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Leverage Increased Focus On ‘Self-Care’ For Better Patient Outcomes

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‘People have been practicing self-care for thousands of years. Now an increase in self-care interventions is shifting the way health care is perceived, understood, and accessed, and adding to the many medicines, diagnostics, and technologies available for people to use by themselves.’ This was articulated in an article titled, ‘Self-care during the COVID-19’, published by the World Health Organization (W.H.O) on June 12, 2020.

That COVID-19 prompts increased focus on self-care was also vindicated by several research studies, including some conducted by global pharma majors, such as GSK, Johnson & Johnson, Sanofi as you will find below. In this article I shall, therefore, deliberate whether an increasing focus on ‘self-care’, as a critical service to patients can fetch better disease treatment outcomes with respective pharma brands in the new normal. Moving in that direction, let us first be on the same page about the definition of ‘self-care’.

‘Self-care’ and its key benefits?

The W.H.O defined self-care as: ‘Your ability to promote health, prevent disease, maintain health, and cope with illness and disability with or without the support of a healthcare provider is known as self-care.’ Regular practice of self-care offers a holistic interlinked benefits to its practitioners, which many people have started experiencing during the COVID-19 pandemic.

As observed by BMI Healthcare, some of these benefits include:

  • Improving your physical health: By committing to looking after your body and becoming more attuned to its needs.
  • Reducing stress and anxiety: By making time for relaxing activities.
  • Boosting self-esteem: By helping to calm your nerves, taking time to relax and look after yourself can have a positive impact on the way you see yourself. Treating yourself with kindness can also make you look upon yourself kindlier. Studies have found that people with higher self-esteem find it easier to deal with setbacks and are more likely to achieve goals of self-improvement.
  • Protecting mental health: By making changes to prioritize self-care can help to manage mental health issues and might even prevent them from getting worse.
  • Fostering better relationships: Happier and healthier you are, the more you can give to a relationship. This is especially important if you are a parent or career. It can be so easy to put someone else’s needs first, but you must look after your own health too.

Pharma companies also echoed that COVID-19 has boosted self-care:

As I wrote above, besides W.H.O, several global pharma majors have also recently conducted their own research studies this area, for several reasons. One such research, shared by GSK Consumer Healthcare and IPSOS on 20 July 2020, reiterated that ‘the COVID-19 pandemic has had a significant impact on people’s behavior and attitudes to self-care.’ The study also endorsed, the pandemic has impacted attitudes towards personal wellbeing and self-care. This gets reflected on the increased importance that many people are now placing on looking after their own and others’ health.

Another article, published in the  Johnson & Johnson website on September 16, 2021, emphasized the same point. The Company reiterated, self-care – a holistic and preventive way to look after one’s health and wellness – is more than a passing trend. It’s a lifestyle shift that’s here to stay – one that has only been accelerated by the COVID-19 pandemic. The paper highlighted, ‘According to one recent national survey, 80% of adults said they intend to be more mindful about practicing self-care regularly after the pandemic. And global research conducted this year found that consumers’ prioritization of wellness has jumped as much as 65% in the past two to three years.’

Recently, even Sanofi in its website acknowledged, ‘COVID-19 highlights Value of self-care as a first line of defense.’ The article added, although, ‘there has been a global trend towards wellness for some time now, but the onset of the COVID-19 pandemic has accelerated it.  It also endorsed that defensive wellness is growing exponentially with people trying to protect their own health alongside their families. So, there has been a shift in attitudes in how people are practicing self-care, especially, as face-to-face consultations with doctors are now more difficult.

Why ‘self-care’ concept got a boost during COVID-19 pandemic?

There are several reasons behind such unprecedented boost in practicing self-care within the global population. The key ones include intense and continuous public messaging by various governments in response to the COVID-19 pandemic, has emphasized the importance of self-care by manifold. Some of these self-caring activities, such as, social distancing, wearing face masks and other preventative hygiene measures, which have been pivotal in the disease control process.

The national campaigns to tackle the virus with various social measures deployed by citizens, in tandem with traditional public health interventions, like testing and contact tracing, have been widely supported by NGOs, media and key influencers in many sectors. The core message has been, staying home or working from home, and observing government guidelines is – ‘doing your bit’ for others, as well as yourself. The same was also well-articulated in a paper – ‘Self-care and health: by all, for all. Learning from COVID-19’, published by the Mitchell Institute, Victoria University, in July 2020.

 ‘Self-care’ messaging in the old and new normal – the key difference: 

Several pharma companies have tried to understand what factors prompted to accelerate the ‘self-care’ process during the pandemic, as compared to the old normal. And what is the key difference in the core messaging content. For example, Sanofi construed that the self-care messages in pre-pandemic period were generally ‘positive’ ones, such as benefits of practicing yoga and other changes in the general lifestyle activities. Whereas, during the pandemic, the message has been very different. It generally revolved round the ‘fear of the unknown’ that can jeopardize lives and livelihoods.

This factor emerged as a powerful motivator in accelerating a shift to life-saving preventative wellness – not just for self, but also for others. An overwhelming sense of uncertainty put a different perspective altogether to ‘self-care’, especially, for people with co-morbidities or pre-existing health conditions, being more vulnerable to die from COVID-19 infection.

Can pharma leverage the win-win opportunity?

A global study by  McKinsey & Company in this area, published on April 08, 2021, vindicated the increasing trend of self-care among global population. Elaborating the point, it said: ‘These days, consumers view wellness through a much broader and more sophisticated lens, encompassing not just fitness and nutrition but also overall physical and mental health and appearance.’ The Company estimated ‘the global wellness market at more than $1.5 trillion, with annual growth of 5 to 10 percent.’ If pharma marketers can leverage this win-win opportunity creatively, brand related self-care measures would also come under this market.

Leveraging increased focus on patients’ self-care:

The fact that an opportunity exists for pharma players to leverage a new opportunity in the ‘self-care’ space, creating win-win treatment outcomes for all, isn’t a new concept. Over a decade, this is being deliberated in the healthcare space. This is evident from an interesting article titled, ‘Helping patients help themselves’, published in the ‘Modern Healthcare’ on June 21, 2010. Acknowledging that “Self-management is critical,” it wrote: “The patient spends one-tenth of 1% of their time in the doctor’s office and the rest of the time on their own. Coming up with good ways to engage them and encourage them to take control and make changes is very important.”

Interestingly, another article carrying exactly the same title – ‘Helping patients help themselves’ – penned by another author, was published after more than a decade – in the ‘Reuters Event’, on November 19, 2021. This author also emphasized: ‘Self-care offers a new way for health care companies to serve patients better, globally and industry collaboration will drive faster progress.’ It reiterated: ‘There’s an opportunity here for healthcare companies to put patients even more at the center of care and to help them achieve better outcomes.’ Pharma marketers, wearing their best creative hats, will find several novel strategic ways to reap a rich harvest from this opportunity. I shall, therefore, won’t step into that area in this article.   

Conclusion:

Ongoing awareness campaigns, encouraging people to take primary ownership of their own health to prevent any serious medical interventions – both for infectious and non-infectious ailments, can be a force multiplier to protect a nation’s health.

Several ‘self-care’ practices during the pandemic like, wearing face masks, maintaining social distancing, hand washing and self-isolation to contain spread of infection, continues. In tandem, as many experts reported, more people are now using digital tools, wearables, symptom trackers – for self-care. Alongside, virtual medical consultation, home care and telehealth services, purchasing medical products and diagnostic services from e-pharmacies, digital health solutions and the likes are also increasing significantly, for the same reason.

Collectively, self-care initiatives have paid rich dividend – in varying degree, almost in every country, notwithstanding some catastrophic onslaught of the virus in many nations, including India. Otherwise, the numbers could have been worse, as many experts project. That said, as the McKinsey & Companysaid: ‘If the pandemic has taught us one thing, it’s that physical and mental health will remain a priority for millions of people across the globe for a long time to come.’ Being in the thick of this process, the drug industry, by and large, has also realized that ‘self-care’ is crucial to ensure better treatment outcomes. This, I reckon, opens a new vista of opportunity for pharma to leverage, with increased focus on most of these ‘self-care’ practices – for business excellence.

By: Tapan J. Ray

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

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

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

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

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

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

3 innovation areas to make health care better and cheaper:

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

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

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

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

Subsequent studies reinforce the point:

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

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

Changing business model concept gaining steam during Covid pandemic:

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

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

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

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

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

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

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

Some laudable past initiatives for affordable access to innovative drugs:

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

  • Abbott Laboratories – the patent holder of lopinavir and ritonavir had initially announced a tiered price of $650 in 2001 for African countries and 16 non-African least developed countries. In 2002, the Company reduced the price to $500 for these countries and in August 2009 dropped it to $440 – slightly below the lowest generic price.
  • In 2001, Novartis offered “at-cost” tiered price of $2.40 per adult treatment course for artemether-lumefantrine FDC to WHO for developing countries After 5 years when a generic version of the same was available, Novartis decreased its tiered price to $1.80, thereafter to $1.50.
  • Eli Lilly’s two key DR-TB drugs, capreomycin and cycloserine were not widely available from other suppliers even after it went off patent. In 2002, Lilly transferred the drug manufacturing technology to several generic drug companies in TB-endemic countries. Eli Lilly’s tiered price has consistently remained below the generic prices for these drugs.

More examples of voluntary licensing during Covid pandemic:

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

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

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

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

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

Conclusion:

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

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

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

By: Tapan J. Ray      

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

Creative Pharma Marketers To Unshackle Covid Fetters

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Pharma industry, just as most others, has started recognizing that the business needs to be brought back to normal, despite Covid fetters. Some early evidences suggest, a new breed of pharma marketers is refusing to get confined to Covid triggered operational limits, without breaching any prescribed safety norms.

These pacesetters no longer grapple with finding right answers to the question – when and how the brand building activities can be brought back to the old normal? Truly speaking, none has its answer, as yet. Covid has the power to strike back, anytime – anywhere, in waves, when the guards are even slightly down. Moreover, as and when vaccines will come, these may not be ‘silver bullets’ for many – throughout a lifetime, at least, in the foreseeable future.

Accordingly, these forerunners are effectively leveraging the art of turning challenges into opportunities. They are conceptualizing new business models for making path-breaking progress in contemporary purpose driven branding exercises. For all pharma marketers, I reckon, this is the moment of truth, when what you do reflects what you really are, in this area. Thus, in this article. I shall deliberate, with examples, how these creative new age pharma marketers are trying to unshackle Covid fetters.

Today’s reality on the ground: 

A number of global surveys on how patients’ have reacted to Covid-19 pandemic with reasons behind the same, are now available. One such study was conducted by Medisafe, during March and April, 2020. Some of its key findings are as follows:

  • More than half of the respondents, especially those with comorbidities, worry about getting Covid infected while accessing to in-person treatments.
  • Over 9 out of 10 respondents were practicing social distancing, as a remedial measure.
  • Consequently, they are missing doctors’ appointments, and many are opting for telehealth wherever appropriate and necessary.

In many situations, such as,  common and repetitive health issues, including some mental health conditions, virtual health care are more convenient. It has also been established during the pandemic that telehealth can deliver similar outcomes at a lower cost, than in-person visits. In addition, remote monitoring of some key health parameters, like heart rhythm, blood sugar, weight, respiratory rate, also help people control their chronic conditions better, and assist clinicians with diagnosis and treatment.

More doctors prefer telehealth, but the majority wants some in-person visits too: 

An interesting study – ‘Want Both In-Person and Virtual Visits with Sales Reps,’ published by Bain & Company on June 02, 2020, ferreted out today’s reality, in this space. It found, prior to Covid, about three-fourths of physicians preferred face-to-face engagement with sales reps. In contrast, today more of them are asking for a reduction in Rep visit frequency and more remote support or virtual approaches. Curiously, a majority still prefers, at least some in-person interaction ‘once the pandemic passes.’

Interestingly, no one seems to know, just yet, when exactly will this pandemic get over. Besides, whether or not Covid will keep coming back in waves, for an indefinite period. Or, any similar or even worse global health crisis, in future, could bring greater disruption for the industry.

Driven by such apprehensions, it is possible that more and more patients will prefer telehealth, expanding access to health care for an increasing number of people. Nonetheless, one should also take into consideration that virtual health care has also some significant limitations, especially those which may lead to serious or life-threatening conditions.

Some key limitations to overcome:

Alongside multiple advantages of telehealth, it has some significant limitations, which can’t be wished away, either. This point was also well articulated in the article – ‘Where Telemedicine Falls Short,’ published in the Harvard Business Review (HBR) on June 30, 2020. The author, who is also a primary care physician gave a number of examples in this regard. For example, in one place he wrote:

‘I have found treatable cancers multiple times in routine exams that would be impossible to replicate in the virtual world. Could a Zoom visit detect a lymph node too firm, a spleen or liver too large, or an unexpected prostate nodule (with a normal PSA)?’ The paper also emphasized: ‘Trust and face-to-face encounters are even more important for patients with complex and intertwined problems.’

Be that as it may, the task to encourage patients, even with serious ailments, for in-person consultation and examination by doctors’ in their clinics, won’t be ‘a piece of cake’ too. On the contrary, it will be rather a colossal exercise.

Why will this task be colossal?

One can get a sense of tough challenges involved in this effort from the IQVIA report titled, ‘COVID-19 Pandemic and the Impact on SEA Healthcare Market.’ Along with other areas, the study captured several details of the above area, specifically for the South East Asia (SEA), as follows:

  • Decrease in patient visits (Out-Patient): 2 out of 3 hospital doctors are experiencing >60% decrease in patient visits.
  • Extended period of time before patient load resumes to normal: ~50% of doctors think that it will take 4 to 6 months to resume normal operations.
  • Increase in prescription duration: ~25% of doctors have 2x their standard prescription duration to reduce patient visits.

The study also observed, ‘in order to reduce the risk of getting infected, patients are reducing their visits to the HCPs.’ Such an unusual situation is unlikely to be mitigated, soon, with any traditional or ‘one size-fits all’ type strategy. Particularly when Covid threat still looms large on the population. As is happening today, even after signs of waning, Covid may return in waves – for an indefinite period. Thus, innovative marketing interventions, backed by actionable insights, are essential to help overcome the fear of getting Covid infected, by both patients and doctors.

How to respond to this situation in a creative way?

The creative marketing response to overcoming the possible barriers on the way, would call for predictive rather than reactive pharma strategies. The game plan not only needs to be purpose drivenfor the marketers, but should also be perceived that way by all concerned. For example, the core purpose of marketing in this scenario, will be to provide a life-saving patient ‘service’, with win-win outcomes.

And the additional ‘service’ in this case is encouragement in-person physician visits during early symptoms of life-threatening health conditions – taking all safety precautions and overcoming ‘paranoia’ of getting infected. The win-win outcomes will include – saving lives, preventing deterioration of the disease condition, and of course, facilitation of the brand demand. The good news is some global pharma majors have already started making progress in this direction.

Promoting doctor visits during the pandemic – an example:

Leaving footprints to follow, some pharma marketers have already started creatively working on it. Let me cite a recent example of this unique initiative. This was reported by Fierce Pharma in its November 02, 2020 issue. The marketing process carries all the required ingredients for excellence, as mentioned above.

It wrote, ‘Pfizer and Bristol Myers Squibb are the latest drugmakers to join the swell of campaigns promoting doctor visits during the pandemic.’ This decision was based on data, showing many people haven’t been going to their primary care appointments for symptoms that may lead to potentially serious conditions.

This initiative is focused on three critical health conditions, namely, atrial fibrillation, deep vein thrombosis and pulmonary embolism. The rationale for selecting these three indications is, these are all treated by the partners’ anticoagulant Eliquis.

Accordingly, the BMS-Pfizer Alliance launched a campaign to raise awareness and encourage people to seek prompt medical attention. The American campaign was built around the theme – ‘Your symptoms could mean something serious, so this is no time to wait.’ In tandem, the companies also widely communicated through multiple channels that ‘Decreases in Americans’ Primary Care Visits May Lead to Late Diagnoses of Potentially Serious Conditions.’

According to reports, the net result of this creative marketing, so far, is no less than outstanding, as compared to many other pharma players operating in similar situations. ‘Eliquis’ brand sales for the first six months of 2020 topped $4.8 billion, a 21% increase over the same time period last year. Doesn’t this initiative demonstrate that creative pharma marketers can unshackle even Covid fetters?

Conclusion:

Meanwhile, as on November 08, 2020 morning, India recorded a staggering figure of 8,507,754 of Coronavirus cases with 126,162 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks. But, the threat of further spread of Covid infection, in waves, still looms large in the country.

Most scientists agree – while effective vaccines offer the best chance of reaching zero COVID-19 – eliminating the virus across much of the world, while not unthinkable, could take a significant number of years. Thus, it may be realistic for some time to focus on flattening the curve with stringent control measures, involving efficient contact tracing, testing and isolation, together with social distancing and mask wearing – till it happens, ultimately.

Meanwhile, the business must flourish, even amid a new normal. And this is, in no way, a pipe dream, but a proven reality, as we have seen above. No doubt, this calls for most pharma marketers wearing a fresh thinking cap, equipped with more cerebral power, as it were, to unshackle Covid fetters on their way – effectively.

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.

 

A New Pharma Marketing Combo Places Patients At The Center Of Business

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As discussed in several of my previous articles, most pharma players need to walk the talk on ‘patient-centricity’, coming out of prevailing high decibel lip-service. This is not an easy task, and far from being every company’s cup of tea.

Effective implementation of patient-centricity by an organization, entails understanding of behavioral science by today’s pharma marketers. Many of them, I am sure, have already studied it in Business Schools. Be that as it may, by harnessing this scientific knowledge, the insights that they will acquire on primary and secondary pharma customers, will be unique. The important cues that will come out of the insights, will help them create well- targeted strategic marketing game plans having a cutting-edge. When implemented on an ongoing basis, this will help catalyze a win-win business environment, for reaping a rich harvest over a long period of time.

In today’s article, I shall dwell on the increasing relevance of an interesting combo of behavioral science – predictive analytics and patient-centricity, for a sustainable business performance. This is especially for the millennial pharma marketers to try and implement. With blessings from the top management, this model will help them jettison – the increasingly counterproductive – ‘gratification model’ of pharma business, imbibing ‘patient-centric ones’ – that patients themselves can feel and will appreciate.

The basic requirements to make it happen:

The basic requirements of the pharma companies to make it happen is to gradually move away from its core strategy of ‘buying prescriptions’ that often happens through contentious means. No doubt, it has the power to create a temporary strong brand push. But is definitely not sustainable, as these usually go against patients’ health and economic interest.

For a sustainable demand for a pharma brand, pharma companies would need to design a strong ‘brand pull’ in the new paradigm. This would prompt drug companies acquiring deep insights on how to leave a cherishing treatment experience with the patients for the brand. This would, consequently, have a strong-positive rub-off effect on the corporate image, as well. Likewise, a doctor would also like to know, how to create similar patient-experience with his treatment, to draw more of them in the future. This is diametrically opposite to generation of demand for a brand through ‘payment to doctors for prescriptions.’

Pharma marketer’s understanding of behavioral science is necessary:

This is because, it helps to get targeted deep-stick studies done on the way pharma customers, such as doctors and patients, behave. The span of the behavioral study should commence from the onset of a patient’s search for a disease treatment process, right up to when the individual gets an ‘after treatment experience’ – good, bad or average. It is, therefore, necessary for a drug company, to become more patient-centric, rather than self-serving, for achieving the desired goals of pharma business, consistently.

This wisdom would enable pharma marketers developing the following five broad insights for being ‘patient-centric’:

  • Understanding the process of thinking of a type or a group of patients about making their treatment choices. It could often mean not going for any treatment at all, or not adhering to prescribed treatment.
  • What makes patients behave the way they do, while undergoing a treatment?
  • Understanding both mental and physical feelings of patients while suffering from certain disease conditions, for effective engagement with them.
  • What type of holistic treatment experience the patients would value most to cherish.
  • What type of treatment experience the doctors would value most to provide to patients to enhance their practice and professional reputation.

While doing so, pharma marketers would need to clearly harmonize the two areas – one pertaining to doctors, and the other involving patients. This is important for the purpose of a clear focus on a comprehensive brand strategy formulation, based on well-analyzed data.

The key point to note, however – a creative blend of behavioral science with new-age pharma marketing tools can bring a sea change in the business performance of a company, along with providing a delightful treatment experience to patients with its drugs.

Generation of a huge pool of customer behavioral data is the starting point:

The first step of making a patient-centric organization is the generation of a huge pool of data on customer-behavior dynamics. That said, making predictions on the company’s customer behavior for future outcomes of the brand performance, from this data pool, would involve the use data analytics, which for this purpose will be ‘predictive data analytics.’

The use of ‘predictive analytics’ in pharma marketing:

In my article titled, ‘Data: The New Magic Wand For Pharma Business Excellence’, published in this Blog on October 01, 2018, I discussed the importance of well targeted data-based decision-making process, across the pharma functional areas. Taking this idea forward, let me explain here the critical role that ‘predictive data analytics’ can play in acquiring insights of the trend of behavior of the customers, especially patients and doctors.

Simply put, ‘predictive analytics’ is a type of advanced analytics, which are used to get deep insights and making well-informed predictions, based on both past and current data feeds. In pharma, especially for the subject that I am discussing, it pertains to insights on doctor and patient behavior related predictions, encompassing the entire span of a disease treatment process. Skillfully executed, this will strengthen, at least, two critical success factors in the pharma business:

  • Acquiring predictable insights on the targeted customers’ behavioral trend and pattern any given time-frame.
  • With such customer insights making the organization ‘patient-centric’ for more effective engagement with its customers.

Combining the above two points, I can well say, by analyzing a huge pool of data from behavioral-science-based information – ‘predictive analytics’ helps acquire deep insights on predictable customer behavior, with high precision. These are so useful, not just for better engagement with doctors, patients and other stakeholders, but also in making the organization patient-centric, in true sense. Nevertheless, many still question - Is ‘patients centricity’ really feasible in the pharma industry?

Is ‘patient centricity’ really feasible in the pharma industry?

This question was also raised in the 2017 paper titled, “Patient Centricity and Pharmaceutical Companies: Is It Feasible?” -  published in Vol. 51(4) of the Therapeutic Innovation & Regulatory Science (TIRS). The paper captures patient-centricity as integrated measures for listening to and partnering with patients, and placing patients’ well-being at the core of all business initiatives. It represents a holistic approach to the disease management process.

The concept brand-oriented patient-centricity is not too difficult to understand. But, I reckon, the difficulty lies somewhere else. It is to fathom where and how a pharma player can predictably add differentiating value, for those patients who need a right kind of treatment. That’s why, the question of feasibility of ‘patient-centricity’ is being raised.

There is no doubt that such an effort presupposes considerable insights on patients’ behavior, alongside the requisite expertise to predict these, for different time-frames, with a great degree of precision. This not an insurmountable task, either, particularly in today’s paradigm – with state-of-the-art ‘predictive data analytic’ tools. This prompts me to believe, it is very much possible to make a truly patient centric organization, assuming that there will exist a strong will to survive in the business and prosper!

Are ‘predictive data analytics’ different from other analytics?

Yes, the following two key points make ‘predictive data analytics’ quite different from other data analytics:

  • General data analytics usually help acquire insights on the past and present.
  • Whereas, predictive data analytics help looking at near-mid and long-term future, regarding most probable customer behavior pattern and trend, with great accuracy.

Currently, with the ability to generate relevant and real-time big data pool, together with application of machine learning, data-mining and statistical modelling – predictive analytics have the power to help acquire future insights. This insight is totally data-based, sans any gut-feel. Thus, effective use of this process can enable pharma players effectively predict trends and behaviors of doctors and patients for meaningful engagement with them for their chosen brands.

Has potential to create a win-win outcome: 

To ensure a game-changing payback from this process, crafty dovetailing of the following three steps, complementing each other is critical:

  • Generate a huge pool of real-time data on doctors’ and patients’ behavior pattern, for a pre-selected time-frame.
  • With the knowledge of behavioral science, help analyze them with predictive analytics.
  • Understand from the results, the trend of behavioral dynamics of selected customers from the brand perspective.
  • Frame rewarding business strategies to create a win-win situation, involving both – the pharma players and the patients.

Some pharma players are on the ball:

One of the key reasons for imbibing patient-centricity, is the proliferation of ‘me-too’ types of brands – both patented and generics. It has started happening even in the market of high-priced oncology medicines, with not much difference in price between them.

In this situation, predictive data analytic tools can help understand multi-variable relationship between patient’s needs, their interaction with physicians, the oncologist’s prescriptions to them, type of physician-engagement of drug companies and patients’ experience before, during and after the treatment. This is not an easy task, nor all pharma companies have wherewithal of doing this, to gain brand market share, significantly.

With predictive data analytics, many pharma companies are keeping eyes on the ball, using it in different business areas, such as drug discovery. But not many of them, are using this combo-approach to make a patient-centric pharma organization. It is just a matter of time, I reckon, that global pharma will decide to move in this direction – fortified with deep pockets, but with a battered reputation, and facing a hostile pricing environment, across the world.    

Conclusion:

Customer insights, acquired through the crafty application of behavioral science, have immense potential to make sales and marketing decisions more informed, than what it is today. In tandem, it will help create a ‘worth remembering’ treatment experience for the patients with the brand used.

From this perspective, I reckon, skillful application of behavioral science to generate a huge pool of data, and their analysis with ‘predictive analytics’ will go a long way to create a truly ‘patient-centric’ organization.

When executed by a well-integrated expert team of market research, medical affairs and pharma marketing professionals, this new marketing-combo-approach has the potential to fetch a game-changing performance outcome, placing patients at the center of business. The net gain to the organization will be much more than the sum total of what each of these steps can ensue individually – remarkably enhancing corporate reputation, in tandem.

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.

More Glivec Like Deals in China and Mounting Global Challenges: Innovators poised Joining Biosimilar Bandwagon

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Pressure from the emerging markets on pricing of patented products is mounting fast. This time the country involved is China.

Recently, the Health Minister of China who stepped down last month after a seven-year stint in the top health job reportedly commented that western drugmakers will require to give hefty subsidies and forgo significant amount of profit on expensive cancer drugs, if they want access to huge market of China. He further voiced as follows:

“If the cost (of patented drugs) is too high, maybe only a few percent of patients can benefit. If we can arrange an appropriate, acceptable, affordable price, then you can have a huge market.”

‘Glivec deal’ in China: 

In the same report, it was indicated that in China Novartis ultimately agreed to donate three doses of its leukemia drug Glivec for every one sold to the government.

It is expected that many more such deals will take place in China.

The situation to get more challenging in the emerging markets: 

Many experts believe that due to high cost of patented drugs, especially biologics, negotiating hefty discounts with the Governments may be the best alternative for the innovator companies to avoid any possibilities of Compulsory Licensing (CL), like what happened to Bayer’s cancer drug Nexavar in India.

An opportunity in biosimilar drugs: 

Biologic drugs came to the international market slightly more than three decades ago, in 1980s. Growing at a scorching pace, the value turnover of these products exceeded US$ 138 billion in 2010 (IMS Health).

Launch of biologics like, Recombinant Insulin, Human Growth Hormone (HGH), Alteplase, Erythropoietin (EPOs), Granulocyte Colony Stimulating Factors (G-CSFs) and Monoclonal Antibodies (MAbs) kept fueling the market growth further.

Patent expiry of a number of biologic drugs over a period of next five years, especially in areas like, various types of cancer, diabetes and rheumatoid arthritis, besides many others, will help opening a huge window of opportunity for the global biosimilar players, including from India, to reap a rich harvest.

Global innovators joining the bandwagon: 

After a dream-run with high priced patented drugs for a reasonably long time, now stung by the current reality in various developed and emerging markets and factoring-in the width/depth/robustness of their own research pipeline, many global players have started taking a hard look at the emerging opportunities offered by biosimilar drugs.

Moreover, high price of original biologic drugs, cost containment pressure by various Governments, encouragement of generic prescriptions, large number of such drugs going off patent and growing demand of their low cost alternatives across the world, are making biosimilar market more and more lucrative from the global business perspective to all interested players, including from India.

According to Bloomberg Industries (2013), during the next six years biologic drugs with a total annual sales turnover of US$ 47 billion in 2012, will go off patent.

Sniffing opportunities for business growth, as stated above, many hard-nosed large research-based global pharmaceutical companies, currently fighting a challenging battle also in the ground of a tougher ‘patent cliff’, have started venturing into the biosimilar market, that too in a mega scale.

Some of them have already initiated developing biosimilar versions of blockbuster biologics, as reported below:

Originator Product Indication Biosimilar development by:
Roche/Genentech Rituxan Rheumatoid arthritis Boehringer Ingelheim
Roche/Genentech Herceptin, Rituxan Breast Cancer, Rheumatoid arthritis Pfizer
Roche/Genentech Rituxan Non-Hodgkin’s lymphoma Novartis
Johnson & Johnson Remicade Rheumatoid arthritis Hospira

Source: Bloomberg BusinessWeek

Thus, I reckon, continuous quest for development of cost-effective alternatives to high-priced biologic medicines would keep on propelling the growth of biosimilar drugs, across the world.

Glivec maker Novartis fought a court battle to launch the first ‘Biosimilar drug’ in America: 

In mid-2006, US FDA approved its first ‘biosimilar drug’-Omnitrope of Sandoz, the generic arm of the Glivec maker Novartis, following a Court directive. Omnitrope is a copycat version of Pfizer’s human growth hormone Genotropin. Interestingly, Novartis had also taken the US FDA to court for keeping its regulatory approval pending for a while in the absence of a well-defined regulatory pathway for ‘biosimilar drugs’ in the USA at that time.

More interestingly, having received the US-FDA approval, the CEO of Sandoz (Novartis) had then commented as follows:

“The FDA’s approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like, Omnitrope available for healthcare providers and patients worldwide”.

Biosimilar market started shaping-up:

Internationally most known companies in the biosimilar drugs space are Teva, Stada, Hospira and Sandoz. Other large research based global innovator pharmaceutical companies, which so far have expressed interest in the field of biosimilar drugs, are Pfizer, Astra Zeneca, Merck and Eli Lilly.

Following are examples of some biosimilar drug related initiatives of the global players as the market started developing:

  • Merck announced its entry into the biosimilar drugs business on February 12, 2009 with its acquisition of Insmed’s portfolio for US$ 130 million. The company also paid US$ 720 million to Hanwha for rights to its copy of Enbrel of Amgen.
  • Samsung of South Korea has set up a biosimilars joint venture with Quintiles to create a contract manufacturer for biotech drugs.
  • Celltrion and LG Life Sciences have expressed global ambitions in biosimilar drugs.
  • Some leading global innovator biotech companies also like, Biogen Idec and Amgen have reportedly been mulling entry into biosimilar market.

According to Reuter (June 22, 2011), Merck, Sandoz, Teva and Pfizer are expected to emerge stronger in the global biosimilar market, in the years ahead. 

Why is still so low penetration of lower cost biosimilar drugs?

Although at present over 150 different biologic medicines are available globally, just around 11 countries have access to low cost biosimilar drugs, India being one of them. Supporters of biosimilar medicines are indeed swelling as time passes by.

It has been widely reported that the cost of treatment with patented biologic drugs can vary from US$ 100,000 to US$ 300,000 a year. A 2010 review on biosimilar drugs published by the Duke University highlights that biosimilar equivalent of the respective biologics would not only reduce the cost of treatment, but would also improve access to such drugs significantly for the patients across the globe. (Source: Chow, S. and Liu, J. 2010, Statistical assessment of biosimilar products, Journal of Biopharmaceutical Statistics 20.1:10-30)

Now with the entry of global pharma majors, the biosimilar market is expected to get further heated up and develop at a much faster pace with artificial barriers created by vested interests, if any, being removed.

Recent removal of regulatory hurdles for the marketing approval of such drugs in the US  will indeed be the key growth driver.

Other growth drivers:

According to a study (2011) conducted by Global Industry Analysts Inc., besides recent establishment of the above regulatory guidelines for biosimilars in the US, the key growth drivers for global biosimilar market, will be as follows:

▪   Patent expiries of blockbuster biologic drugs

▪   Cost containment measures of various governments

▪   Aging population

▪   Supporting legislation in increasing number of countries

The business potential in India:

The size of biotech industry in India is estimated to be around US$ 4 billion by 2015 with a scorching pace of growth driven by both local and global demands (E&Y Report 2011).

The biosimilar drugs market in India is expected to reach US$ 2 billion in 2014 (source: Evalueserve, April 2010).

Recombinant vaccines, erythropoietin, recombinant insulin, monoclonal antibody, interferon alpha, granulocyte cell stimulating factor like products are now being manufactured by a number of domestic biotech companies like, Biocon, Panacea Biotech, Wockhardt, Emcure, Bharat Biotech, Serum Institute of India and Dr. Reddy’s Laboratories (DRL), besides others.

DRL is the largest biosimilar player in India with an impressive product portfolio. Reditux of DRL is the world’s first Biosimilar monoclonal antibody, which is a copy version of Mabthera/ Rituxan of Roche and costs almost 50 percent less than the original brands.

Some of the Biosimilar products of the Indian Companies are as follows:

Indian Company

Biosimilar Product
Dr Reddy’s Lab Grafeel, Reditux, Cresp
Intas Neukine, Neupeg, Intalfa, Epofit
Shantha Biotech/Merieux Alliance Shanferon,Shankinase,Shanpoietin
Reliance Life Sciences ReliPoietin, ReliGrast, ReliFeron, MIRel
Wockhardt Wepox, Wosulin
Biocon Eripro, Biomab, Nufil, Myokinase, Insugen

(Source: Stellarix Consultancy Services)

The cost of development of Biosimilars in India is around US$ 10-20 million, which is expected to go up, as “Biosimilar Guidelines” are now in place for marketing approval of such products in India.

The ultimate objective of all these Indian companies will be to get regulatory approval of their respective biosimilar products in the US and the EU, either on their own or through collaborative initiatives.

Indian players making rapid strides:

As stated above, biosimilar version of Rituxan (Rituximab) of Roche used in the treatment of Non-Hodgkin’s lymphoma has already been developed by DRL in India. It also has developed Filgastrim of Amgen, which enhances production of white blood cell by the body and markets the product as Grafeel in India.

Similarly Ranbaxy has collaborated with Zenotech Laboratories to manufacture G-CSF.

On the other hand Glenmark reportedly is planning to come out with its first biotech product soon from its biological research establishment located in Switzerland.

Indian pharmaceutical major Cipla reportedly has invested around US$ 60 million in 2010 to acquire stakes of MabPharm in India and BioMab in China and is planning to launch a biosimilar drug in the field of oncology by 2013.

Another large pharmaceutical company of India, Lupin signed a deal with a private specialty life science company NeuClone Pty Ltd of Sydney, Australia for their cell-line technology. Lupin reportedly will use this technology for developing biosimilar drugs in the field of oncology, the first one of which, will reportedly be launched in India by 2013.

The global Market:

In 2011 the turnover of Biologic drugs increased to over US$ 175 billion in the total market of US$ 847 billion. The sale of Biosimilar drugs outside USA exceeded US$ 1 billion.

Six biologic drugs featured in the top 10 best selling global brands in 2012 with Humira of AbbVie emerging as the highest-selling biologics during the year.  Roche remained the top company by sales for biologics with anticancer and monoclonal antibodies.

According to IMS Health report, by 2015, sales of biosimilars are expected to reach between US$ 1.9 – 2.6 billion. The report also states that this market has the potential to be the single fastest-growing biologics sector in the next five years.

Cost of biosimilar development in the developed markets:

The process of developing a biosimilar drug is complex and requires significantly more investment, technical capabilities and clinical trial expertise than any small molecule generic drug. As per industry sources, average product developmental cost ranges between US$ 100 and 250 million in the developed markets, which is several times higher than the same associated with development of small molecule generics, ranging around US$ 1to 4 million.

All these factors create a significant market entry barrier for many smaller players with similar intent but less than adequate wherewithal.

Even higher market entry barrier with ‘second generation’ biosimilar drugs:

Emergence of second generation branded biosimilar products such as PEGylated products and PegIntron (peginterferon alpha), Neulasta (pegfilgrastim) and insulin analogs have the potential to reduce the market size for first generation biosimilar drugs creating significant entry barrier.

Negotiating the entry barriers:

As stated above, the barriers to market entry for biosimilar drugs are, in general, are much higher than any small molecule generic drugs. In various markets within EU, many companies face the challenge of higher development costs for biosimilar drugs due to stringent regulatory requirements and greater lead-time for product development.

Navigating through such tough regulatory environment will demand different type of skill sets, especially for the generic companies not only in areas of clinical trials and pharmacovigilance, but also in manufacturing and marketing. Consequently, the investment needed to take biosimilar drugs from clinical trials to launch in the developed markets will indeed be quite significant.

The future potential:

According to an IMS Health study, the emerging markets will drive biosimilar market growth with significantly more number of patients. The report estimates that over a period of time US will emerge as the number one global biosimilars market.

By 2020, emerging markets and the US are expected to register a turnover of US$11 billion and US$ 25 billion representing a share of 4 percent to 10 percent of the total global biologics market, respectively.

The report estimates that overall penetration of biosimilars within the off-patent biological market will reach up to 50 percent by 2020, assuming a price discount in the range of 20 to 30 percent.

Is 12 years exclusivity in the US a significant entry barrier?

In the US, the innovator companies get 12 years exclusivity for their original biologic drugs from the date of respective marketing approvals by the USFDA.

The BPCI Act clearly specifies that applications for ‘biosimilar drugs’ to the USFDA will not be made effective by the regulator before 12 years from the date of approval of the innovators’ products. In addition, if the original product is for pediatric indications, the 12-years exclusivity may get an extension for another six months.

The key point to note here is, if the USFDA starts its review process for the ‘biosimilar drugs’ only after the ’12 year period’, the innovator companies will effectively get, at least, one additional year of exclusivity over and above the ’12 year period’, keeping applicants for ‘biosimilar drugs’ waiting for that longer.

Conclusion:

As stated above, with around 40 percent cost arbitrage and without compromising on the required stringent international regulatory standards, the domestic ‘biosimilar’ players should be able to establish India as one of the most preferred manufacturing destinations to meet the global requirements for such drugs, just as small molecule generic medicines.

With experience in conforming to stringent US FDA manufacturing standards, having largest number of US FDA approved plants outside USA, India has already acquired a clear advantage in manufacturing high technology chemical based pharmaceutical products in the country. Now with significant improvement in conformance to Good Clinical Practices (GCP) and honed skill sets in the field of biologics, Indian biosimilar players are clearly poised to catapult themselves to even a higher growth trajectory, either on their own or with appropriate collaborative arrangements with the international partners.

Thus, the initiatives of joining the biosimilar bandwagon by the hard-nosed research based global players, I reckon, will ultimately get translated into a win-win advantage for India in the rapidly evolving pharmaceutical space of the world.

Besides, like what they had to do in China, working with the Government to put in place a robust and win-win mechanism of ‘Price Negotiation for Patented Drugs’ in India could augur well for the global players of pharmaceutical and biologic drugs. This mechanism may also help putting forth even a stronger argument against any Government initiative to grant CL on the pricing ground for expensive patented drugs in India.

With all these developments, patients will be the ultimate winners having much greater access to both innovative medicines and biosimilar drugs than what they have today, fetching a huge relief to all right thinking population in the country.

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.