective drug companies.
  • Interestingly, other research data reveals that ‘drug companies spend far more on marketing drugs – in some cases twice as much – than on developing them.’ This was published by the BBC New with details, in an article, titled ‘Pharmaceutical industry gets high on fat profits.’

World Health Organization (WHO) recommends transparency in drug pricing:

The report of the United Nations Secretary-General’s High-Level Panel on ‘Access to Medicines’ released on September 14, 2016 emphasized the need of transparency in this area of the pharma sector. It recommended, governments should require manufacturers and distributors to disclose to drug regulatory and procurement authorities information pertaining to:

  • The costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval to each expense category separated; and
  • Any public funding received in the development of any health technology, including tax credits, subsidies and grants.

But the bottom-line is, not much, if any, progress has been made by any UN member countries participating in this study. The overall situation today still remains as it has always been.

Conclusion:

The Oxfam report, as mentioned above, captures how arbitrarily fixed exorbitant drug pricing, creates a profound adverse impact on the lives of billions of people in developing and underdeveloped countries. Let me quote here only one such example from this report corroborating this point. It underlined that the breast cancer drug trastuzumab, costing around USD 38,000 for a 12-month course, is almost five times the average income for a South African household. The situation in India for such drugs, I reckon, is no quite different.

To make drug pricing transparent for all, the paper recommends, “attacking that system of secrecy around R&D costs is key.” Pharma players have erected a wall around them, as it were, by giving reasons, such as, ‘commercial secret, commercial information, no we can’t find out about this’…if you question intellectual property, it’s like you’re questioning God.” The report adds.

In India, the near-term solution for greater access to new and innovative lifesaving drugs to patients, is to implement a transparent patented drug pricing policy mechanism in the country. This is clearly enshrined in the current national pharma policy document, but has not seen the light of the day, just yet.

In the battle against disease, life-threatening ailments are getting increasingly more complex to treat, warranting newer and innovative medicines. But these ‘drugs are too damn expensive’.

In the midst of this complicated scenario, billions of people across the world are getting a sense of being trapped between ‘the devil and the deep blue sea.’Occasional price tweaking of such drugs by the regulator are no more than ‘palliative’ measures. Whereas, a long-term solution to this important issue by the policy makers are now absolutely necessary for public health interest, especially in a country like 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.

Gamification in Pharma: Creates Engaging Patient Experience For Better Results

Posted on by
Reply

On January 03, 2019, media reports flashed – “A video game-based ‘digital medicine’ tool can help reduce symptoms in children with autism spectrum disorder (ASD) and attention/deficit-hyperactivity disorder (ADHD).” This study was published in the Journal of Autism and Developmental Disorders, confirming the feasibility and safety of the tool called Project: EVO, which delivers sensory and motor stimuli through an action video game experience.

This initiative reconfirms that technology is becoming a great enabler to provide integrated, comprehensive and cost effective approach in treating many diseases, particularly with ‘Digital Medicine.’ The above report on ‘Project EVO’ is an example of application of the concept of ‘gamification’ in digital medicine. Many consider ‘gamification’ as a game changer to create an engaging patient experience with added value. It makes patients getting involved in the disease-treatment process, especially for effective self-management of chronic disorders.

I shall focus on this area in today’s article, giving examples wherever available. However, let me start by recapitulating what is ‘gamification’ in the pharma industry.

Gamification: 

The Oxford dictionary defines ‘gamification’ as: ‘The application of typical elements of game playing (e.g. point scoring, competition with others, rules of play) to other areas of activity, typically as an online marketing technique to encourage engagement with a product or service.’ It further adds, ‘gamification is exciting because it promises to make the hard stuff in life fun.’

‘Gamification’ is assuming increasing importance, with disruptive digital innovations gradually becoming game changers in the pharma business. This is mainly because, it can deliver to a specific group of patients, doctors or other stakeholders exactly what they look for – with precision.

I suggested in my article, published in this blog on January 07, 2019 that pharma companies should facilitate self-management of chronicailments,not just for better outcomes, but also for improving the quality of patient engagement. To achieve this objective,‘gamification’ could play a remarkable role-such as disease awareness and prevention and when afflicted its desirable self-management. This has the potential to create a win-win situation between patients and a drug company.

This is so important, as ‘the old paradigm of the paternalistic model of medicine is now transforming into an equal level partnership between patients and professionals, aided and augmented by disruptive technologies. This comment was made in a study titled, ‘Digital health is a cultural transformation of traditional health care,’ published in mHealth on September 14, 2017.

‘Patient-doctor partnership is critical in the new paradigm:

One of the major ways to develop a partnership between the treating doctors along with the product/service providing pharma companies and patients is through mutually beneficial ‘patient engagement’ programs with added value.

That such programs can create a unique patient experience of better outcomes at a lesser cost, has already been established by a number of credible research studies. Taking a cue from quantum benefits that this initiative provides, many pharma companies are now making ‘patient engagement’ strategy as an integral part of their overall market access program, including the process of branding.

What does an effective patient engagement strategy involve?

An article titled, ‘Patient Engagement: A Key Element in Pharmaceutical Marketing Strategy,’ published in the IgeaHub on May 29, 2016 defines ‘patient engagement’ as a concept that combines a patient’s knowledge, skills, ability and willingness to manage his own health and care with interventions designed to increase activation and promote positive patient behaviors. This measure also involves offering relevant services to patients.

To assess the opportunity of patient services in the pharma industry, Accenture conducted a survey titled, ‘Pharma’s Growing Opportunity in Patient Services’, on 200+ pharma patient services executives, covering seven therapeutic areas – heart, lungs, brain, immune systems, bones, hormone/metabolism, and cancer. The study concluded,the future of patient services that requires patient engagement, is bright. It elaborated by saying, this approach offers pharmaceutical companies a tremendous opportunity – for those willing to invest in the right places and let patients know about them in the right way.

To move in this direction, ‘gamification’ is an efficient way for the pharma companies to follow. Let us see below how does ‘gamification’ work on the ground.

How does ‘gamification’ work?

According to the findings of Innovatemedtec, ‘gamification’ with health apps typically works in the following three ways:

  • Allowing users to share progress and results with their friends or other users of the service, creating a competitive spirit to elicit more or better use of the specific health app service.
  • Giving virtual gifts, such as badges, medals, stars during each stage of progress, generating a sense of achievement for greater patient motivation levels in disease monitoring and management.
  • Advanced medical health applications can provide real-time biofeedback with built-in sensors. Or using a storytelling approach and explaining health literature related to diagnoses, medical procedures and patient behavior.

Thus, the primary reasons for introducing ‘gamification’ in the pharma industry would be to improve the disease awareness and increasing patients’ motivation for self-management for mutual benefits.

Improves disease awareness and motivation for self-management:

The precise rationale for ‘gamification’ in the pharma industry was nicely articulated in the ‘M.Sc. Thesis titled, ‘Gamification in the Pharmaceutical Industry – Exploring how European Pharmaceutical Organizations can build and use Gamified Mobile Applications to Improve Relations with Patients.’ This was written by Nanna Birkedal and jointly delivered by the University of Stirling and Lund University.

It highlighted: “Patients and industry experts both argue that awareness is important; constant reminders about healthy habits are pivotal for an improved lifestyle. Patients furthermore need to be motivated to act upon this and actively implement the required lifestyle changes. If pharmaceutical organizations succeed in helping the patients with overcoming challenges related to their illness by motivating them to enact the needed lifestyle changes, it will increase the perceived trust towards their brand and thereby strengthen their relationship with the patients. This research argues that digital gamification is suited for this purpose, hence why it may be advantageous for organizations to incorporate digital gamification …”

Why and how to motivate patients for self-management of chronic disease?

As I said before, after proper diagnosis of a chronic ailment and charting out a medical treatment pathway, self-management of the disease by patients plays a critical role. Thus, the question arises, how to motivate patients and more importantly, keep patients motivated for engaging in self-management of such nature.

There is also a need for continuous improvement of the ‘gamification’ process for a long-term engagement of patients, leading to progressively better outcomes. Many examples of success with ‘gamification’ are available for chronic diseases, such as diabetes.

One of the metrics used in ‘gamification’ to help diabetic patients stick with a digital health platform, making it a higher priority in their daily lives, is to provide useful timely information on their disease condition. This metric may include informing the user about some tangible changes in their health risks due to the disease. For example: “Over the last month your effective glucose has reduced the risk of losing your eyesight by 10 percent.” Accordingly, the patients may earn points or badges for using the app and accomplishing certain important tasks.

In this way, gamification can immensely help self-management through behavioral changes, improving disease outcomes. As Healthcare in America also reiterates: ‘There is nothing more motivating than knowing your health is improving in real time.’

Another study, and two examples of ‘gamification’ in pharma:

Another study titled, ‘Gamification: Applications for Health Promotion And Health Information Technology Engagement’, published by ResearchGate arrived at an interesting conclusion. It reiterated: ‘Game-based approaches (gamification) can provide ideal strategies for health promotion, prevention, and self-management of chronic conditions. However, there is a need to clearly define components and uses of gamification in healthcare for increased patient engagement in health information technology.’

Elaborating the point further, the authors emphasized that many health/physical activity apps provide feedback in a clear and concise manner and in a variety of formats (e.g., graphs, text or icons). The available option to share the feedbacks on social networking sites allows for further engagement by individuals and adds additional motivation and encouragement in attaining users’ goals. However, it recommends more studies to explore and identify the suitability of ‘gamification’ for health in clinical settings.

There have been several instances of gamification efforts health care with powerful effects. Let me cite just two interesting illustrations from mobihealthnews, as follows:

Conclusion:

As available from various literature, such as Healthcare in America, there are enough well-verified testimony, indicating that patients are motivated by gamified elements.

Consequently, some major global pharmaceutical companies have started testing the water. For example, the Media Release of Roche dated June 30, 2017 announces, the company has acquired mySugr - an Austrian startup that offers gamified solutions for diabetes management in a fun way, both for children and adults. It, reportedly, has more than a million registered users in 52 countries and is available in 13 different languages. Post-acquisition, it will be an integral part of Roche’s new patient-centered digital health services in diabetes care.

Hence, ‘gamification’ in pharma carries potential to be a win-win strategy in creating engaging, motivating and a unique patient experience in self-management of chronic diseases, for better outcomes.

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.

Rewriting Pharma Strategy For ‘Doctor Google’ Era

Posted on by
Reply

In search of more and more information on an ailment, a large number of Internet savvy individuals now feel comfortable to consult ‘Doctor Google’ – much before approaching a qualified medical professional for the same. If and when they visit one, many would possibly have arrived at a ‘symptoms-diagnosis correlation’ – based on their own interpretations of the sessions with ‘Doctor Google’– right or wrong.

‘Doctor Google’ – a ‘weird’ terminology, was virtually unheard of, until recently. This name owes its origin to universally popular ‘Google Search Engine.’ The number of frequent ‘consultations’ with ‘Doctor Google’ is breaking new records almost every day – primarily driven by deep penetration of smartphones – a versatile device that helps to charting unhindered, anywhere in the cyberspace.

In this article, I shall not go into whether this trend is good or bad. Nonetheless, the hard fact is, in the modern digital age, this trend is fast gaining popularity, across the world, including India. I shall discuss below, why and how the impact of ‘Doctor Google’ syndrome sends a strong signal to pharma companies to rewrite their business strategies for sustainable future growth.

‘Doctor Google’ syndrome:

To be on the same page with all my readers, ‘Doctor Google’ terminology is used for the process of getting various disease, treatment or medicine related information from cyberspace and especially through Google Search.This practice is currently being followed by many individuals who arenot qualified medical professionals, but through ‘Google Search’ often try to self-diagnose a disease or medical condition, or other health related issues. Some may even cross verify a professional doctor’s advice with ‘Doctor Google’.

Today, it is not uncommon to visit ‘Doctor Google’ first, instead of immediately visiting a General Practitioner (GP) for seeking professional advice. The areas of such search may range from trivial to even serious health conditions. The bottom-line therefore is, prompt ‘information seeking’ of all kinds, including health, and forming an opinion based on available information, is fast becoming a behavioral pattern within Internet canny and smartphone equipped population, across the world.

Medical Journals also reported this trend:

This trend has been captured in medical journals, as well. For example, a paper on Dr. Google in the Emergency Department (ED), published by the Medical Journal of Australia (MJA) on August 20, 2018 concluded as follows:

“Online health care information was frequently sought before presenting to an ED, especially by younger or e-health literate patients. Searching had a positive impact on the doctor-patient interaction and was unlikely to reduce adherence to treatment.”

Yet another study titled, ‘What Did You Google? Describing Online Health Information Search Patterns of ED patients and Their Relationship with Final Diagnoses’, published onJuly 14, 2017 in the ‘Western Journal of Emergency Medicine’, came with a thought-provoking conclusion. Reiterating that Internet has become an important source of health information for patients, this study observed, many of these online health searches may be more general or related to an already-diagnosed condition or planned treatment, as follows:

  • 35 percent of Americans reported looking online, specifically to determine what medical condition they may have;
  • 46 percent of those reported that the information they found online led them to think they needed medical attention;
  • The majority of patients used symptoms as the basis of their pre-ED presentation Internet search. When patients did search for specific diagnoses, only a minority searched for the diagnosis they eventually received.

Availability of credible online ‘symptom-checkers’:

To help patients getting credible information on many symptoms, there are several highly regarded online sources for the same, such as, a Symptom Checker provided by the Mayo Clinic of global repute.

The purpose of this tool is to help narrow search along a person’s information journey. This is not purported to be a self-diagnostic tool. A ‘symptom-checker’allows searchers to choose a variety of factors related to symptoms, helping to limit the potential medical conditions accordingly. This tool does not incorporate all personal, health and demographic factors related to the concerned person, which could allow a definitive cause or causes to be pinpointed. It also flags, the most reliable way to determine the cause of any symptom, and what to do, is to visit a competent health care provider.

Further, the research letter titled, ‘Comparison of Physician and Computer Diagnostic Accuracy’, published in the December 2016 issue of JAMA Internal Medicine, records additional important findings, as follows:

  • Physician diagnostic error is common and information technology may be part of the solution.
  • Given advancements in computer science, computers may be able to independently make accurate clinical diagnoses.
  • Researchers compared the diagnostic accuracy of physicians with computer algorithms called symptom-checkers and evaluated the diagnostic accuracy of 23 symptom-checkers using 45 clinical vignettes. These included the patient’s medical history and had no physical examination or test findings.
  • Across physicians, they were more likely to list the correct diagnosis first for high-acuity vignettes and for uncommon vignettes. In contrast, symptom checkers were more likely to list the correct diagnosis first for low-acuity vignettes and common vignettes.

Nonetheless, the above examples further reinforce the fact that patients now have access to robust online health-related data, on various aspects of a disease treatment process.

Technology is rapidly transforming healthcare:

That technology is rapidly transforming healthcare is vindicated by the estimate that the global market for digital health is expected to reach £43 billion by the end of 2018. This was noted in an article, titled ‘3 ways the healthcare industry is looking more like Google, Apple and Amazon’, published in Pharma IQ on November 16, 2018.

Pharma companies are realizing that an increasing number of patients now have better access to online information regarding their overall health and medical conditions, including various prevention and treatment options with costs for each. As people take a more active role in managing their health, pharma players, especially in their engagement with patients, require moving from mostly passive to active communication platforms. Consequently, personalizing health care products and services is expected to become the new norm, making the traditional pharma business models virtually redundant, the article highlights.

While going through this metamorphosis, pharma sector would willy-nilly emerge as an integrated technology-based industry. More tech-based changes will call for in various critical interfaces related to an organization’s ‘patient-orientation’, which is today more a lip-service than the ground reality. Entry of pure tech-based companies such as Google, Amazon and Apple into the healthcare space would hasten this process.Although such changes are taking place even in India, pharma companies in the country are yet to take it seriously.

Pioneering ‘omnichannel’ engagement is pivotal: 

Again, to be on the same page with all, the term Omnichannel in the pharma parlance may be used for a cross-channel content strategy for improving patient engagement and overall patient-experience. This should include all touchpoints in the diagnosis and treatment process of a disease. It is believed, the ‘companies that use ‘omnichannel’, contend that a customer values the ability to engage with a company through multiple avenues at the same time.’ Thus, pioneering ‘omnichannel’ engagement is critical for a pharma player in today’s scenario.

A valid question may come up – is ‘Omnichannel (all-channel)’ patient engagement is just another name of ‘Multichannel (many-channel)’ engagement? No – not really. Interestingly, both will be able to deliver targeted contents to patients through a number of interactive digital platforms, namely smartphone-based Apps, specially formatted websites, social media community and the likes. But the difference is, as a related paper lucidly puts it - ‘Omnichannel approach connects these channels, bridging technology-communication gaps that may exist in multichannel solutions.’

That said, just as the above-mentioned pure technology companies, pharma players also need to learn the art of gathering a large volume of credible data, analyze those through modern data analytics for taking strategic decisions. This is emerging as an essential success requirement, even in the health care arena.

Precise data-based answers to strategic questions, as planned, are to be used effectively for omnichannel personalized patient engagement. This is fundamental to offer a delightful personal experience to patients, encompassing diagnosis, treatment, recovery, including follow-up stages of an ailment, especially involving the chronic ones. Only well-qualified and adequately trained professionals with in-depth pharma domain knowledge can make it happen – consistently, across multiple channels, such as social media, Apps and devices – seamlessly.

Real time customer data management is critical:

Virtually real time customer data management of huge volume that aims to provide ‘Unique Patient Experience (UPQ)’,is the lifeblood of success in any ‘omnichannel’ engagement. This is criticalnot just for right content strategy formulation, but also to ensure effective interaction and utilization between all channels, as intended, besides assessing the quality of UPQ. Once the process is in place, the marketers get to know promptly and on an ongoing basis, about the quality patient experience – as they travel through various touchpoints, to intervene promptly whenever it calls for. I explained this point in my article titled ‘Holistic Disease Treatment Solution: Critical for Pharma Success’, featured in this blog on October 29, 2018.

Credible data are all important – not just any data:

Real time voluminous data generation, coupled with astute analysis and crafty usage   of the same, has immense potential to unlock doors of many opportunities. The effective leverage of which ensures excellence in business. But most important in this endeavor, it is of utmost importance to ensure that such data are of high quality – always. Similarly, use of any high-quality data, if not relevant to time, in any way or outdated, can be equally counterproductive.

An article titled, ‘Hitting Your Targets: A Check-up on Data’, published at PharmExec.com on August 02, 2018, aptly epitomizes it. It says, no matter what sophisticated technologies a life sciences organization uses, and how smart its sales and marketing strategy is, if there are flaws and gaps in foundational provider data, the company will end up with wasted resources and lost market share. Implementing ongoing data governance and stewardship programs will help improve efficiencies, allocate resources, and target customers with increased precision.

Conclusion:

Going back to where I started from, it’s a fact that many Internet-friendly people now visit ‘Doctor Google’, much before they visit a medical doctor. Most probably, they will also arrive at a list of possible diagnoses, according to their own assessment.

While going through this process, they acquire an experience, which may or may not be new or unique in nature – depending on various circumstances. But the key point is, such patients – the number of which is fast increasing, are no longer as naïve as before on information related to a host of ailments. Consequently, the ‘pharma-patient interaction’ that has traditionally been passive, and through the doctors, will require to be more active and even proactive. This has to happen covering all the touchpoints in an involved disease treatment process where pharma is directly or indirectly involved.

To be successful in this new paradigm, pharma companies need to ensure that such ‘active communication’ with patients is necessarily based on a large pool of constantly updated credible data, exchanged through ‘omnichannel’ interactive platforms. The key success factor that will matter most is providing ‘unique patient experience’ through this process and its high quality. From this perspective, I reckon, rewriting pharma business strategy is of prime importance in the fast unfolding ‘Doctor Google’ era.

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.

Holistic Disease Treatment Solution: Critical For Pharma Success

Posted on by
Reply

The speculation over quite some time has ended now. The most important C-suite office of the world’s top pharma company will find a brand-new occupant at the dawn of a brand-new year, on January 01, 2019. Albert Bourla will now be on the saddle to lead Pfizer moving towards a new horizon of success, in place of Ian Read.

What makes this change interesting to me, is the new leader’s not just shaking up the top team at Pfizer, but his simultaneous announcement for another brand-new C-Suite role in the company – The Chief Digital Officer (CDO). She will ‘lead the company’s digital efforts across research, discovery and business processes.’

Merck & Co. also joined ‘the chief digital officer parade’ on October 17, 2018 when it announced the appointment of chief information and digital officer, also as a member of the company’s Executive Committee. Notwithstanding a few global pharma companies’ have already started creating this role, the timing of this initiative by the top global pharma player, sends an interesting signal to many. Undoubtedly, it is a strategic move, and is surely backed by a profound intent. In this article, while exploring this point I shall try to fathom whether or not any fundamental change is taking shape in the strategic space of pharma business.

A fundamental change is taking shape:

This fundamental change, I reckon, is driven by realization that just discovery of new medicines, high quality manufacturing and high voltage marketing can no longer be regarded as success potent in the industry. There emerges a palpable and growing demand for holistic solutions in the disease treatment process, for optimal clinical outcomes and reduction of the burden of disease.

That several top global pharma companies have recognized this fact, is vindicated by what the Sandoz Division of Novartis acknowledged on its website. It quoted Vas Narasimhan – CEO of Novartis saying: “We are on the verge of a digital revolution across every aspect of the healthcare sector, from the lab bench to the patient’s bedside.”

Interestingly, pharma stakeholders’ interests and expectations, including those of patients, are also progressing in the same direction. This, in turn, is changing the way of leading and managing a pharma business – requiring a kind leadership with specific expertise in several new areas. The new C-suite position for a CDO is a proof of this change gathering strong tailwind.

What prompts this change?

As I see it, besides scores of other associated factors that digital technology offers to all, a single characteristic that stands out is the changing patients’ expectations for optimal clinical outcomes out of an affordable and involved disease treatment process.

This has always been so, but is now changing from mere expectations or just a hope, to patients’ demand, from both physicians and the pharma companies. This is a clear writing on the wall in the days ahead, and all concerned should take note of it, seriously. Does it mean that the broad flowchart of the disease-treatment-process, as I call it, has changed? Before delving into that area, let me briefly explain what exactly I mean by saying so.

A flowchart of the disease-treatment-process:

The broad flowchart for most of the disease-treatment-process, have primarily 6 ‘touchpoints’ or points of references, as I see it, which may be summarized as follows:

Patients – Signs & Symptoms – Doctors – Diagnosis – Medicines – Clinical outcomes

This means, patients with signs and symptoms of a disease come to the doctors. With various diagnostic tests, the disease or a combination of diseases is diagnosed. Then, doctors prescribe medicines or any other required medical interventions for desired clinical outcomes.

Has it changed now?

There doesn’t seem to be any fundamental change in this flowchart even today. But, the way the pharma players cherry-pick their areas of focus from its various touch points, is undergoing a metamorphosis.

As it stands today, to sell medicines – innovative or even generic pharma companies primarily focus on the doctors and off-late on patients – but just a few of them, to offer clinical outcomes better or same as others. In the evolving new paradigm, a successful drug companies would need to focus on each of these six elements of the flowchart with great expertise and sensitivity, from the patients’ perspective.

The position of CDO is expected to be a great enabler to facilitate the process of integrating all the touchpoints in the disease-treatment-flow. This will, in turn, offer a holistic treatment solution for patients – selling more medicines being the endpoint of this objective. If it doesn’t happen, the touchpoints where pharma is not focusing today would be captured soon by the non-pharma tech players. This will make achieving the financial goals of the organization even more difficult.

Let me illustrate this point by adding just one important area from this flowchart to the traditional pharma focus areas. This touchpoint goes hand in hand with the prescription of medicines – medical diagnosis. Providing patient- friendly disease prevention and monitoring tools may be yet another such area.

Current accuracy of medical diagnosis – ‘only correct in 80 percent of cases’:

The above was quoted by Sandoz (a Division of Novartis) in its website. It highlighted that the researchers at John Radcliffe Hospital in Oxford, UK found that several medical diagnoses based on a limited range of factors are only correct in 80 percent of cases. It means ‘a diagnosis may miss imminent heart attacks, or it may lead to an unnecessary operation,’ it said.

The January 31, 2018 article published by Futurism.com - the publishing arm of Futurism, based in New York City, also underscores some interesting facts in this regard, including the above example. Some of these are fascinating, as I quote hereunder:

  • Researchers at the John Radcliffe Hospital in Oxford, England, developed an AI diagnostics system that’s more accurate than doctors at diagnosing heart disease, at least 80 percent of the time.
  • At Harvard University, researchers created a “smart” microscope that can detect potentially lethal blood infections with a 95 percent accuracy rate.
  • A study from Showa University in Yokohama, Japan revealed that a new computer-aided endoscopic system can reveal signs of potentially cancerous growths in the colon with 94 percent sensitivity, 79 percent specificity, and 86 percent accuracy.
  • In one study, published in December 2017 by JAMA, it was found that deep learning algorithms were able to better diagnose metastatic breast cancer than human radiologists when under a time crunch. While human radiologists may do well when they have unrestricted time to review cases, in the real world a rapid diagnosis could make the difference between life and death for patients.
  • When challenged to glean meaningful insights from the genetic data of tumor cells, human experts took about 160 hours to review and provide treatment recommendations based on their findings. IBM’s Watson took just ten minutes to deliver the same actionable advice.

Thus, the bottom-line is: Medical or clinical diagnosis is a crucial area where the tech savvy environment can add significant unmet needs to save lives of many. Consequently, this space is emerging as an Eldorado, as it were, for all those who are seriously interested in diving deep in search of a golden future in the related business.

Technological players are making forays:

Several tech companies have sensed the reward of a pot of gold in the above space, despite the journey being quite arduous. Consequently, many of them are coming up with user-friendly and disease-specific digital tools and health apps, compatible with smart phones or smart watches. These help patients monitoring their own health data, independently, and be aware of the disease progression, if any. Simultaneously, it also enables physicians not only to accurately diagnose a disease, but also to keep a careful vigil on the progress of the treatment.

To illustrate the point with an example – say about Apple. The company began making inroads into the healthcare space with health apps and fitness-tracking via iPhone and Apple Watch. Interestingly, riding on partnership and acquisition initiatives, it is now carving a niche for itself to provide complete health records of the users by capturing relevant disease-specific clinical data.

Apple Watch Series 4, for example, has ECG feature and the ability to detect irregular heart-rhythm, which is US-FDA approved. Reports indicate the company is also in the process of developing a non-invasive glucose monitoring tool, besides many others. Curiously, the company has already given a signal to extend the usage of iPhone to a reliable diagnostic tool for many disease conditions. Most important to note is, this concept is fast gaining popularity.

Calls for of a holistic approach in the disease-treatment process-flow: 

As this trend keeps going north, many pharma companies are realizing the underlying opportunity to adopt a holistic strategic business approach to move into the new frontier. This would encompass the entire disease-treatment-process-flow with digital technology, across the organization. Before other non-pharma companies firmly position themselves on the saddle while entering into this area, pharma needs to move fast. This calls for an urgent action to collaborate with tech companies in all the critical touchpoints of this flow, including diagnosis. That this realization gas dawned in pharma is evident from a number of related developments. Let me quote just a couple of examples, as follows:

  • Onduo, a US$500-million diabetes-focused joint venture between Sanofi and Verily Life Sciences, an Alphabet company was founded in September 2016. Onduo recently launched its first product – an app plus, a continuous glucose-monitoring device plus an insulin pump that are all linked together. The Onduo app has a built-in coach (i.e., an electronic assistant) to help patients better manage their diabetes and accomplish their health goals.
  • GlaxoSmithKline (GSK) and Verily (formerly Google Life Sciences) have formed a joint venture to develop and commercialize bioelectronic medicine – miniaturized nerve implants that modulate electrical impulses to treat certain diseases.

Lack of digital leadership talent within the pharma industry?

It is interesting to note that both the Pfizer and Merck CDOs were recruited from non-pharma companies – Pfizer’s from Quest Diagnostics and Merck’s from Nike.  Earlier, in mid 2017, former Walmart CIO was named the Chief Digital and Technology Officer of GlaxoSmithKline. This trend probably brings to the fore, the lack of top digital leadership talent within the pharma industry.

Conclusion:

Increasingly pharma companies are realizing that enormous efforts and money spent in just marketing a drug, is producing a lesser and lesser yield, as the new paradigm unfolds. As we move on, patients no longer will want to buy just a medicine from the pharma players. They will want an integrated solution for prevention, cure or management of a disease.

At the same time, strong technology players, such as Apple, Google, IBM’s Watson are on the verge of capturing a sizeable ground, offering a gamut of patient-friendly offerings in the healthcare space. This would eventually make prescription of digital therapy a new reality. These tech companies are now entering through several virtually open doors in the disease-treatment-flow process, as I call it, primarily covering – diagnosis, disease monitoring and preventive care.

To effectively compete and grow in this environment, drug companies have to cover all the touchpoints of this process, not just the selective ones as are generally happening even today.

Creation of a new C-suite position of Chief Digital Officer to address this issue in a holistic away, across the organization, gives a clear signal to this realization. Thus, I reckon, offering a holistic treatment solution, covering all the touchpoints in the disease-treatment-flow process will be a new normal for pharma, not just for excellence in business, but for a long-term survival too.

By: Tapan J. Ray

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

Prescription Digital Therapy Now A Reality

Posted on by
Reply

The pursuit of offering ‘prescription digital therapeutics’ or ‘digiceuticals’ by Big Pharma, to ensure better clinical outcomes for patients, has apparently come to fruition now.

On April 18, 2018, by a media release, Novartis announced that the Sandoz Division of the Company has entered into collaboration with Pear Therapeutics to commercialize and continued development of digital therapeutics, designed to effectively treat disease and improve clinical outcomes for patients.

The collaboration brings on to the table, a synergy between Sandoz expertise in launching and commercializing various disease treatments, with Pear’s leading experience in digital therapeutics design and implementation. This deal has attracted attention of many. Mainly because, any pharma player will, for the first-time, detail a digital therapy treatment directly to the medical profession, and seek their prescription support.

It is worth noting that Pear’s flagship digital therapeutic – reSET is the first USFDA-cleared mobile medical application with both a safety and efficacy label to help treat patients with Substance Use Disorder, in September 2017. According to published reports, several studies have established that it is two-times more effective than conventional in person therapy sessions. Interestingly, the rate of treatment efficacy increases even up to tenfold, in refractory patients.

Just the beginning of a long run: 

The above market launch of a digital therapy by Novartis signals just the beginning of a long run in changing in the disease treatment archetype for better outcomes. Incidentally, prior to this announcement, on March 1, 2018, the same Company had announced, “Novartis and Pear Therapeutics to collaborate on prescription software applications aimed to treat patients with schizophrenia and multiple sclerosis.”

The media release underscored:“Psychiatric and neurodegenerative diseases place a heavy physical, mental and economic burden on patients and their families. With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need”.

The scope and potential:

An article titled – ‘Digital therapeutics: Preparing for takeoff’,published by McKinsey & Company in February 2018, captures its scope succinctly. It says, “digital therapeutics tend to target conditions that are poorly addressed by the healthcare system today, such as chronic diseases or neurological disorders. In addition, they can often deliver treatment more cheaply than traditional therapy by reducing demands on clinicians’ time.”

A separate McKinsey interview article, titled ‘Exploring the potential of digital therapeutics’, published in the same month, elucidated the potential of digital therapy equally well.  It highlighted:“A digital therapeutic is an intervention based on software as the key ingredient, which has a direct impact on a disease. This is what distinguishes this category from the broader term digital health. We will see digital therapeutics and digital diagnostics integrate into the health system…”

‘Prescription digital therapy’ are not just ‘Fitness and Well-being’ Apps:

Prescription digital therapy are not just to monitor a person’s general fitness level against pre-identified parameters, and overall well-being. Whereas, digital therapeutics help patients to regularly and consistently monitor relevant and tailor-made disease related data - in real-time to detect behavioral, lifestyle and requisite biological changes on a daily basis. However, this is not ‘a so well-realized necessity’ today, especially, in the treatment of certain serious disease conditions, to ensure significantly better clinical outcomes for patients.

Digital therapeutics can ensure making a favorable change in patient behavior, which is not merely as efficient as administering medicines, but could also ensure greater effectiveness than conventional medications. Further, it assists patients to better understand, manage and control several disease conditions, and more importantly, sans any untoward side-effects.

Besides, with digital therapy, the required treatment interventions will reach patients faster than traditional treatment processes. Both the patient request and the medical response for the same can be quickly exchanged, together with relevant data support, through smartphones or other wearable digital interfaces – either in the form of voice or text or both. I shall dwell on this later in the article. Thus, digital therapy may not require patients to meet the doctor every time a need arises.

Moreover, fitness and wellbeing Apps do not require marketing approval from a country’s drug regulator. Mostly because, they help monitoring general and generic fitness parameters, capturing some low-risk changes. Whereas, a custom-made prescription digital therapy would necessarily require such regulatory nod.

In tandem, various studies are also being conducted on wearables, such as an Apple Watch, as an interface. The following are examples of some of these studies:

Digital therapy study with Apple Watch as an interface:

In February 2017, Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited, announced a collaboration to pilot the use of a specially designed app on an Apple Watch wearable to monitor and assess cognitive function in patients with Major Depressive Disorder (MDD).

In November 2017, they presented results from ‘Digital Wearable Technology Study’ in patients with MDD. The observational study involved 30 participants, aged 18-65, with a clinical diagnosis of mild to moderate depression who have been prescribed antidepressant monotherapy for MDD.

The study also evaluated feasibility and participant compliance with measures of mood and cognition on wearable technology; and compared measures of mood and cognition on wearable technology using traditional neuropsychological testing and patient reported outcomes on depression symptoms at 6 weeks. Participants were provided with an Apple Watch on which brief cognitive and mood tests were administered daily.

The researchers observed that patients were compliant with the wearable Apple Watch device on a daily basis to evaluate mood (95 percent) and cognition (96 percent). The study also demonstrated that abbreviated daily assessments delivered through the wearable Apple Watch device corresponded with objective Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests and full-length patient reported outcomes, PHQ-9 and PDQ-D, assessed during weeks 1, 3 and 6. No adverse events were reported in the study.

According to another report, this user interface with Apple’s smart-watch versions 2 and 3 is now being used in a number of studies for chronic conditions, such as Parkinson’s disease – combining biometric data with user input. Again, in February 2017, Johns Hopkins University announced a project to use the smart-watch for research on possible triggers of epileptic seizures.

When used as an interface with prescription digital therapy, the provision of e-SIM and GPS in Apple Watch Series 3, I reckon, would also help patients to immediately communicate with the remote therapy centers using the same device, anytime – as and when the patients want.

Digital therapy initiatives in India:

Initiative on digital therapy has already started rolling in India, as well. Its pace is also quite encouraging. For example, Wellthy Therapeutics is building a patient centric solution for diabetes through digital intervention and management. On February 20, 2018, the Company, reportedly, shared the interim results of an ongoing real-world pilot to evaluate the effectiveness of the Wellthy Diabetes Smartphone App (WD). The results were shared at the 11th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2018) in Vienna, Austria.

The data demonstrated how the use of WD improved glycemic control. On completion of 16 weeks, participants showed a reduction in their HbA1c by (-0.61%) on average, with 61.5% of participants having showed significant reduction in their HbA1c with an average of (-1.17%) reduction.

Conclusion:

As indicated in my article titled, ‘Digiceuticals: A Force Multiplier to Contain Chronic Diseases’, published in this blog on October 23, 2017,prescription digital therapies are primarily of two types – one for “medication augmentation” and the other for “medication replacement.”

Be that as it may, prescription digital therapyimproves clinical outcomes for patients by manifold. It also shows potential to take over from traditional treatment with medicines in several serious and virtually crippling ailments, mostly related to human behavior and lifestyle, such as a host of chronic diseases, and without causing any side-effects.

Thus, prescription digital therapy is now a reality. It has come to stay for long – can’t be wished away, any longer.

By: Tapan J. Ray

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

Providing Unique Patient Experience – A New Brand Differentiator

Posted on by
Reply

“Pharma industry, including the patients in India are so different from other countries. Thus, any strategic shift from conventional pharma brand marketing approach – going beyond doctors, won’t be necessary.”

The above mindset is interesting and may well hold good in a static business environment. But, will it remain so when ‘information enabled’ consumer behavior is fast-changing?

“Shall cross the bridge when we come to it” – is another common viewpoint of pharma marketers.

Many might have also noted that such outlooks are not of just a few industry greenhorns. A wide spectrum of, mostly industry-inbred marketers – including some die-hard trainers too, subscribe to it – very strongly.

Consequently, the age-old pharma marketing mold remains intact. Not much effort is seen around to reap a rich harvest out of the new challenge of change, proactively. The Juggernaut keeps moving, unhindered, despite several storm signals.

Against this backdrop, let me discuss some recent well-researched studies in the related field. This is basically to understand how some global pharma companies are taking note of the new expectations of patients and taking pragmatic and proactive measures to create a unique ‘patient experience’ with their drugs.

Simultaneously, I shall try to explore briefly how these drug companies are shaping themselves up to derive the first-mover advantage, honing a cutting edge in the market place. This is quite unlike what we generally experience in India.

As I look around:

When I look around with a modest data mining, I get increasingly convinced that the quality of mind of pharma marketers in India needs to undergo a significant change in the forthcoming years. This is because, slowly but surely, value creation to provide unique ‘patient experience’ in a disease treatment process, will become a critical differentiator in the pharma marketing ball game. Taking prime mover advantage, by shaping up the change proactively for excellence, and not by following the process reactively for survival, would separate the men from the boys in India, as well.

Patient experience – a key differentiator:

A recent report titled, “2017 Digital Trends in Healthcare and Pharma”, was published by Econsultancy in association with Adobe. This study is based on a sample of 497 respondents working in the healthcare and pharma sector who were among more than 14,000 digital marketing and eCommerce professionals from all sectors. The participants were from countries across EMEA, North America and Asia Pacific, including India.

Regarding the emerging scenario, the paper focuses mainly on the following areas:

  • Pharma companies will sharpen focus on the customer experience to differentiate themselves from their competitors.
  • ‘The internet of things (IoT)’ – the rapidly growing Internet based network of interconnected everyday use computing devices that are able to exchange data using embedded sensors, has opened new vistas of opportunity in the pharma business. Drug players consider it as the most exciting prospect for 2020.
  • Virtual Reality (VR) and Augmented Reality (AR) have started filling critical gaps in pharma and healthcare technologies and systems. Their uses now range from training doctors in operating techniques to gamifying patient treatment plans. Over 26 percent of respondents in the study see the potential in VR and AR as the most exciting prospect for 2020.

Commensurate digital transformation of pharma industry is, therefore, essential.

Prompts a shift from marketing drugs to marketing outcomes:

The above study also well underscores a major shift – from ‘marketing drugs and treatments’ – to ‘marketing outcome-based approaches and tools’, both for prevention and treatment of illnesses. This shift has already begun, though many Indian pharma marketers prefer clinging on to their belief – ‘Indian pharma market and the patients are different.’

If it still continues, there could possibly be a significant business impact in the longer-term future.

Global companies have sensed this change:

Realizing that providing a unique experience to patients during the treatment process will be a key differentiator, some global companies have already started acting. In this article I shall highlight only one recent example that was reported in March 01, 2018.

Reuters in an article on that day titled, “Big pharma, big data: why drugmakers want your health records,” reported this new trend. It wrote, pharma players are now racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform in the real world. This is critical, I reckon, to provide a unique treatment experience to the patients.

A recent example:

Vindicating the point that with effective leverage of this powerful tool, drug manufacturers can offer unique value of their medicines to patients, on February 15, 2018, by a Media Release, Roche announced, it will ‘acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer.’ Roche acquired Flatiron Health for USD 1.9 billion.

New York based Flatiron Health – a privately held healthcare technology and services company is a market leader in oncology-specific electronic health record (EHR) software, besides the curation and development of real-world evidence for cancer research.

“There’s an opportunity for us to have a strategic advantage by bringing together diagnostics and pharma with the data management. This triangle is almost impossible for anybody else to copy,” said Roche’s Chief Executive Severin Schwan, as reported in a December interview. He also believes, “data is the next frontier for drugmakers.”

Conclusion:

Several global pharma companies have now recognized that providing unique patient experience will ultimately be one of the key differentiators in the pharma marketing ballgame.

Alongside, especially in many developed countries, the drug price regulators are focusing more on outcomes-based treatment. Health insurance companies too, have started looking for ‘value-based pricing,’ even for innovative patented medicines.

Accordingly, going beyond the product marketing, many drug companies plan to focus more on outcomes-based marketing. In tandem, they are trying to give shape to a new form of patient expectation in the disease prevention and treatment value chain, together with managing patient expectations.

Such initiatives necessitate increasing use advanced data analytics by the pharma marketers to track overall ‘patient experience’ – against various parameters of a drug’s effectiveness, safety and side-effects. This would also help immensely in the customized content development for ‘outcomes-based marketing’ with a win-win intent.

Providing unique ‘patient experience’ is emerging as a new normal and a critical brand differentiator in the global marketing arena. It will, therefore, be interesting to track how long the current belief – ‘Pharma industry and the patients in India are so different from other countries’, can hold its root on the ground, firmly. Or perhaps will continue till it becomes a necessity for the very survival of the business.

By: Tapan J. Ray   

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