Sandra Sanchez-Oldenhage – General Manager NoLA Region, Novartis Oncology

Sandra Sanchez-Oldenhage, General Manager Novartis Oncology North Latin America (NoLa) Region, outlines her concerns regarding access to innovation in Mexico, and her strategy to position Novartis as the key partner of choice for the government in diagnosing and treating cancer and blood disorders in Mexico and the region. Sanchez-Oldenhage also highlights the company’s “Unbossed, Inspired and Curious” culture, what this means to her, and the challenges of implementing this in a country like Mexico.

 

As the head of the Novartis Oncology NoLA region, there is really one overarching priority: Access

Sandra, what attracted you to take up this general manager role at Novartis Oncology?

Novartis and its predecessor companies trace their roots back more than 250 years, with a rich history of developing innovative products, honoured with numerous awards for progress in R&D, solid growth track record, working environment and corporate responsibility activities, which make it a well-respected and leading company. Novartis ranks #4 in Fortune Magazine’s Most Admired Companies in the Pharmaceutical Industry list. Within this context, let me tell you what else attracted me to Novartis Oncology.

First, it is a global leader in oncology and blood disorders with the largest oncology portfolio in the world. The company has 25 approved medicines and has one of the largest clinical engines (in breast, lung, melanoma, kidney, haematology), hence a broad pipeline with over 10 new molecular entities. Our history precedes us, as we have been in the oncology business for over 20 years and have revolutionized cancer treatments.

Cancer is not one disease, but a constellation of diseases of immense complexity that cannot be solved by only one approach. Novartis is uniquely positioned to lead the next wave of novel treatments in cancer & blood disorders through their presence and strengths in four bold treatment platforms across key disease areas: targeted therapies, cell & gene, differentiated immunotherapies, and radioligand therapies. No other company is doing this. Novartis is looking at different pathways, different MoAs, etc. to treat grievous illnesses. As you can understand, oncology is an important growth driver for Novartis. We are indeed reimagining science in everything we do.

Second, since becoming CEO, Dr Vas Narasimhan has led a strategic and cultural transformation at Novartis to build a leading medicines company globally powered by advanced therapy platforms and data science. He has been working relentlessly to set the company on a new path to reinvent itself. Culture has been a big push at Novartis. He strives to show that culture drives both performance and innovation, pushing towards productivity and building trust with society, thus keeping us at the cutting edge for years to come

The culture at Novartis emphasizes an informal environment that relies on three leadership pillars: Inspired, Curious & Unbossed. This is a culture where people engage in our purpose, become a learner and not a “knower”, become accountable, empower & support others, remove obstacles and are self-aware of their energy and impact. This culture is cascading down through the management chain as we speak. I see this as a very forward-thinking and entrepreneurial culture that will indeed put us at the forefront of the industry. Even as a top ten company worldwide, Novartis continues to reinvent itself, especially now before a “new normal” and with a global crisis underway.

The third reason I decided to join Novartis relates to the opportunities and challenges in the NoLA Region. One of these challenges is access to innovation, not just for Novartis but across the industry; this is a challenge I want to be part of unlocking. Overall survival rates have a direct correlation to access to innovation. This is part of making a difference in patients’ lives.

In summary, I wanted to be part of a company that is continuously reimagining science in the pursuit of transformative treatments by unleashing the power of people through an “unbossed” culture and that strives to make a difference by dramatically improving patients’ quality of life (QoL) and reaching underserved populations.

 

The first 100 days in a country or region role are crucial. What priorities and groundwork have you put in place since you joined earlier in 2020?

Currently, and understandably, in the next few weeks, my focus is to get us through the COVID-19 outbreak, which has been challenging for all. Thus, my list of immediate priorities has changed. I am trying to be present and focused, along with being adaptable and agile so I can ensure I am supporting my team and removing obstacles. This way they can stay safe & healthy, take care of their families while guaranteeing we are serving and delivering medicines for our patients.

However, my first 90 days have enabled me to:

1) LEARN (@ 30days) the organization’s perception of its purpose and strategy, gathering data by observation, listening, learning, and resisting the urge to “fix things”. This first 30 days has been about understanding how the organization is structured, what staff believe the organization’s customers need, how well those needs are being met, the details of the organization’s finances. In the end, this period is about being neutral with factual data to help highlight the current operation’s strengths and opportunities.

2) CLARIFY (@ 60days) the desired expectations for all players. I described priorities, “What” targets and “How” we should deliver on those targets. This time was about clarifying vision, values, strategy, and goals.

3) ALIGN (@ 90days) plans, decisions, and actions to best serve customers, stakeholders, and staff. I attempted to align activities to declared expectations.

In terms of priorities as the head of the Novartis Oncology NoLA region, there is really one overarching priority: Access. This means ensuring we can expand the availability of our drugs in Mexico and the region; making sure that patients and especially the underserved populations who are fighting & suffering from cancer and blood disorders can access our drugs if prescribed. These two chronic grievous illnesses, cancer and blood disorders, have an incredible social and economic impact and burden on the patients, caregivers and the healthcare systems. Novartis is committed to advancing science aimed at dramatically improving people’s lives; but we need to ensure patients can access this innovation, which has been proven to extend people’s lives and/or improve quality of life, thus unburdening the system.

Novartis Oncology has amazing science and truly innovative treatments in breast cancer, lung cancer, melanoma and blood disorders ((chronic myeloid leukemia (CML), myelofibrosis (MF), Polycythaemia vera (PV), chronic immune (idiopathic) thrombocytopenic purpura (ITP), severe aplastic anaemia (SAA)).

Our strategy is to closely collaborate with key stakeholders across the healthcare arena, including government, academia, the medical community, patients, and NGOs, to ensure we can find holistic solutions to the challenging demographic and epidemiological changes occurring, coupled with cost-burden and budget containment dynamics in the country. At Novartis, I am working to approach business as a community-building effort. In my opinion, this is the only way to secure a win-win outcome.

We have to continue to innovate the way we join forces with external business partners, payers, patients, advocates, governments, healthcare systems, and academic institutions, looking for solutions that evolve our business model and serve patients with a strong value proposition that expands access – looking at risk sharing models, managed access programs, digital patient and customer support initiatives and the like.

We know it is not enough just to introduce transformative therapies; we must get them to patients who need them. Therefore, we need to share responsibility among all key stakeholders.

 

What do you believe is holding the region back when it comes to access to innovation?

Mexico, Central America & the Caribbean together gathers more than 200 million people, which represents over 30 percent of the total population of Latin America, clearly a sizeable population in the developing world, with health issues which need addressing. We must understand that health is a pillar of development for a country and our region must improve public health outcomes, or social and economic improvements will not be sustainable. Innovation is part of aiding in that improvement.

All stakeholders need to be involved and collaborate to be able to do this. Novartis sees itself as a partner of choice committed to doing our share to reach the most vulnerable and most neglected sectors in a sustainable way. How? By helping to expand access of our new treatments for unmet medical needs, either through local clinical trials, formulary inclusions, patient support programs, managed access programs, innovative risk-sharing models, etc. Why? To help address the huge health challenges countries that this region faces. These include:

Below average health expenditure. Health Expenditure as a percentage of GDP in Latin American countries is 6.7 percent. In Mexico  it is less than 5.7 percent; the OECD average is nine percent. There is a high variability in the expenditure, coverage of healthcare systems and per capita income in each country; average investment in public health is below that of First World countries

Partial access to health services. Since the 1990s the WHO has urged countries in the region towards universal health coverage (insurance). Approximately 30 percent of the population of Latin America and the Caribbean do not have access to healthcare for economic reasons and 21 percent do not seek care because of geographical barriers.

Burden of epidemiological transition and chronic non-communicable diseases (NCDs). Life expectancy is higher and with that comes an increased burden of disease resulting from chronic NCDs such as hypertension, diabetes, cancer, and obesity.

Limited availability, training and distribution of human resources in health. Few countries in the region meet international indicators, such as number of doctors/nurses per 10,000 inhabitants, or hospital beds available per 1,000 inhabitants, coupled with poor distribution across the countries

Inequalities in health. Latin America is characterized by a high level of inequity and inequality, with a significant percentage of the population at the base of the pyramid.

Challenged & pressured health system financing. Changes in patterns of disease and rising aging populations increase the cost of healthcare. Currently health systems finance their services based on illness, which means resources have to increase as more people get sick. This mechanism becomes unsustainable because it encourages a system based on disease and not health, and for this reason over time, the system, as well as the resources become limited.

In the end, the biggest challenge is not only an issue of balancing budgets and cost-containment, but a lack of understanding of the science and promise behind innovation by decision makers. If key stakeholders do not understand the science behind it, then there is little hope for them appreciating how innovation can improve a patient’s QoL, hence their productivity and in many cases improved overall survival rates that at the end unburden the healthcare system.

Moreover, the decision-making process in Mexico is extremely fragmented, and there is no sole entity making a final decision; someone decides on access from a medical perspective, someone else from a financial perspective, and finally someone else from a prescription perspective. Through this fragmentation, and by not viewing healthcare or the treatment of a disease in its entirety, you have a final decision that is not truly reflective of the patient or institution’s / country’s needs. It is critical that the final decision-making body connects the dots to fully recognize the value of innovation.

To give you an example, we have an oral treatment for advanced breast cancer vs traditional therapy, which usually involves chemotherapy (IV infusion) constituting a significant financial burden. This economic burden has an increasing trend, with hospitalization being the highest cost factor, lost productivity days, nurses, etc. This oral drug has revolutionized the treatment of the disease as patients no longer have to be hospitalized and any dose adjustment can be easily done with the same SKU and no drug waste. If we were to tally the cost of a chemotherapy treatment against the cost of an oral treatment, we have significantly reduced the financial burden on the healthcare system. The “cost” of innovation is now a different picture, relieving budgets and having a direct impact on QoL, thus patient productivity and well-being

 

What is your initial take on the new administration in Mexico and their view on healthcare in the country? Would you say it is untrustworthy?

I would be hesitant to label the new administration as untrustworthy, but rather their “good” intentions lack realistic experience. There have been communications from different stakeholders in authority which have been conflicting. Everything that President Andrés Manuel López Obrador (AMLO) has stated in terms of creating universal healthcare and trying to deliver a social healthcare message sounds idealistic. His intentions may be genuine, but I feel that they are disconnected from the real world and he is struggling to achieve them. Regardless, decisions are being made too fast without a thorough consultation and guide adoption from experts. To repeal and replace Seguro Popular with the Institute for Welfare (INSABI) when you do not even have a clear outlined program to replace it with results in a big stormy cloud over what INSABI entails.

For Novartis, Mexico is one of the top markets in the region and often considered the entry point to LatAm given its border to the US. Mexico is usually an early adopter for new technologies, innovation and treatment trends, i.e. the country to follow in the region. Moreover, cancer represents the third biggest cause of death in the country (1) and is growing. As we have already discussed, its population, its demographic & epidemiological trends and the transformation of the healthcare system, represent a huge opportunity to rethink the way in which our medicines reach the population in need, despite the fragmented system and the highest out-of-pocket spending (47 percent vs a 19.5 percent OECD average) dynamics of the country. This changing environment represents the chance for Novartis Oncology to position ourselves as the trusted partner of choice in cancer and blood disorders to improve outcomes for patients and change the practice of medicine. We need to approach the oncology business as a community-building effort.

Let’s look at the facts:

Oncology, blood disorders and diabetes are the fastest-growing therapeutic areas (Breast cancer, melanoma, lung cancer, leukemia (CML – chronic myelogenous leukemia), myelofibrosis, ITP).

Access to innovation has been very slow & bureaucratic vs other countries (less than four years, but five to six years for oncology compared one year in the US, two in the UK and three in Brazil. This impacts overall survival years (two years in Mexico) compared to first world countries (eight to ten years). This is not sustainable.

Healthcare today is at the forefront of the agenda, not only because of COVID-19, but also because of drug shortages, especially cancer drugs, which have forced patients to the streets to protest against the government, thus getting strong government / AMLO attention.

AMLO has expressed his vision of integrating and centralizing the current significantly fragmented healthcare system and committing to increase its investment by one GDP percentage point, hence major reforms have been introduced by the government:

  • Aiming for Universal health coverage
  • Dissolution of SP – repealed & replaced for INSABI
  • “Elimination” of NBFormulary (Cuadro Básico)
  • Social healthcare messaging – constitutional right to healthcare, free drugs for all, focused on base of pyramid who are in dire need of healthcare and therapies
  • Centralization of power and resources vs significant fragmentation in the current healthcare system
  • Finance minister’s role – centralization of tenders and procurement, favouring generics, thus liberating resources for potential investment in innovator drugs (sole source)

 

Potential opportunities for Novartis Mexico include:

  • Cancer at the frontline of the news, thus sensibility to treat and address the issue
  • Spill over effect in the private segment given shortages in government – significant growing trend of over 30 percent
  • Providing tailored and scalable access solutions by teaming up with government to come forward with value propositions, such as risk sharing innovator approaches, to address dire needs in cancer and blood disorders
  • Develop commercial and social business models that address the government’s concerns
  • Patient organisation engagement by providing educational opportunities to understand their journey & needs to empower them to seek the right care and help healthcare professionals to best treat them.
  • Potential to explore options for access to investigational medicines – clinical trials

 

Our commitment to patients, caregivers, healthcare professionals, payers and the local healthcare system is to become the partner if choice that drives collaborative relationships to improve outcomes for patients thus becoming a trusted cohort in changing the practice of medicine

We know it is not enough just to introduce transformative therapies; we must get them to patients who need them. Therefore, we need to share responsibility among all key stakeholders.

Examples of what we do:

  • Expanding sustainable access – depending on the ability to pay
    • Novartis Oncology has been a leader in patient access programs since launching the Glivec International Patient Assistance Program (GIPAP) in 2002, which entails medicine donation (imatinib – leukemia). Glivec reimagined and significantly changed the therapy of chronic myelogenous leukemia (CML), transforming it into a chronic disease rather than a mortal disease.
    • After over ten years of GIPAP and four years of Novartis Oncology Access (NOA – donation and commercial mix / co-pay)), Novartis has expanded access to oncology medicines for more than 80,000 patients
  • Clinical Trials – a way of expanding early access and reducing costs to patients and systems
  • Payers
    • An array of value-based approaches such as risk sharing (i.e. outcomes based, testing, diagnosis & tracking, sub-populations…), patient support programs
  • Managed Access Programs (MAPs)
  • Patient Organisations
    • We continuously work hand by hand with Patient Advocacy Groups to understand the patient community perspective and needs. One of our goals is to help them build capabilities and support them in their continuous growth towards their professionalization. i.e.:
      • Disease awareness
      • Improving adherence
    • Diagnosis and monitoring (melanoma, myeloproliferative neoplasms and chronic myeloid leukemia, among others)

 

By partnering with all key stakeholders at different levels and intensities we can extend affordable access to more of our medicines for a broader number of patients. This partnership-based approach allows for local adaptation of different models based on each country’s specific needs

Our access strategies are grounded on three principles: addressing the needs of underserved populations through R&D, further improving the affordability of our drugs and strengthening health systems. We are committed to continuing to provide tailored access solutions, including fair business models.

Thankfully, healthcare today is at the forefront of the federal agenda. We can thus work with key stakeholders to provide tailored and scalable access-solutions for the government, but this requires compromise on both sides. We need to be a part of the solution.

My personal commitment and company strategy is to increase access and establish Novartis Oncology as a partner of choice, who is committed to expanding access and reaching the most vulnerable and neglected sectors sustainably.

 

Where does Mexico stand in terms of the introduction of CAR-T Therapies?

Novartis continues to innovate with cell & gene therapies. Both therapies aim to treat, prevent and potentially cure diseases. Cell & gene therapies offer hope for a wide array of untreatable diseases and difficult to treat diseases which actually have poor prognosis such as acute lymphoblastic leukemia (ALL) for which our CAR-T cell product was FDA approved (Aug ’17/ EU Aug’18) as the first breakthrough ever CAR-T therapy (chimeric antigen receptor T cell). Patients with this disease often have to undergo multiple treatments, including chemotherapy, radiation, targeted therapy or stem cell transplant, yet less than 10 percent of patients survive five years.

Our CAR-T cell is an innovative immunocellular therapy designed as a one-time treatment. A first-in-class therapy, that has shown high rates (83 percent within three months of Therapy) of remission (CR complete remission) and durable response | in this patient population. A significant step forward in cancer treatment. Novartis is proud to be at the forefront of advancing this breakthrough innovation for patients.

CAR-T therapy represents a significant step forward in treatment and is the embodiment of personalized medicine – each dose is tailored individually to, and manufactured for, each patient using the patient’s own T-cells, a type of white blood cell. The therapy, which is not a pill or traditional chemotherapy, is produced via pioneering technology and a sophisticated manufacturing process.

We have designed a reliable, flexible and integrated manufacturing and supply chain platform (Morris Plains, NJ) that allows for individualized treatment approach on a global scale.

In terms of access, Novartis is committed to ensuring eligible patients have access to this therapy and is working to ensure payers understand the value, where it has been approved (reimbursed in 20+ countries). To address the unique aspects of the therapy, Novartis has also developed various patient access programs to support safe and timely access. We are also providing traditional support to patients by helping them navigate insurance coverage, and by providing financial assistance for those who are uninsured or underinsured. When and if approved in LatAm countries, we will establish patient / access support programs too.

 

Looking at Novartis’ three pillars, how do you apply an “Unbossed” culture in a country like Mexico?

First let me comment on the culture as a whole at Novartis. Our culture aspiration is for everybody at Novartis to be inspired, curious and unbossed. As we evolve into a more focused medicines company powered by data science, advanced therapy platforms and breakthrough innovation, our culture will continue to determine how we perform. We are in the business of discovery and will deliver more for patients if we are able to break down barriers to innovation, shift away from a perfectionist culture and unleash the power of our people.

Therefore, the “unbossed” part needs to go hand in hand with being inspired by a sense of purpose (inspired) and becoming a learner, not a knower, encouraging others to challenge the status-quo, your views and assumptions (curious). With this we can then become clear on what our role is at the company, become accountable for it, empower and support others by removing obstacles, thus ultimately becoming “unbossed”.

This is a culture we are fostering from within the organization. Changes in culture of this transformative nature, need to have the tone-at-the-top and at-the-middle to ensure it works. As mentioned, it is our aspiration, it will take time to get there. Many country cultures, such as ours in Mexico, may take longer to adopt or influence, as per our hierarchical upbringing and history. However, every challenge we face, such as the COVID-19 global crisis, only puts us to the test, disrupts the status-quo, and make us shape up and step up to the challenge, becoming more and more inspired to help others, curious to find innovative solutions – all in an unbossed matter.

As far as my circle of influence, I aim to guide and support my team by giving them the empowerment to make decisions but being accountable of the results. Of course, I realize that these decisions in some cases will entail failure, but mistakes and failures are gifts, gems, guideposts in our learning and growth as people and leaders. So we need to embrace failures, mistakes, screw-ups and shortcomings because they not only make us uniquely who we are, but also teach us powerful lessons you need to learn from. You gain experience through wrong and bad decisions, which in turn can only become right decisions with experience and the right decisions at the end are the secret to success. Therefore, it is an inevitable roadmap you need to go through with accountability and responsibility.

As a leader, every so often, it is important to let your people carry the flag, as they feel trusted when you share your power and they know you are at the back for encouragement. I have learned, making many mistakes in the past that leadership is about people. It is never about you. You cannot achieve anything without people and followers—what matters is how well you as a leader connect with the team. You may find yourself in a top position without these qualities, but few people will want to be led by you. There are 5 essential qualities I believe a leader should embody, and they are not about results per se, they are more about excelling at inspiring people – in capturing hearts, minds and souls.

Nevertheless, with these traits, you will definitely build a high performing team, which in turn will lead to great financial returns. These qualities are – (1) recognizing leadership is about people, where you inspire your people and get inspiration from them too, (2) have a shared articulated and communicated vision, (3) manage the team with something I call “Tough Empathy” being tough on standards and tender hearted to people, (4) have a sense of purpose and set of values that underlie everything you do and (5) reveal your differences, make your mark.

 

Can you conclude with a final message for our international audience of industry executives and key healthcare stakeholders?

Novartis is a leader in oncology innovation, and we will continue to be a key player for years to come. We have a unique value proposition as the only leading global oncology company with four distinct treatment platforms: targeted therapies, radioligand therapies, cell and gene therapies and differentiated immunotherapies; and the ability to combine these modalities for greater impact.

We are in the unique position to combine these four cutting-edge modalities to have a greater impact on cancer and blood disorders. We anticipate that attacking cancer with multiple therapeutic modalities at once we will kill more cancer cells and thwart the development of resistance. This will mean a shift from single-agent targeted therapies and 1st generation drugs, which have become key backbone therapies, to these next wave approaches to transform the care of patients with cancer.

In the NoLA Region, my aim is for Novartis to become the partner of choice for key stakeholders in the areas of oncology and blood disorders and a leading player in expanding access to vulnerable and underserved populations in the years to come. I am personally and professionally committed to being a part of defining accessible cutting-edge treatments as the new normal.

Finally, I want to be able to accelerate our inspired, curious and unbossed culture in the NoLA region, and relentlessly pursue our passion for the best science leading to the biggest impact for patients with cancer and blood disorders.

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