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Meeting India’s Unmet Biologic Drug Needs Some Global Synergy Evident – But Patients Need More

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Many reports have vindicated the rapidly growing importance of biologic drugs in the treatment of a wide range of complex ailments. These include autoimmune diseases, cancers, hormonal irregularities, anemia, and to prevent various diseases such as vaccines, have drawn healthcare experts’ attention globally.

As defined by experts, Biologics are larger, more complex molecules compared to traditional small molecule pharmaceutical drugs. Unlike traditional pharmaceuticals, they require some components from a living organism to be manufactured.

The critical importance of biologic drugs lies in their ability to provide innovative treatment options, address unmet medical needs, and significantly impact patient outcomes in various disease areas. Towards this endeavor, a clear pathway for focused initiatives is warranted, especially in countries like India.

This article will explore this domain to get a sense of how much and how fast the country is progressing in this space, having huge healthcare significance, for all. Let me start with a quick recap on the areas of seminal importance of biologic drugs – to help all to be on the same page – as I start this deliberation.

The critical importance of biologic drugs:

The critical importance of biologic drugs, I reckon, lies in their unique properties and therapeutic potential:

Targeted Therapies: Designed to interact with specific molecules or receptors in the body, allowing for targeted treatment. This specificity can enhance the efficacy of the drug while reducing potential side effects on healthy cells and tissues.

Novel Treatment Options: Offer novel treatment options for diseases that were previously difficult to manage or had limited treatment options. They have revolutionized the management of conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, and certain types of cancer.

Personalized Medicine: Paving the way for personalized medicine, as it can be tailored to individual patients based on factors like genetic profiles or specific disease characteristics. This approach allows for more precise and effective treatment strategies.

Disease Modification: Unlike some traditional drugs that primarily alleviate symptoms, biologics can often modify the underlying disease process. They can target specific pathways or molecules involved in disease progression, potentially leading to long-term benefits and improved outcomes.

Improved Quality of Life: Has the potential to significantly improve the quality of life for patients living with chronic or debilitating conditions. By effectively managing symptoms and slowing disease progression, they can reduce pain, disability, and the need for other interventions.

It is important to note that biologic drugs are complex to manufacture, often require specialized infrastructure, and can be costly. No wonder why the India specific research paper - published on January 18, 2023 commented: “Although various biologic drugs are already available, they are still not within reach of the common person due to financial constraints.”  This prompts me to explore with examples some of the key issues that Indian patients confront while meeting this health need.

Patient access to original biologic drugs in India faces several key barriers:

Patient access to original biologic drugs in India faces several key barriers, including: 

1. Cost and Affordability:

- Trastuzumab (Herceptin): The cost of a single course of Herceptin, used in the treatment of breast cancer, can range from several lakhs to crores of rupees, making it financially burdensome for many patients in India.

- Eculizumab (Soliris): Eculizumab, used in the treatment of rare blood disorders, can cost several lakhs of rupees per month, making it unaffordable for most patients.

2. Limited Healthcare Coverage:

- Many health insurance policies in India have limitations or restrictions on coverage for expensive biologic drugs, requiring patients to bear a significant portion of the cost out of pocket.

- Some government-funded healthcare schemes, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY), may have restrictions on coverage for expensive biologic therapies, limiting patient access.

3. Regulatory Barriers:

- The approval process for biosimilar versions of original biologic drugs could face delays in India. For example, the biosimilar version of Trastuzumab (Herceptin) faced delays in obtaining regulatory clearance, resulting in delayed patient access to more affordable alternatives.

- The regulatory requirements for original biologic drugs can be complex and time-consuming, leading to delays in drug approvals and subsequent patient access.

4. Limited Local Manufacturing:

- Drugs like Bevacizumab (Avastin) and Adalimumab (Humira) used in India are often imported, leading to supply chain challenges and potential delays in availability.

- Limited local manufacturing of certain original biologic drugs can result in dependence on imported versions, leading to potential pricing issues and supply disruptions.

5. Physician Awareness and Education:

- Some physicians may have limited awareness or familiarity with prescribing guidelines and clinical benefits of certain original biologic drugs. This can result in underutilization or hesitation in prescribing these therapies.

- Lack of specific training and education programs for physicians regarding the latest advancements in original biologic drugs can impact their knowledge and confidence in prescribing them.

6. Patient Education and Understanding:

- Patients may have limited knowledge about the availability and benefits of original biologic drugs. For instance, patients with chronic diseases like rheumatoid arthritis may not be aware of the benefits of newer biologic treatments over traditional therapies.

- Lack of patient education about the appropriate use and potential side effects of original biologic drugs can lead to hesitancy or misconceptions among patients, affecting their willingness to pursue these therapies.

These specific examples illustrate how cost, limited healthcare coverage, regulatory barriers, limited local manufacturing, physician awareness, and patient education can act as barriers to patient access to original biologic drugs in India.

Healthcare impact of inadequate access and availability of biologic drugs in India:

The inadequate access and availability of biologic drugs in India can have several significant healthcare impacts: 

Suboptimal Disease Management: Biologic drugs often provide highly effective and targeted treatments for complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. The lack of access to these therapies can result in suboptimal disease management, leading to poorer patient outcomes, increased disease progression, and reduced quality of life for affected individuals.

Delayed or Incomplete Treatment: Inadequate access to biologic drugs can result in delays or interruptions in treatment. For chronic or progressive diseases, timely initiation and consistent use of these therapies are critical. Delayed or incomplete treatment can compromise the effectiveness of interventions, leading to prolonged disease activity, exacerbation of symptoms, and potential irreversible damage in some cases.

Increased Healthcare Burden: Without access to appropriate biologic therapies, patients may require more frequent hospitalizations, emergency room visits, or other healthcare interventions to manage their conditions. This can place an additional burden on healthcare systems, leading to increased healthcare costs and strain on resources.

Reduced Treatment Options: Biologic drugs often represent the most advanced and effective treatments available for certain diseases. Inadequate access to these therapies limits treatment options for patients, forcing them to rely on less effective or outdated treatments. This restricts the ability of healthcare providers to offer the best available care to patients, potentially leading to compromised treatment outcomes.

Health Inequity: Inadequate access to biologic drugs can exacerbate health inequities in India. Patients from lower socioeconomic backgrounds or those without sufficient insurance coverage may face greater barriers to accessing these expensive therapies. This can result in disparities in healthcare outcomes, with some individuals being unable to afford or access the best available treatments for their conditions.

Impact on Research and Innovation: Inadequate access to biologic drugs can hinder clinical research and innovation in India. Limited availability may reduce opportunities for conducting clinical trials and studying the effectiveness of these therapies in the local population. This, in turn, can hamper the development of new treatments and advancements in healthcare.

Addressing the inadequate access and availability of biologic drugs is crucial to ensure equitable healthcare outcomes, optimize disease management, and reduce the burden of complex diseases in India.  

Increasing need for biosimilar drugs in India and issues involved:

From the above perspective, increasing the availability of biosimilar drugs in India is crucial. Fostering competition may improve affordability. Thereby, it would increase access to essential therapies – bridging treatment gaps, disease management, healthcare system sustainability and foster market competition and innovation.

However, it can ensure that patients receive appropriate and effective treatments while addressing the healthcare challenges faced by a diverse population, only when some key barriers created for biosimilar drug entry, besides patent thickets, are also adequately addressed. One such way is creating a global synergy in this space by collaborating with MNC pharma – having deep pockets and other requisite wherewithal.

Some global synergy is evident in this critical healthcare space:

The good news in this space has started flowing. There have been several collaborations between multinational pharmaceutical companies (MNCs) and domestic Indian drug companies to develop even high potential interchangeable biosimilar drugs in India. Here are a few examples:

- Biocon and Mylan: Biocon has collaborated with Mylan, a global pharmaceutical company, to develop and market biosimilar products. This collaboration has resulted in the development and approval of biosimilar drugs such as Trastuzumab (Herceptin) and Adalimumab (Humira) in India. 

- Dr. Reddy’s Laboratories and Merck: Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, entered into a collaboration with Merck & Co., a global pharmaceutical company, to develop biosimilar versions of biologic drugs. This collaboration has resulted in the development and launch of biosimilars such as Pegfilgrastim (Neulasta) and Rituximab (Rituxan) in India.

- Cadila Healthcare and Novartis: Cadila Healthcare, an Indian pharmaceutical company, collaborated with Novartis, a multinational pharmaceutical company, to develop and manufacture biosimilars. This collaboration has resulted in the development of biosimilar drugs such as Rituximab (Ritucad) and Bevacizumab (Bevatas) in India.

These are just a few examples of collaborations between MNCs and Indian drug companies in the field of interchangeable biologic drugs. The landscape of collaborations and partnerships in this area is dynamic, and there may be more ongoing collaborations between companies to develop and commercialize biosimilars in India.

Conclusion:

Overall, patient access to biosimilar drugs in India is crucial for ensuring affordable and comprehensive healthcare, improving patient outcomes, and promoting a competitive pharmaceutical market. It helps address the challenges of access and affordability of biologic drugs, ultimately benefiting the well-being of patients across the country – promoting healthcare equity, and the sustainability of the healthcare system in the country. But patients need more…much more.

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.

Exploiting India’s Weakness For Monopolistic Commercial Gain?

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Public access to healthcare in India is a complex issue with several challenges. While India has been making progress over the years in improving healthcare access and reducing the burden of disease, there are still significant disparities in healthcare access and outcomes across the country. The three primary barriers continue to remain:

  • Affordable access to quality healthcare: This arises out of the shortage of healthcare infrastructure and resources, more in rural areas. The shortage includes an inadequate number of doctors, nurses, and other healthcare professionals, as well as inadequate facilities and equipment.
  • Cost of healthcare: While India has a largely publicly funded healthcare system, the quality of care in public hospitals is often poor, and many people are forced to opt for private healthcare, which can be expensive.
  • Access to affordable drugs: Despite India being a major producer of generic drugs, many people in India still lack access to essential medicines. This is due in part to the high cost of branded medicines, which are often out of reach for many people, as well as a lack of availability of certain medicines in some areas.

Undoubtedly, this remains a weak area for the country, till date. Successive Indian governments have taken steps to address these challenges. However, public funding on healthcare as a percentage of GDP and implementation of policies to increase access to medicine, continue to remain below par. Much work needs to be done to ensure that all people have access to quality healthcare and essential medicines.

Amid this situation, especially on the international political front, drug MNCs are continuously blaming India for the fact that the Indian Patents Act is not robust enough to protect their drug patents on NMEs and technologies. For example, in its 2022 Special 301 Report, the USTR designated seven countries on the Priority Watch List. These are Argentina, Chile, China, India, Indonesia, Russia, and Venezuela. To give some more examples from the available reports:

  • In February 2021, PhRMA, a trade group representing multinational pharmaceutical companies, raised concerns about India’s policies related to IP rights and access to medicines. PhRMA argued that India’s policies were undermining innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 
  • In March 2021, Pfizer’s CEO also expressed concerns about India’s policies related to IP rights and access to medicines. He said that Pfizer was facing challenges in obtaining patents for its products in India, and that the lack of adequate patent protection was discouraging investment in research and development.
  • In May 2021, Novartis’s CEO criticized India’s policies related to IP rights and access to medicines. HE stated that the lack of adequate patent protection in India was discouraging innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 

Against this backdrop, in today’s article I shall deliberate on this vexing issue – starting from some key grievances of drug MNCs in this regard. Thereafter we will look at the Indian industry response to drug MNCs’ concern about the robustness of the Indian Patents Acts. This could possibly help us to understand the key question – Is it then an attempt to exploit India’s weakness regarding inadequate overall access to medicines for monopolistic gain by the vested interest?

Key grievances of drug MNCs for poor access to medicines in India: 

One can recall that the Patent Act in India was amended in 2005 to comply with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amendment made it more difficult for multinational pharmaceutical companies to obtain patents for their products in India for the ‘me too’ type of innovation, which has led to lower prices for medicines and increased access to affordable drugs for the Indian population.

However, drug MNCs generally argue that:

  • The lack of adequate patent protection in India discourages innovation and investment in research and development, which ultimately limits the availability of new drugs for patients in India.
  • They have also criticized the Indian government’s use of compulsory licensing, which allows the government to authorize a third party to produce a patented drug without the consent of the patent holder. They argue that this undermines their intellectual property rights and discourages investment in research and development, which ultimately limits access to new and innovative drugs for patients in India.

Counter argument by Indian companies:

Indian companies, on the contrary, defend their position and policies related to access to medicines and healthcare in India, and have responded to the accusations made by drug MNCs in the following ways:

  • Provides adequate patent protection: The Indian Patents Act provides adequate IP protection, in accordance with the TRIPS agreement. They have also pointed out that the patent laws in India allow for the grant of patents for genuine inventions, while preventing the grant of frivolous or secondary patents (the me-too types), which can result in excessive monopolies and high prices for medicine. 
  • Encourage innovation: Indian policies have not discouraged innovation in the pharmaceutical industry. They have pointed out that Indian companies invest heavily in research and development and have developed several innovative drugs that have been approved by regulatory authorities in India and around the world. 
  • Rare occurrence of Compulsory licensing: The use of compulsory licensing is a legitimate tool under international law and is aimed at promoting public health and ensuring that life-saving drugs are accessible and affordable to patients in India. They have also pointed out that the use of compulsory licensing is a rare occurrence in India and is only used in exceptional circumstances.

Overall, Indian drug companies have emphasized their commitment to improving access to medicines and healthcare in India, while ensuring that their policies are in line with international laws and regulations. They have also emphasized the need for collaboration and dialogue with multinational pharmaceutical companies to find mutually acceptable solutions that benefit patients in India and around the world.

Examples of innovative drugs developed by Indian drug companies:

It’s interesting to note that in the same IP scenario, Indian companies with limited resources, are developing innovative drugs that have been approved by regulatory authorities around the world. Here are a few examples, as reported at different times:

  • Lipaglyn: Developed by Zydus Cadila, Lipaglyn is the first-ever drug approved for the treatment of diabetic dyslipidemia. It has been approved in India and several other countries, including the European Union. 
  • Tafinlar: Developed by Dr. Reddy’s Laboratories, Tafinlar is a kinase inhibitor that has been approved by the US FDA for the treatment of advanced melanoma. 
  • Mycapssa: Developed by Sun Pharma, Mycapssa is a novel oral formulation of octreotide, a hormone therapy used to treat acromegaly. It has been approved by the US FDA. 
  • Saroglitazar: Developed by Zydus Cadila, Saroglitazar is a dual PPAR agonist that has been approved in India for the treatment of diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD). 
  • Nexavar: This much discussed drug, originally developed by Bayer and by Natco Pharma, is a kinase inhibitor that has been approved by the US FDA for the treatment of liver and kidney cancers.

Conclusion:

The IP issues keep haunting India and are being captured in different Special 301 Reports of the USTR, even after The Indian Patents Act 2005 came into force – till 2022. Any change to this Act seems very unlikely now as this is an important piece of legislation that helps balance the interests of protecting intellectual property, promoting innovation and access to affordable medicines. Any dilution of this Act could have negative consequences for India and its citizens.

From this perspective, I reckon, any further pressure in this area may be construed as an attempt to exploit India’s weakness of inadequate access to medicines for monopolistic gain by vested interests. 

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.

Deliver Patient-Perceived Value – Not Incrementally But In Quantum Measure

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Many critical functional areas of most drug companies, such as, marketing, manufacturing, supply chain, medical affairs, human resource, R&D, quality assurance, information technology – traditionally work in silos. It doesn’t mean, though, that there isn’t any interaction between them. Nevertheless, a large majority of them don’t work as a team with a purpose or to achieve a shared goal of delighting customers with value delivered. Such a silo-mindset could often be detrimental to smooth and sustainable business operations. This was also vindicated during the recent pandemic.

Having gone through the harrowing experience of recent disruptions in the lifesaving pharma business operations, a fresh realization has dawned on many leaders’ mind. This point also came to the fore in many studies. One such is the article on ‘Overcoming industry obstacles with a cross-functional strategy’, published by the strategy&, which is a part of PwC network.

The paper came out with some thought-provoking findings. It said, while in the pre-Covid days, mostly competing business pressures used to drive the operational strategies, today the drivers are quite different. ‘Factors such as the COVID-19 pandemic, inflation, geopolitics, new therapeutic modalities, and new ways of working make it vital’ for pharma players to make such transformational operational overhaul for long term excellence.

The spotlight needs to shift from continuous incremental improvement, such as, cost savings, quality assurance, and readiness to deliver—to long-term external challenges. ‘These include high inflation and an increase in complexity and risk, as well as the compounding effects these forces have on each other.”

Several studies have underscored that this approach can ‘make sure operations can protect enterprise continuity while still delivering to patients.’ this article will venture to simplify this complex, yet critical issue. The aim is to achieve a quantum increase in value offering to customers that this strategic approach can potentially deliver to accelerate growth momentum the pharma business.

Some see pharma business as usual, astute leaders see a unique opportunity for change:

An interesting point to note. As the disruptions caused by the Covid pandemic are fading away, some critical health safety norms are also being eased by the authorities. Apparently, the overall daily working-life seems to be limping back to normal. Many pharma leaders are, therefore, considering that the industry operations are going back to pre-pandemic normal, and the business operations will soon revert to the old normal mode soon.

On the other hand, we find some astute leadership who could derive a long-term lesson from the above disruptions and are already in the process of executing those operational changes. This leadership mindset gets reflected in two recent media reports related to two pharma majors – Sanofi and GSK.

On November 28, 2022, it was reported, ‘Sanofi moves into swanky new Paris HQ designed around hybrid work and sustainability.’ Again, on December 12, 2022, another media headline flashed as ‘GSK embraces hybrid work for the long haul at new London HQ.’

To me these are interesting examples to convert problems into opportunities for long-term business success and sustainability, in the new normal. These tasks entail the transformation of business infrastructure alongside its operational strategies.

The need for re-strategizing reverberates across several recent studies:

The need for such an action, as captured by researchers, is prompted by more waves of innovation coming in various operations and functions of pharma business, mostly triggered by the pandemic. The spectrum of innovation, as reports reveal, ranges ‘from new treatment modalities, to smart machines, advanced analytics, and digital connectivity.’

Hence, the future of pharma operations strategy needs to be different now from the past. This finding was also published by the McKinsey & Company on October 10, 2022. It reiterated, as pharma companies are emerging from two years of intense firefighting, now is exactly the right time for their renewed emphasis on a new operations strategy. It emphasized: ‘Succeeding in pharma under these new and challenging conditions will require succeeding in operations.’

This point was further vindicated by the results of the latest McKinsey Global Survey, which states:‘Less than one-third of the surveyed respondents, all of whom had been part of a transformation in the past five years, said their companies’ transformations had achieved a sustained performance improvement.’

Another study very specific to India:

Another survey on ‘Indian consumer sentiment during the coronavirus crisis,’ published by theMcKinsey & Company on October 13, 2022, also reconfirms the subtle changing trend in Indian consumer behavior. Its findings include some of the following areas:

  • More than 70 percent consumers are engaging in modified out-of-home behavior, even as social gathering returning to almost normalcy.
  • Digital continues to hold sway with more than 75 percent consumers using either digital or omnichannel while purchasing across categories.
  • Social media continues to be an important influence while shopping.
  • Gen Z and millennial are leading in new shopping behavior, with value being the top reason and sustainability as an emerging factor.

Hence, to engage with such healthcare consumers and deliver the value as they perceive, pharma operational strategies may call for a rejig – for longer term success and sustainability. That said, a key point to remember is that the marketing function is central while redrawing new operational strategy.

The marketing function is central while redrawing new operational strategy:

The need for the above was well articulated in another study published by ResearchGate in May 2020. It pointed out that many drug companies invest lots of funds to be more productive in various key operational areas, like R&D, manufacturing, or supply chain. However, if marketing strategies are not in sync with contemporary market dynamics and customer behavioral trends, despite game changing improvements in those areas, achieving business growth objectives will be challenging.

Based on the study, the researchers concluded, “an effective marketing in the organization has significant impact in achieving Organizational goals and Operational Excellence in Pharmaceuticals.” The study further emphasized, ‘Operational Excellence and marketing are always interlinked. Therefore, marketing plays a vital role in achieving Operational Excellence in Pharmaceuticals or any other industry.”

Conclusion:

As we know, market dynamics keep changing with time. Generally, some strong trigger factors, such as, Covid related disruptions of lives and livelihoods, may hasten the process of this crucial change. Such changes necessitate long-term transformation of pharma operational strategies, as initiated, for example, by GSK and Sanofi.

As McKinsey & Company articles have articulated, the transformation process and scale may differ from company to company with common long-term challenges remaining the same. Such operating model transformations – involving digital tools, data science with analytics capabilities across the company, often ‘help companies interact with healthcare professionals and other stakeholders more effectively’.

Consequently, the company garners greater capabilities to deliver new patient-perceived value – not just for incremental, but quantum business growth. This, I reckon, could be a game changer for long-term success and sustainability in the pharma 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.

 

Why And How To Be In-Sync With Gen Z As Pharma Paradigm Shifts?

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As science and technology, across the world, are progressing at a scorching pace – Covid-19 pandemic notwithstanding, today’s generations are growing up tech savvy – more than ever before. The trend will keep going north faster and with a steeper gradient. This is being driven by transforming social and economic environments – necessitating quicker solutions to any needs, problems, and expectations.

The current signals, as underscored by an article appeared in the Abbott Website on November 19, 2019: ‘Generation Z’s relationship with technology will also influence how the group relates to healthcare.’ Thus, it’s no secret that millennials approach their health care in drastically different ways than members of the Silent Generation, baby boomers or Gen Z, the article added.

Which is why, gradually shifting paradigm of the pharma industry would also eventually create a brand new one – with the Gen Z population growing at a faster pace. From the above perspective, in today’s article, I shall focus on the importance of this shifting paradigm, especially from the pharma industry perspective, including India.

Expectations and experience of Gen Z are contrasting:

Let me start with the definition of Gen Z. In January 2019, Pew Research defined Gen Z as anyone born after1996, just as ‘anyone born between 1981 and 1996 (ages 23 to 38 in 2019) is considered a Millennial.’ Gen Z grew up with technology, the internet, and social media. Moreover, according to another study of Pew Research, published on May 14, 2020, Gen Z is growing up having experienced catastrophic disruptions in almost all spheres of life and livelihoods, triggered by Covid-19 pandemic. It further ascertained, ‘the oldest Gen Zers have been particularly hard hit in the early weeks and months of the Coronavirus crisis.’

Thus, I reckon, the experience and expectations of many of such Gen Z from business and overall environment around – are quite different from earlier generations. More importantly, they will also have a strong influence on younger ones. Hence, the expected transformation would be much broader than what is currently visible today on the ground.

Some core characteristics of Gen X from pharma business perspective:

Various studies have captured the core characteristics of Gen Z, some of which are very relevant to pharma industry and are worth taking note of – for excellence in business performance. These include the followings:

Digital natives:

As McKinsey & Company highlighted in an article, published on November 12, 2018 that Gen Z is the first generation of true digital natives, and they are expanding. Whereas Millennials were regarded as ‘digital pioneers,’ who bore wit­ness to the explo­sion of tech­nol­o­gy and social media, Gen Z populations are born into a world of peak tech­no­log­i­cal inno­va­tion. In that environment infor­ma­tion is imme­di­ate­ly acces­si­ble and social media becoming increas­ing­ly ubiquitous – endorses another study by the Casey Foundation with its own findings on the core characteristics of Gen Z.

Financial minded:

Finan­cial mind­ed­ness is anoth­er core char­ac­ter­is­tic of Gen­er­a­tion Z for several reasons. A major one being, as discussed – many of them grew up witnessing unprecedented impact on lives and livelihoods caused by Covid-19 pandemic. Several other studies, like the one published recently by the Harvard Pilgrim Healthcare, indicates that millennials and Gen Z are especially sensitive to healthcare costs.

Shrewd consumers and cost-value conscious:

Gen Z show characteristics of shrewd consumers and are also cost-value conscious. Being tech savvy, they are more influenced by fast-expanding digital, world and would like to make well-informed purchasing decisions after evaluating a range of options – both for products and services. They tend to be more influenced by the experience of real-life users, rather than a celebrity endorsement and val­ue per­son­al­ized prod­ucts.

Gen Z to herald metamorphosis of future healthcare:

That it is happening gets retreated in the caption of the Fierce Healthcare article of June 16, 2020 – ‘Industry Voices -Generation Z is a game changer for healthcare.’ It emphasized, ‘Generation Z – are likely to turn the health industry on its head with their unique expectations for how healthcare should be delivered.’

Convenience is such a paramount for Gen Z that they are often willing to forgo a personal relationship with their healthcare provider. Besides, they will come to their physician and provider armed with data, information, and knowledge, unlike the past generations. Consequently, the danger for providers is, if Gen Z doesn’t get that desired convenience, they’ll go elsewhere, the article says. Simultaneously, ‘they also want a trusted adviser who can guide them toward holistic health and wellness.’ Thus, delivering patient-centric care, capitalizing on real-world data and automated care experiences, will be key to the transformative process of healthcare.

A recent survey also vindicates that the transformation has begun:

A recent Accenture healthcare consumer survey reiterated: “The new healthcare consumer is here.” The study clearly signaled a paradigm shift in this space spearheaded by millennials and Gen Z. Some of the survey findings encompass the following areas:

  • This group of healthcare consumer expectations for convenience, affordability and quality are redefining how they engage at each stage of care.
  • They are most dissatisfied with health care’s status quo and more willing to try non-traditional services, such as, virtual care and retail walk-in clinics, which are gaining in popularity and use with them.
  • With greater health care needs, they will increasingly look for services to satisfy their expectations for effectiveness, convenience, efficiency, and transparency.
  • With millennials and Gen Z to become the largest generation in not-too-distant future, they hold the most power to influence future healthcare models.

Some pharma players are tracking Gen Z and the changing paradigm:

Some global majors, such as Abbott, are also writing about it in their website Abbott.com. The Company has noted some of these changes, as follows:

  • Generation Z’s relationship with technology will influence how the group relates to healthcare. While growing up in a fully connected world, they ‘are less likely to have primary care providers and are more likely to use apps for scheduling, viewing medical records and paying bills.’ They are also more receptive to telehealth visits and connected healthcare than previous generations.
  • With the wait times for an appointment with a doctor growing longer, Gen X populations are more likely to use walk-in clinics or opt for urgent care centers which are more convenient.
  • Self-service and convenience play into Gen Z’s interactions with doctor’s and the industry as a whole. They prefer email, texting, and apps to manage their appointments or communications with doctors. Finding ways to communicate with this younger generation in their preferred modes, can help keep them engaged with the industry.
  • Millennials and Gen Z populations are most likely to use a wearable device. They typically reach out to friends or online communities to ask about a particular health condition before speaking with a doctor. Although they aren’t the groups using the more healthcare services, millennials and members of Gen Z are showing what the health industry needs to do to provide the best care.

Size of Gen Z population in India:

According to EY Gen Z survey, released on November 04, 2021, the next decade will be shaped by the maturation of Gen Z, the largest generational cohort in history, where India stands out with a population that includes 375 million people or 27% of the total population in Gen Z. Besides, the survey also underscores the importance of Gen Z in the shifting paradigm of market dynamics for the pharma industry, as well.

Conclusion:

Currently, healthcare industry, in general, and most drug companies, in particular -especially, in India, don’t seem to nurture the fast-growing population of Gen Z with a customer engagement strategy that they can relate to. What these players are currently marketing is mostly aimed at traditional customers, and who still form the majority.

Exploring these evolving changes, I wrote an article in this blog, on November 07, 2016. This was titled ‘Millennial Generation Doctors And Patients: Changing Mindset, Aspirations, And Expectations.’ However, the unprecedented impact of Covid-19 pandemic, alongside rapid advancement and adaptation of digital technology, tools, and platforms, has expedited this process.Apace with these changes the pharma paradigm is also shifting, at a much faster pace than ever before. Which is why, I reckon, it’s important for the entire health care industry in India to be in-sync with Gen Z expectations and engage them, accordingly.

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.

 

Physicians’ Increasing Digital Proficiency And Its Implication

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At a time, when an unexpected and unprecedented Covid-19 pandemic struck a catastrophic impact on human lives, livelihood, and the global economy the healthcare sector continued surging ahead. This is being fueled by exponential advances in medical science, and the pandemic-triggered explosion of digital technologies, data access, analytics – besides emergence of more informed and empowered consumers with new expectations and aspirations.

Echoing this, Deloitte’s paper - ‘2022 Global Health Care Outlook’ articulated: ‘The global health care sector continues to rise up to the new challenges presented by the ongoing pandemic, which continues to dominate health care systems’ attention and resources.’

No more than just a couple of years back, none could predict that a pandemic in these modern days, would have the power to initiate the unforeseen changes so quickly. This is especially applicable to – mostly tradition bound and slow to change – the pharmaceutical industry, even in India, which gets reflected in the growth of this sector. That too, amid sporadic disruptions in the operational areas of many companies.

As reported on December 29, 2021, Indian Pharma Industry registered a growth of 15% in 2021 led by growth of Covid-19 products, against a growth of 3% last year. The report emphasized that the challenges posed by the pandemic gave rise to new opportunities for the pharma sector to evolve quickly under changing circumstances.

Which is why, many players are being compelled to adapt newer digital processes and practices to survive and excel – while navigating through this uncharted frontier. These will call for growing investments for paving a high-tech digital pathway, primarily for an effective customer engagement, besides refinement of the product life cycle through digitization.

To give a sense of perspective on strategic implications of increasing digital proficiency of physicians, particularly in the context of an effective, patient-centric engagement by pharma companies, I shall focus on this development, in this article.

HCPs digital proficiency poses a fresh challenge – it’s real:

Increasing digital proficiency of HCPs during Covid-19 pandemic poses a fresh challenge to pharma marketers for several reasons. It’s so real, which will invite many fundamental strategic changes, as Covid-19 isn’t going anywhere, at least, anytime soon, contrary to what many people are expecting.

The emergence of Delta and Omicron like variants that infected a large number of fully vaccinated people, as well, is expected to continue. For example, as reported on January 27, 2022: ‘Just as the omicron surge starts to recede in parts of the U.S., scientists have their eye on another coronavirus variant spreading rapidly in parts of Asia and Europe.’

Increasing digital savviness of HCPs is now unstoppable. It is expected to keep rolling at faster a faster pace now than ever before. Endorsing this trend, an article published in the Pharmaceutical Executiveon January 20, 2022, made some interesting observations.

The author underscored that the trend of the digital shift of HCPs in their professional space, is an outcome of a catalytic effect of the pandemic. It poses a new challenge for the life sciences industry, requiring a complete revamp of the content strategy and customer engagement channels, for each specialty. It further said: ‘The wave of consumerism led by digital natives has impacted HCPs when it comes to engaging with content on various digital channels for personal consumption.’  

A recent research study vindicates the magnitude of the challenge:

A recently published Indegene study, revealed some thought-provoking areas in this space. The research surveyed 984 physicians from the United States, Europe, India, and China for this study. All participants have >10 years of experience and represent a broad spectrum of specialty areas. According to Indegene, the process of surveying HCPs had started since 2014, to identify how their digital habits manifest and how do they change. Some of the key findings of the study include:

  • More HCPs, in general, are increasingly adopting digital channels to consume content.
  • 77% of HCPs use digital channels primarily for personal learning and development.
  • 68% of HCPs prefer short webinars or webcasts over other virtual
    engagement channels, globally.
  • Only 47% of HCPs prefer receiving communication through the marketing e-mail channel, although, marketing emails are among the top 5 channels used by pharma companies to engage HCPs. 
  • 62% of HCPs are overwhelmed by product promotional content pushed by pharma companies on various digital channels.
  • 70% of HCPs said that pharma representatives do not understand their requirements completely. Further, 62% of HCPs said that the most significant area where pharma representatives can add value is, by understanding the needs of HCPs and sharing only relevant content with them to make the interactions more insightful. The one-size-fits-all approach will no longer work, and pharma companies will have to invest in greater personalization at scale and build better content development and operations capabilities.
  • Pharma to consider using digital channels to provide HCPs on demand access to reps and content.
  • Need to map and implement geographic variations in HCP preferences for content, channels, device, and time.

This evolving trend sends clear signals to pharma marketers that need for professional engagement with the HCPs has to be on their own terms in the new normal

‘Engaging HCPs on their own terms’ – the need of the new normal:

This emerging need also came out clearly in another recent Global Physician Specialty Survey by Medscape - with over 12,000 participants in key specialties across Europe, Latin America, Canada, Asia, and MENA.

It provided some actionable insights, highlighting online content consumption habits of HCPs across the globe, in the new normal. This study also found: ‘The pandemic has had an undeniable impact on the interactions between HCPs and the pharmaceutical industry, with the shift towards virtual engagement and online events likely to be long-lasting.’

Based on this finding, it flagged a critical issue. This is, while the consumption of online medical content is growing and traditional in-person meetings are still not completely back on the agenda, how can pharma players reimagine the way they reach their target audience? This is indeed a primary business requirement to maintain respective drug company’s share of voice and foster relationships with their key customers. The key takeaway from this study includes the following:

  • Being incredibly time poor even now, HCPs mostly prefer to engage with the pharma companies on their own terms.
  • Compared to traditional in-person interactions, most HCPs feel, digital engagement channels offer them greater flexibility that they desire.
  • Over half of the survey respondents rated their online consumption of digital content higher, or much higher now than before the pandemic.

Conclusion:

On the positive side, during a short span of the last couple of years, Covid-19 pandemic has also triggered unprecedented advances in various critical areas of medical science and related areas. These include, remote healthcare services, digital technologies, ease of access to required data by all, the application of sophisticated analytics and above all emergence of an increasing number of digitally empowered customers. Consequently, aided by greater disease awareness and the need for prevention, the ‘self-care’ space also witnessed exponential advances.

Besides, the pandemic has also offered a fresh opportunity to the pharma and biotech sectors – to leverage the break in the cloud for accelerating all-round innovation – charting new frontiers of the modern digital world to remodel their business models for a faster growth in a new paradigm. Although, pharma customers have remained mostly unchanged, their expectations, behavior, practices, and preferences have undergone a metamorphosis. Some of these changes may be stark, and more may be a bit nuanced. Marketers, need to map all the changes, which are specific to their organizations, to excel in the new paradigm.

That said and, as pointed out above, results of expert surveys and syndicated studies in this area, send a clear signal about the pandemic-triggered – increasing digital proficiency of HCPs, even in India. This trend needs to be leveraged for a thorough overhaul of pharma’s customer engagement models. This is a new ball game of the new normal – having a huge impact on the business performance of drug companies.

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.

Deliver The Best Patient Outcomes With Right High-Tech-High-Touch Combo

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Healthcare is regarded as an industry where high-quality technology and high-quality human touch can’t possibly be separated from each other, ever. Since long, this is considered essential in delivering better treatment outcomes – the core value most patients desire, and buy – directly or indirectly.

Why high-quality technology helps make treatment of various diseases increasingly more effective, is no-brainer. However, amid high decibel ‘digital’ buzz during Covid-19 pandemic, some may also wonder how does ‘high-touch’ help improve treatment outcomes? Against this new backdrop, I shall explore in today’s article: why high-touch is so important for most patients alongside high-tech, and the critical need of striking a right balance between high-tech and high-touch in most areas of healthcare delivery. Let me start with a brief recap of the same in the pharma industry perspective. 

Balancing high-tech and high-touch in pharma – a brief recap:

In a similar context – against the  contemporary market dynamics, I discussed about Pharma’s new and still evolving pathway for digital and F2F customer engagement on February 15, 2021. This is primarily because, today’s patient-centric marketing model has to be on Omnichannel platforms to deliver patient-expected value, effectively – and more.

In this mix, F2F customer engagement process is just one among several channels – but a critical brand demand generation tool, though – giving a feel of ‘high-touch’ – in-person interactions to many key customers. Many studies show, alongside acceptance of ‘high-tech’ digital channels, customer expectations for ‘high-touch’, by and large, continue to exist, even today. Thus, one of the key responsibilities of pharma marketers is to arrive at the optimal combination of in-person F2F engagement channel, and high-tech digital channels for remote engagement.

However, this isn’t the unique need of the new normal. On April 29, 2019, I wrote about the evolving new pathway is a hybrid business model. It is customer-centric and helps create a right blend of high-tech and high-touch approaches. Striking an optimal balance between the two is critical to successful business outcomes. This brings me to the point of the relevance of ‘high-touch’ in healthcare.

The relevance of ‘high touch’ in healthcare:

Since time immemorial, a strong bond of trust-based doctor-patient relationship has remained pivotal in the disease treatment process, across the world. This still exists regardless of the socio-economic status, and degree of patient literacy, including digital – particularly for moderate to severe ailments.

A recent article – ‘High-Touch Telemedicine’, published by CFHA on June 04, 2020, also highlighted, “Touch has been central to the physician-patient relationship for as long as there have been physicians. Patients allow their doctors to touch them in places and in ways that they would allow to no one else.  The gentleness and the carefulness that doctors are trained to use on this touch is a bonding experience that supports healing.  If this trust is violated, if a doctor is unduly forceful or disrespectful, this can be a cause for grievance and even litigation.”

The scientific pertinence of physicians’ high touch for patients:

This point was lucidly elaborated in the above paper. It said, the doctor’s comforting physical touch, and interactional touch, have impacts on the Neuroendocrinology of the patients involved. Thus, physicians’ high touch when used in a benevolent conversation, releases the neuropeptide oxytocin in the brains of both participants. This, among others, helps to improve recognition of emotions, increase mutual trust, so compliments and the recognition of a person’s efforts and successes.

Covid-19 propelled ‘high tech’ in healthcare to a new high sans ‘high touch’:

The Covid-19 pandemic, undoubtedly, propelled healthcare into a virtual world. It triggered the development of a plethora of ‘high tech’ innovations to deliver prompt healthcare to patients suffering from various ailments, even from remote locations. One such example is telehealth. Many healthcare providers, including the Government of India realized that leveraging the potential of ‘Telemedicine’ can effectively address the healthcare needs of a large population, across the world.

That said, I reckon, although, healthcare can’t survive without high tech. But, a high-tech-healthcare, like telemedicine, can’t totally replace high touch, at least, in the treatment process of several moderate to severe ailments.

The Best and the worst-case scenario for only high-tech healthcare:

As studies indicate, only high-technology based healthcare sans high-touch, in the best case scenario, would facilitate affordable access to treatment for more patients, bringing down administrative time and cost, in tandem. Which is why, when Covid-19 pandemic posed unique challenges to providing health care, India’s health policy makers revised the nation’s Telemedicine Practice Guidelines on March 25, 2020. They acknowledged in the manual, high-tech Telemedicine ‘increases timely accessto appropriate interventions, including faster access and access to services that may not otherwise be available’.

Whereas, in a worst-case scenario, only digital access to healthcare may create some barrier to direct physical examination of the patient by the doctor, and their interaction. This may impact patient emotion – so important in the disease treatment process. Thus, although high-tech is essential for the advancement of healthcare, but can’t totally replace a patient’s need for high touch care.

High tech is essential, but can’t replace high touch-based trust:

Several recent papers deliberated this point with umpteen evidences. One such paper was published in the Harvard Business Review on October 30, 2019. The article is titled, ‘AI Can Outperform Doctors. So Why Don’t Patients Trust It?

The research points out, ‘patients are reluctant to use health care provided by medical artificial intelligence, even when it outperforms human doctors. This is because, patients believe that their medical needs are unique and cannot be adequately addressed by algorithms. To realize the many advantages and cost savings that medical AI promises, care providers must find ways to overcome these misgivings.’

The study also found that when health care was provided by AI rather than by a human care provider, patients were less likely to utilize the service and wanted to pay less for it. They also preferred having a human provider perform the service even if that meant there would be a greater risk of an inaccurate diagnosis or a surgical complication.

Given a choice – ‘patients will always highly value and seek out human touch’:

This point was also deliberated in another study, published in the MedCity News on January 14, 2021. Acknowledging: ‘Effective, modern medicine cannot survive without technology,’ it brought to the fore an important finding: ‘Regardless of how intuitive the software – or how advanced the technology – patients will always highly value and seek out human touch’ because of several reasons. Some of which are as follows:

  • Patients believe that their medical needs are unique and cannot be adequately addressed by algorithms. Patient experiences aren’t meant to be 100% digital. And despite the accuracy of computers, humans prefer to seek care from other human beings.
  • Different patients have different emotional needs. Life-altering diagnoses and unforeseen outcomes are best delivered by a living, breathing, feeling individual who can fully understand and address these needs.
  • Physical examinations by a doctor are more reassuring and restorative for patients.

The author concluded, high tech is absolutely necessary for the progress of health care, in general. However, in the foreseeable future, high touch would remain an instrumental part of patients’ healthcare experience.

I believe, one can even experience it as the Covid-19 safety restrictions will start easing, or even now – to some extent. Therefore, ‘healthcare professionals must find a way to blend the sophistication of technology with the power of touch in order to continue improving patient experiences, care, and outcomes’, the paper underscores.

Conclusion:

Just as in the pharma business, a right-mix of high-tech and high-touch is also necessary in overall healthcare space, to deliver the best health outcomes to patients. After initial disruptions, a similar trend is emerging even in the new normal. No doubt, usage of high-tech digital platforms is here to stay, and further improve in the years ahead. But, digitalization alone in the healthcare space, should not be construed as something that can make high-touch totally irrelevant or redundant in a patient’s journey for disease treatment.

The mindset of mutual exclusiveness of high-tech and high-touch, if any, either during patient-treatment or in the customer engagement process needs a revisit. As it appears, it is neither desirable in customer engagement, nor in patient treatment processes – akin to one approach suits all. This is because, healthcare is very personal to patients – more than most other areas. A lot of individual feelings and emotions are involved in patients’ end-to-end journey for treatment, where only high tech-based solutions may not meet all patient expectations – sans high-touch of physicians, as I deliberated above.

Thus, effective integration of high-tech-healthcare with high-touch of physicians, nurses, and some technicians, is evolving as the right way to deliver patient expected values, for better health outcomes. From this perspective, alongside most other stakeholders, astute marketers are realizing that high-tech digitalization isn’t a panacea for effective pharma marketing. Delivering the best patient outcomes with the right high-tech-high-touch combo, is the name of the game.

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.

What Have And Haven’t Changed In Pharma’s New Normal?

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While navigating through the challenge of disruptive changes, several pharma marketers are now focusing more on creating, connecting, and leveraging all market and customer related data, across the organization. Astute ones are using state-of-the-art tools, platforms, and techniques to gain actionable insights on new demands of pharma markets. I wrote about it in my article - ‘Data: the new ‘Magic Wand’ For Pharma Business Excellence,’ published in this blog on October 01, 2018.

This process is helping them to fathom what areas the pandemic has changed and what it hasn’t. Their aim is to draw cutting-edge strategies accordingly for market effectiveness – outperforming competition. This article will explore that space with contemporary examples. Let me start with a few illustrations of some hits and misses for the treatment of Covid – as the world started learning to live with this menacing virus. This was enviable, as the requisite scientific date wasn’t readily available at that moment of truth. But the time has changed now.

Some hits and misses:

As the pandemic overwhelmed the world, and no well-documented treatment for infection caused by the brand new virus – Covid-19 was available, many drug players were given quick emergency approval by country regulators for some repurposed drugs. But most of those weren’t found effective as fresh clinical data started pouring in. For example, the World Health Organization (WHO), have, reportedly, indicated that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.

More recently, Gilead Sciences Veklury – a failed Ebola drug, repurposed for hospitalized Covid-19 patients, suddenly became a blockbuster drug, according to a September 17, 2021 report. However, in less than a year, alongside more research data - a study from Europe, published in The Lancet Infectious Diseases, showed that Veklury has no real benefit. The report also highlights: ‘Aided by a ringing endorsement from then-president Donald Trump, Veklury rang up sales of $2.8 billion in 2020, including $1.9 billion in the final quarter. But those sales slid this year to $1.5 billion in the first quarter followed by $829 million in the second quarter.’

Similarly, there are several areas that are seemingly getting transformed, triggered by the pandemic and the time for resorting to a hit or miss approach, is now virtually over. From pharma marketers’ point of interest, it will now be at one’s own peril for not challenging the pre-Covid business traditions, rules, and well-tried strategies on customer relationships and brand building models. This brings us to the question on what specifically have changed in the new normal as the pharma industry navigates thorough the Covid pandemic – for close to two years now.  

Pandemic-triggered changes in the pharma marketing area:

Changes are many and are being studied across the world. One such recent analysis, articulating how the pandemic triggered changes have redefined marketing, was published by the Harvard Business Review (HBR), on March 10, 2021. This paper came more than a year after the pandemic overwhelmed the world. This article listed some interesting macro-level changes, including the following:

  • Old normal: You are competing with your competitors.
  • New normal: You are competing with the last best experience your customer had.
  • Old normal: Customers hope you have what they want.
  • New normall: Customers expect you to have exactly what they want.
  • Old normal: Courting customers is just like dating.
  • New normal: Courting customers is just like online dating.
  • Old normal: Customers must sit at the heart of your marketing strategy.
  • New normal: Customers must sit at the heart of your customer journey.
  • Old normal: Agility is a technology process.
  • New normal: Agility is a modern marketing approach.
  • Old normal: Your brand should stand behind great products.
  • New normal: Your brand should stand behind great values.

To illustrate the point, let me now give a few examples of some micro-level changes in the same space.

Some transformation trends:

I am citing a few examples related to pharma’s traditional sales and marketing models. One such area is, quite a few companies are adopting connected data based and analytics-supported Omnichannel approach for customer engagement. The key objective is to deliver coherent and high-quality customer experience.

The need for new commercial models for the changing life sciences market, was also highlighted in an interesting article, published in the Pharmaceutical Executive on September 16, 2021. The authors identified six health care macro trends, demonstrating the value of transforming care delivery and shifting market behavior that prompt to reframe customer value propositions.

Taking a cue from this paper, I am listing below some of the current trends – as I see these and wrote before in this blog. Each one of these calls for well-connected data with analytics support:

  • Fostering a new genre of ‘customer-brand relationship’ to drive more targeted go‑to‑market strategies, enhanced agility/mobility of resources and highly personalized customer interactions.
  • Meeting the growing demand for value‑based care with novel risk‑adjusted and outcome‑based Price-Value-Models, supported by ongoing innovation in this area and sophisticated approach to value, affordability and outcomes.

Interestingly, despite Herculean constraints, many pharma players continued creating and delivering value, as the customers were expecting with changing situations.  

Drug-price sensitivity is increasing:

In the new normal, drug price sensitivity of customers is increasing manifold, for various reasons. 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.

In my article of September 14, 2020, I also wrote that the concept of ‘fair pricing a drug’ is being deliberated by many experts around the world, since quite some time, till today. But it continues. Most recently, as reported on September 22, 2021, for different reasons related to its new Alzheimer’s drug - Aduhelm, including its hefty price tag of $56,000 annually per patient, ‘Biogen reps banned from D.C.-area neurology clinics.’

Regardless of such customer reactions, the pharma industry, as reported on September 17, 2021, continues to advocate – drug pricing pressure will stifle innovation, blocking patient access to needed medicines and dry up investment in important R&D on new therapies. Curiously, the Pharmaceutical Research and Manufacturers of America (PhRMA), is spending more than $1 million on TV ads as part of a massive lobbying and communications campaign emphasizing the potential harm to patients seeking cures for deadly diseases, as the report highlights.

Innovation – remained mostly unhindered from old to new normal:

Customers’ expectations can’t be ignored indefinitely. Interestingly, the world has also witnessed it with Covid drug and vaccine innovation continuing even during the most trying times during the pandemic, even in India. It is, therefore, quite understandable why unfettered access to drug innovation is considered an oxymoron, by many.

The good news is, despite shrill voices over pricing measures, the quest for adding meaningful value to the healthcare space continues unhindered. As reported on September 19, 2021, both Pfizer and Merck are advancing oral antiviral candidates targeting Covid-19 into late-stage testing. Thus, I reckon, regardless of jarring noise from pharma lobbyists, drug innovation, willy-nilly, has to satisfy the diverse demand of health care customers.

Innovation needs to satisfy demands of diverse healthcare customers:

That, increasingly, drug innovations will need to be based on their ability to satisfy the demands of life sciences companies’ diverse customer-perceived value-based, was also echoed by the Pharmaceutical Executive article of September 16, 2021.

While doing so, companies will need to structure innovation in terms of health outcomes, affordability, and personalization, as the paper emphasized. It further added, ‘broader definition of innovation means products are no longer the central driver of value.’ Instead, innovation will be powered by an increasingly diverse stream of data that resides outside the confines of the traditional health ecosystem.

Covid pandemic accelerated the transition of this process of innovation, drawing its new focus on providing a seamless and holistic customer experience in the disease treatment process – supported by advanced analytics and this deeper understanding of customer segments.

Conclusion:

Many pharma marketers have possibly undertaken a sophisticated and credible market scanning exercise in the new normal, to assess by themselves what have or haven’t changed in their customer preferences and market dynamics. If not, I would encourage them to initiate it, at least, now.

Equally noteworthy, as the above HBR article wrote, in the post pandemic period: ‘Beyond geography, marketing messages need to be personally relevant, aligned to an individual’s situation and values, as opposed to demographics, such as age and gender.’

The objective is to create a personal connection between the customer and the brand promotional content, aiming to influence the prescribing and purchasing behavior, based on their psychographic to attitudinal characteristics. This process would require creating and screening lots of customized data, supported by sophisticated analytics.

From the above perspective, I reckon, deep insight on what have or haven’t changed in the healthcare environment alongside its customers, would be of fundamental importance for pharma marketers, 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.