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Winning against COVID-19: The implications for biopharma

How companies act individually and collectively in the next few weeks and months will shape the outcome of the pandemic and the reputation of the biopharma industry for decades to come.

 

Pandemics, like other humanitarian crises, are times of great change and uncertainty. The society that emerges in the wake of COVID-19 will be different. People’s behavior and values will change in ways we can’t predict. Health systems will be fundamentally altered. The pace of adoption of some new technologies, such as telemedicine, may step up. Patient journeys will be transformed through new settings of care. Health systems will face different priorities and pressures on funding, depending on the depth of the economic downturn and the pace of recovery.

 

In these unprecedented times, the world is looking to the biopharma and medical-products industry for a response. Its contribution spans testing, ventilators and other critical medical devices, repurposed and novel therapeutics, and vaccines. Beyond that, it provides the only path to whatever next normal we may find on the other side. It is the source of hope and the primary path to mitigating and, ultimately, helping resolve a potential humanitarian catastrophe.

How companies act individually and collectively in the next few weeks and months will shape the outcome of the pandemic and the reputation of the biopharma industry for decades to come.

Our thinking, like yours, is evolving from day to day. Below we share perspectives we have developed following discussions with industry leaders and stakeholders, and from what we are seeing more broadly. We have divided them into three horizons anchored in our 5R framework (Exhibit 1):

  • Immediate crisis response (Resolve)—where most companies are today

  • Shaping the recovery (Resilience, Return)

  • Shaping the next normal (Reimagination, Reform)

Immediate crisis response

Here, our sense is that most companies have acted decisively in standing up “nerve centers” to plan for the challenges to come. We see the primary imperatives as follows:

  • Keeping employees safe.

  • Managing the transition to effective home working, using new technologies and exploring new ways of connecting.

  • Maintaining business continuity: preparing for possible site closures and distribution delays; evaluating the need for new sources of supply for raw materials, active pharmaceutical ingredients (APIs), and outsourced products; introducing new safety measures.

  • Ensuring the supply of medicines to patients and physicians and ensuring treatment and support for non-COVID-19 patients, some of whom are particularly vulnerable to the virus. Some companies in the United States have recently taken the step of extending their patient support programs with this in mind.

  • Identifying immediate implications across the value chain, by market and by therapeutic area, and, where applicable, planning how to respond to huge spikes in demand that are putting pressure on supply chains.

  • Mobilizing to help fight the pandemic by contributing to the supply of tests, medical equipment, and devices as well as the development of repurposed therapies and vaccines. As of early April, we tracked more than 200 vaccine and therapeutic candidates in development—an unprecedented level of mobilization within three months. Companies are also stepping in to donate funds or products—such as Novartis, Bayer, and Sanofi, who have committed to donating chloroquine, should that prove effective in addressing the virus—and adding their capabilities and expertise to national and global efforts.

 

Shaping the recovery

The key is for the industry to engage proactively, and positive signs are already emerging. We urge companies to take a health systems’ view and ask where we can make the biggest difference.

At a company level, we encourage you to set up a plan-ahead team that works across all time horizons to help you to stay on top of escalating issues and make the right decisions. To navigate the huge uncertainties ahead, model a broad range of scenarios covering both the epidemiological and economic perspectives. We have developed nine macro economy-wide scenarios and explored four in greater depth (Exhibit 2). The implications for each company will of course differ.

 

To help shape the recovery, consider the following critical steps:

  • Taking an end-to-end view across the value chain to assess the implications from the pandemic and identifying the challenges and areas where the disruptions from the pandemic may accelerate change.

  • Staying close to your customers and stakeholders. In particular, what do healthcare providers need? When will they have the capacity to engage with you?

  • Planning how to support patients through uncertain and anxious times, focusing on how they are experiencing the crisis and taking a granular view by therapy area and geography. Different health systems will emerge from the crisis at different rates and in different ways. There may be stark differences even within countries such as the United States and China.

 

Looking across your business, consider the following:

  • Accelerating your transformation, especially in using digital and analytics tools and adopting digital channels to engage with healthcare professionals, such as telemedicine or remote consultation. In a recent April survey, physicians reported a sixfold spike in remote patient engagement across specialties and geographies—a trend that many of these physicians believe will endure post-crisis.1 New channels may also emerge to further address patient needs during the crisis. The use of customer-facing field personnel also could be uncertain for some time to come. In China, some pharma companies have used the enforced pause to refine their go-to-market model and invest in digital capability building for physician engagement.

  • Developing contingency plans for launches over the next six to 12 months, recognizing that health systems are coming under enormous strain in many markets, with the pandemic putting frontline healthcare professionals at considerable risk and exacting a heavy personal toll.

  • Seizing opportunities presented by remote working and spare capacity among field sales representatives and other groups to accelerate capability development. Past experience indicates that the capability gap between those who successfully adapt and those who fall behind widens during crises. We are seeing companies building muscle in driving change and boosting digital and analytics skills among key cohorts.

  • Taking a forensic view of your supply chain and operations to derisk key elements such as in-market supply, while also deepening your capabilities in data availability and transparency and modelling capacity needs.

  • Developing granular, data-backed plans on “when” and “how” to restart paused trials as well as ensuring existing trials can continue to retain patients using quick-win tools, such as telemedicine, sending drugs directly to patients, and travelling nurses. At an industry level, more than 2,800 trials and nearly a million trial patients—accounting for more than 80 percent of multisite trials sponsored by pharma companies—are at sites that are in locations that are now partly or fully locked due to COVID-19. In addition, starting new trials and sites in this environment is challenging; a recent survey showed that over 75 pharma and biotech companies are facing significant disruption in their clinical trials.2   One especially urgent task is to identify and decide how to address those trials for which data may already be compromised.

  • Accelerating productivity improvements to create head room to respond to the pricing and access challenges that major economic shocks could bring, and taking a forward-looking view on how to increase the agility of operating models for countries and therapeutic areas to handle demand shocks better.

  • Evaluating bold moves, such as undertaking M&A in adjacent segments or deepening integration between digital and health tech.

At an industry level, we see many signs that companies are coming together in exciting new ways.3 We believe now is the time for a critical shift from a competitive to a collaborative mindset based on shared humanitarian goals. By pooling capabilities, pharma companies could unleash a huge wave of innovation. Positive steps to consider include the following:

  • Continuing to deepen your collaborations in R&D, including supporting biotechs by providing them with access to your capabilities and capacity, and sharing data, assets (such as compound libraries), and platforms to accelerate the approval of vaccines and therapeutics.

  • Working with industry peers to shape new modes of engagement with regulatory bodies and establishing trial infrastructure and regulations that are better equipped to withstand future disruptions with more robust data management, remote trial capabilities, and real-world-evidence-based regulatory processes.

  • Deepening collaboration in manufacturing, taking advantage of collective capacity and capabilities to rapidly scale up vaccines and therapeutics, particularly from biotechs. An encouraging collaboration model is the recent announcement by several plasma manufacturers to work collectively to produce a single unbranded product.

  • Continuing to commit resources to support the needs of health systems. For example, Pfizer and Merck are enabling employees who are licensed medical professionals to volunteer on the frontlines providing services such as public-health support, diagnostic testing and treatments, and patient services. Eli Lilly has medical professionals staffing a free drive-through COVID-19 testing facility at its corporate headquarters in Indianapolis as a service to the community.4

  • Engaging in transparent, responsible behavior, as exemplified in AbbVie’s decision to give up its intellectual-property protection on Kaletra. Proactive engagement with external stakeholders—regulators, global agencies, health systems—will help the whole healthcare ecosystem navigate the fast-evolving crisis.

 

We propose taking a dynamic view of emerging scenarios, identifying no-regrets moves and looking for ways to emerge stronger from the crisis.

 

Shaping the next normal

This is the right moment to start shaping how you want to be operating two years from now and reflect on the choices that you will have to make as a biopharma leader. At a company level, you will need to navigate numerous uncertainties, including the level of economic disruption caused by the pandemic, and the nature of the response from governments, regulators, and health systems. This will be a marathon, not a sprint. We propose taking a dynamic view of emerging scenarios, identifying no-regrets moves and looking for ways to emerge stronger from the crisis. Shaping the next normal could involve the following:

  • Committing to pushing the boundaries on digital, data and analytics, and customer-centricity—for both patients and healthcare professionals.

  • Evolving your perspective across the value chain and ecosystem, including the greater use of shared platforms in research.

  • Embracing both patient- and principal investigator–centricity to drive trial design and conduct: including protocols that reduce patient burden and, as one of many tools toward that goal, deploying digital and remote engagement platforms, such as remote assessment of vitals and end-points, to increase virtualization of trials. Among major pharma companies, 60 percent are already using telemedicine for trial visits in response to the COVID-195 crisis and more seem likely to follow.

  • Looking across the value chain to identify how to build more resilience in the network and finding the right trade-off between global efficiency and local resilience. Implementing operations and supply chain 4.0, with greater site automation and more flexible manufacturing platforms, could speed up supply–demand response rates. With an “Amazonification” of the pharmacy value chain on the horizon, companies also need to prepare to service new direct-to-patient channels.

  • Considering bold moves in areas such as productivity improvements and cost reductions, M&A, new ecosystems of collaborations, and increased use of health tech to improve patient outcomes.

 

Across the industry, we believe companies need to work together not only to shape both a positive outcome for the pandemic but to safeguard their broad license to operate in the decades ahead. There is a real imperative for change to get to a better next normal. Here are our suggestions:

  • Deepening engagement with governments, bearing in mind the potential implications of more locally driven agendas over the next few years, with respect to local manufacturing capacity, and product security. Indeed, governments may see health through a similar lens to that of defense—one of national security requiring controls.

  • Collaborating with relevant stakeholders to shape an economic model that makes it compelling for the industry to invest in preventing pandemics and working on areas subject to market failures, such as anti-infectives and antimicrobial resistance. How can the industry ensure lessons are learned from the crisis so that nothing on this scale can ever happen again?

  • Planning for other possible “black swan” events, such as biosecurity hazards and cybersecurity threats.

  • Building closer industry-wide collaboration in R&D and manufacturing, with fewer silos and faster joint innovation, and cultivating a new mindset of collaboration both across the industry and between biotech and universities.

  • Considering the potential for a more fundamental shift to prevention (which typically accounts for just 4 to 6 percent of today’s healthcare spending), giving greater prominence to considerations for the health of the broader population and raising questions on how the industry should participate in this broader dialogue.

  • Developing new contracts and nurturing closer relationships with health systems, payers, healthcare professionals, and patients.

Critical care capacity: The number to watch during the battle of COVID-19

Since the explosion of COVID-19, most countries have put in place public health measures to “flatten the curve” and accepted the concomitant economic pull back. But there is another number everyone should watch now: the capacity in hospitals to deliver critical care in intensive care units (ICU) with ventilators. It is the metric that indicates whether hospital systems will be overwhelmed.

 

Each day the world watches the number of COVID-19 cases climb and asks: “Is it slowing yet?”

But there is another number everyone should watch now: the capacity in hospitals to deliver critical care in intensive care units (ICU) with ventilators. It is the metric that indicates whether hospital systems will be overwhelmed. It is the reason to “flatten the curve,” because without more capacity more lives will be lost.

To safeguard our lives, critical care capacity must be increased in weeks, not months. While some countries and regions may have more capacity than others all need more. It almost does not matter the cost, as every month health systems are faster ahead of the peak of patients requiring critical care, we save lives and $200 billion dollars in GDP.

How much should we increase capacity? It depends on the starting point of each country, but in most instances is four to five times. This increase is possible; and is part of the focus of the health response across the world. But we strongly suggest to healthcare leaders to put this sentence on top of their and their colleagues’ proverbial inbox: Start watching critical care capacity.

Below we outline the need and possible actions to increase critical care capacity.

Since the explosion of COVID-19, most countries have put in place public health measures to “flatten the curve” and accepted the concomitant economic pull back. While the effectiveness of different approaches can be debated, these have been essential to gain control over the pandemic’s growth.

The unprecedented rise in US unemployment in recent days also portends human suffering stemming from economic turmoil. As we noted earlier this month, the virus could set the global economy back $1 trillion to 1.5 trillion in the second quarter of 2020 alone. In the United States, every four weeks of shutdown could set the economy back about $200 billion in GDP.1 In particular, those who work in the travel, restaurant, and transportation industries are at risk, as are a large percentage of households around the world. Even in advanced economies like the United States, 25 percent of households live from paycheck to paycheck, and 40 percent of Americans are unable to cover an unexpected expense of $400 without borrowing.

The race is now on to boost critical care capacity. Expanding healthcare system capacity is vital to saving lives, as an overwhelmed healthcare system results in a material increase in the rate of mortality and can slow our return to normalcy (Exhibit

 

1).The two main questions now are: What do we control? Where should we focus?

 

Growing healthcare capacity at lightning speed

Critical care capacity reflects ICUs, required hospital supplies, patient ventilator units, plus a trained workforce that has what it needs to do its job. While some of the following are already in motion, leaders are likely to want to consider the following actions, taken in tandem:

  • Cease all non-emergent care across hospitals and other sites of care, which would free up to 30 percent bed capacity, caregiver capacity, and a portion of ventilator and personal protective equipment (PPE) capacity almost immediately. Many countries around the globe have already done this.

  • Increase critical supplies—such as PPE, ventilators—to keep current facilities fully functional and keep healthcare workers protected. Please see Exhibit 2 below for actions we can deploy now that could expand available supplies in six to eight weeks.

  • Train additional frontline staff (for example, nurses trained on mechanical ventilator care) to deliver capacity expansion. Curricula to upskill healthcare workers in a matter of days have been developed in Asia and Italy. Independent healthcare providers across all countries may want to deploy similar plans in order to increase workforce numbers.

  • Build out of alternate hospital capacity (for example, field hospitals, converting outpatient/ambulatory facilities to acute, converting non-healthcare facilities to acute—hotels, dorms). Make-shift hospitals were built in a matter of weeks in China earlier this year as they dealt with the biggest surge of patients. With the assistance of the United States Army Corps of Engineers, FEMA, and mobilizing the military, at a wartime pace, the United States could likely build required bed capacity in waves in six weeks. These would not be facilities that in any regular time would be considered hospitals but could meet the needs of the affected population in extremis.

  • Activate strategic healthcare capacity within military or other defense healthcare systems around the globe.

  • Accelerate approval of treatments, as well as scale-up of manufacturing and distribution of the treatments that reduce severity or duration of critical care requirement, thereby reducing length of stay.

 

 

Slowing the demand for critical care

Most countries and states/provinces have deployed public health measures to slow the spread of the virus (for example, physical distancing, shelter-in-place, closing of public areas such as beaches and basketball courts). Without a vaccine or prophylactic treatment in sight the risk of resurgence of spread remains real. At the same time, given the large impact of these public health measures on people’s livelihoods, all leaders are seeking a balance of managing critical care demand growth while alleviating the sharp pullback in economic activity. A few actions may be critical to achieving these twin goals:

  • Realize maximum curve-flattening impact from the public health measures already deployed (which have driven the sharp economic pullback). While social norms and political systems vary around the world, more rigid application of distancing measures means that they will be more effective and can be dismissed more quickly. A number of countries have used technology effectively to support effective physical distancing (for example, the use of phone-based passes to minimize congestion in grocery stores). Create social and economic incentives for those in quarantine, perhaps including community-funded food delivery, income guarantees, solutions around caregiving needs, and job-security guarantees.

  • Exponentially scale-up testing capacity and contract tracing capability. While some countries currently have too many cases to trace all contacts, the ability to test rapidly and isolate those at highest risk of infecting others will help contain a future resurgence in cases. For countries with few cases to date, rigorous testing can prevent escalation to the point where critical care capacity is strained. Mass-testing in early hot spots such as South Korea and temperature screening, testing, and contact tracing deployed in Singapore are examples of such approaches.

 

Start watching critical care capacity. Reporting is improving. We encourage leaders to help increase critical care capacity to the extent they can. This will hopefully save lives and livelihoods, especially for the most vulnerable members of our society. It can be done!

Returning to resilience: The impact of COVID-19 on mental health and substance use

As governments race to contain COVID-19, it is important to know the actions society can take to mitigate the behavioral health impact of the pandemic and economic crisis.

 

The COVID-19 pandemic is a threat to our population, not only for its risk to human life and ensuing economic distress, but also for its invisible emotional strain. Recent days have seen the sharpest economic pullback in modern history and a record-breaking spike in unemployment. It is inevitable that the global pandemic, compounded by financial crisis, will have a material impact on the behavioral health of society. Following the global financial crisis in 2007–08, for example, many countries saw higher rates of depression, anxiety, and alcohol and drug use. In 2008, the Great Recession ushered in a 13 percent increase in suicides attributable to unemployment with over 46,000 lives lost due to unemployment and income inequality in that year alone.

Beyond the negative impact of a traditional economic downturn, COVID-19 presents additional challenges—fear from the virus itself, collective grief, prolonged physical distancing and associated social isolation—that will compound the impact on our collective psyche.4 5 As noted by the Aura Global Institute in Safeguarding Lives and Livelihoods, “Daily reports of increasing infections and deaths across the world raise our anxiety and, in cases of personal loss, plug us into grief. There is uncertainty about tomorrow; about the health and safety of our families, friends and loved ones; and about our ability to live the lives we love.” A Aura national consumer survey from March 27–29, illustrates this widespread distress, exacerbated even further among those whose jobs have been adversely affected by COVID-19 (Exhibit 1). This confluence of factors poses an unprecedented threat to the current and future health of our society.

 

Theodore Roosevelt once said, “The more you know about the past, the better prepared you are for the future.” By examining the behavioral health impact of the Great Recession and other large-scale disasters, we can mitigate the negative impact to society from further economic loss and human suffering. Extensive research has documented the association of recessions, mass layoffs, and prolonged periods of unemployment with an increase in income inequality and devastating impact on health and life expectancy in the United States.6 7 8 An examination of these data show income inequality maps closely to the rate of suicides among working age adults (Exhibit 2). These effects may deepen through the course of the COVID-19 pandemic.

 

Not only do mental and substance use disorders stem from economic hardship, they also are known drivers of lower productivity, increased healthcare costs, and higher mortality.9 The World Health Organization has noted that depression and anxiety have an estimated cost to the global economy of $1 trillion per year in lost productivity.10 A likely surge of people experiencing acute behavioral health problems—both those with new symptoms and those with existing conditions—has potential to further strain the healthcare system and add cost to an already unprecedented economic downturn.

To better understand behavioral health as a cost driver, Aura conducted an analysis of national insurance claims data and found that 60 percent of overall medical expenditures are driven by the 23 percent of members who have mental or substance use disorders (Exhibit 3). This disproportionate spend is driven largely by increased medical costs. For example, the cost to treat the diabetes of a patient with depression is, on average, almost $20,000 higher than for a patient without depression, due to factors such as medical complications, reduced access to preventive care, and challenges with illness self-management.

 

As governments race to contain COVID-19, it is important to know the actions society can take to mitigate the behavioral health impact of the pandemic and economic crisis.11 12 For every one dollar spent on scaling up treatment for common mental disorders, a four-dollar return can be realized in improved health and productivity.13 In the United States, the Coronavirus Aid, Relief, and Economic Security (CARES) Act provides $425 million for additional community-based behavioral healthcare and suicide prevention. Given the urgency of this issue, no-regrets steps for healthcare stakeholders could include the following:

  • Strengthen community prevention: Provide risk-stratified crisis counseling support to individuals and families directly affected by COVID-19, including individuals who lose their jobs, healthcare and essential workers, older adults, people with disabilities, and individuals experiencing extended quarantine. Across whole communities, conduct outreach to promote resilience, normalize reactions, and let people know when and where to seek help.

  • Leverage data and technology: In the initial “resolve” phase,14 use predictive analytics to direct prevention and clinical resources to those most at-risk for mental health or substance use problems and unmet basic needs. As we move towards recovery in the “return” phase, leverage and improve available data sources, encourage the use of artificial intelligence, and scale digital platforms (for example, digital therapeutics) to connect consumers seamlessly to evidence- and measurement-based care. As governments consider how they fund telehealth, examine what impact emergency waivers, flexibilities, and rate increases for telehealth under COVID-19 are having on care delivery.

  • Integrate behavioral and physical health services: Initiate or accelerate efforts to reduce stigma and encourage understanding of behavioral health as fundamental to overall health. Implement universal screening and treatment for mental health and substance use problems in primary and specialty healthcare settings, including for individuals with or at high risk for COVID-19. Increase behavioral health competency of primary care providers, expand the use of peer counselors to enable timely behavioral healthcare, and strengthen capacity of the behavioral health workforce. Provide appropriate physical health care to individuals with ongoing behavioral health needs.

  • Address unemployment and income disparities: To reduce long-term psychosocial risk from COVID-19, policy makers and employers may want to reimagine the future to alleviate economic disparities. More innovation may be valuable around accelerated skill redevelopment, job redeployment, supported employment, and incentivizing investments in local job growth. And, proven interventions can be applied, including enabling people to protect their health (for example, paid sick leave); and ensuring people whose livelihoods have been affected by COVID-19 are able to meet basic needs such as food, housing, and childcare.

 

In the turmoil around the economy and the coronavirus itself, society should be mindful of its collective resilience. The anxiety, stress, financial strife, grief, and general uncertainty of this time will undoubtedly lead to behavioral health crises. It is therefore important that communities seeking a “next normal” can draw from their inherent strength and compassion to recognize, treat, and support those experiencing this human toll of the COVID-19 pandemic.

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