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Perspectives

From Olympic trials to clinical trials, emerging technologies can boost performance

Health Care Current | February 13, 2018

This weekly series explores breaking news and developments in the US health care industry, examines key issues facing life sciences and health care companies and provides updates and insights on policy, regulatory, and legislative changes.

My take

From Olympic trials to clinical trials, emerging technologies can boost performance

By Greg Reh, Vice Chairman, US and Global Life Sciences Leader, Deloitte LLP

The Olympic flame was lit in PyeongChang, South Korea last Friday, opening the XXIII Winter Games. Technology, now more than ever, is pushing athletes to perform at the highest level while also keeping them safe.

Smartsuits worn by some short-track speed skaters relay body-position data to coaches through a smartphone; coaches then transmit adjustment advice back to the skaters—via vibrating wristband—as they glide across the ice.1 3D-motion sensors attached to the bodies of figure skaters allow coaches to analyze practice routines and develop strategies to master complex moves.2 During downhill training runs, some skiers have been wearing vests equipped with airbag technology3 that can deploy milliseconds before a potentially lethal crash.

Just as technology is helping these athletes excel, technology also could help biopharmaceutical companies pull more meaningful data from clinical trials and speed cycle times for products in development. Patients could see benefits, too, including higher satisfaction rates and better overall experiences during each phase of the trial. But, given the complexity of institutions and the broader drug environment, adoption has typically been slow and there are challenges ahead.

Clinical-trial model has not kept pace with technology
Biopharmaceutical manufacturers rely on technology to discover and develop breakthrough treatments that can turn deadly diseases into manageable chronic conditions—or sometimes cure a disease altogether. But the costs of developing a new therapy and bringing it to market can top $2 billion;4 and the research and development (R&D) process often relies on a clinical-trial model that has changed little since the 1990s.

Costs are now increasing faster than revenues, which makes this model unsustainable. A Deloitte analysis of the return on pharmaceutical R&D investments among 12 large biopharma companies revealed a sustained decline—from 10.1 percent in 2010 to 3.2 percent in 2017.

Just as technology will help some Olympic athletes shatter records by improving their sleds, skies, and boards, technology also could help solve for some productivity challenges in the clinical-trial stage of drug development. The Center for Health Solutions recently interviewed 43 leaders across the clinical-development ecosystem in our new research, Digital R&D: Transforming the future of clinical development. We sought to understand how digital technologies are being used (or not) by biopharmaceutical firms. We also wanted to understand the relatively slow adoption of digital technologies in clinical development. 

Despite the potential of digital technology, digital tools are generally not being incorporated into clinical trials. (In our research, the term “digital” covers a wide range of disruptive and emerging technologies, such as social media, artificial intelligence, wearables, blockchain, and virtual reality.) Surprisingly, many clinical trials still rely on paper. Even the largest and most technically advanced organizations are often only beginning to integrate digital technologies into their clinical-development processes.

What are the barriers?
Our interviewees certainly recognize the potential for digital technologies to transform clinical development. But they also acknowledge challenges, such as data infrastructure problems (including interoperability issues), privacy rules, and a lack of data standards. There are also regulatory and cultural considerations. These issues can make it difficult to take advantage of new technologies and data sources. Moreover, interviewees agreed that issues related to the safety, performance, and reliability of new technologies must be addressed before they could be included in clinical development.

What are the opportunities?
Based on our research, digital technology could help improve clinical trials and other R&D processes in the following ways:

  • Reach and enroll a more diverse patient base: Digital technologies can help researchers more accurately assess trial feasibility, and adjust inclusion-exclusion criteria accordingly. This can help enroll a more diverse patient base more quickly compared to traditional approaches. Case in point: Using a cloud-based platform, a technology-enabled clinical research company recruited patients for a rare-disease trial 20–30 times faster than could have been possible using more traditional recruitment methods. The company sifted through patient records from hundreds of trial sites across the US, and recruited 372 patients from seven states. The result was a diverse study population. 
  • Remove barriers to trial participation: An estimated 70 percent of prospective clinical-trial participants live more than two hours from the nearest study center, which could impact their willingness and ability to participate.5 Along with travel time, participants might need to take time off from work, or find childcare. The ability to conduct virtual clinical trials could encourage more patients to participate. Taking part in a clinical trial without having to leave home also could ensure that fewer patients drop out once they sign up for a trial. Some interviewees estimate that as many as half of all clinical trials could be conducted virtually. 
  • Improve drug adherence: Ensuring medication adherence among patients is commonly an ongoing challenge during clinical trials, and it is becoming increasingly difficult as treatment regimens become more complex. Adherence ensures that the effect of an investigational drug is fully reflected in the data. Some adherence tools use facial recognition to confirm that a medicine has been ingested, and generate non-adherence alerts to investigators. 
  • Capture patient-centered endpoints: Many endpoints used in trials today offer just a glimpse into a patient’s physical and mental functioning. Advances in sensors and mobile technologies have made it easier to continuously collect patient-generated data. New technologies also make it possible to electronically gather patient-reported outcomes, including the ways an intervention impacts a patient’s quality of life. Analytical insights on clinical and patient-reported outcomes can provide a competitive advantage and support the case for reimbursement. 
  • Expand collaboration: The use of blockchain could make it easier to securely store and share clinical data—even among competitors. Blockchain is sort of a living, unalterable ledger of digital records. The technology can also be used to manage and track informed consent across multiple sites, systems, and protocols.

A comprehensive digital R&D strategy can be essential to process large amounts of data effectively, make business decisions quickly and accurately, and generate evidence that supports the development of future products. Many of the people we interviewed expressed a desire to be fast followers. Given the complexity of operationalizing a digital strategy, they also understand the risks in falling behind.

Behind the scenes in PyeongChang this month, technology will help athletes achieve the Olympic motto: Faster, Higher, Stronger. Similarly, digital technology could allow early adopters in the biopharmaceutical space to develop Better patient experiences, Deeper insights, and Faster cycle times for future therapies.

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1 https://www.sammobile.com/news/samsung-created-a-smartsuit-to-help-improve-training-for-dutch-short-trackers/
2 http://www.cnn.com/2013/06/28/tech/the-3-d-technology-that-is-helping-ice-skaters/index.html
https://www.dainese.com/protection/d-air-ski/
4 http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study
5 https://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-trials-offering-science-37

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In the news

Bipartisan budget deal funds government and key health programs

Last week, after another temporary government shutdown, Congress passed bipartisan legislation to fund the government through March 23, raise spending caps on domestic and military spending by $300 billion, and lift the debt ceiling through March 2019. The deal also includes a number of Medicare “extenders” and other provisions affecting a broad spectrum of health care stakeholders. Although many of these provisions were in the House and Senate bills, there were some surprises, including a sooner-than-expected change to the Medicare Part D program’s “doughnut hole” coverage gap. The provision included in the budget plan would require drug companies to pick up a larger portion of costs for beneficiaries who fall into that gap a year earlier, from 2020 to 2019.

Summary of key provisions:

Stay tuned for more in the RegPulse blog.

HHS briefing and CEA report show Administration’s interest in drug pricing policies

In a February 8 briefing with reporters, US Department of Health and Human Services (HHS) Secretary Alex Azar outlined several ideas that are being considered to address prescription drug pricing and to reduce out-of-pocket spending for patients. The following day, the White House Council of Economic Advisors (CEA) released a document entitled, “Reforming Biopharmaceutical Pricing at Home and Abroad.” The document focuses on reducing prescription drug prices for Americans, while also spurring medical innovation, and notes that these two goals do not have to be in conflict.

The CEA document discusses drug pricing policy ideas, many of which would require statutory or regulatory change:

  • Allowing Medicare beneficiaries to take advantage of discounts negotiated by pharmacy benefit managers. This could be done by establishing a spending cap on out-of-pocket prescription costs, and potentially making generic drugs free for low-income seniors.
  • Moving drugs that are now administered under Medicare Part B—which include treatments or infusions that are provided in a physician’s office—to Part D. 
  • Cutting the price drug companies get for new products in the Part B program, from 6 percent above the wholesale acquisition cost, to 3 percent.
  • Allowing 340B hospitals (a program that helps hospitals and clinics offset the cost of medicines for providers that serve a large low-income population) to keep savings from the drug discounts if they deliver a minimum amount of charity care.
  • Increasing competition among generic drugs, possibly through expedited review pathways for certain drugs. 
  • Launching a pilot program for state Medicaid programs that would let them exclude some treatments from their covered-drug list so that they can win deeper discounts.

The ideas listed did not include price negotiation for Medicare Part D drugs.

The document states that the US is the engine of worldwide pharmaceutical innovation and that meaningful reform could address the imbalance of what other countries contribute. This could be accomplished through enhanced trade policy or policies that tie payments from public programs in the US to prices paid by foreign governments.

RELATED: Deloitte’s report, Managing prescription drug prices: What options are on the table, includes an overview of some of the major proposals to address drug pricing that have been considered in recent years.

(Source: White House Council of Economic Advisors, Reforming Biopharmaceutical Pricing at Home and Abroad, February 9, 2018)

FDA lays out opioid risk-mitigation strategies for clinicians

The US Food and Drug Administration (FDA) will require opioid analgesic companies to provide information to health care clinicians about how to treat, monitor, and advise patients with pain. On January 31, the agency outlined what these educational programs should include in an update to its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Blueprint.

The Blueprint consists of two sections. The first section outlines foundational knowledge about pain management, including how to define and categorize pain and how to assess patients in pain. The second section describes how to treat patients in pain, including through non-pharmacologic approaches—such as surgery and physical therapy—and non-opioid medications. The Blueprint also offers strategies for initiating and managing treatment with opioids for acute and chronic pain, and explains how to recognize signs of opioid addiction.

Many policymakers involved in combatting the opioid epidemic—from state-level officials to the President’s Commission—have called for clinician and provider education about alternative pain management strategies and the risks that come with prescribing opioids.

Related: House Ways and Means committee examines opioid abuse in Medicare
The House Ways and Means Health Subcommittee held a hearing February 6 to discuss strategies to prevent and treat opioid addiction among Medicare beneficiaries. Vermont Governor Phil Scott (R), who was joined by his Human Services Secretary Al Gobeille, detailed the state’s opioid prevention and treatment program. Scott suggested that Medicare should treat addiction as a chronic condition, and urged lawmakers to consider expanding coverage to include opioid treatment and prevention. The subcommittee also heard from health plan executives and leaders in pain management. Multiple witnesses called for lock-in programs that could help prevent “shopping” for opioids. They also suggested that Medicare cover opioid treatment programs through a bundled payment or integrated models. Medicare covers prescription opioids, and witnesses noted that nearly one-third of Part D enrollees used the drugs in 2015.

(Source: FDA, Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain, January 2018)

CMS provides $8.1M to help states review essential health benefits

On February 5, the Center for Consumer Information and Insurance Oversight (CCIIO) announced the availability of $8.1 million to help states implement the market reforms and consumer protections outlined in the Affordable Care Act (ACA). In addition to performing market scans, states can use the funding to review, analyze, and comment on the selection of essential health benefits (EHB) and EHB benchmark plans. EHBs are the services that exchange-based plans must cover. On October 27, CMS released a proposed rule that would authorize states to define EHBs (see the November 7, 2017 Health Care Current).

CMS approves Indiana Medicaid waiver, with requirements for work and tobacco cessation

On February 1, CMS approved a waiver that allows Indiana to require certain Medicaid enrollees to work. The state also will add a premium surcharge for enrollees who use tobacco but do not participate in tobacco cessation activities. The work requirement will begin in 2019 and the tobacco surcharge will begin after an enrollee has been enrolled in Medicaid for one year.

Under the waiver, Indiana Medicaid enrollees will need to demonstrate that they either work, are seeking work, are engaging in job training, or are volunteering for a minimum of 20 hours a week for at least eight months of the year. The number of hours required will be phased in. Medicaid beneficiaries who fail to meet these requirements, or do not submit the required paperwork, will have their benefits revoked for three months. The requirement will exempt certain groups, such as the medically frail, pregnant women, and some caregivers of dependents.

Indiana intends to test whether this type of program leads to better health outcomes for enrollees. CMS approved the waiver through 2020.

Some states consider adding mandates that individuals purchase health insurance

Several states are looking to institute individual mandate penalties, now that the recent tax reconciliation bill repealed the ACA’s federal individual mandate penalty starting in 2019 (see the December 21, 2017 Health Care Current).

Maryland is the first state to officially propose individual mandate legislation. State Senator Brian Feldman (D) introduced the “Protect Maryland Health Care Act” on February 5. If enacted, the state would notify uninsured Marylanders that part of their tax payments will be collected by the state’s insurance exchange and used as a down payment toward a qualified health plan. Those who do not purchase coverage would be enrolled automatically in a zero-cost plan (i.e., one that does not cost any more than the amount of the down payment).

Lawmakers in several other states have discussed individual mandate proposals, but none have introduced legislation yet.

Some analysts have drawn parallels between these potential state-based mandates and Massachusetts’ shared-responsibility provision, which went into effect four years before the ACA was signed into law. According to the Census Bureau, only 2.5 percent of Massachusetts residents were uninsured in 2016—well below the national rate of 8.8 percent in 2016.

Before the tax bill passed, the Congressional Budget Office estimated that repealing the individual mandate would save $338 billion by 2027, though premiums would rise (see the November 14, 2017 Health Care Current). Some proponents of the repeal said health insurance regulations are better left to states.

Breaking Boundaries

Digital health comes to the rescue as flu season rages on

The US is facing the worst influenza season in a decade, according to the Centers for Disease Control and Prevention (CDC). The agency’s most recent numbers show about 12,000 hospitalizations and high mortality rates. Unfortunately, we may not yet have reached the peak. But we do have one critical weapon this season that was not available a decade ago: Digital and virtual health care.

Some of the bigger telehealth vendors say they have seen a 300 percent increase in flu-related calls on their platforms. While the CDC reported that roughly six percent of clinician office visits are flu-related, telehealth vendors say about 20 percent of their telehealth visits are flu-related. This percentage is higher than in previous years, and is likely due to a combination of consumer awareness and interest in telehealth, and more physician and hospital referrals. Media attention around the severity of this year’s flu season might have made people more hesitant about visiting the physician’s office for fear of catching or transmitting the virus.

In addition to telehealth visits, other digital health strategies are gaining traction. Kinsa’s smart connected thermometers have been used around the country to take temperatures, and their use has increased this flu season. Buoy Health—a company that makes a machine learning-powered chatbot—says it has tripled its users this season.

Many more people could take advantage of virtual and digital tools if they want to avoid a visit to a doctor’s office or clinic. Along with offering patients more convenience, increased use of digital tools also could benefit the health care system. Automated triage systems and symptom checkers can inform patients about their condition in a way that is more customized than simply going online. For example, instead of finding general information online about a condition, patients can enter certain information into the tool to get more personalized feedback. And when dealing with a highly contagious flu virus, transmission can be avoided if people can receive advice, diagnosis, and prescription anti-virals from their home. It can also can make it easier for hospitals and clinics to prioritize high-risk patients who need to be treated in the hospital.

Finally, these digital tools have the potential to provide powerful surveillance analysis. The ability to collect and aggregate data with these tools in real time, in addition to social media and other channels, can help public health officials track the flu and other outbreaks of disease, or foodborne illness.

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