Monthly Archives: February 2019

Is India A Success Story With Biosimilar Drugs?

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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?

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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

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.

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

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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    

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

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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   

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.