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Expand Market Share Unleashing Digital Health Potential For All

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“Advancement in digital health is currently restricted mainly to economically and socially privileged populations. Those having access, resources and basic digital skills, are reaping disproportionate benefits from the technology and other associated infrastructure available for this purpose. Unfortunately, underserved population, mostly in rural hinterland and in some urban areas, still do not have much access to this technical advancement in the healthcare space. Ensuring affordable access to “Digital Health” in digital India, would help augment quality healthcare support with equity, to all in the country.” I wrote the above in my article on digital health, published in this blog, way back on March 09, 2015.

About two years down the line from that date, the IQVIA report – ‘The Growing Value of Digital Health’, published on November 07, 2017, also reported: ‘The impact of Digital Health on patient care is accelerating with the increasing adoption of mobile health apps and wearable sensors.’ It highlighted, among others, the following important points:

  • Health-related mobile applications available to consumers nearly doubled from the number available just two years ago, with increasing clinical evidence on app efficacy – supported by 571 published studies in 2017.
  • The use of Digital Health apps with proven reductions in acute care utilization include, diabetes prevention, diabetes management, asthma, cardiac rehabilitation, and pulmonary rehabilitation.
  • ‘Digital health’ signals a high potential in reducing overall health care cost for both patients and the providers – reducing huge burden on the health system, significantly.
  • Efforts by patient care organizations to fit ‘’Digital Health tools into clinical practice have progressed with 540 current clinical trials in the U.S. incorporating these tools, and an estimated 20% of large health systems shifting from pilot ‘Digital Health’ programs to more full-scale rollouts.
  • However, despite progress to date, several barriers still exist to widespread adoption by patient care institutions, and only an intermediate level of adoption has yet occurred.

In this article, I shall explore – how pharma marketers can expand their respective brand market share by unleashing the full potential of digital health, for all, and equitably, while formulating their marketing strategies of the new normal.

Digital health accelerated effective response to COVID-19 challenges:

Never has extensive operational overhaul been more urgent in health care than in the current climate of the COVID-19 pandemic – emphasized the article on ‘Digital health during COVID-19’, published in the February 2021 online issue of The Lancet (Digital Health). The paper underlined – the urgency of the pandemic prompted new models of patient treatment, providing medical professionals tools to respond effectively to the unprecedented crisis, with the advances in digital health.

However, the authors cautioned, ‘to ensure sustained adoption, it is necessary to not assume that digital solutions will naturally assimilate into clinical practice, and instead adopt participatory approaches that regularly involve stakeholders.’ Meanwhile, a confused signal is causing delay in the speedy adoption of digital health.

Is a confused signal delaying speedy adoption of digital health?

As Covid vaccination process gaining steam, the pandemic, apparently, is coming under control in many places of the world, just as it is in India. Alongside, several optimistic health care facilitators, providers and even regulators are probably awaiting the old normal to return – especially, F2F customer services.

Whereas, the above The Lancet (Digital Health) study finds – the clinical demand for digital services are gradually picking up – mostly because of the sudden surge in patient demand during the pandemic. Intriguingly, amid this situation, weak governance of digital technologies and platforms, is increasing health inequities and compromising human rights, which I wrote in my article on digital health, published in this blog, on March 09, 2015.

Weak governance of digital health results, increasing health inequities:

That weak governance of digital technologies and platforms, is increasing health inequities, was reiterated by yet another contemporary article titled – ‘Digital technologies: a new determinant of health,’ published in the November 2021 issue of The Lancet (Digital Health).

The article revealed, ‘The Lancet’ and ‘Financial Times’ Commission on governing health futures 2030’ has made important recommendations for successful integration of digital technologies in health. The bottom line of which is, weak governance of digital technologies is causing health inequities and compromising human rights. The study also emphasized, the future governance of digital technologies in health care ‘must be driven by the public purpose, not private profit’.  

Points to ponder for pharma marketers:

As iterated in the article of the November 2021 issue of The Lancet (Digital Health), the following facts needs to be considered by all, especially I reckon, by astute pharma marketers:

  • The COVID-19 pandemic has caused massive disruptions within health care, both directly as a result of the infectious disease outbreak, and indirectly because of prompt public health measures to mitigate against transmission.
  • This unprecedented disruption has caused rapid dynamic fluctuations in demand, capacity, and even contextual aspects of health care.
  • Therefore, the traditional face-to-face patient–physician care model has had to be re-examined in many countries, including India.
  • To rapidly tide over the crisis, and thereafter to avoid similar possible situations in the future, digital technology and new models of care are being rapidly deployed to meet the challenges of change, triggered by the pandemic.
  • The new models include remote digital health solutions such as telehealth, artificial intelligence – decision support for triaging and clinical care, and home monitoring of several ailments.
  • Operationalizing these new models will be based on the choice of technology support, clinical need, demand from patients, and manpower availability – ranging from pre-hospital to out-of-hospital models, including the hub-and-spoke model.

Conclusion:

It is widely believed today, the pan-industry shift toward digital health of different types is here to stay, in varying degree, though, and accelerate further for several strategic reasons. These include, adding more flexibility in attaining greater efficiency and effectiveness for customer engagement, and patient-perceived brand value delivery to them.

That said, as I wrote before, customer engagement may call for a hybrid business model of virtual and in-person F2F engagements. However, going back to the old normal of in-person F2F engagements for all doctors could probably be a far cry. Similarly, the initial success of e-customer engagement is unlikely to replace in-person and in-clinic F2F engagements of sales reps completely.

From the above perspective, I reckon, pharma marketers may now wish to expand their brand market share, significantly, by unleashing the full potential of digital health for all, and equitably, particularly, in the new normal.

However, in that process, they need to be vigilant for not deviating from the key purpose of digital health for the end users. This must reach across all socioeconomic strata, regardless of patient demographics or their geographical locations. It’s, no doubt, easier said than done, but has to happen – for the sake of health-equity - augmenting healthcare for all 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.

A Game-Changing Non-Covid Drug Approval In the Pandemic Milieu

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Amid high decibel deliberations on Covid-19 pandemic, something similar to groundbreaking happened – involving Biosimilar drugs, in just a couple of months ago. On July 28, 2021, in the Eldorado of the pharma industry, the US-FDA approved  the first ‘interchangeable’ biosimilar drug, for wider access to modern and much affordable treatment of diabetes. This is expected to open new vistas of opportunity for biosimilar drugs, in general, across the world.

The development is even more interesting, as the product named Semglee belongs to India’s largest biopharmaceutical company - Biocon Biologic. It’s an ‘interchangeable’ biosimilar insulin glargine, referencing Sanofi’s, reportedly  the second best-selling product in 2020 - Lantus. Notably, the Biocon product was launched in 2020 without the ‘interchangeability’ designation.

Although, the patent of this long-acting insulin (glargine) – used to treat diabetes type I and II, expired during 2015, in 2020 also Lantus generated some 2.7 billion U.S. dollars worldwide. Many envisage, the approval of this first ‘interchangeable’ biosimilar insulin glargine will foster stronger competition in the insulin market, which is currently dominated by a handful of brands, like Lantus – and characterized by their stubbornly high prices.

In today’s article, I shall focus on what it means to pharma marketers for greater market access to ‘interchangeable’ biosimilar drugs.

What ‘interchangeability’ really means:

As I wrote in my article on July 31,2017, there are two key barriers to improving patient access to biosimilar drugs, and one of which is the issue of their ‘interchangeability’ with original biologic drugs. It means, besides being highly similar, a biosimilar drug would require indisputable clinical evidence – that it gives the same result to patients, just as the original biologic medicine.

Thus, lack of the ‘interchangeability’ designation makes many physicians hesitant to switch, for all those existing patients who are on expensive original biologic drugs, to less expensive available biosimilar alternatives. Only new patients in that case, are prescribed biosimilar drugs, sans ‘interchangeability’ label from the drug regulator, especially in the US.

Overcoming a tough barrier to biosimilar market growth:

This was echoed by another article on ‘Interchangeability’ of biosimilars, published in the Pharmaceutical Journal on July 22, 2020. It wrote, ‘One of the hurdles in the adoption of biosimilars is the lack of interchangeability with reference biologics.’ While interchangeability is an important issue for doctors, ‘different definitions and regulatory frameworks that exist in the United States, Europe and other jurisdictions add to the complexity.’

What the ‘interchangeable’ designation of Semglee will really mean, in terms of affordability to patients, was lucidly explained in an article, published in the AJMC – the center for Biosimilars – on July 29, 2021. It underscored: ‘An interchangeable designation means that Semglee can be substituted for Lantus automatically by pharmacists without physicians’ permission.’ As reported, Semglee will cost nearly 3 times less than the list price of Sanofi’s Lantus, which in 2019 clocked in at $283.56 for a single vial and $425.31 for a box of five pens, in the US.

Are interchangeable biosimilars superior to other biosimilars?

The ‘interchangeable’ designation is not meant to suggest that such biosimilars are superior to ones without this label. However, to obtain the ‘interchangeable’ designation, biosimilar manufacturers are required to perform ‘switching studies.’ These provide evidence that patients who are using originator’s biologic drug, when switch to a comparable biosimilar, do not experience higher rates of adverse events or decreased efficacy. The same has also been clearly explained in the AJMC article of July 29, 2021, as mentioned above.

But, if marketed well, ‘interchangeable’ biosimilars can provide a cutting edge to encourage consumers to switch to the less-expensive ‘interchangeable’ versions of the original higher priced biologic drugs. Consequently, more economical ‘interchangeable’ biosimilars would carve out a larger market share, creating a win-win situation. For patients, it will expand affordable access to biologic drugs- and for the company increased revenue from the expanding biosimilar market, as several studies point out.

Expanding biosimilar market:

According to the IQVIA report of March 04, 2021, the global biosimilars market currently shows double-digit growth and is expected to maintain a similar level of uptake in the coming years. This will be driven by the rising incidence of chronic diseases and the cost-effectiveness of biosimilars, especially as more stringent cost-containment measures are likely – post COVID-19 pandemic.

The paper concluded, biosimilars will continue to register impressive growth in their market share, aided by patent expiries and regulatory improvements which will permit easier and more rapid market access. Many pharmaceutical companies – having witnessed this trend, are now preparing to leverage the biosimilar opportunity. However, marketing large molecule biosimilar drugs will not be quite the same as marketing small molecule generics. 

Estimated savings to patients with biosimilars – in Covid-19 context:

As the IQVIA Institute estimates, over the next five years biosimilars could globally contribute a cumulative $285 billions of savings to patients and payers. To put this in context, it says, over the same period, around $150 billion will be spent on COVID-19 vaccines. According to a senior IQVIA official, as quoted by Reuters Events of July 2, 2021: “The five-year savings from biosimilars could almost double the amount of incremental spending that will be going out to get everybody vaccinated around the world.”

Going by the IQVIA data, biosimilars are between 20% and 50% more affordable. And this is especially at a time when affordability drives a lot of healthcare - sustainability that has emerged as a major issue during the pandemic.

Conclusion:

Currently, in many countries of the world, alongside Covid vaccination drive in top gear, creation of a disruptive pandemic-specific – a robust health infrastructure for the future, is yet to be in place. More importantly, public health facilities, especially in India, are still struggling hard to meet affordable health care needs of patients – sans restrictions or apprehensions of getting infected by Covid-19.

Against this backdrop, the very first approval of an ‘interchangeable’ biosimilar drug, in the Eldorado of pharma business – the US, brings a new hope to many patients, in 2021. An expectation of reducing their healthcare burden, significantly. This will happen, as the prescribers muster enough confidence to advise patients switching from highly expensive original biologic to more affordable ‘interchangeable’ biosimilar drugs, as and when these are launched.

In tandem, with this growing new confidence, others – even ‘non-interchangeable’ biosimilar drugs, will be able to deliver more value being, besides greater affordability – wider access to sustainable-treatments for patients.

This comes, possibly with a caveat. Biosimilar drug marketers will need to chart a new marketing frontier, without holding on to their pre-covid strategies – especially for large molecule biosimilar drugs.

From this perspective, the US-FDA’s regulatory approval of the first ‘interchangeable’ biosimilar insulin to Sanofi’s high-priced Lantus, carries a game-changing potential in the biosimilar drug market, for astute pharma marketers to leverage.

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.

Unleashing Pharma’s New Potential In Changing Market Dynamics

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Several pharma majors have started pondering in this space. This is evident from several recent developments, both in India, and also in other places of the world. One such articulation can be heard from the very top of the domestic pharma industry, which could be a pacesetter for many others.

The founder and Managing Director’s Message of India’s top pharma company – Sun pharmaceuticals, was released to the media on June 02, 2021. This speech is a part of the company’s Annual Report 2019-20. It is indeed interesting from overall pharma business operations’ perspective in India amid Covid-19 pandemic. It is also in sync with what many of his global counterparts have also expressed in recent times. To give a sense of Sun Pharma Chief’s reading and understanding of the fast-changing business dynamics, I am quoting below a few critical points of his above message:

  • There is a gradual realization that the COVID-19 virus is here to stay and that all of us will have to learn to coexist with the virus till an effective treatment or vaccine becomes available.
  • There will be far-reaching changes in the way in which organizations are likely to operate going forward.
  • Consumer behavior and consumption patterns are also likely to change due to the global pandemic.
  • Social distancing and maintaining individual hygiene (like using masks and hand sanitizers) have become imperative.
  • Work-from-home (WFH) option has been exercised by most organizations for certain functions and there is a likelihood that it will continue for some more time till the viral infection comes under control.
  • There is a possibility that WFH may become the new-normal for certain categories of corporate work force even after COVID-19 comes under control.
  • Also, there is a higher focus on automation, digitalization as well as an increased dependence on analytical tools for decision making.

Overall, in the global pharma and biotech arena, one can now witness a varied response to opening-up – some quite bold, others are flexible and cautious – as the scenario unfolds. In this article, I shall dwell on the importance of framing a well-thought-out plan, with clearly stated Plan B, C and D in this area, to prevent any business opportunities to slip by due to delayed action.

Key questions to answer – what to open and when to open:

It goes without saying that remote working or WFH for all pharma employees can’t remain in-force for any indefinite period. It will mostly depend on two critical drivers, mainly to avoid any reckless decision with grave consequences. One – how fast several – reasonably strong preventive measures, such as, vaccinations, can provide a reasonable herd immunity to most people around. And also, how most other similar businesses successfully start carrying out their commercial operations in the same environment.

Pharma players would then need to have a clarity on the business functions where selective personal presence of the qualified staff is necessary, as no extent of technological interventions can compensate it. Then follows the question, when to start opening – without being reckless and following all prescribed Covid related health norms. The answer to these questions should be addressed along with Plan B, C and D ready – just in case something doesn’t work out or because of competitive reasons.

To elaborate this point, let me first give an example of what an Indian tech behemoth is planning to get back some employees in the workplace, based on a sophisticated digital model. Thereafter, we will have a glimpse on how several pharma and biotech players are planning in this space. The basic assumption is – the grand show must go on – with collective scientific learnings on how to coexist with the virus, for an indefinite period, if inevitable.

Integrated digital plan to get back more employees at the workplace by TCS: 

Lilly, Amgen, PfizerAs reported on June 02, Tata Consultancy Services (TCS) are working on a plan to get back more employees to the workplace. The tech giant is focusing more ‘on increasing talent fungibility as global clients increasingly require associates with niche skills to be deployed on projects at short notices.

Thus, to evaluate how it will get a certain percentage of people back, TCS has drawn up a risk assessment model, Intelligent Urban Exchange (IUX). To effectively address the new requirements for employees’ safety, regulatory compliance, and operational efficiency, the company has devised this system. It will help TCS to get real-time insights that will help restore operations and ensure safety, while becoming nimbler and more resilient in the new normal.

What some global companies are planning now:

One will witness a mixed approach of global pharma players to get back employees at the workplace, soon. This will be evident from a few examples, as below.

A Bloomberg report on April 27, 2021, highlighted: ‘As vaccine drives ramp up and open the possibility of a return to the office, a growing number of companies have pointed to a continued role for remote work — and less of a need for pricey office space.’ It quoted Novartis CEO saying: ‘“We’ve all learned from the pandemic that we can work from home and work from the office, and it will always be a combination going forward.”

Thus, in Novartis, “hybrid-based working environment” – at-home and in-office work, will persist for the long term – extending beyond the pandemic. The Company CEO also reiterated: “We think this is the future.” The flexibility should allow Novartis to “access talent pools we would not have been able to access in the past,” he believes.

Similar approach, but with specific dates for returning to the workplace: 

By an open announcement on Linkedin, the Chairman and CEO of Eli Lilly declared the Company’s plan at the current stage of Covid pandemic. He said: “More than a year later, I’m pleased to say that we’re actively planning Lilly’s return to our workplace in downtown Indianapolis, and other facilities around the world.”

He further said, on June 1, 2021, Lilly will begin reopening their Indianapolis offices, inviting 25 percent of our workforce back – with masking and distancing indoors, and a requirement for vaccination. Barring a change in the steady downward case rate in the community, the Company will then open to all Indianapolis-based employees on July 12, 2021.

The company’s new work model will be based on the requirements for each job. Some employees will be on site all the time, others most of the time, and some will have even more flexibility. As ‘individual work’, and some ‘transactional work’, is easier done remotely, employees in those roles can choose that option in consultation with their supervisor. But collaboration, innovation and learning are best done in-person at the Company facilities, the Chairman and CEO said.

He reiterated, Lilly is not taking these steps casually, but based on a data-based approach, and will continue to do so. If external factors change, Lilly will adapt. In other countries, the Company offices will continue to follow local guidelines and open as they are allowed based on local circumstances, the Company clarified.

More remote working being planned by many other global majors:

According to another report of May 07, 2021, many other global pharma and biotech majors are now planning in favor of long-term remote working for several critical business than ever before. For example, on May 07, 2021 Amgen announced that the Company will make working from home a permanent policy for much of its international workforce, including locally.

It said, “Most of our employees who are currently working remotely will continue to do so for a majority of their time, even after the pandemic ends. Our intent is to create a more flexible environment that intentionally combines the benefits of remote and in-person working.” The statement further added. “We are not initiating any changes to our Thousand Oaks campus at the time. Though some staff may come to campus less frequently.”

As reported on April 27, 2021, Pfizer has put its large Philadelphia-area campus up for sale, as it considers the future of work. According to the company, as revealed by Fierce Pharma, “The decision to do so is primarily being driven by the company’s evolving – flexible working model, providing employees with greater flexibility to work remotely while still maintaining the ability to connect and collaborate regularly on-site.”

Conclusion:

It’s over a year of business disruptions within the pharmaceutical industry, at varying intensity and in different phases, though. For example, after more than a year since the pandemic hit India, Covid 2.0 has, reportedly, pushed up Indian pharmaceutical sales to a new high. It recorded an exponential growth of 59% year on year in April 2021, against 16 per cent – year on year in March 2021. This is obviously an outlier and is apparently unsustainable. Thus, for a sustainable good growth with greater certainty, Indian pharma players would require working out a well-researched digital blueprint of the future working framework of business operations with ‘what if’ options.

As has been revealed, remote working, wherever it makes robust business sense, will help getting hard-to-reach talent pools regardless of geography. This opportunity needs to be leveraged. However, it’s also a fact that for various reasons, everyone may not be too comfortable to work from home. Thus, the future work plan may call for a balanced and employee specific approaches.

Which is why, the process will require in-depth analysis of key functions where the personal presence of qualified staff is necessary, mainly because, no extent of technological interventions can compensate the human presence. Then follows the question – when to start opening in a responsible way – following all prescribed Covid related health norms. A representative pilot trial may help in this area.

Some of the key factors to consider will include speed of getting the staff vaccinated. Besides, arrangement for quick identification of breakthrough Covid infections among staff through quick tracing, testing, and provisions for appropriate hospitalization, if necessary, need to be put in place. Thus, I reckon, it’s time for the domestic pharma companies to diligently plan for unleashing the new potential of the respective organizations – amid the pandemic-triggered changes in market dynamics.

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.

 

 

With Changing Customer Behavior Pharma To Leverage AI For Better Engagement

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More than 55 million doses of Coronavirus vaccines were administered in India, reportedly, at the beginning of the last week of March 2021, in what is the world’s biggest inoculation drive. Notably, amid this mega initiative, the news media simultaneously reported that ‘India is facing a second wave of coronavirus because it let its guard down too soon.’ I also reiterated in my article of November 16, 2020 that in the thick of ‘Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard.’

From the pharmaceutical industry perspective – as I had written on July 06, 2020, in the midst of this pandemic, there appears to be a break in the clouds that pharma should effectively leverage. There isn’t an iota of doubt that Covid pandemic, for-all-practical-purposes, has propelled healthcare into a virtual world, primarily for survival of business, maintaining the continuity.

Most pharma players, especially in the sales and marketing domain, either were not or, were using e-marketing, in a selective way, as a key strategic tool in their brand prescription generation process. The pace of this shift in the digital space is now getting accelerated to more than neutralize the long-term impact of unprecedented business disruptions that overwhelmed the industry, last year.

Interestingly, a large number of pharma marketers weren’t focusing much beyond syndicated retail and prescription audit data, in the old normal. Whereas, to make digital strategies work effectively during rapidly changing customer behavior and business environment, ‘customer centricity’ is no longer an option today. It’s rather a key business success factor for effective customer engagement, in the prevailing environment. Thus, unlocking the ‘Herculean Power’ of targeted data of many types and genre, is a pre-requisite for acquiring deep insight in this area, while moving in this direction.

Alongside, comes the need to unleash the power of Artificial Intelligence (AI) to ensure pinpoint accuracy in targeted strategy formulation for the same. Well before Covid struck, I wrote on April 01, 2019 – ‘A New Pharma Marketing Combo That Places Patients At The Center of Business,’ flagging a slowly emerging need. Covid, unexpectedly, has provided a strong tailwind to it, increasing its urgency manifold in the new normal.

Consequently, pharma marketers should have, at least, a working knowledge in this area – such as ‘machine learning’ and other analytics-based processes of AI that can help them enormously. In this article I shall discuss, why it is so important for today’s astute pharma marketers to hone their knowledge in this area for making a strategic shift towards ‘real-life’ Patient-Centricity. No wonder, why top pharma leaders now consider this transformation so critical for pharma strategy formulators, to acquire a cutting-edge in the digital marketing warfare.

Patient needs aren’t really at the center of a business strategy, today:

Despite so much hype on patient-centricity – in a true sense, patient-expressed needs aren’t generally placed at the center of a business strategy, as on date, unlike most non-pharma companies. That pharma players, by and large, don’t have a robust online feedback mechanism in place to capture ‘patient-experience’ with medications – directly from patients, vindicates the point.

As I reiterated in my article of March 21, 2021: ‘Measuring patient-experience has always been an integral part, virtually of all types of sales and marketing using digital platforms. We experience it almost every day, such as, while buying a product through Amazon, buying grocery items through D-Mart, scheduling a doctor appointment through Practo, buying medicines through PharmEasy, or even for availing a service through Urban Company.’

Thus, patient-experience, in their own words, with prescribed medications, is generally expressed to the physician, if at all. The process, generally, doesn’t get extended to drug companies’ strategy formulators for taking a patient-centric amendment, wherever needed.

However, assuming that doctors would convey the same to concerned medical representatives, it becomes a third hand (patient-doctor-Rep-Company) feedback, with commensurate distortions in each verbal transfer of communications. The outcome of this strategic gap has been captured in several research studies.

Outcomes of absence of online direct ‘patient experience’ feedback system:

Let me elaborate this point by quoting an example from a contemporary research in this area. This study was conducted by DrugsDisclosed.com in August 2020 with a total of 3,346 patients all taking medicine on a daily basis – aged between 18 and 80. The key findings are as follows:

  • 72% of patients feel ignored by pharma companies.
  • 76% don’t trust advice from them.
  • 81% feel that drug players influence prescribing decisions.
  • 63% would like to give product feedback to directly to companies.
  • 69% find their medication effective.
  • 81% feel their medication is needed.
  • 77% feel confident with their medication.
  • 82% don’t feel bothered by side effects from their medicine.
  • 73% take the medicine as agreed with their doctor.
  • 74% feel that the benefits of their medication outweigh the disadvantages.

The study concluded – the above insights show the need for patients’ voices to be heard by the pharma companies. If medicines are to solve health problems for billions of people who need them, listening to real-life patient-experience with medication, is the key to unshackle the full potential of the world’s health systems. Thus, pharma companies need to directly listen to what patients experience and express with their medicines. It will help them earn customer-trust and greatness in business, while gaining new and important insights for performance excellence.

I hasten to add, although, this study was conducted among patients residing in the UK, Ireland and Denmark, the core issue, even in India, is unlikely to be much different from what appears above. This genre of pharma marketing approach would warrant extensive use of AI, much more in the coming days – than ever before.

The above genre of pharma marketing calls for extensive use of AI:

The above genre of pharma marketing calls for extensive use of AI, much more in the coming days than ever before. For example, as new generations of Covid vaccines will come – with some without the use of needles, like a nasal drop, machine learning tools may be necessary for pinpoint accuracy in market segmentation. I reckon, there will be many such areas, where those companies who would use AI to orchestrate a cohesive customer experience, will drive stronger differentiation, better customer access and higher sales impact.

In that process, creating opportunities and empowerment for deserving marketers to reap the benefits of AI based digital tools and systems, such as machine learning with human integration within sales and marketing, will be the need of the hour. Gaining actionable insights from this endeavor, marketers need to go whole hog to unleashing the power and value of AI for achieving business excellence. I wrote about it, even during pre-Covid days – on July 15, 2019. But, this approach has assumed much greater importance in the new normal, when innovative e-marketing is gaining momentum to gain a competitive edge. However, this would require more investment in AI than what it is today.

The process has accelerated during the Covid pandemic:

This has come out clearly in the results of McKinsey Global Survey 2020 on AI. The paper is titled – ‘The state of AI in 2020’ and was published on November 17, 2020. The findings of the study ‘suggest that organizations are using AI as a tool for generating value. Increasingly, that value is coming in the form of revenues.’

Although, the number of these companies is small, they are planning ‘to invest even more in AI in response to the COVID-19 pandemic and its acceleration of all things digital.’ The paper emphasizes that this could create a wider divide between AI leaders and the majority of companies who are still struggling to capitalize on the technology.

Pharma’s increasing use of AI during the pandemic:

The above trend gets reflected in the ‘AI In Pharma Global Market Report 2021: Covid-19 Growth And Change.’ The report underscores, the global AI in pharma market is expected to grow from $0.91 billion in 2020 to $5.94 billion in 2025 at a CAGR of 47%. The initial spurt in growth was mainly due to companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, the report underscores.

Although, the number of pharma entrants in this space isn’t yet very many, major players includePfizer, Novartis, IBM Watson, Merck, AstraZeneca and Bayer. Gradually, some Indian drug companies are also testing water in this area, as discussed in the article – ‘The Increasing Use Of AI In The Pharmaceutical Industry,’ published by Forbes on December 26, 2020.

Conclusion:

“Patient-Centricity” emerging as a hallmark, fueled by rapidly changing expectations and behavior of pharma customers, especially doctors and patients. To be effective with such changes in market dynamics – capturing ‘patient experience’ with medication – directly from them – to the respective companies online, is a necessity today.

Most other industries involved in digital marketing are already doing so. Pharma companies while embracing e-marketing can’t just wish it away, any longer. Today, when digital marketing has commenced in the pharma industry, with accelerated speed – machine learning alongside the creative application of AI powered analytics, can immensely help gaining actionable insights on customers. These include customer experience, their perception and pattern of usage of brands, besides channel preferences, preferred contents for effective engagement.

Thus, the consequences of not directly listening to patients’ voice on structured digital platforms – supported by analytics, can be ignored at pharma marketer’s own peril. Many of them may not yet be able to fathom the depth of its potential, opportunities and possible roadblocks, or simply unable to figure out where to begin with and – how. Experts’ hand-holding will be pivotal for them in the transition phase of this endeavor. From this perspective, I reckon, to keep pace with fast-changing customer behavior, pharma marketers need directly listen to patients’ voice online. And based on which, develop customized strategies by leveraging AI – for more productive engagement with them.

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.

Creating A Unique Patient Experience By Listening To Patients Voice – An Imperative In The New Normal

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Acquiring deeper insight on the patient journey through a disease treatment process to create and enhance end-to-end patient experience, never assumed such critical importance, ever in the past. Without this realization, I reckon, even digitalization of any scale in the pharmaceutical industry, is unlikely to yield desired results. The term ‘Patient experience’ is generally considered as ‘the summation of interactions that influence patient perceptions across the continuum of care, until now,’ as defined in an article, published by Aranca on February 28, 2020.

This isn’t a new concept. This subject was well-deliberated even before the pandemic crisis. For example, an article, published in the Pharma Voice on April 2014, had also highlighted this point. It wrote: “Too many companies continue to view the world as a physician-centric, and do not recognize the growing influence of the patient in treatment decisions. The evolution toward a fully integrated commercialization approach centering on the patient experience will continue to crystallize over the next five to 10 years. Within a few years the industry will universally have one goal that supports the patient experience, as there is a tremendous amount of attention being put on the patient today.”

Even thereafter, another paper, published in the Reuters Event Pharma, on August 17, 2017, also reiterated: ‘A greater understanding of the patient journey is rapidly becoming an essential tool for market access.’ It further elaborated that the use of patient journey data stands to benefit everyone:

  • Patients: through empowerment programs,
  • Pharma marketers and more widely, the Company: by targeting the right patient segment and the company more widely.

The paper concluded: ‘Given the potential benefits, pharmaceutical companies should develop a robust mechanism to design effective patient journeys, which could prove instrumental when it comes to bridging treatment gaps and improving quality of life for countless patients around the world.’

From this perspective, Covid-19 pandemic seems to have hastened the process with changing customer behavior and expectations in the new normal, thorough understanding of customer needs emerged as a key success requirement for pharma marketers. That said, customer experience has to be measured both qualitatively and quantitively through credible market research initiatives, capturing the patients’ views. Guessing the same, as was generally the common practice in the old normal, would no longer suffice. This article will dwell in this area.

The pandemic played a catalytic role:

That Covid-19 pandemic played a catalytic role to hasten the process of providing a unique patient experience during a patient’s journey through a disease treatment process in the digital world. This was vindicated by a ZS study, published on July 05, 2020. The analysis found – over the last three months several companies started looking at new ways to engage with patients. These include:

  • Forming patient panels – to continually check and monitor the quality of patient experience that the company is providing,
  • Connecting with patient advocacy groups – to get a pulse on critical needs
  • Leveraging the field force – to hear from physicians where their patients need the most help.

These are laudable initiatives for dovetailing patients’ views in the drug marketing strategy to provide a unique experience to patients during their end-end-to journey through a disease treatment process.

Measuring patient-experience – an integral part of digital sales and marketing:

Measuring patient-experience has always been an integral part, virtually of all types of sales and marketing using digital platforms. We experience it almost every day, such as, while buying a product through Amazon, buying grocery items through D-Mart, scheduling a doctor appointment through Practo, buying medicines through PharmaEasy, or even for availing a service through Urban Company.

The November 15, 2020 research report of DT Consulting has also reiterated this need. It found, patients seeking and receiving care, depend on a complex system of health providers—an environment in which pharmaceutical companies play an important role. ‘When seeking care, patients gravitate to experiences that other patients rated well; when receiving care, they prefer experiences that consistently meet or exceed their expectations,’ it underscored.

Why then all pharma digital initiatives for its customers aren’t in sync with such practices? It’s about time that pharma players also follow a similar path, to continually improve company offerings, based on what the customers expect from a company’s brand and services – regardless of whether they are doctors, patients or any other key stakeholder.

I re-emphasize, this initiative has to cover end-to-end of a customer journey starting from clinical development, brand launch and expansion of market access. In each of these stages, loose knots, if any, require to be tightened, after thorough deliberations, to delight the customers – and consequently rewarded by them, appropriately. While some progress can be seen in this area, pan industry progress in this space, still falls much short of other industries. A pharma company may continue to ignore its importance, even in the new normal, at its own peril.

The way forward won’t be a bed of roses, expect thorns to overcome:

The above ZS study also brought out some interesting facts, as follows:

  • 43% of participants cited difficulty identifying quantitative, measurable KPIs that fit within the organizational structure and practices,
  • 29% indicated a lack of tools and resources to help communicate tangible outcomes and the case for change
  • 22% cited organizational silos as the true barriers.

The good news is, as the study highlights, Covid-19 has proven that it’s quite possible to actually be more patient centric to create an exclusive brand experience for patients. But, many ‘organizations still have work to do, in getting there.’

Sermonizing what patients’ need, without involving them, may be counterproductive:

Things were quite different in predominantly a physician-centric world for patients, in the old normal. At that time, sermonizing the treatment needs of patients, blended with a heavy dose of respective company’s self-serving interest, sans patient involvement in the treatment decision making processes – worked. The same approach may not yield desired cost-effective outcomes, when the customer behavior, triggered by the pandemic, is fast changing, for various reasons.

‘Patients want more services before they are treated’ for a disease: 

Many patients have been asking for more services, especially from the pharmaceutical companies, even before they undertake the journey of getting a disease well treated by medical professionals, regardless of disease types. Till Covid-pandemic, this remained mostly an unmet need for many patients, as this is an arduous for most pharma players. Which is why, most drug companies did not want to jettison the traditional approach, in favor of being ‘patient-centric.’ Thus, the entire decision-making process for any disease treatment continued to remain ‘doctor-centric.’

This wasn’t an unknown need for most patients, either, as it was well documented through several research studies. For example, an Accenture survey of 10,000 patients had examined their unmet needs in seven different therapeutic areas across the entire patient journey. Its findings concluded, ‘patients want more services before they are treated for a disease, regardless of disease type.’ Interestingly, even when such services were available in some places, the vast majority of patients still are not aware of the availability of these patient services, the paper added.

The situation is different today:

Overall, the situation is different today, mostly because, during a long Covid-19 lockdown period, many patients started visiting the cyberspace to manage their health, in increasing numbers. With the experience thus gained, a large population, even in India, now consider digital as a primary channel to initiate the journey for their disease treatment, such as telehealth.

As judicious assimilation of knowledge has always been a source of wisdom, patients have now become wiser to demand more services from a drug company that will help them to get cured of diseases and maintain good health – the way they want. More importantly, patients have also realized that in most cases treatment alternatives to choose from, are plenty.

Thus, the above study of Accenture raised the following question for the pharma companies to ponder that is more relevant today than ever before: ‘Are pharmaceutical companies missing a significant opportunity to provide services at the earliest possible point in the patient journey – before they are even being treated for a disease?’ That’s why, ‘patients deserve as much focus, if not more, in pharma market research as ‘physicians.’

‘Patients’ deserve as much focus on market research as ‘physicians’:

In the old normal, medical reps, in general, used to expect their target physicians to educate the patients about the disease while prescribing their respective company’s brands. With many patients getting more and more informed in the digital world, pharma companies need to strategize a comprehensive patient engagement and educational campaigns, enabling patients to actively participate in their treatment decision making process, exactly the way they want, to improve quality of life.

From this perspective, collecting first-hand data on patient-experience, straight from the voice of patients, isn’t too common a practice for the drug companies, even today. It will rather be a new venture for many, to gain meaningful insights on the impact of their operational endeavor – from the patients’ perspective. This will, in turn, help organizations strategize more productive engagements with them, reaping a rich harvest.

The process starts with ferreting out patients’ needs from a variety of credible sources – after cross-checking and getting it vetted by focus groups of patients, in due course. Some pharma majors, reportedly, invite patients to narrate their experience in the disease treatment process, directly to medical reps at their sales meeting on virtual platforms. A few others have started patient-groups in the selected therapy areas, for the same purpose.

Nonetheless, pharma marketers to please ensure that their organizations need to genuinely care about the patients, making this onerous task deliver a win-win outcome for both. The key point to take note of is that its real purpose, in no way, should be achieving any company’s self-serving objectives, under this creative façade.

Conclusion:

Creating and enhancing the unique customer experience has been recognized as one of the key success factors in any industry, pharma business is no exception. Curiously, it could not draw as much focus as it should have been, until Covid-pandemic struck, triggering disruptive changes in the customer behavior and the overall commercial environment. The good news is, in tandem with their digital transformation process, several drug majors are now mulling about patient experience-driven marketing strategies.

For this purpose, the pre-requirement is to put in place a comprehensive patient experience measurement framework, to accurately understand the end-to-end journey of the patients in their disease treat processes. This would include, capturing their key unmet needs from various sources, including focus group studies of real patients, in various formats.

Prudent use of connected health applications and AI platforms may be of great help – supported by state-of-the-art analytics, to gain meaningful access to patients’ behavioral and attitudinal data for strategic use, in various digital platforms. This has the potential to deliver a quantum leap in business outcomes. From this perspective, I reckon, for creating a unique patient experience, listening to patient voice, is an imperative in the new normal.

By: Tapan J. Ray  

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

Create Greater Patient–Value To Excel With Repurposed Covid Brands

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Regular introduction of new molecules, line extensions or a Novel Drug delivery System (NDDS) has remained the life blood for pharma to rejuvenate a company’s product portfolio for driving organizational growth. But, Covid’s unprecedented and devastating assault on human lives and livelihoods, has pushed many of these initiatives off track. Covid infection was declared pandemic by the World health organization (WHO) on March 11, 2020, compelling the industry to primarily focus on finding solutions for survival, especially in the product development areas.

As the fight against time, the need for survival became so intense, there was no time for pharma companies going back to primary research, to discover new effective Covid specific drug molecules. Vaccines – at the initial stage of the pandemic, were considered by experts could be the only ‘magic bullet’, to get the humanity back again on its feet, after a fierce knockout blow by the virus. As on date, although vaccines seem to be nearer the finishing line of creating adequate initial immunity against Covid, still there are no scientifically proven drugs to predictably cure this infection.

Meanwhile, the focus of all concerned is on the existing drugs, to examine their effectiveness against Covid-19. Accordingly, right from hydroxychloroquine, dexamethasone to a number of already existing antiviral agents were repurposed for Covid treatment, under emergency approval by country regulators, pending detailed clinical trials.

For various critical reasons, experts now feel that the use various NDDS technologies in repurposing existing drugs, would create greater value for patients in Covid treatment. At the same time, this will help pharma companies to create a cutting-edge differentiator for their repurposed brands – being more patient centric. In this article, I shall dwell in this area, starting with the current status and issues with repurposed Covid drugs, as of date.

Current status and issues with repurposed Covid drugs:

According to recent reports, such as one titled ‘Formulation and delivery strategies for COVId-19 drugs,’ published by the AIchE in June 2020, more than 40 different drugs are currently being explored for efficacy against COVID-19. Unfortunately, side effects of many of these repurposed drugs limit their use in most severe cases, besides preventing their use as prophylactics.

A large proportion of repurposed Covid drugs are small-molecule medications, antivirals, and immune-modulating antibodies. These are already approved for other indications (like hydroxychloroquine, ribavirin, favipiravir), or under clinical trials, but not yet approved by the U.S. Food and Drug Administration, FDA (like, remdesivir, galidesivir, leronlimab).

If proven effective, these drugs would offer several advantages from a rapid- response perspective, such as the availability of safety data. In addition, several of these drugs offer broad-spectrum activity that makes it more likely they will remain functional even if the SARS-CoV-2 virus mutates. However, there are also exists some critical issues with repurposed Covid drugs.

Some critical issues with repurposed Covid drugs:

Let me cite below two examples, just to drive home the point of some critical medical issues, now existing with these repurposed Covid drugs:

  • Hydroxychloroquine – the malaria drug, when used as directed, commonly produces nausea, diarrhea, vomiting, besides muscle weakness. Importantly, at higher concentrations – only two to three times the daily dose, it can cause potentially fatal acute cardiovascular toxicity. Thus, the possibility of severe side effects makes the drug unattractive as a preventive measure. Drug formulation and delivery strategies, such as controlled release and targeted delivery could expand the use of such existing drugs, the report recommends.
  • The HIV drug combination lopinavir and ritonavir, which is under evaluation as a COVID-19 treatment, has side effects that include diarrhea, nausea, and liver damage. With a half-life of about 4–6 hours, the systemic concentrations can vary by a factor of eight between peak and trough. Developing a controlled-release formulation that maintains the minimum effective drug concentration, could mitigate side effects by reducing the steady-state drug concentration by as much as eightfold and reducing the burden on the liver by 81%, the above study, published by the AIchE in June 2020, highlighted.

At this point, for greater clarity, let me recapitulate what NDDS really means.

NDDS – clinical and marketing relevance:

Novel Drug Delivers Systems or NDDS generally ‘refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects.’

This process was lucidly explained in a contemporary article, which also inferred that the method by which a drug is delivered can have a significant effect on its efficacy and safety profile.

Yet another paper underscored, ‘if therapeutic agents can be made more efficacious and safer, using an improved drug delivery system, could achieve both –lucrative marketing opportunities for pharmaceutical companies, alongside advancement in the treatment of diseases of mankind.’ Moreover, NDDS can also help maintain the drug concentration in the therapeutic range for a longer period of time and deliver the content to the site of action if required.

Leaving aside the technical details behind these mechanisms let me underscore - that NDDS will be a boon for the repurposing of drugs, was also discussed in detail in an article titled, ‘Role of Novel Drug Delivery Systems in Coronavirus Disease-2019 (COVID-19): Time to Act Now,’ published on September 09, 2020.

Some broad categories of NDDS and new initiatives:

For this purpose, some of the broad categories of NDDS may include the following:

  • Sustained- or controlled drug delivery systems provide drug action at a pre-determined rate.
  • Localized drug delivery devices for drug release in the vicinity of the target.
  • Rate – pre-programed drug delivery systems.
  • Targeted drug delivery provides drug action by using carries, which recognize their receptor at the target.

It goes without saying that NDDS mechanism may be used both for new molecules that may eventually be developed, and also for the existing repurposed drugs for Covid treatment.

Some encouraging initiatives of NDDS for Covid drugs:

The encouraging news is pharma initiatives in this regard has already commenced. For example, unprecedented interest in inhaled delivery of antiviral drugs has led to Aerogen’s involvement in multiple COVID-19 drug development initiatives, with more than 15 leading pharmaceutical companies - worldwide.

Several of these collaborations are already in clinical trials. Others are also on track to enter studies on moderately and severely ill COVID-19 patients, the Press Information of Aerogen dated October 22, 2020 highlighted. Let me cite below two more examples in this area, to explain the intensity of work that has commenced in the NDDS space for repurposed Covid drugs.

Covis Pharma’s inhaled glucocorticoid, Alvesco (ciclesonide) has entered Phase III safety and efficacy trial in 400 non-hospitalized patients  -12 years of age and older with symptomatic COVID-19. The product is delivered twice daily via a pressurized metered dose inhaler (pMDI).

Senzer Pharmaceuticals - a UK based company, is also in the process of formulating two specific medicines with antiviral properties, to allow them to be inhaled directly into the respiratory tract. The primary aim is to reduce the number of COVID-19 patients requiring intensive care treatment. Senzer is also using a pMDI for targeted drug delivery of actives through inhalation, as it offers potential advantages over oral intake. These include, ease of administration, assisting early treatment, allowing a lower dose by reducing unwanted side effects and supporting the safety profile of the products.

Experts consider preparations of inhalable particles for local delivery is a simpler approach. This is because the lungs comprise only about 2% of the total body weight, targeted delivery could reduce the amount of drug required by a factor of 50 or more, as compared to oral administration.

Be that as it may, the primary purpose of all such initiatives is to ensure more effective and safer drug delivery to Covid patients. It is now up to the pharma marketing leadership to ascertain how to leverage such NDDS opportunities to deliver extra patient-value, simultaneously creating a cutting edge for marketing these repurposed brands.

Impact of Covid on the NDDS market segments:

The May 11, 2020 report titled, ‘Drug Delivery Systems Market Forecast, Trend Analysis & Competition Tracking – Global Market Insights 2020 to 2025,’ presents some interesting details in this area. It forecasts, the global drug delivery systems market shall register an upswing, expanding at a strong CAGR of 7.0% during the forecast period (2020-2025).

The ongoing COVID-19 pandemic is expected to further heighten prospects of NDDS, with the number of infections still increasing every day. Consequently, many leading pharma companies have accelerated production of essential drug delivery systems, as stated above. According to the above report, the key growth drivers of the NDDS market include:

  • Targeted drug delivery - being most dominant, is expected to capture nearly half of the global NDDS market, expanding at a healthy CAGR of 6.8% across the above forecast period.
  • Polymeric drug delivery segment is anticipated to be the second-most lucrative area, expanding at a CAGR of 7.3% across the forecast period. The popularity of this delivery type is attributed to its efficiency in localized drug delivery in large amounts, alongside lowering drug toxicity rate. The polymeric drug delivery segment is expected to capture more than 1/3rd of the global drug delivery systems market during the forecast period.
  • Application of nanotechnology is another key growth determinant for the segment. Insertion of nanoparticles help penetrate the targeted tissue in a much better manner. These particles are easily absorbed by cells, facilitating efficient drug delivery.
  • Microneedle drug delivery helps deliver vaccines or other drugs across various barriers.

Conclusion:

The Covid clock keeps ticking. As on November 22, 2020 morning, India recorded a staggering figure of 9,095,908 of Coronavirus cases with 133,263 deaths. The average number of daily new cases appeared, after the festive season, have started climbing up again. The threat of subsequent waves for further spread of Covid infection now looms large.

In this regard, many experts initially thought that Covid vaccines will be magic bullets to win the war against the new Coronavirus. But in the most recent times, this situation has changed, and it is no longer so – not even Pfizer vaccine. Indian media also deliberated the same on November 05, 2020.

Under this backdrop, Arthur L. Caplan, professor of bioethics at New York University’s Grossman School of Medicine, who wrote a 2017 book on vaccine ethics and policy have also made a profound comment. He said recently: “We’re going to have to continue our behavioral efforts - the masking and distancing and the quarantining and the testing and so on — in parallel with vaccination because it would be very, very surprising if we got a very highly effective vaccine first one out of the box.”

Currently, the world doesn’t have any clinically proven new Covid treatment drugs, either. What we have now is a number of repurposed Covid drugs, many of these are in advanced stage of clinical trials. As and when these are approved by the country’s regulators, pharma marketers will have a task cut to excel with those – among many ‘me-too’ types. In this scenario, there will be a critical need to create greater patient-value with a company’s own repurposed brand, where right application of NDDS technology could play a game changing role. The time to keep pondering is over. Time to decide is – now.

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.

 

 

Neutralize Covid-19 Impact on Drug Prices And Market Access For Faster Recovery

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Covid-19 pandemic that has not spared any facet of human lives and livelihoods, has also reignited several ongoing debates related to the drug industry. The need to urgently resolve these issues grows manifold, as the real magnitude of this health crisis doesn’t seem to be clear even to the key Government decision makers.

This is vindicated by the research paper, written by government scientists and other experts, published on September 10, 2020 in the Indian Journal of Medical Research. It reveals, India had nearly 6.5 million cases as early as May 2020. Whereas, according to the health ministry, the total number cases stood at around 180,000 in late May. This happened because, ‘large numbers of cases could have gone under the radar earlier this year, because testing was limited to symptomatic patients or states had varying testing rates,’ the paper highlighted.

From the pharma industry perspective, a pandemic of such magnitude is also causing indefinite delay in pre-planned market access of several important drugs and vaccines. Some are due to technical reasons. However, many others are related to their value-based cost-effectiveness in the new normal, when the pandemic has put enormous strain on health expenditure, across the world.

In this situation, past mechanisms of new drug pricing, are required to undergo significant changes. The new yardsticks, I reckon, will be based on two critical factors. The first – the disease treatment priorities, as will be decided jointly by both doctors and patients. And the second – the paying capacity of both payers and individual patients, based on the value that each treatment will offer – again, as perceived by patients.

As it appears, the impact of Covid-19 on the pharma industry will continue till the medium term, if not beyond. Consequently, the concept of new drug pricing – based on well-documented, differential value offerings of treatments, would need to be revisited and recalibrated. This has to be realigned with evolving patient needs. Considering the emerging scenario, this article will focus on the exigency to neutralize Covid-19 impact on new drug prices and pre-planned ‘market access’ – for faster business recovery.

Covid-19 has increased the drug price sensitivity:

The challenge of increasing drug price sensitivity – triggered by the new Coronavirus pandemic, has now assumed a global dimension. A June 18, 2020 study, flags: ‘Nine in 10 Concerned About Rising Drug Costs Due to COVID-19.’ Although, this particular study (Gallup Poll) was conducted in the United States, general public apprehension is no different in other parts of the world, including India, for various reasons.

Even in America, which is considered Eldorado for pharma business, primarily for unregulated drug pricing, is also changing with the impact of Covid-19. The reason being, reported instances of drug prices are rapidly rising, amid the pandemic. As the above Gallup Poll highlights, today ‘a large majority of Americans support direct negotiations by the federal government with the drug manufacturer on the price of a treatment for the disease itself.” Interestingly, ‘significant support exists across all major demographic groups.’

Other specialists on pharmaceutical pricing and market access, also envisage that pharmaceutical companies will be faced with increased price sensitivity, and are quite concerned with the long-term impact of the pandemic on health care systems.

Covid-19 pandemic would seriously impact pharma spending:

As quoted above, several other specialists for pharmaceutical pricing and market access have also pointed out some critical Covid-19 impact areas, including:

  • Tremendous increase in pandemic related public expenditure, could prompt further austerity measures in already strained health care budgets, besides job losses or pay cuts of scores of people for different reasons.
  • The pandemic is likely to result in a redistribution of health care funding towards infectious diseases (e.g. prioritization of antivirals and vaccines) and chronic diseases associated with worsening COVID-19 outcomes.
  • This may result in more drug pricing pressure in other disease areas, besides push for increasing use of similar cheaper generics and biosimilars, unless absolutely necessary.
  • Stricter monitoring of usage of medicines, especially in private hospitals, to ensure their use within the regulatory label and/or within the reimbursed population.
  • Possibility of mandatory price cuts either across the board or for drugs which have been on the market for a specific duration.

The report also envisages, pharmaceutical companies will be faced with increased price sensitivity and decrease in willingness to pay by authorities. Consequently, the key question in this area becomes: What impact will COVID-19 have on the future of pricing and market access? And how to address this issue, effectively? 

Need for an appropriate drug pricing models in the new normal:

Overall scenario for drug pricing model has not changed much, till Convid-19 pandemic overwhelmed the world. The age-old concept of drug pricing, being treated as almost given, is changing fast. As I wrote earlier, it started in the developed world, with newer concepts, such as, Health Technology Assessment (HTA), besides a few others. However, to illustrate the point, I shall focus only on the HTA model. It includes a multi-faceted assessment of the clinical, economic, ethical, legal, and societal perspectives that may be impacted by a new technology, procedure, drug, or process.

Application of HTA in Medicine Pricing:

The ‘Working Paper 6’ of June 2013, on ‘The Role of Health Technology Assessment in Medicine Pricing and Reimbursement,’ published jointly by the World Health Organization (WHO) and the Health Action International (HAI), is worth referring to.

The paper aims to identify and describe the role of HTA in price-setting and reimbursement of pharmaceuticals, with a focus on its use in low and middle-income countries (LMICs). However, as Covid-19 is now fueling the drug price sensitivity across the globe, and not just in the LMIC, this reference will help drive home the point, as one faces today.

While combating health care resource crunch in the face of the Coronavirus quagmire, many countries are contemplating a variety of approaches to maintain affordable access to healthcare for patients. The concept of HTA is one such common approach. It includes pharmaceuticals, vaccines, medical devices, medical and surgical procedures, besides the systems within which health is protected and maintained.

Relevance of a recalibrated HTA in the new normal:

For a new drug, as the Institute For Clinical And Economic Review (ICER) puts it, a final HTA report would attempt to answer the following questions, besides a few others:

  • Is it safe and effective?
  • Which patients benefit the most?
  • Is there a meaningful improvement in health status?
  • Can all people afford to pay who might need it?
  • Will it offer a good value in the long run?
  • What other considerations make it important?

These points need to be looked at keeping in view that Covid-19 pandemic has seriously impacted the health care spending. Thus, the process needs to be recalibrated in the new normal. In any case, HTA has the potential to play a critical role in new drug pricing, by assessing the intrinsic value of medicines that can significantly expand patient-access to care. In tandem, it could maximize the value for money in health expenditure with most efficient allocation of scarce health resources, that most countries are facing today. Nevertheless, there could well be a few company or country specific barriers to capture the value of a drug or treatment, as well. A robust plan for their mitigation needs to be well-thought through, to ensure effective implementation and achieve desirable outcomes.

HTA in India:

At least, on paper HTA exists even in India. The Government of India had created an institutional arrangement called “Health Technology Assessment in India (HTAIn)”, under the Department of Health Research (DHR). It was entrusted with collation and the generation of evidences on cost effectiveness and safety of health care interventions, including medicines and devices.

The key goals are, to reduce the cost of patient care, overall cost of medical treatment, reduction in out of pocket expenditure of patients, besides streamlining the medical reimbursement procedures. Nevertheless, it remains a million dollar question whether India would leverage this system to ensure fair pricing of new drugs in India.

Some pre-requisites to implement HTA – afresh:

In those countries, where HTA for drug pricing and reimbursement doesn’t already exist, there could be several pre-requisites. These may include, as the above paper indicates, establishing a medicines regulatory system, developing and enforcing legislation, employing the appropriate technical expertise, and the allocation of sector-wide financial resources in accordance with the decisions of the organization using the HTA.

That said, the bottom-line is, the quest to arrive at fair pricing for a new drug, could also help ‘market access’, especially in a difficult time, like today’s health care crisis. In that endeavor, let me briefly dwell on the concept of ‘fair pricing a drug’.    

The concept of ‘fair pricing a drug’:

This issue has been well deliberated by many experts around the world. However, let me quote a recent article – ‘Defining the concept of fair pricing for medicines,’ published by The BMJ on January 13, 2020.

The paper articulates, ‘a fair price for a medicine is affordable to the buyer while covering the seller’s costs and providing a reasonable profit margin. Within a fair pricing zone, a specific price may be higher or lower, possibly reflecting differential value.

Interestingly, the authors also noted: ‘Applying the framework to decision making would require access to data on R&D, manufacturing, and distribution costs, which is generally not publicly disclosed. This lack of transparency about costs undermines efforts to assess the fairness of medicines prices.’

The article underscored, lack of transparency in these areas, ‘also exacerbates information asymmetry to the sellers’ advantage.’ It suggested, disclosure can be enforced through legislation, regulation, and judicial action. Or as a condition of receiving public research funds, tax benefits, regulatory approval. Or listing in a formulary for reimbursement. ‘In the absence of disclosure, decision makers may rely on reasonable estimates based on publicly available information,’ the paper concluded.

Conclusion:

As recorded in the morning of September 13, 2020, total Coronavirus cases in India have reached a staggering figure of 4,754,356 with 78,614 deaths, overtaking Brazil. This trend continues going North, as days pass by.

All-pervasive Covid-19 pandemic is fueling severe resource constraints, especially for health care. Amid this complexity, to combat this deadly virus – alongside other non-Covid related illnesses – value added drugs and treatments could help overcome many hurdles in this area. They could help improve cost-effectiveness of treatments to price-sensitive patients, besides other stakeholders.

Recalibrated HTA mechanism, which I have used in this article as an example to effectively overcome prevailing drug price sensitivity, is one among a few others. Importantly, HTA mechanism exists even in India. It can be appropriately used for new drugs and vaccines pricing, if the Government wishes to.

On the other hand, it’s up to individual companies to choose any other price-value model’ that they will deem appropriate, to arrive at a ‘fair value for new drugs’. However, the goal remains common for all - Neutralizing Covid-19 impact on drug prices and market access, to ensure faster recovery of the business.

By: Tapan J. Ray   

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

Shifting Pharma Supply Chain Strategy From Global To Local

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Alongside large-scale disruptions of many critical industrial operations, Covid-19 global pandemic took the wind out of the sail of pharma supply chain, as well, at the very onset of lockdowns. This happened in many countries around the world, including the largest global pharma market – the United States, and also in ‘the pharmacy of the world’ – India.

That there were such disruptions in India, both in procurement and logistics, during the national lockdown, was widely reported in the media. Besides product non-availability, cost of goods also went up significantly in several cases.

From this perspective, I shall deliberate in this article, how different countries are contemplating to respond to any similar crisis in the future, primarily to safeguard patients’ health interest, despite some opposition, though. To drive home the points, I shall cite examples from India and the United States, as specified above.

Supply Chain vulnerability of the ‘largest pharma market of the world’:

There are several examples to vindicate such vulnerability, both for the US and also India. From the US perspective, the country’s supply of generic and branded medicines are, reportedly, heavily rely on emerging markets, like India and China.

This point has now ‘come under close scrutiny of the American policy makers, as COVID-19 sends shockwaves through the industry. According to the US Food and Drug Administration, China and India represent 31 percent of the plants that are registered with the US to supply Active Pharmaceutical Ingredients (API), as of August 2019. The details are as hereunder:

Place

United States

European Union

India

China

Rest of the world

Canada

%

28

26

18

13

13

2

It is worth noting, the number of facilities in China supplying APIs has, reportedly, more than doubled since 2010 – to 13 percent of all those serving the US market.

Examples from India:

The outbreak of Coronavirus had just not shut factories in China - impacting supplies and leading to fears of a shortage of drugs and medicines. It happened in India, too. Several critical supply chain issues were reported during this period. For example,  a major Indian drug manufacturing hub - Baddi,reportedly, was either shut down or operated with reduced capacity, since COVID-19 pandemic related national lockdown.

Its impact also got captured by the twitter handle of the former USFDA Commissioner – Scott Gottlieb. He twitted, “Drug supply chain at risk as Asia’s largest pharmaceutical manufacturing hub in Baddi (an industrial town in southwestern Solan district of Himachal Pradesh, India) is declared a #COVID19 containment zone – forcing many pharma units to slow or stop operations.”

Supply Chain vulnerability of the ‘pharmacy of the world’:

Supply Chain vulnerability related to the domestic issues in India, can possibly be sorted out by the country’s decision-making authorities. However, the country’s vulnerability arising out of the reasons originating in the other countries, needs a greater priority focus of the nation.

As is widely known – India caters to about 20 percent of the world’s generic drug supply. However, according to Bloomberg, 70 percent of the country’s imports of APIs come from China, ‘totaling US$ 2.4 billion of India’s US$ 3.56 billion in import spending for those products each year.

Consequently, ‘pharma companies in the country are dependent on China for two-thirds of the chemical components needed to make them.’ Exposures of such nature are now coming on to the center table – mostly triggered by Covid-19 pandemic, both in India, as well as in the United States.

India is reevaluating its import dependence from China:

To illustrate this point, let me begin with some related recent developments. While reevaluating the import dependence, India has taken both immediate and medium to long term measures – at the policy level.

The immediate reaction of India to Covid-19 outbreak, was to shift focus on local with restricted export of common medicines, such as paracetamol and 25 other pharmaceutical ingredients and drugs made from China. Curiously, prior to the national lockdown, on March 17, 2020 by a written reply the Government had informed the Indian Parliament about the import of APIs /drugs and the extent of the country’s dependence on China for the same.

Be that as it may, to protect the local interest, the above ban was followed by another export ban of the age-old malarial drug - hydroxychloroquine, ‘touted by President Trump as a possible weapon in the fight against Covid-19,’ but has been in short supply, globally. Interestingly, India produces around 47 percent of the U.S. supply of hydroxychloroquine. Thus, understandably, Indian Government had to partially lift this ban after the U.S. President Donald Trump sought supplies for the United States.

For medium longer-term measures, while announcing a ₹20 lakh crore stimulus package, Prime Minister Narendra Modi articulated that Covid-19 pandemic had taught India to ramp up domestic production and create supply chains to meet internal demands. Earlier, for safeguarding ‘national healthcare security’, the Government had allocated US$ 1.2 billion for the pharma industry to be self-reliant, by reducing its import dependence, especially for APIs. The government also wants to finance the construction of three bulk drugs with an investment of ₹300 Crores.

The United States is reevaluating import dependence from one region:

The Fierce Pharma article of June 03, 2020 also reported a shifting focus of supply chain from global to local, as the United States seeks to ‘onshore’ drug production, with the fallout of Covid-19 pandemic looming large on its drug supply chain.

U.S. legislators have argued that ‘U.S. reliance on drugs made or sourced outside the country has created a security issue that could be addressed by erecting parallel supply chains stateside and eliminating reliance on potential bad actors abroad.’ Accordingly, they have put forward ‘a raft of legislation’ that would seek to “onshore” drug manufacturing at the expense of major producers abroad.

Its biggest obstacle could be the pharma industry and its lobbyists:

Nevertheless, the same article also underscores that the biggest obstacle to that plan could be the pharmaceutical industry and its lobbyists on Capitol Hill. This is because, PhRMA - the industry’s biggest lobbying group, has pushed back against Congressional support for a supply chain shake-up. It said, “Policymakers must take a long-term, more holistic look at global pharmaceutical manufacturing supply chains before jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines.”

Will it happen in India?

My article, published in this blog on February 03, 2020, also focused on this issue. There I had emphasized, about five years back - the Government of India had also announced on February 25, 2015 – terming ‘2015 – Year of Active Pharmaceutical Ingredients’ (API). This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’, I wrote.

Two years down the line from the above date, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ However, not much change has been witnessed till date, in this regard. The same vow is now being taken afresh. Nonetheless, let me hasten to add, Covid-19 has changed the life of all – in several respects. Thus, no one can possibly vouch with a high degree of certainty what can happen hereafter, as we move on.

Conclusion:

As the ‘Lockdown. 05’ or ‘Unlock down. 01’ begins in India – the ‘pharmacy of the world, as on June 02, 2020 morning, the recorded Coronavirus cases in the country reached 247,040 with 6,946 deaths. India is now racing ahead with its number Covid-19 cases, surpassing Italy and Spain, occupying the global fifth rank, in this regard. Whereas, the top ranked pharma market in the world – the United States, where Covid-19 struck hard before India, recorded 1,988,545 cases with 112,096 deaths, on the same day.

Thus, the need to have a fresh look at the strategic design of pharma supply chain is being felt in both these countries. The requirement for becoming less global and more local is attracting a priority focus of Governments in both countries. With an increasing State-push for safeguarding the health security of the country, the need to reshape pharma supply chain – call it transient or otherwise, is now more palpable than ever before.

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.