Is India A Success Story With Biosimilar Drugs?

Posted on February 25, 2019 by Tapan Ray

How Indian generic companies are expanding, if not shifting their business focus on biosimilar and complex generic drugs, may be a current trend of general discourse – but the initiative is not a current one. This journey commenced decades ago with an eye on the future. In those days, Indian players were already dominating the global markets of small molecule generic drugs. Interestingly, it started much before the big global players decided to enter into this segment – especially post patent expiry of large molecule blockbuster drugs.

This strategy not just exhibits a sound business rationale, but also benefits patients with affordable access to biosimilar versions of high cost biologic drugs. In this article, I shall dwell on this subject, basically to understand whether India is a success story with large molecule biosimilar drugs, both in terms of drug development, and also in its commercial performance.

India’s journey began with the dawn of the new millennium:

About two decades back from now, some Indian pharma companies decided to step into an uncharted frontier of large molecule biosimilar drugs. According to the ‘Generics and Biosimilars Initiative (GaBI)’, in 2000 – the first biosimilar drug, duly approved by the Drug Controller General of India (DCGI), was launched in the country. This was hepatitis B vaccine from Wockhardt – Biovac-B.

I hasten to add, in those years, there were no specific regulatory pathways for approval of large molecule biosimilar drugs in India. Thus, the same marketing approval guidelines as applicable to small molecule generic drugs, used to be followed by the DCGI for this purpose. Specific guidelines for biosimilar drugs were implemented on September 15, 2012, which was subsequently updated in August 2016. To date, around 70 large molecule biosimilar drugs, including biopharmaceuticals, have been introduced in India, as the GaBI list indicates.

It is equally important to note that well before any other countries, domestic pharma companies launched in India, AbbVie’s blockbuster Humira (adalimumab) and Roche’s breast cancer treatment Herceptin (trastuzumab). In this context, it is worth mentioning that US-FDA approved the first biosimilar product, Zarxio (filgrastim-sndz), in March 2015.

Will India be a key driver for global biosimilar market growth?

According to the Grand View Research Report of July 2018, increasing focus on biosimilar product development in countries, such as India, China and South Korea, is a major growth driver of the global biosimilar market. As this report indicates, the global biosimilars market size was valued at USD 4.36 billion in 2016, which is expected to record a CAGR of 34.2 percent during 2018-25 period.

Europe has held the largest revenue market share due to a well-defined regulatory framework for biosimilars was in place there for quite some time, and was followed by Asia Pacific (AP), in 2016. Growing demand for less expensive therapeutic products and high prevalence of chronic diseases in the AP region are expected to contribute to the regional market growth – the report highlighted.

Further, the Report on ‘Country-wise biosimilar pipelines number in development worldwide 2017’ of Statista also indicated that as of October 2017, India has a pipeline of 257 biosimilar drugs, against 269 of China, 187 of the United States, 109 of South Korea, 97 of Russia and 57 of Switzerland. However, post 2009 – after biosimilar regulatory pathway was established in the United States, the country has gained significant momentum in this segment, presenting new opportunities and also some challenges to biosimilar players across the world.

Is Indian biosimilar market growth enough now?

An important point to ponder at this stage: Is Indian biosimilar market growth good enough as of now, as compared to its expected potential? Against the backdrop of India’s global success with generic drugs – right from the initial stages, the current biosimilar market growth is certainly not what it ought to be. Let me illustrate this point by drawing an example from theAssociated Chambers of Commerce of India’s October 2016 White Paper.

According to the Paper, biosimilars were worth USD 2.2 billion out of the USD 32 billion of the Indian pharmaceutical market, in 2016, and is expected to reach USD 40 billion by 2030. This represents a CAGR of 30 percent. A range of biologic patent expiry in the next few years could add further fuel to this growth.

A similar scenario prevails in the global market, as well. According to Energias Market Research report of August 2018, ‘the global biosimilar market is expected to grow significantly from USD 3,748 million in 2017 to USD 34,865 million in 2024, at a CAGR of 32.6 percent from 2018 to 2024.’

Many other reports also forecast that the future of biosimilar drugs would be dramatically different. For example, the ‘World Preview 2017, Outlook to 2022 Report’ of Evaluate Pharma estimated that the entry of biosimilars would erode the total sales of biologics by as much as 54 percent through 2022, in the global markets. It further elaborated that biologic sales may stand to lose up to USD 194 billion as several top blockbuster biologic drugs will go off-patent during this period.

Although, current growth rate of the biosimilar market isn’t at par with expectations, there is a reasonable possibility of its zooming north, both in India and the overseas markets, in the near future. However, I would put a few riders for this to happen, some of which are as follows:

Some uncertainties still exist:

I shall not discuss here the basic barriers that restrict entry of too many players in this segment, unlike small molecule generics. Some of which are – requisite scientific and regulatory expertise, alongside wherewithal to create a world class manufacturing facility a complex nature. Keeping those aside, there are some different types of uncertainties, which need to be successfully navigated to succeed with biosimilars. To get an idea of such unpredictability, let me cite a couple of examples, as hereunder:

1. Unforeseen patent challenges, manufacturing and regulatory issues:

Wherewithal to effectively navigate through any unexpected labyrinth of intricate patent challenges, which are very expensive and time-consuming. It may crop up even during the final stages of development, till drug marketing, especially in potentially high profit developed markets, like for biosimilars of Humira (AbbVie) in the United States or for Roche’s Herceptin and Avastin in India.

It is expensive, time consuming and risk-intensive to correct even a minor modification or unforeseen variation in the highly controlled manufacturing environment to maintain quality across the system, to ensure high product safety. For example, what happened to Biocon and Mylan with Herceptin Biosimilar. As the production volume goes up, the financial risk becomes greater.

There are reports that innovator companies may make access to supplies of reference products difficult, which are so vital for ‘comparability testing and clinical trials.’ This could delay the entire process of development of biosimilar drugs, inviting a cost and time-overrun.

Current regulatory requirements in various countries may not be exactly the same, involving significant additional expenditure for overseas market access.

2. User-perception of biosimilar drugs:

Studies on perception of biosimilar vis-à-vis originator’s biologic drugs have brought out that many prescribing physicians still believe that there can be differences between originator’s biologic medicine and their biosimilar equivalents. With drug safety being the major concern of patients, who trust their physician’s decision to start on or switch to a biosimilar, this dilemma gets often translated into doctors’ preferring the originator’s product to its biosimilar version. One such study was published in the September 2017 issue of Bio Drugs. Thus, the evolution of the uptake of biosimilars could also depend mainly on similar perception of physicians.

What happens if this perception continues?

Whereas, the W.H.O and drug regulators in different countries are quite clear about comparable safety and efficacy between the originator’s product and its biosimilar variety, some innovator companies’ position on biosimilar drug definition, could help creating a perception that both are not being quite the same, both in efficacy and safety.

To illustrate this point, let me reproduce below how a top ranked global pharma company - Amgen, defines biosimilar drugs, starting with a perspective of biologic medicines:

“Biologic medicines have led to significant advances in the treatment of patients with serious illnesses.These medicines are large, complex molecules that are difficult to manufacture because they are made in living cells grown in a laboratory. It is impossible for a different manufacturer to make an exact replica of a biologic medicine due to several factors, including the inherent complexity of biologics and the proprietary details of the manufacturing process for the original biologic medicine, often referred to as the reference product.It is because of this that copies of biological products are referred to as “biosimilars”; they are highly SIMILAR but not identical to the biologic upon which they are based.”

Could dissemination of the above concept through a mammoth sales and marketing machine to the target audience, lead to creating a better perception that the originators’ biologic drugs are better than their biosimilar genre?

Other realities:

Despite the availability of a wide array of biosimilar drugs, the prescription pattern of these molecules is still very modest, even in India. One of its reasons, as many believe, these are still not affordable to many, due to high out-of-pocket drug expenses in India.

Thus, where other biosimilars of the same category already exist, competitive domestic pricing would play a critical role for faster market penetration, as happens with small molecule generic drugs.

Another strategic approach to address cost aspect of the issue, is to explore possibilities of sharing the high cost and risks associated with biosimilar drug development, through collaborative arrangements with global drug companies. One good Indian example in this area is Biocon’s collaboration with Mylan.

Conclusion:

The question on whether Indian biosimilar market growth is good enough, assumes greater importance, specifically against the backdrop of domestic players’ engagement in this segment, since around last two decades. Apart from the important perception issue with biosimilars , these medicines are still not affordable to many in India, owing to high ‘out of pocket’ drug expenditure. Just focusing on the price difference between original biologic drugs and their biosimilars, it is unlikely to get this issue resolved. There should be enough competition even within biosimilars to drive down the price, as happened earlier with small molecule generics.

That said, with around 100 private biopharmaceutical companies associated with development, manufacturing and marketing of biosimilar drugs in India, the segment certainly offers a good opportunity for future growth. Over 70 such drugs, most of which are biosimilar versions of blockbuster biologic, are already in the market. Today, Indian companies are stepping out of the shores of India, expecting to make their presence felt in the global biosimilar markets, as they did with generic drugs.

The future projections of biosimilar drugs, both in the domestic and global markets are indeed very bullish. But to reap a rich harvest from expected future opportunities, Indian players would still require some more grounds to cover. Overall, in terms of biosimilar drug development since 2000, India indeed stands out as a success story, but a spectacular commercial success with biosimilars is yet to eventuate.

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.

Uniting Pharma With Business Ethics: A Bridge Too Far?

Posted on February 18, 2019 by Tapan Ray

Operating ethically not only is the right thing to do but also is fundamental to success in business. Poor governance and poor ethical business practices can lead to fines, public scrutiny and distrust – overshadowing good performance, destroying reputation, and undermining the morale and engagement of employees. …We must act in ways that build and maintain the trust of patients, healthcare professionals, governments and society. This was articulated in the Novartis Corporate Responsibility Report 2017, highlighting how important it is to unite pharma operations with business ethics for each company. But is it happening in reality?

The same question haunts yet again with the announcement of a new Code of Marketing Practice by the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA),effective January 2019. The pronouncement prescribes ‘a global ban on gifts and promotional aids for prescription drugs wherever the association’s member companies operate.’

However, the overall scenario gets more complex to comprehend, when on January 03, 2019 Bloomberg Law reported: ‘The change is causing concern among both U.S.-based and multinational companies like Astra Zeneca, Bristol-Myers Squib, Johnson & Johnson, and Pfizer Inc. about how to balance appropriate business behavior with respect for cultural norms in other countries.’ Interestingly, the IFPMA membership virtually covers all MNC drug companies, operating across the world. Thus, any concern on its implementation, especiallyamong some of the bigger names, raises more questions than answers about its effectiveness. What exactly has been the outcome of all such actions being taken, especially by the multinational pharma industry associations, from time to time. Have the patients been benefited – at all?

Keeping this recent development as the backdrop, I shall try to gauge in this article, is the bridge still too far to mitigate the widening gap between overall pharma operations and the standard of business ethics -voluntary code of practices of pharma associations notwithstanding?

Why pharma ‘business-practices’ and ‘business-ethics’ are so important?

Before charting onto the sensitive areas of ‘business practices’ and ‘business ethics’, let me recapitulate the meaning of these two terminologies to fathom why these are so important in pharma to protect patient health interest.

Business practice is defined as a method, procedure, process, or rule employed or followed by a company in pursuit of achieving its objectives. Itmay also refer to these collectively.
Similarly, Business ethics is defined as a form of professional ethics that examines the ethical and moral principles and problems that arise in a business environment. It applies to all aspects of business conduct on behalf of both individuals and the entire company.

Thus, ethical business policies and practices for pharma industry, when worked out both by an industry association or an individual company, aims at addressing potentially controversial issues, such as corporate governance, insider trading, bribery, discrimination, corporate responsibility and fiduciary responsibilities.

Ironically, despite well-hyped announcements of voluntary codes of practices from time to time, no commensurate changes in patients’ health interest are visible in real life. Thus, the very relevance of such edicts is now being seriously questioned by many.

What do reports reflect on ongoing pharma business practices?

To get an idea in this area, let me quote below from three reports, out of which one is specifically on the Indian scenario, which has not changed much even today:

“The interaction between physicians and medical representatives (MRs) through gift offering is a common cause for conflicts of interest for physicians that negatively influence pre- scribing behaviors of physicians throughout the world.” This was articulated in an article titled, “Gift Acceptance and Its Effect on Prescribing Behavior among Iraqi Specialist Physicians”, published by Scientific Research Publishing (SCIRP) in June 2014.

A couple of years before that, on September 07, 2012, Reuters also published an article with the headline: “In India, gift-giving drives drug makers’ marketing.” Thereafter, many similar articles were published in various newspapers and magazines, possibly to trigger remedial action by the regulators in the country.

Very recently, on January 18, 2019, The New York Times (NYT) came out with a mind boggling headline – “Study Links Drug Maker Gifts for Doctors to More Overdose Deaths.” Elaborating on this JAMA study, the NYT wrote: “Counties where the doctors got more meals, trips and consulting fees from opioid makers had higher overdose deaths involving prescription opioids.”

The point I want to drive home here is that freebies in the form of gifts, travel to exotic places with free meals and stay, fees of various types clubbed under a mysterious nomenclature ‘consulting fees’, purported to influence doctor’s prescribing behavior, are now rampant. These are adversely impacting patients, as they are often compelled to buy high-priced drugs, unnecessary drugs, including antibiotics, sedatives and opioids, to name a few.

Are big pharma companies following the codes – both in letter and spirit?

The doubt that surfaces, are these changes just for displaying to the stakeholders how well and with stringent measures, drug companies are self-regulating themselves, on an ongoing basis? Before jumping to any conclusion, let us try to make out whether, at least the big pharma players are following these codes in both letter and spirit.

To establish the point, instead of providing a long list of large pharma settlements with governments for various malpractices, I shall cite just the following two relatively recent ‘novel’ examples related two top global pharma companies, for you to have your own inferences.

The first one is related to reports that flashed across the world in May 2018 related to Novartis. One such article described, “Congress demands info from Novartis about its USD 1.2m in outflows to Michael Cohen, just as it was negotiating payments for its cancer drug.” The report further elaborated, Novartis’ USD 1.2 million payment was made in the shell company of Michael Cohen, President Donald Trump’s personal lawyer and so-called ‘fixer’.

The second one is the September 13, 2018 report of The New York Times. It revealed: ‘Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles.”

The report also stated: “Dr. Baselga, a prominent figure in the world of cancer research, omitted his financial ties to companies like the Swiss drugmaker Roche and several small biotech startups in prestigious medical publications like The New England Journal of Medicine and The Lancet. He also failed to disclose any company affiliations in articles he published in the journal Cancer Discovery, for which he serves as one of two editors in chief.”

Indian companies aren’t trailing far behind, either:

Many Indian companies are, apparently, sailing on the same boat. Let me illustrate this point by citing an example related to India’s top ranked domestic pharma player.

What it said: Way back on November 13, 2010, Sun Pharmain a communication expressed its concern by saying: ‘Over four decades since Independence, the government nurtured a largely self-sufficient pharma industry. But the entry of MNCs is putting most drugs beyond the reach of millions.’

The communique further added: ‘Even as the domestic industry begins to feel the heat of an unprotected market, public health experts are examining why drug prices in India are higher than in Sri Lanka, which imports most of its drugs. The MNC takeover raises the specter of an MNC-dominated pharma sector selling drugs at un-affordable prices, a throw ‘back to the scenario just after Independence, which the government painstakingly changed over four decades. Are we setting the clock back on the country’s health security?’

The reality thereafter: It’s a different story that today, the same Sun Pharma, despite alleged ‘high price drugs of MNCs’, occupies the top ranking in the Indian pharmaceutical market. Be that as it may, the point to note that the same company is now facing similar charges from other countries, almost a decade after. On March 2017, a media report came with a headline: ‘Sun Pharma, Mylan face price fixing probe in US.’

Incidentally,the company is mired with allegation on governance related issues, as well. A media report dated November 20, 2018 carried a headline: ‘Governance cloud over Sun Pharma, stock at 6-month low.’ This example is quite relevant to this discussion, as well, for its link with ethical business practices, as discussed earlier.

Additionally, class-action lawsuits in the United States for alleged business malpractices, including ‘pay for delay conspiracies’, against Indian pharma companies are also on the rise – Sun Pharma and Dr. Reddy’s top the list in terms of those who face most class-action litigation, reported a leading Indian business daily on September 02, 2017.

Pharma malpractices continue, DOP is still to make UCPMP mandatory:

In this quagmire, where self-regulation doesn’t work, the government usually steps in, as happened in the United States and Europe. Whereas, in India, no decisive government action is yet visible to curb this menace, especially for protection of patients’ health interest. Let me try to illustrate this point with the following chronology of four key events:

On May 08, 2012, the Parliamentary Standing in its 58th Report, strongly indicted the DoP for not taking any tangible action in this regard to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.

Ultimately, effective January 01, 2015, the Department of Pharmaceuticals (DOP) put in place the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) for voluntary implementation, despite knowing it has not worked anywhere in that format.

When voluntary UCPMP did not work, on September 20, 2016, the then secretary of the DoP reportedly said, the mandatory “UCPMP is in the last leg of clearance with the government. The draft guidance has incorporated suggestions of the pharma industry and other stakeholders.”

After another year passed by, on April 16, 2018, a news report reconfirmed: ‘4 years on, code to punish pharma firms for bribing doctors still in works.’ Its status remains unchanged till date.

Conclusion:

Even after Prime Minister Modi’s comment on April 2018 regarding the alleged nexus between doctors and pharmaceutical firms and doctors attending conferences abroad to promote these companies, decision paralysis of DOP continues on this important issue.

Pharma companies continue practicing what they deem necessary to further their business interest, alongside, of course, announcing their new and newer voluntary codes of practices. But, patients keep suffering, apparently for the apathy of the DOP to curb such malpractices forthwith.

Coming back to where I started from, when the malice is so deeply rooted, would any global ban ‘brand-reminders’, such as gifts, even if implemented religiously, work? Thus, the doubt lingers, for uniting pharma operations with corporate business ethics is the bridge still too far?

By: Tapan J. Ray

Does ‘Patient-Centricity’ Now Sound Like A Cliché?

Posted on February 11, 2019 by Tapan Ray

Today, many pharma companies claim ‘patient-centricity’ as one of their primary focus areas in business. Many industry experts, as well, have been advocating so, over a period of time. A number of research studies, published during the last several years, also recommended that ‘patient centricity’ should be the key focus area for long-term sustainability of any pharma business, across the world, including India. In the fast unfolding scenario of date, this is absolutely essential to keep pace with the changing needs and aspirations of a new generation of well-informed patients.

Currently, one can easily spot inclusion ‘patient-centricity’ even in the corporate vision and mission statements of many drug companies, especially those with global footprints. But the question arises, how efficient is its implementation in the field?

In this article, I shall try to fathom whether patients are in sync with pharma’s claim of moving towards this goal, or the term ‘patient centricity’ just sounds like a cliché, at least, as of now. Let me start by giving a brief perspective of the subject to illustrate the point, why it represents a fundamental shift in the healthcare space.

‘Patient-centricity’ – a fundamental shift in healthcare space:

As I discussed in my article, titled ‘Increasing Consumerism: A Prime Mover For Change in Healthcare’: ‘Patients’ longing for better participative treatment experience at an affordable cost, has started gathering momentum as a major disrupting force in the healthcare space of India, as well.

This is a fundamental shift in the healthcare space, especially in terms of patients’ behavior, needs, aspirations and expectations while charting across any end-to-end treatment process. This change is taking place over the last couple of decades, pushing many pharma players to adopt a ‘patient-centric’ approach for greater sustainability in the business.

‘Patient-centricity’ has started occupying the center stage in the successful pharma business, as patients are becoming more and more informative. The reasons for this change are many. I have already discussed many of these, along with suggestions on corrective measures, in my various articles, published in this blog on the subject.

What’s happening on the ground?

Drug manufacturers’ various strategic communications aimed at stakeholders, signal that the ball has started rolling. According to a report, well-known pharma majors, such as Novartis, GSK, Janssen Pharmaceutical, UCB, LEO Pharma, among others, are actively participating in conversation on ‘patient-centricity.’ Apace with, a number of research studies also point towards a clear dichotomy, and a glaring disparity between drug companies’ claims and people’s perception of ‘patient-centricity’ in real life. Let me first touch upon the glaring dichotomy in this area.

A glaring dichotomy exists:

That more organizations are becoming more ‘patient-centric’, will get captured by the increasing trust of patients – both on the individual companies and also the pharma industry, in general. But today, what we witness is a clear dichotomy between the claims of many pharma companies of being ‘patient-centric’ and the declining patients’ trust, along with dented reputation and image of the industry, in general.

Declining public trust towards pharma industry is also evident from increasing consumerism in the healthcare space, besides stringent policy and price regulatory measures being taken by various governments, across the world. It also significantly increases their cost of advocacy with governments, through their own trade associations. Either patients pay for such avoidable costs indirectly, by paying higher drug price, or the pharma players absorb its impact with reduced margin, which is also avoidable.

This gets reinforced by another measure of disparity. It also points to the widening gap between drug companies’ claim on becoming ‘patient-centric’ – together with their employee perceptions on the same, and the reality as experienced by patients. Let me illustrate this point below by quoting from another recent research study.

Measuring disparity between the claim and reality:

Interestingly, the August 2018 annual benchmarking survey carried out by the Aurora Project, also finds a disparity in perception and reality related to the much often-used terminology – ‘patient-centricity’. Aurora Project is a non-profit group, founded by eyeforpharma and Excellerate. It is made up of more than 200 health sector leaders from around the world, with an objective ‘to move ‘patient-centricity’ from words to actions and outcomes’.

The study was conducted between July and November 2018. It covered 1,282 respondents, which include patients, HCPs and employees from biopharmaceutical and medical device companies. Expert perspectives were obtained from senior managers working with 10 of the world’s leading pharma companies, and views from specialists in behavior change and organizational psychology.

The respondents were asked to score the degree of ‘patient-centricity’ in pharma across 10 metrics, and patients consistently rated companies lower than industry employees. Some of the important findings that came out clearly while measuring the disparity between pharma’s claim and the reality, are as follows:

In total, 72 percent of employees agreed with the statement “my company communicates with care and compassion, transparent and unbiased information on diseases, treatment options and available resources”.

- Whereas only 32 percent of patients agreed with the equivalent statement.

More than half (53 percent) of the employee participants said they were “actively looking for what to do and how to teach” patient centricity.

- Whereas only 22 percent said they knew “exactly what to do

- And 16 percent said they “didn’t know what to do or how to teach it”.

Only 36 percent of the patients surveyed indicate that they have “quite a bit” or “a lot” of trust in the pharmaceutical industry overall.

The survey brought to the fore, while people believe in the importance of pharma delivering on its ‘patient-centered’ mission, most are not confident in pharma’s ability to deliver.

Most companies focus sharper on meeting short-term goals than ‘patient-centricity’:

That most companies focus sharper on achieving short term goals than ‘Patient-centricity’, as also captured unambiguously in the above survey, as it noted:

90 percent of survey participants employed by biopharmaceutical and medical device companies agree that a long-term focus is key to the success of patient- centric efforts. However, the need for a long-term view is sometimes at odds with business realities, and 53 percent agree that their companies are mostly concerned about results this quarter (9 percent) or this year (44 percent).

Thus, there is a clear need for not just of ‘patient-centricity’, but also an appetite for it among those best placed to make it happen. Therefore, the question to ponder for pharma companies is: How best to be ‘patient-centric’? While trying to ferret out a robust answer to this question, many domain experts suggest that ‘patient centricity’ demands a fundamental shift in the cultural mindset of the organization.

Demands a fundamental shift in corporate cultural mindset:

As I pointed out in several of my articles in the past, the need for creating an appropriate ‘patient-centric’ corporate cultural mindset is to reverse the organizational pyramid. This means transforming the business from being product focused to patient focused.

That ‘patient-centricity’ demands a shift in the corporate cultural mindset within the pharmaceutical industry, was also emphasized in the article published in the Journal of Therapeutic Innovation & Regulatory Science (TIRS) onMarch 28, 2017, titled ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’

Elaborating this point further, the paper said that at the highest level, it involves listening to and partnering with the patient, and understanding the patient perspective, rather than simply inserting patient views into the established process. Aided by the top management, the answers to the following questions on ‘patient-centricity’ should be crystal clear to all employees:

Why are we doing this?
How should we do it?
What are the results we aim to achieve?

Conclusion:

Quoting the December 2012 NHS document, the essence of ‘patient-centricity’ may be expressed as – ‘making “no decision about me, without me” a reality, all along the patient pathway: in primary care, before a diagnosis, at referral and after a diagnosis.’ This is applicable to all in the healthcare space, equally, including the pharma industry. There doesn’t seem to be any alternative to it, either. Which is why, ‘patient-centricity’ is emerging as a ‘take it or perish’ type of a situation for all pharma players. It may not happen immediately, but eventually it would certainly form the bedrock of pharmaceutical business.

Probably due to this reason, ‘patient-centricity’ has become a new a new buzz word to demonstrate how a pharma player is keeping pace with time. Consequently, more and more companies are joining this chorus of informing the stakeholders that ‘I am game’. Be that as it may, the core concept of ‘patient centricity’ is still not yet getting properly translated into better patient outcomes, through actionable strategies on the ground.

There are several studies on the measurement of ‘patient centricity’. The Aurora Project, as discussed above, is one such. It clearly brings out that there is still a significant gap between words and actions of many drug companies on ‘patient-centricity’. Consequently, a large number of patients are still unable to reap the consequential benefits of ‘patient centricity’, the way it is publicized by several companies. Despite this, the terminology continues to be overused, sans proper application of mind to translate the pharma’s good intent into reality.

By: Tapan J. Ray

Pharma’s ‘Value Delivery System’ Still Tuned To A Self-serving Mode?

Posted on February 4, 2019 by Tapan Ray

Just as any other industry, pharma business is also primarily a ‘value delivery system.’ Its each and every employee need to understand and internalize this basic philosophy of the business. This organizational mindset needs to be created by the very top – setting examples for others to embody the same. The top could encompass the promoters themselves, or the professional CEOs – truly heading the organization and not working under the shadow of the promoters, or even the Board of Directors of professionally managed companies.

Although, this mindset should prevail pan organization, pharma sales and marketing functions are usually responsible to deliver a well-thought out set of brand values and associated services to doctors, patients and other stakeholders, effectively.

Against the above backdrop, I shall explore in this article whether it is happening in the pharma industry. If yes, is the ‘value delivery system’ is tuned to a self-serving mode, wherever it is happening? If so, to what extent it is denting the reputation and image of not just of the companies concerned, but of the drug industry as a whole. Before I proceed further, let me elaborate on what exactly I mean by the ‘value delivery system (VDS).’

Value Delivery System (VDS):

Creating more and more customers and retaining them, as long as possible, is the core purpose of any business, as was articulated by the management guru Peter Drucker, decades ago. Thus, like others, pharma organizations, as well, require making it happen in a sustainable way for business excellence.

The entire organization – starting from product and service development activities, right up to the frontline sales and marketing, should always be engaged in delighting the customers with the values they expect – driven by this mindset. It is worth noting that value expectations of pharma customers, are expressed in various ways. These need to be properly captured, analyzed, interpreted, packaged and effectively delivered during each company- customer contact, such as, while interacting with doctors, patients, hospitals and Government.

Thus, the term ‘Value Delivery System (VDS), encompasses an integrated chain of processes within an organization. From this perspective, it should get ingrained in the culture of a pharma company – without any broken links – between the functional areas and the integrated value delivery process.

Who is deciding what patients would value in pharma?

In the real world, ‘customers point of view’ or ‘what the patients would value’ in a product, is decided by the pharma companies – derived generally from the published clinical trial results of the products. Accordingly, these are woven around the brand features and benefits.

The value delivery system of the company packages these in a way that it thinks would generate increased prescription demand and delivers to all concerned. These values, which are overall financial business performance-centric, are mostly ‘self-serving’, and was working very well to meet the internal objectives, until recently.

How to ascertain value for patients in pharma marketing?

One way to ascertain these factors is to ask patients directly. But this process has certain limitations. This was once aptly articulated by Steve Jobs in an interview, where he said: ‘I think really great products come from melding two points of view -the technology point of view and the customer point of view. You need both. You can’t just ask customers what they want and then try to give that to them. By the time you get it built, they’ll want something new.’

Taking a cue from it, I reckon, drug companies need continuously generate and analyze enough relevant data, from multiple sources, for an in-depth understanding of what patients will value. Making these values an integral part of the product and services, in a creative way, pharma should aim at delighting the customers through effective delivery.

The article titled, “Reclaim The Glory Of Value,” published in the eyeforpharma on January 08, 2019 also reiterated that such ‘value’ must always be defined by the customer. ‘And true value can only be achieved by understanding the world of the patient and solving the issues most critical to them.’

The external impact of product centric value assessment:

This financial result focused value delivery system got exposed to the stakeholders, since sometime. Overall business performance, though generally slowed down, some companies did produce extraordinary results, even after remaining tuned-in to the self-serving mode. Nevertheless, what got dented most is the pharma industry reputation, with a long-term impact.

Although, the survey capturing fast declining reputation of the drug industry, was done in the United States, it is apparently no different in other countries. Consequently, the quality of general public’s trust in pharma started getting murkier. Strong headwinds are now limiting the pace of progress of the industry, with many governments, including India, taking stringent policy measures to protect the patient interest.

The only way is to ‘reverse the pyramid’:

The only way for the pharma industry, in general, is to take a fresh look at their business approach, which still remains a value delivering machine. The companies need to think afresh while arriving at the ‘value for the patients’, by reversing the business pyramid – positioning the patients’ core values at the top, and delivering them to all concerned with well-crafted content, on the most effective platforms.

Tuning VDS in sync with patients’ core values, is fundamental:

It has been well established today the delivering values built around the quality, efficacy and safety of a brand can no longer ensure the best clinical outcomes for patients. This holds good even when the conventional sales and marketing activities are carried out through a large sales force and backed by huge financial resources. The main reason being, the pharma value delivery system is not delivering the core value that modern day patients expect.

Many patients of the new generation value empowerment and desire greater involvement in their end-to-end disease treatment process. For example, when they want understanding and help on how to manage the high treatment cost to survive from a life-threatening illness, some companies try to compare the ‘cost of treatment’ with the ‘cost of life’, which is an undiluted self-serving value.

It may sound absurd, but I have witnessed the top echelons of pharma companies saying so. This can possibly happen only when they feel contended with a smaller patient base fetching higher profit due to high drug prices, though unaffordable to most patients. But this model is not sustainable. It would further damage already dented pharma reputation, drawing more ire from stakeholders, including the government.

Thus, tuning VDS in sync with patients’ core values is fundamental in the emerging scenario. The question that follows what then are the core values of the new generation patients?

Two ‘core values’ that patients generally expect:

In my personal view, there are the following two ‘core values’ that consumers of medicines would generally expect during their end-to-end disease treatment process. However, the signals of such expectations – direct or indirect, may come in different ways and forms that need to be properly captured by the pharma companies, with the careful application mind:

Value of unique product and service offerings: The need for this value arises right in the beginning, when patients are in search of a solution for prevention, cure, or management of a disease. It is, primarily, the difference felt by the customers between the product and service offerings of one pharma company from the other. While finalizing the choice for the resolution of the problem, patients may take into account one more important factor. This usually covers the quality of their interaction with the doctors, including the pharma companies, though their respective patient engagement platforms, if any.

Value of a unique patient experience: After making the final choice, patients would value to feel a unique experience during the entire span of the treatment process. The quality of a brand, its effectiveness, safety, affordability and accessibility, among others, would be the individual components of the whole experience. What would matter most is the residual impact, created by the sum total of each of these components. And this value may be termed as – the unique patient experience.

Effectively delivered, the wholesome impact of patients’ treatment experience will be a lot more than the sum total of each the individual components, as mentioned above. Conversely, any hurdle faced by patients even with one component of this value chain, can potentially create a bad patient experience. This may adversely affect both patients and the concerned pharma company, in tangible terms, which I shall discuss below. Thus, the perceived value of ‘unique patient experience’ is very high, and can’t be wished away, any longer.

Tangible gain of pharma for doing so, or vice versa:

Let me illustrate this point with an example – drawing from the above core values and a self-serving value delivery system.

As we know, non-adherence to medication is one of the important reasons for poor clinical outcomes, besides progression of the ailment – further compounding the disease burden. Ample research studies indicate that ‘high cost of drugs is the biggest barrier to medication adherence,’ or, at least, one of the major causes of non-adherence.

Patients pay for non-adherence by their deteriorating health conditions. Alongside, pharma companies also pay a high price in terms of lost sales and profit, besides dent in reputation – for this single factor. Another research report estimated an annual revenue loss of USD 637 billion for non-adherence to medications for the treatment of chronic conditions. The same report highlighted, globally, revenue loss has increased from USD 564 billion in 2012 to USD 637 billion in 2015, with US-based revenue losses increasing from USD 188 billion in 2012 to USD 250 billion in 2015. Otherwise, this could have been a significant tangible gain for pharma.

Conclusion:

Pharma business, just as any other industry, is a value delivery system. This system needs to be optimized, both for tangible financial gains and also for building company reputation. Creating increasingly satisfied patients, including other stakeholders, should be the prime drivers for this optimization process.

Two core values – built on signals, suggestions and indications coming from the bottom of a conventional business pyramid – the patients, need to be effectively captured, analyzed, packaged and then delivered through the VDS. In no way, these values are to be based on what the top of the pyramid thinks, based on only clinical trial results. Such values are usually self-serving in nature, the long-term impact of which is not quite favorable, either. Reversing the pyramid, patients should be allowed to play a pivotal role for the company in the core value creation of a brand, in innovative ways, for subsequent delivery on appropriate platforms.

This will create a win-win situation, both for business growth and also in delighting most patients with access to high quality and affordable novel treatments, for a healthy life. However,considering today’s reality where most pharma companies’ ‘Value Delivery Systems’ are still tuned to a self-serving mode, a serious introspection by individual companies seems to be an urgent need. More proactive players in this game, will emerge as winners with better business performance, in tandem with improved corporate image and reputation.

By: Tapan J. Ray

Pharma’s Oncology Focus: Some Key Drivers With Pros And Cons For Patients

Posted on January 28, 2019 by Tapan Ray

Just in the first ten days of the brand-new year – 2019, three important oncology focused acquisitions were announced by three top global pharma companies.

On January 03, 2019, Bristol-Myers Squibb announced that it will acquire Celgene for a hefty sum of USD 74 billion to be a leading Biopharma player, focusing on high-value innovative medicines. As reported by BioSpace on January 04, 2019, the BMS CEO said, the combined might of the two pipelines will create “the number one oncology franchise” for both solid and hematologic tumors.

Just four days thereafter, on January 7, 2019, at the J.P. Morgan Healthcare Conference, Eli Lilly announced that it will acquire targeted cancer drug maker Loxo Oncology for USD 8 billion. This deal gives the company TRK inhibitor Vitrakvi – the first drug approved by the FDA to target tumors based on genetic abnormality, rather than the location of the cancer.

On June 08 2019, at the same J.P. Morgan Healthcare Conference, GlaxoSmithKline CEO Emma Walmsley, reportedly said that GSK has agreed to acquire already approved PARP inhibitor Zejula as well as a range of pipeline assets valued USD 5 billion.It’s noteworthy that Walmsley announced the company’s new focus on oncology just the last year and has now almost doubled its immuno-oncology pipeline.

Even in the last year – 2018, a significant number of oncology focused Merger and Acquisitions (M&A) took place. The acquisition values are also interesting – ranging from a few-hundred million to billions of USD. In this article, I shall examine what could be the main drivers of this emerging trend with its pros and cons from the patients’ perspective, in general. As a brief backdrop, let me start with a few examples of such M&As in 2018.

Some oncology focused M&As in 2018:

Following are examples of some oncology focused acquisitions that took place in 2018:

In January 2018, Celgene Corporation, which has now been acquired by Bristol-Myers Squibb, announced theacquisition of Juno Therapeutics for about USD 9 billion. This deal came shortly after Celgene’s deal for Impact Biomedicines valuing USD 1.1 billion.

In late-January 2018, the biggest deals this year were by Sanofi. It acquired Waltham, Massachusetts-based Bioverativ for about USD 11.6 billion. Bioverativ was a spinoff by Biogen. About a week later, Sanofi bought Ghent, Belgium-based Ablynx for USD 4.8 billion.

In April 2018, Roche completed its acquisition of Flatiron Health, an oncology-specific digital health company for about USD 1.9 billion.

In the same month of April 2018, Shire sold its oncology business to France’s Servier for USD 2.4 billion.

In May 2018, Janssen Biotech, a subsidiary of Johnson & Johnson’s Janssen Pharmaceuticals, announced that it was buying Rockville, Maryland-based BeneVir Biopharma, in a deal of more than USD 1 billion.

Thus, the question that follows: what could be the primary drivers of this trend?

The primary drivers:

In my view, the primary drivers for focus on the oncology segment by pharma and biotech companies is a combination of the following factors:

Leading cause of death: The incidence of cancer is fast increasing across the world, making it the leading cause of death, says 2018 report of the International Agency for Research on Cancer (IARC).

High incidence: Cancer burden rose to 18.1 million new cases, with 9.6 million cancer deaths in 2018. IARC report further highlighted, one in 5 men and one in 6 women worldwide develop cancer during their lifetime, and one in 8 men and one in 11 women die from the disease.

The need for new treatment approaches is increasing: Various types of cancers are getting more and more complex.Genetic and epigenetic alterations in tumor cell populations are generating heritable variation, requiring new drugs along with novel treatment approaches.

High price: According to Journal of Oncology Practice, the average cancer drug price for approximately 1 year of therapy or a total treatment duration was less than USD 10,000 before 2000. This had increased to USD 30,000 to USD 50,000 by 2005. In 2012, twelve of thirteen new drugs approved for cancer indications were priced above USD 100,000 per year of therapy. For example, Keytruda (Merck) was launched in the US in 2014 at a price of reportedly USD 12,500 for each patient monthly or USD 150,000 annually. The drug is expected to be 30 percent cheaper in India than the global prices.

Longer product exclusivity period: As is often reported, many of the newer high-priced cancer drugs are for very specific types of cancer, with virtually no real competition. Consequently, they generally enjoy the benefits of a longer price exclusivity period, even after patent expiry. Humira of AbbVie is one such example.

The strategy is paying rich dividend to pharma players:

That this strategy continues paying rich dividend to concerned pharma players, gets reflected on the therapy group-wise performance of the global drug industry. Today, the global cancer therapeutics segment assumed mind-boggling size in value term. It was estimated at USD 121 billion in 2017 and projected to reach USD 172.6 billion by 2022. The top 10 oncology drugs accounted for revenue of USD 54.48 billion in 2017. Celgene, which has just been acquired by Bristol-Myers Squibb, dominates the oncology market, with its best-selling product – Revlimid.

Successive launches of a large number of high-priced novel cancer drugs, has pushed the oncology segment in the top slot in therapy ranking. It is expected to remain this way, at least for some time, as June 2018 report of Evaluate Pharma forecasts that the oncology therapy area will maintain the top ranking in the 2017-2024 period.

IQVIA report on ‘Global Oncology Trends 2018’ ofMay 24, 2018 also reconfirms that the number of approved cancer therapies continues to rise, with 63 cancer drugs launching within the past five years.’ Illustrating the point further, the report highlights that global spending on cancer medicines keeps rising with therapeutic and supportive care use at USD133 billion globally in 2017, up from USD 96 billion in 2013.

Pros and Cons of this trend for patients:

Interestingly, this trend has both pros and cons for patients, almost in equal measure. Some of the important pros are, as follows:

Advancement of cancer treatments at an accelerated pace in recent years, is offering notable improvements in clinical benefit to patients, comments the above IQVIA report.

Consequently, cancer incidence and mortality have been declining with an increase in the survival rate, especially in the developed countries, such as the United States, in recent times.

Nevertheless, decreased incidence and improved survival rate have also been attributed to both – reductions in smoking, as well as advances in early detection and treatments.

Alongside, examples of some of major cons are also bothering many patients, such as:

The real benefits of newer and novel high-priced cancer drugs have not been felt by most people in the developing world, which constitutes the majority of the global population.

The GLOBOCAN 2018 database, accessible online as part of the IARC Global Cancer Observatory, also highlights that countries with lower Human Development Index (HDI) have a higher frequency of certain cancer types associated with poorer survival. This is mainly because access to timely diagnosis and effective treatment is less common.

Although, the new generation of treatment is transforming the field of cancer, yielding more cures and long-term remissions than ever before, the healthcare systems worldwide continue to struggle to deliver the benefits of these drugs to deserving patients.

As the above IQVIA report says, the list prices of new cancer drugs at launch have risen steadily over the past decade, and the median annual cost of a new cancer drug launched in 2017 exceeded USD 150,000, compared to USD 79,000 for the new cancer drugs launched in 2013.

If the affordability of drugs is not addressed soon, many people with cancer might not be able to reap the rewards of cutting-edge therapies.This concern was also expressed by Nature in an article titled, ‘Bringing down the cost of cancer treatment,’ published on March 07, 2018.

Thus,access to cancer treatment, mostly with modern cancer drugs, is becoming a major challenge in all countries, but much more acute in the developing nations. A special article titled, ‘Facing the Global Challenges of Access to Cancer Medication,’ published in the Journal of Global Oncology on March 28, 2018, also broached the question of affordability of modern anticancer medication and commented, “the financial challenge presented by the rising cost of care will create a barrier to its delivery.”

Conclusion:

On the above perspective, the emerging trend of large pharma and biotech companies’ focus on novel oncology drugs is an interesting one. The key drivers fueling this ascending trend are also understandable. However, a deep-stick analysis of pros and cons of its impact on patients indicate, it has helped patients in the developed world, significantly more than those in the developing world, with affordability being the primary issue.

The article titled, ‘Bringing down the cost of cancer treatment,’ published in Nature on March 07, 2018, also reconfirms the current situation eloquently. It asserted, there isn’t an iota of doubt that new generations of cancer drugs are transforming the field of cancer treatment, yielding long-term remissions and even cure – more than ever before. Nevertheless, while medicine’s ability to tackle tumors increases by manifold, patients and healthcare systems worldwide are struggling to deliver their benefits to most cancer patients.

To address this situation, some drug players did try out ‘tiered pricing’, while a few others announced – ‘patient assistance programs’. Unfortunately, none of these measures seem to have benefitted majority of deserving patients, materially. Thus, echoing the above article from Nature, I would emphasize, if the affordability issue of new cancer drugs is not effectively addressed soon, collectively by all stakeholders, a vast majority of cancer patient won’t be able to reap expected rewards from such cutting-edge therapies.

By: Tapan J. Ray

Gamification in Pharma: Creates Engaging Patient Experience For Better Results

Posted on January 21, 2019 by Tapan Ray

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:

One game, from 1997, was designed to help kids manage diabetes and led to a 77 percent reduction in urgent care visits.
The other one showed, people were motivated to exercise after doing virtual exercise in a game with an avatar that looked like them.

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.

Pharma: Experts’ Handholding is Pivotal in Digital Marketing Transition Phase

Posted on January 14, 2019 by Tapan Ray

“Pilman – A Tapan Ray Website on Helathcare” completes 10 years, today.

Inspired by some of my dear friends, I created this website on January 14, 2009. Since then, reasonably well-researched articles, penned by me, on various aspects of health care, and the pharma industry, appeared in this blog – on every Monday morning of every week – uninterrupted – not even once. It did not just happen, I took a vow to make it happen with the same zeal, consistency and frequency, in the first 10 years of its launch – come what may.

During this period, I have been humbled by tens of thousands of my dear readers, from all over the world, who went through these articles – spending their valuable time. Today, with all humility, I bow my head before each of my readers to make it happen. After Ten years – a time has now come for me to decide what next. Thank you so much, from the very core of my heart.

Talking about digital marketing in pharma is virtually a fad now. It sounds so modern, sleek and is a great attention getter, especially in the tradition bound pharma industry. Advertisements of umpteen number of training programs are spilling all over. Even those who never worked with digital marketing in pharma, or possess any basic theoretical knowledge in this technology, are jumping into the fray. Some trainers claim to impart subject knowledge in the pharma domain, while others assert facilitating quick implementation of digital marketing by pharma executives.

Thus, the question that follows, why is the sudden interest in digital marketing for pharma by such trainers? What is happening in reality after these trainings? Is one blind man trying to help another blind man in this area, or it is a competition for sheer eyeball grabbing? Some friends in the industry do say, the common thread of ‘imparting training’ of this nature on digital marketing – outside any pharma company, is possibly the intent of ‘making a quick buck, while the sun shines.’

To me, this sounds too blunt a statement, as I reckon, expression of such a view will be unfair to formally qualified digital experts with proven experience of success in the pharma domain. Some of them also offer handholding young marketing professionals, with reasonable accountability, as they gradually transition from the traditional pharma to an integrated digital marketing model. In this article, I shall focus on this area by affirming, while digital softwares, tools and their applications aren’t anything new in pharma, making an integrated digital marketing process work effectively, is indeed a new necessity in the industry.

Digital tools and applications aren’t new in pharma:

As I said, digital tools and applications aren’t new in pharma. For example, many Indian companies have already implemented likes of ‘Enterprise resource planning (ERP)’. This is basically an integrated business process management software that enables the organization to run their business processes, including finance, accounting, supply chain, sales, manufacturing and human resources, in an integrated environment. Some companies have also introduced field-staff reporting in digital format and online. Nevertheless, digital marketing in pharma being a new necessity, let me elaborate below what is digital marketing, and what it is not.

What is digital marketing and what it is not:

As defined by The Financial Times Lexicon, digital marketing is:

Marketing of products or services using digital channels to reach consumers. The key objective is to promote brands through various forms of digital media.

Digital marketing extends beyond internet marketing to include channels that do not require the use of the internet. It includes mobile phones, social media marketing, display advertising, search engine marketing, and any other form of digital media.

And what digital marketing is not:

Digital marketing is not just yet another channel for marketing It requires a new approach to marketing and a new understanding of customer behavior.

Pharma’s transitioning to integrated digital marketing is critical:

There isn’t any doubt today that transitioning into an integrated digital marketing for pharma is critical.

The paper titled, ‘Time for Pharma to Dive into Digital – New Medicine for a New World,’ published by AT Kearney advises drug companies to act now or get left behind. The paper makes some interesting observations to drive home this point, some of which are as follows:

Digital is changing the way healthcare is delivered, as pharma customers transitioning fast into the digital world.
Effective customer engagement in cyberspace with digital tools will increase customer reach, lower costs, improve sales, and enable greater value creation.
Necessary technologies are readily available for digital customer management in a cost-effective way.
Regulation, while not fully resolved, is becoming clearer.
Reduced effectiveness of traditional promotional expenditure makes the transition to digital marketing both critical and timely.
Digital disruption has rejuvenated many businesses. It is time for pharma to do the same.

In reality, many traditional pharma companies are still apprehensive:

Digital marketing sounds great. There isn’t an iota of doubt, either, that this new ball game help achieve many business goals with precision, in the complexity of pharma sales and marketing. When conceptualized and implemented creatively with hands-on involvement of both digital and pharma domain experts, its benefits could be exponential, instead of being incremental. All strategic business communication can be accurately targeted and delivered to precise stakeholders for better, faster and quality engagement, yielding desired outcomes.

Nevertheless, the reality is, as I sense through my direct interaction with pharma friends, many of them are still apprehensive of imbibing an integrated digital marketing, going whole hog. They carry ‘a fear of failure’, if… the initiative doesn’t work, for various reasons. Moreover, any possibility that they may even lose what they currently have for such disruptive measures, makes them quite edgy, as well.

Is the apprehension totally unfounded?

As I fathom, the answer is no. They have a genuine reason to think so, because they carry the can and prefer to avoid any kind of possible risk in the performance of their respective business. They may not be totally happy with the traditional model with decline productivity. But are not also willing to make any unfamiliar drastic change by replacing the traditional marketing model by a cohesive digital one, spanning across the organization.

Nether, do they want to take any such decisions where the requirement of employee competency for success will call for a drastic overhaul, which is understandable. Be that as it may, their feelings and the associated views can’t be brushed aside, either, – as they have been at the helm of pharma business with envious track records, since long.

Precise process, timing and the end-goal of digital marketing needs clarity:

Interestingly, they all understand and agree that the transition from traditional to digital pharma marketing is inevitable. But they are not very sure about when should this transition commence for the India pharma business. Also, what are the sequential steps for the organization to move in this direction with least risk and chaos.

Many of them are also not quite clear of the end-goal of this process, which I think should go beyond offering just good drugs with unique features and benefits, to creating a unique full-service patient experience, with cutting-edge and ethical sales and marketing practices.

When to commence and where to start?

The following two pertinent questions that often arise need to be deliberated before a digital marketing initiative is undertaken by a pharma company:

When does a company to commence digital marketing?
Where to start with minimal risk exposure?

When to commence it?

Now – is the obvious answer. This is because, as I wrote in my article of June 11, with increasing number of pharma stakeholders using and interacting in the digital space, ‘consumerism’ is fast becoming a strong prime mover, even in the pharma industry. In tandem, patients’ longing for better participative treatment experience, at affordable cost, is turning into a major disruptive force in the healthcare space.Pharma players in the country, require to be on the same page, soon, to deliver sustainable results, before it’s too late.

Where does the transition from traditional to digital marketing start?

The answer will depend on marketing practices followed in a particular company, which digital experts will study and come out with an organization-specific action plan. Whosoever is the initiator of the project, the company CEO should be the final decision maker, with his total involvement in the project, for multiple reasons.

However, in my view, for those who are risk averse, it will be prudent to demonstrate that important marketing strategy when executed on integrated digital platforms, pay handsome dividend. Thus, I reckon, instead of replacing all traditional practices with a totally new and harmonized digital model, in one go, it may be better to add new marketing activities on digital platforms – having the potential to add significant value to the business, for example:

Capture and analyze useful information from various sources and functions within the organization, as inputs for marketing strategy formulation, by using state of the art digital tools and analytics.

Select those areas of sales and marketing where switching over to digital mode will add speed to the operation and the decision-making process. In any case there should be a parallel run of the traditional process and the digital one, for a pre-fixed time frame, to tighten the loose knots, if any.

Trying out social media under expert guidance. When used in innovative ways, it helps immensely to actively engage with targeted stakeholders, including patients, for getting a positive digital ‘word of mouth,’ besides important feedbacks.

Using mobile-friendly, well-targeted emails or text messages with useful, well-researched content eliciting response, either as feedbacks on selected business activities or on any other area useful for the business operation.

When ready for digital transformation across all functions of the organization, the CEO should solicit help of well-qualified professional digital experts, preferably from within the organization. If adequate resources are not available internally, experts in digital technology with a proven track record of success may be engaged from outside, equipped with high-quality pharma domain knowledge.

Conclusion:

As I said, digital interventions are not new in pharma. However, a well-harmonized digital marketing is. There could be many starting points for the transition from traditional to digital marketing. However, I reckon, low-risk initiatives to this direction – having the potential to add significant value to the business, would be prudent to start with.

Thereafter, the new and robust digital marketing platform – well-coordinated with all functions, need to necessarily undergo parallel pilot runs. The objective is to resolve the glitches in the new digital system, if any, minimizing business risks. The awareness and the need of digital marketing should preferably generate and be felt from within the organization. The trigger factor may be many, including the professional digital experts recently recruited or the CEO himself, who will decide how to cascade it down the line for effective implementation.

The name of the game is making the concept of digital marketing work effectively in the marketplace – separating the men from the boys, in the midst of cut-throat competition within the pharma industry. To take this giant leap, mere lip-services of external general advisors won’t be enough, and may not work, at all. This process requires a new approach to drug marketing digitally, involving a thorough understanding of patients’ and other stakeholders’ behavior. More importantly, in the transition phase of its implementation, handholding by high quality professional digital experts, ably supported by pharma domain experts, is pivotal for success.

By: Tapan J. Ray

Pharma To Facilitate Self-Managing Chronic Diseases For Better Outcomes?

Posted on January 7, 2019 by Tapan Ray

“India’s burden of non-communicable disease (NCD) is escalating, but still the country does not have sufficiently detailed data on NCDs for research and policy purposes.” This was captured in a recent study, titled “India’s escalating burden of non-communicable diseases,” published in The Lancet Global Health on October 03, 2018. Thus, many experts are pondering, how to contain this menace and lower the disease burden of NCDs, in this situation. One of the ways to address this issue is exploring some unconventional ways.

As several studies have established, improving ‘self-management’ of chronic diseases by patients, after proper diagnosis and a treatment plan being in place, is one of the pillars to lower the disease burden. One such study is titled, ‘Patients’ knowledge of their chronic disease,’ appeared on June 2013 – Vol 42 (6) issue in the journal of afp – Australian Family Physician. The paper highlights that effective tools, policies and other measures to help self-management, would facilitate the process. These arecritical not just for better outcomes, but also to reduce the overall treatment cost.

In a similar context, another recent article, titled ‘Why Apps for Managing Chronic Disease Haven’t Been Widely Used, and How to Fix It,’ published in The Harvard Business Review (HBR) on April 04, 2018 made an interesting observation. The authors wondered: “In an era where nearly, every consumer good and service — from books and groceries to babysitting and shared rides — can be purchased through an electronic transaction on a mobile device, it seems reasonable to think that more and more of our health care can also be managed using apps on mobile devices.”

This article will dwell in this area, based on several interesting and credible research findings. Nevertheless, to give a proper perspective, I shall start with a brief outline on the incidence of chronic diseases in India.

Increasing incidence of chronic diseases in India:

There are several recent reports confirming the ascending trend of non-infectious chronic diseases in India, two of which are as follows:

The National Health profile 2018, published by the Ministry of Health also records that between 1990 and 2016 the disease burden due to:

Communicable, maternal, neonatal, and nutritional diseases, as measured using Disability-adjusted life years (DALYs), dropped from 61 per cent to 33 per cent.
Noncommunicable diseases increased from 30 per cent to 55 per cent.
The epidemiological transition varies widely among Indian states: 48 percent to 75 percent for non-communicable diseases, 14 percent to 43 percent related to infectious and associated diseases; and 9 percent to 14 percent associated with injuries.

Alongside, the above article of The Lancet Global Health also underscores the following takeaways from its comprehensive analyses of NCDs in the Indian situation:

The three leading causes of mortality—cardiovascular diseases, respiratory diseases, and diabetes.
In absolute terms, these three diseases together kill around 4 million Indians annually (as in 2016).
Most of these deaths are premature, occurring among Indians aged 30–70 years, representing some of the world’s largest health losses, with enormous policy ramifications.
India’s Ministry of Health and Family Welfare is making efforts to establish policies and intervention strategies for prevention and control NCDs. For example, the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke, launched in 2010, and the National Program for Health Care of Elderly, launched in 2010–11, the article noted.

As none of the measures taken so far could create an appreciable impact, India needs to come up with a major intervention to tackle this escalating health issue, the article concluded. In my view, optimal use of modern technology in the self-management of such virtually lifelong diseases, can be a great enabler for patients to bring down the disease treatment and management cost, significantly. Let me hasten to add again, the question of self-management comes only after a proper medical diagnosis and a prescribed treatment plan for the same being in place.

The key benefits of self-management and the unmet need:

The key benefits of effective self-management of chronic diseases are many. However, the following four clearly stands out:

Improves Patients’ quality of life significantly.
Arrests progression of the ailment – containing associated disease related complications.
Substantially reduces the interval and number of follow-up visits with doctors.
Thus, reduces the disease burden appreciably.

Curiously, most traditional pharma companies are yet to take any major step to address, at least, the above four critical areas. They don’t seem to go beyond the conventional methods of disease related advices. Whereas, the crucial need to fetch a behavioral change in patients for participative self-management of NCDs, keeps lingering.

A number of research studies have also confirmed that ‘mobile health applications are promising tools for improving outcomes in patients suffering from various chronic conditions.’ One of these studies titled, ‘Smartphone app in self-management of chronic low back pain: a randomized controlled trial’, was published in the November 27, 2018 issue of the European Spine Journal.

Sensing an unmet need in this area, besides a large number of brilliant tech startups, many large and pure technology companies, such as Apple and Google have already entered this fray.

A recent example:

Let me cite a recent example to drive home the above point. On December 12, 2018, CNBC featured an article carrying the headline ‘Apple now has dozens of doctors on staff, showing it’s serious about health tech.’ Some of the key points of this article are as follows:

The number of doctors on staff is an indication that Apple is serious about helping customers manage diseases, and not just wellness or fitness.
Doctors can also help Apple guide the medical community on how to use Apple’s new health technologies and to deflect criticism and also to win approval among doctors who fear liability and are already overburdened by technology.
Many of these doctors are also still continuing to see patients. That might also give Apple an edge by emphasizing the patient experience.

This example demonstrates how detail are the plans of these tech companies for gaining a firm foothold in the healthcare space.

‘Effectiveness’ and ‘future scope’ of self-management of diseases:

The article titled, ‘Self-Management: A Comprehensive Approach to Management of Chronic Conditions,’ featured in the August 2014 edition of the American Journal of Public Health (AJPH) reiterated some important points. It established the relevance, future scope and effectiveness of self-management of chronic diseases, as follows:

As chronic conditions emerge as a major public health concern, self-management will continue to grow as a crucial approach to managing these conditions, preventing illness and promoting wellness.
Chronic disease conditions are generally slow in their progression and long in their duration. Thus, self-management can offer those living with these conditions, a means to maintain or even improve their capacity to live well, over the course of their lives.
Self-management intervention programs that address specific diseases are showing success across multiple chronic conditions.
These programs have particular value that represents an amalgamation of the goals of the patient, family, community, and the clinician with everyone working in partnership to best manage the individual’s illness while facilitating comprehensive care.
Self-management reaches beyond traditional illness management by incorporating the larger concept of prevention by emphasizing the notion that those who are chronically ill still have a need for preventive interventions to promote wellness and mitigate the further deterioration of health.
If one considers the nature of self-management in all its elements and practical characteristics, it is not only a logical approach to health and health care, but also an optimal way to address chronic conditions as a major issue in public health.

Inducing a behavioral change in chronic disorders with health apps:

For effective self-management of chronic diseases, there is a need to neutralize the negative influence of the individual’s behavioral traits. Research studies have also established that behavior-change-focused interventions play an important role in this effort.

However, not all patients take adequate care for such changes to take place. While the treating doctor may play an important role of a coach in this area, in reality, they usually don’t find enough time to spend on each patient with NCDs. The McKinsey & Company’s publication titled, ‘Changing patient behavior: the next frontier in health care value,’ also reiterates that to address the rising cost of chronic conditions, health systems must find effective ways to get people to adopt healthier behaviors.

As I mentioned before, this space has attracted active interest of many tech players in business expansion. More evidence-based health apps are being introduced to help drive patient-behavior change for effective self-management of chronic diseases. There are reported surveys on weight management aided by health apps, where ‘ninety-six percent of respondents agreed or strongly agreed that using a diet or nutrition app helped drive positive behavior change and healthy eating habits.’

In my article, titled ‘Prescription Digital Therapy Now A Reality,’ published in this blog on May 07, 2018, I mentioned that in September 2017, the first USFDA-cleared mobile app has been made available to patients. The app has both safety and efficacy label to help treat patients with ‘Substance Use Disorder’. Studies have established that it is two-times more effective than conventional in person therapy sessions.

More recently, in September 2018, Apple’s smart-watch version 4 included a US-FDA cleared electrocardiogram (ECG), officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms. In the same context, US-FDA Commissioner Scott Gottlieb, M.D., said that digital advances, creating a new technological paradigm of health tools and health apps., are empowering consumers to take better informed decisions on their medical care and healthy living.

Conclusion:

It has been well-demonstrated by research studies that evidence-based health-apps for self-managing chronic diseases improve outcomes, remarkably. Consequently, this has triggered some critical activities by purely tech companies in the health care space, even in India. The primary driver being a strong consideration of this segment as an opportunity area to meet an unmet need, where most pharma players don’t seem to be doing enough, as on date.

Before it gets too late, there appears a need to take a serious note of this shifting paradigm. The awareness of which should then play a critical role in developing marketing strategies for brands used in NCDs. Otherwise, non-pharma tech companies will eventually dominate this segment, armed with a different genre of technological prowess that they possess.

The article titled, “Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework,” published inJan-Mar 2016 edition of the Journal of JPMIR Research Protocols, epitomizes it succinctly:

“Mobile health technology creates a shift in the paradigm of chronic disease management. It offers new possibilities to engage patients in self-management of their chronic diseases in ways that did not exist in the past. To maximize the potential of mHealth requires the integration of research and expertise from multiple disciplines including clinical, behavioral, data analytics, and technology to achieve patient engagement and health outcomes. This paradigm shift also triggers a need for new approaches to designing clinical and behavioral support for chronic disease management that can be implemented through existing health care services and programs.”

These developments send a strong signal for pharma to facilitate self-managing chronic diseases, soon enough, for better patient outcomes and, in tandem, creating a win-win situation for both.

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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Pharma To Facilitate Self-Managing Chronic Diseases For Better Outcomes?