Conference Coverage: Community Oncology Alliance

June 17, 2020

Coverage from the Community Oncology Alliance Virtual Meeting, held April 23-24, 2020.

What Matters to Our Patients Matters to Us, and We Must Keep Up, Panel Notes

Community Oncology Alliance (COA) 2020 conference, held virtually, kicked off with the panel discussion “Top Oncology Issues Now & Looking Ahead,” led by Bo Gamble, BBA, COA’s director of strategic practice initiatives. Topics covered ran the gamut, from Zoom being everyone’s new middle name, to telehealth, to caring for patients’ medical and social needs, and beyond. Permeating all facets of this discussion was coronavirus disease 2019 (COVID-19) and how it seems to have fundamentally changed the world of oncology care, especially how physicians and cancer caregivers and providers interact with their patients and loved ones.

Joining Gamble on the panel were:

• Kathy Oubre, MS, chief operating offi cer, Pontchartrain Cancer Center

• Barry Russo, MBA, chief executive offi cer, The Center for Cancer & Blood Disorders, and conference co-chair

• Robert Braun, RN, MA, vice president, Operations and Integration, Regional Cancer Care Associates, LLC

Panelists echoed one another’s sentiments throughout, touching upon common concerns that included telehealth; maintaining clear communication, perhaps being more upfront now than before; the fact that we are in unchartered territory and have to adjust on the fly; and that COVID-19 is a force majeure, an unforeseeable circumstance. All the while, they stressed that it is the oncology community that has to keep up with its patients while helping them navigate an ever-adjusting

health care system.

Gamble opened the discussion with this telling question, “How do you think the current pandemic is shaping the challenges for the future?” The panelists each provided an overview of their top concerns. “We are trying to maintain a sense of normalcy for patients, knowing that permanent adjustments will need to be made when this public health emergency is over. What will that look like?” Oubre proff ered. “Telehealth is here to stay. CMS is interested in hearing our thoughts and our comments on shaping that policy as we move forward.”

“For practices that operate within a financial-risk model, I think we’re going to need organizations, our local representatives and those people on the federal level, to help us navigate those waters [and] come to a happy medium where our practices are not only stable, but where we can provide services to our patients and are ready to move forward,” Braun said.

Russo stressed, “Communication eff orts need to expand and focus on keeping up the electronic aspect, because patients will be [physically] coming in to our practice less often and will continue to social distance. We will have to adapt to our patients, because they are adjusting so fast to the electronic world.

How do we restructure, especially in a value-based world, our needs to interact and communicate with the patients on a much more frequent basis, but in a way that takes into account all the focus on social distancing and protection and patient expectations?”

Gamble next asked about the possible future redesign of reform models, given where we are today. Payer conversations predominated, but given the current ongoing uncertainty, the panelists brought up how important it is to think outside the box and be able to adjust on the fl y, all the while collaborating and keeping the lines of communication open.

“We are in 2-sided risk with the OCM [Oncology Care Model], so we’re certainly very concerned about that,” Russo stated. “And we’re very concerned about the implications of some of our folks who have ended up in the hospital because of COVID-19, and the impact associated with that. And we don’t yet know when that means, and it’s been a challenge.…Going forward, we’re going to have to talk with the payers when these kinds of things, like a pandemic, happen.”

Oubre added, “We’re just trying to keep our practices afl oat and provide the best patient care we can, regardless of the cost or what that looks like. I mean, pandemic, public health emergency, these were not words in our lexicon 6 months ago. I think it’s time to start collecting data and have conversations, and we’re going to have to work through this together.”

“The commercial payers have stepped up and have been very responsive in answering our questions. Obviously, COVID-19 is defi nitely going to have an impact on payment reform,” Braun noted. “But I think collectively that we’re still going to really see growth in value-based contracting. I think we will have to have better business effi ciencies to ensure that our practices are viable and being profi table.”

Gamble then asked about how these challenges have changed how oncology will look at roles in the whole care journey itself, moving forward. Patient satisfaction was the name of the game, in all circumstances, especially in patients’ psychological well-being and addressing their needs beyond just the medical. All the while, outcomes must be kept in mind.

“People are losing their health care or they are unemployed. We need to remember that, when we’re looking at that patient as a whole. We need to address those social aspects as well,” Oubre emphasized.

Braun responded, “I think that we live in a world where we’re taking care of very discerning patients. They want to know where they’re getting their health care, how they’re getting their health care, who is giving them health care. It’s an opportunity to actually ask the patient what matters to them the most and what has concerned or what is concerning them, and not from just a physical point of view.”

“[We have to address] how we remain that safe place,” Russo remarked. “I think we will have to quickly adapt to fi nding the right patient electronic communication system structure. We are their safe place, and we have to remain so because it’s a big part of the healing process, a huge part.”

What major hurdles will oncology have to overcome, and what adjustments will the cancer care community have to make to continue to meet patient expectations in a post—COVID-19 world? Have doctor–patient interactions fundamentally changed? What about the needs of all the parties? These questions hung in the air as the panel discussion came to a close.

“I want you to look at your crystal ball and tell me what it looks like 5 years from now and 10 years from now for your world,” Gamble asked, to conclude the discussion.

“I think we’re all going to have to step it up in terms of our communication methods, and not just via email or text, or telemedicine, but other methods of how we communicate between practitioners,” Braun stated.

Oubre observed, “Telehealth is here to stay. Social distancing, in some fashion, is here to stay. I think it’s important that we all have a seat at the table, though, to fi gure out what that is going to look like. And we have to do that [while] keeping the patient at the center of everything we do, to be able to [go on] providing them with that safe environment.”

“I think what we’re learning in value-based care is that all the other pieces of what’s happening with a patient, all those pieces are part of the journey,” said Russo. He predicted, “I think that over the next 5 years, because of value-based arrangements, because of our access to data, and because of our need and requirement to connect more often to patients electronically, we’re going to have a better picture of the longitudinal journey.”

Communicating with patients more often, taking care of their needs beyond those that fall on the oncology spectrum, and getting a more complete picture of their needs: These are the top community oncology issues now, and they will continue to be, looking ahead.

COVID-19 Adds New Wrinkle in Shift to 2-Sided Risk in Oncology Care

Asking federal officials to give more time to the oncology practices that are pursuing alternative payment models (APMs) before shifting to 2-sided risk was already a worthy request. But the global pandemic of coronavirus disease 2019 (COVID-19) gives this entreaty more urgency, according to the co-chairs

of the payment reform committee of the Community Oncology Alliance (COA), which held a panel discussion on April 23, the fi rst day of the group’s virtual meeting.

Moderated by Bo Gamble, BBA, COA’s director of strategic practice initiatives, the discussion featured co-chairs Kashyap Patel, MD, chief executive officer of Carolina Blood & Cancer Care Associates, and Lalan Wilfong, MD, executive vice president for value-based care and quality programs at Texas Oncology.

It demonstrated that several practices taking part in the Oncology Care Model (OCM), advanced by the Center for Medicare and Medicaid Innovation (CMMI), were willing to commit to 2-sided risk despite their struggles thus far to achieve bonus payments under the model.

COA surveyed 175 practices and received 68 responses, learning that 32% of practices planned to pursue 2-sided risk despite not having received a performance-based payment in the fi rst 4 evaluation periods. “That was really amazing to us,” Gamble said. For the practices, however, value-based payment represents the future, and they vowed to keep trying.

Patel, among the few practice leaders who received a bonus payment in each of the first 4 periods, explained how give-and-take among COA practices enrolled in the OCM has led to critical adjustments that have kept the cause of payment reform going. In particular, collaboration led to changes in calculations for stop loss

that would have caused widespread abandonment of the OCM. But that collaboration is crucial now, because under the original schedule, the OCM was set to end and a new model, Oncology Care First (OCF), was planned to replace it starting next year.

And then came COVID-19, which changed everything. For starters, the fi nal look at OCF is on hold, Patel said, because CMS is busy dealing with the fallout of

the pandemic. “We were expecting the model to come out by spring [2020],” he¯said, but with COVID-19, “Everything has been postponed.”

Even before the current crisis, practices were asking for more time to get a feel for 2-sided risk—because oncologists are at widely varied states of readiness for such a change. Add a pandemic that has forced practices to conduct visits via telemedicine and puts patients with cancer at higher risk of hospitalization because they are immunocompromised, and all bets are off.

As Wilfong explained, the OCF features a dramatic change, shifting from a model built on a fee-for-service framework to one with a monthly prospective fee. “That’s a huge change, and practices need to fully understand what that looks like,” he said, so that staffing and operations can be aligned accordingly. Transparency is needed across the board, Wilfong added. Models must reflect the differences among practices in the types of cancers treated, and “we have to make sure we’re adjusting for the patients in front of us,” Wilfong said. Multiple myeloma, for example, is an area with dramatic treatment advances, so that must be taken into account.

Gamble later explained the concept of “tiered average sales price (ASP),” in which the percentage of ASP that practices receive for administering drugs would be on a sliding scale, with higher percentages for cheaper, generic drugs and much smaller ones for newer, 6-figure drugs. The idea, Gamble said, is to end the myth that oncologists prescribe based on what they will be paid. Also, he said, “it brings some great competition in the market to bring prices down.”

A year ago, COA was poised to bring a revised version of the OCM, called OCM 2.0, before a federal entity called the Physician-Focused Payment Model Technical Advisory Committee, as a way to address the weaknesses seen in the original OCM, especially issues with the way it pays for drugs. Today, however, with the arrival of the proposed OCF, the group has reimagined OCM 2.0 as a tiered model that includes commercial practices, with entry points for all types of practices—from those experienced with taking on risk to those just getting started.

And Wilfong said that going forward, CMMI must reach a point of building models that recognize strong, ongoing performance. “Once you trim the fat, there’s a point where there’s no more fat to trim,” he said. “At some point, we have to really think about rewarding those practices for doing the right thing.…And then we have to also, especially now, think about minimizing our beneficiary costs.”

COA Consensus: Telemedicine Is Here to Stay, but Practice Transformation Could Stall

Oncology practices are grappling with fi nancial uncertainty and supply shortages, as well as with great fear among patients who, already facing risk from cancer, are immunocompromised and threatened by coronavirus disease 2019 (COVID-19).

However, according to a panel convened April 24 by the Community Oncology Alliance (COA) on legislative priorities, the runaway success of telemedicine during the pandemic means that this new tool will likely become a permanent part of the treatment landscape. The session was part of day 2 of the 2020 Community Oncology Conference, held virtually.

Moderated by COA Executive Director Ted Okon, MBA, the discussion featured:

• Deborah Kamin, RN, PhD, vice president of policy and advocacy, American Society of Clinical Oncology

• Brad Tallamy, senior director of government aff airs, AmerisourceBergen

• Ben Jones, vice president of government relations, The US Oncology Network

• Christian G. Downs, JD, MHA, executive director, Association of Community Cancer Centers.

Okon kicked off the session by asking each panelist to list the 3 top issues that COVID-19 has created for cancer care. Although their perspectives varied, all cited lost revenue and general instability, at a time when patients are most vulnerable.

Tallamy said the crisis has created “newfound awareness” of the fact that the bulk of US generic medications are manufactured overseas—and some in Congress think this must change. Downs said that hospitals not hit hard by COVID-19, including those in rural areas, have different issues: Canceled procedures and visits are adding

to their red ink.

Jones echoed concerns heard elsewhere of the need to keep practices stable—hence, CMS’ program to advance payments1—because access could be an issue once the pandemic ends. Downs agreed there will be “pent-up demand” for surgeries, and COA president Michael Diaz, MD, of Florida Cancer Specialists, predicted during a recent webinar with The American Journal of Managed Care® that the post—COVID-19 months could bring a wave of cancers being diagnosed at later stages due

to missed screenings.2

Jones also raised the topic that, without COVID-19, would have been the top issue at a COA gathering: the challenges of practice transformation. “We’re in the midst of this transition to value-based care,” he said, citing proposals for Oncology Care First, a model from the Center for Medicare and Medicaid Innovation (CMMI) to succeed the Oncology Care Model (OCM), as well as a controversial radiation oncology alternative payment model that was set to take eff ect by this summer. Work on these models is in limbo, and whatever CMMI decides to do—and when—will aff ect cash flow in practices that have already been hit hard by the pandemic.

“There’s a significant amount of anxiety from the perspective of practices—they’re under pressure,” Jones said. “They recognize that we’re in the middle of practice transformation that can be truly disruptive at a time like this.”

The most important challenges, he said, involve patients. “Our patients, in particular, are immunocompromised, and they’re under an enormous amount of stress as it is,” Jones said. “If you couple that with the fact that almost 27 million Americans are newly unemployed over the last 5 weeks, there has to be a measure that accounts for that.…In short, these patients have to have access to seamless care.”

Telemedicine. All agreed that the single bright spot of the experience has been the rise of telemedicine. After years of smaller steps, CMS has issued multiple guidance documents to allow the technology to fl ourish, with some practices going from a few visits a week to hundreds. Tallamy said it was a “no-brainer” that CMS should

allow this expansion to continue. Telemedicine makes sense with the OCM, he said, “which already has incentives to keep folks outside of the hospital.”

Downs said that until the pandemic, the barrier was always defined as whether patients would be comfortable with telemedicine. “Patients are comfortable—that’s 1 box we can check going forward,” he said.

There will be reimbursement issues: Commercial payers will have to be sold on paying equal rates, especially when patients can take only a phone visit, with no video component, because of the patient’s lack of technological equipment or comfort. The panelists agreed that, in general, an initial visit should take place in person. Okon credited CMS Administrator Seema Verma, MPH, with moving quickly in this area. “I give her a lot of credit,” he said.

The panel listed issues they will be watching as the presidential election approaches in November:

• Home infusion. COA has come out fi rmly against home infusion for chemotherapy; ASCO’s Kamin said she anticipates battles with pharmacy benefit managers over this issue. “We do not believe it is a safe alternative,” she said.

• Drug prices. Kamin said this issue will not go away, but the panelists discussed how the need for the pharmaceutical industry to come up with a COVID-19 vaccine would strengthen the manufacturers’ position.

• 340B reform. This perennial hot topic among COA members may take a back seat as hospitals seek to shore up revenue.

• The uninsured. The ranks of people who lose employer-based coverage will soar, and it remains to be seen how these newly uninsured or underinsured patients will pay for cancer care.

References

1. CARES Act: Medicare advance payments for COVID19 emergency. American Medical Association. Updated April 6, 2020. Accessed April 23, 2020. amaassn.

org/deliveringcare/publichealth/caresactmedicareadvancepaymentscovid19emergency

Community Oncology on PBMs: “We Just Can’t Let Them Get Away With What They’re Doing”

The byzantine system of rebates and fees, and the favored status that pharmacy benefi t managers (PBMs) bestow on pharmacies they control, all continue to bedevil community oncologists, who must employ special staff to ensure that patients receive appropriate treatments.

So said a pair of experts on PBM practices, along with practicing oncologist Michael Diaz, MD, the president of the Community Oncology Alliance (COA), during a session on the topic on April 24, day 2 of COA’s 2020 Community Oncology Conference, held virtually. Moderated by COA Executive Director Ted Okon, MBA, the panel also featured:

• Jonathan E. Levitt, JD, founding partner of the law fi rm Frier & Levitt, LLC

• Jeffrey C. Mortier, a partner with the lobbying fi rm Farragut Partners

Despite the immediate distraction from coronavirus disease 2019 (COVID19), the panelists said, community oncologists must keep pressure on PBMs as the 2020 campaign heats up—lest they lose the momentum to rein PBM practices within the umbrella of drug pricing reform.

Diaz, the director of patient advocacy and assistant managing physician for Florida Cancer Specialists, noted that his focus is primarily on patients, and as such, he believes “there needs to be a lot more transparency.…It is overly complex, and you can’t help but wonder if it’s that way by design.”

Earlier in the day, Antonio Ciaccia, chief strategy officer at 3 Axis Advisors, had taken the audience through a deep dive into PBM pricing and steering practices, including “spread pricing,” in which PBMs bill state Medicaid divisions for far more than they pay pharmacies for the same drugs.

After hearing from Ciaccia and fellow panelists, Diaz said simply, “We just can’t let them get away with what they’re doing.”

His comments came as COA released its 2020 Practice Impact Report, which cited multiple financial stressors as reasons that, over the past 12 years, 1748 community oncology practices have closed, been acquired by hospitals, merged, or are struggling financially.1

Step therapy. PBM challenges are not new, Diaz said. “We’ve been dealing with this for so long it almost seems like a way of life, and a way of practicing medicine,” he said. Over the years, his practice has addressed higher drug costs, higher patient copays, and more and more patients who need financial assistance programs.

But the rise of step therapy in Medicare Advantage, which CMS allowed in 2018,2 has created a new set of problems. “Whenever they implement ‘fail first,’ it’s usually based on a pathway or algorithm they have. And it doesn’t have anything to do with the patient,” Diaz said. “They’ll deny medications that are appropriate or have been chosen specifically to minimize toxicity so the patient can get the treatment, so we can minimize the risk of complications.”

Diaz recalled a colleague who was treating a woman aged in her 80s with metastatic lung cancer; the physician argued for an oral medication and pointed to cases that were similar to the woman’s medical condition. The PBM manager said the woman should have surgery first, Diaz said, “which is unheard of.”

“These guys have been wanting to practice medicine without a license, and I find it very disturbing,” he said.

Expansion of DIR fees. After Ciaccia spoke with reporters in Ohio who had uncovered $224 million collected by PBMs due to spread pricing, state Medicaid leaders across the country have eliminated the practice and demanded more transparency.3 Since then, dispensing pharmacies have seen more use of direct and indirect remuneration (DIR) fees, which were created to allow Medicare Part D plans and related PBMs to off set member costs; however, they have expanded and found their way into commercial plans. Okon was blunt with his assessment: Once employers who sponsored health plans learned more about PBM rebates, they wanted their share—which meant the revenue had to come from another part of the pharmacy chain. PBMs, Okon surmised, went “downstream” to the pharmacy with DIR fees, “and sometimes they are an easy target.”

Levitt said DIR fees were essentially “invented” by a lone pharmacy, at fi rst, to deal with declining reimbursements. Coupled with the vertical integration of PBMs and insurers in recent years, the dynamic puts most community oncology practices—those that developed pharmacies or that dispense medications—at a disadvantage.

“This hurts patient care,” he said. In oncology, practices want to control dispensing for patient safety, while some PBMs insist on mailing drugs to the practice or even to the patient’s home—requiring the patient to bring their own drugs to the appointment. When practices do their own dispensing, Levitt said, DIR fees can wipe out the “reasonable and relevant” reimbursements the practices are entitled to under the law.

Levitt said that as these mergers add billions to profi ts, he has asked attorneys representing PBMs if they have considered what the law allows when charging fees to physician practices that cause the practices to lose money. The answer? The PBMs believe the “reasonable and relevant” standard might apply to insurers, but not to the PBM. “They believe they are above the law, and that is not good for patient care,” Levitt said.

A louder drumbeat. Although concern was expressed earlier in the meeting that the rise of COVID19 could dampen momentum for drug pricing and PBM reform, Mortier said that Congress is paying attention. Several years ago, Levitt said, few people understood what PBMs were, but that has all changed. While COVID19 may delay drug pricing reform, Mortier believes it will happen—inœpart because of events during the current crisis.

HHS, and the administration more broadly, have “opened their eyes to what’s going on,” Mortier said. During 2019, Congress held many hearings on the drug industry—PBM dynamics, and now members of Congress are seeing how market consolidation has created huge profi ts. “The drumbeat is getting louder and louder,” he exclaimed.

In a recent interview, ADVI Health’s Lindsay Bealor Greenleaf, JD, MBA, vice president for policy, told The American Journal of Managed Care® that CMS’ call for feedback on prior authorization, which came with the 2021 Medicare Advantage rate announcement, would off er oncologists an opening to address these issues, and step therapy in particular.4

During COVID19, Mortier said, health plans and PBMs have suspended steps such as prior authorization, which raises the question, “Why does it take a crisis to ease some of these burdens?” he asked. “We’ve been having thoseœconversations.”

References

1. 2020 Community Oncology Alliance Practice Impact Report. Community Oncology Alliance. Published April 24, 2020. Accessed April 28, 2020. communityoncology.org/2020communityoncologyalliancepracticeimpactreport/

2. Joszt L. CMS will allow Medicare Advantage plans to use step therapy to negotiate drug prices. The American Journal of Managed Care®. Published August 8, 2018. Accessed April 28, 2020. ajmc.com/newsroom/cms-will-allow-medicare-advantage-plans-to-use-step-therapy-to-negotiate-drug-prices

3. Ohio ends pharmacy middlemen contracts over ‘spread pricing’. Associated Press. Published August 14, 2018. Accessed April 28, 2020. https://apnews.com/bcbae6ed076e4841942c9786fac5dd63

4. Caffrey M. Lindsay Greenleaf discusses the 2021 Medicare Advantage rate and related effects of COVID-19. The American Journal of Managed Care®. Published April 19, 2020. Accessed April 29, 2020. ajmc.com/interviews/lindsay-greenleaf-discusses-the-2021-medicare-advantage-rate-and-related-effects-of-covid19.

Lung Cancer Treatment Must Evolve, Spira Says

To continue to move forward in the lung cancer space, there needs to be greater diff erentiation between subtypes of the disease, noted Alex Spira, MD, PhD, director of Virginia Cancer Specialists Research Institute and its phase 1 trial program. Treating all lung cancers eff ectively necessitates this move, Spira said, as he addressed the virtual Community Oncology Alliance (COA) Community Oncology Conference 2020 on April 24.

Spira also serves as co-chair of the US Oncology thoracic oncology research program and is an assistant professor of oncology at Johns Hopkins School of Medicine. In his presentation, “Clinical Update: New Lung Cancer Treatments in the Age of Targeted & Immunotherapy” Spira described recent advancements in the treatment armamentarium for lung cancer.1

According to Spira, “The breast cancer doctors have probably had it right for a very long time. There’s not a breast cancer note that you see about a patient that doesn’t say, [for instance], ‘Mrs. Smith has estrogen receptor—positive, progesterone receptor–positive, HER2-negative breast cancer.’ [It’s not just ‘Mrs. Smith has breast cancer.’] In the lung cancer world, we’re still talking about the patient as [having just] non–small cell lung cancer. But lung cancer is a multitude of many diff erent kinds of malignancies. And if we think about it that way, it will be a better paradigm and better for our patients.”

Spira then began a discussion on immunotherapy approaches plus or minus chemotherapy, as well as novel approaches in targeted therapy. He noted that Taxol (paclitaxel) and carboplatin should not necessarily remain the go-to treatment mainstays.

First, Spira highlighted the results of KEYNOTE-189,2 which looked at pembrolizumab plus pemetrexed and platinum chemotherapy (carboplatin)

compared with pemetrexed and carboplatin alone in patients with adenocarcinoma. The pembrolizumab combination produced superior results, especially

in light of PD-L1 testing results.3

According to Spira, PD-L1 functions as a tumor biomarker to predict therapy outcome, and it’s broken down into 3 ranges, depending on the amount contained in a sample of cancer cells: less than 1%, 1% to 49%, or at least 50%. Patients with a PD-L1 measure of less than 1% who received the pembrolizumab combination had responses close to those of patients in the 50%-and-higher group, which was a surprising result, Spira noted. “It’s really a marker of immune cells in the tumor that would respond to PD-L1 therapy, or inhibition,” Spira said. However, he added, these somewhat unexpected results demonstrate that much remains to be learned about how these drugs work, and that there is a need for more biomarkers.

Among the first trials to show the benefi t of immunotherapy was CheckMate 227,4 which investigated combination checkpoint inhibitor immunotherapy (nivolumab plus ipilimumab) versus platinum doublet chemotherapy in patients with stage IV squamous or nonsquamous non—small cell lung cancer. Will chemotherapy continue to play a role in lung cancer? Yes, he believes, although the potential approval of the nivolumab/ipilimumab combination could be “practice-changing.”

Next-generation sequencing is important, too, because it can pinpoint targetable mutations. Two of the more notable mutations in lung cancer are the RET fusion and cMET exon 14 skipping, he said. Blood-based assays help to identify biomarkers as well, while liquid biopsies enable the detection of earlier-stage cancers.

“We still need a better biomarker,” Spira concluded, “and we’re still trying to build it.”

References

1. Spira A. Clinical update: new lung cancer treatments in the age of targeted & immunotherapy. Presented at: Virtual Community Oncology Alliance Community Oncology Conference 2020; April 23-24, 2020. Accessed April 28, 2020. https://bit.ly/2zefn3j

2. Gandhi L, Rodriguez-Abreu D, Gadgeel S, et al; KEYNOTE-189 Investigators. Pembrolizumab plus chemotherapy in metastatic non—small cell lung cancer. N Engl J Med. 2018;378(22):2078-2092. doi:10.1056/NEJMoa1801005

3. Ott P. What is PD-L1? Dana-Farber Cancer Institute Insight. Updated July 9, 2019. Accessed May 6, 2020. blog.dana-farber.org/insight/2017/05/what-is-a-pd-l1-test/

We Must Bring Clinical Trials to Our Communities, Burris Says

4. Hellmann MD, Paz-Ares L, Bernabe Caro R, et al. Nivolumab plus ipilimumab in advanced non—small cell lung cancer. N Engl J Med. 2019;381(21):2020-2031. doi:10.1056/NEJMoa1910231If oncology trials want more robust, diverse enrollment, there’s a simple answer, according to the current president of the American Society of Clinical Oncology (ASCO): Go where the patients are.

“It’s clear that it’s very, very important for us to think about how we take trials to our patients. The vast majority of patients are seen in a community setting. And the time

is right. We’ve seen a great experience with telehealth over the last few weeks. We’ve seen remote data monitoring and remote data capture. So we really are in a place now to not lose momentum,” said Howard A. “Skip” Burris, MD, during “The Now & Future of Clinical Trials in the Community Oncology Setting” on April 24, the final day of the 2020 Community Oncology Conference, held virtually.

Clinical trials are notoriously diffi cult to qualify for. Some are even shut down before they begin, due to inadequate patient accrual. But these are not the only issues holding them up. According to Burris—who, in addition to being ASCO’s 2019-2020 president, is chief medical offi cer and president of clinical operations at Sarah Cannon Research Institute, and partner at Tennessee Oncology—these are the top challenges in clinical research today:

• Vast numbers of trials

• Rare mutations

• Education

• Expansion cohorts

• Eligibility criteria

• Trial complexity

• Overwhelming paperwork

• Data, both volume and interpretation

What can be done to remedy these issues? According to Burris, we must change how we focus on patients. Because patients’ participation in clinical trials is nonnegotiable, all aspects of the trials—from their design to their data accrual to their results—come down to the patients, and we must focus on them: increasing their numbers, electronically capturing their consent, monitoring them remotely, capturing their data, and molecularly profiling their disease. In essence, the clinical trials process needs to change.

“I do think that we’re at a place right now with the pandemic, with COVID-19, that we’re going to see acceleration of modernizing the clinical trial process,” he noted.

Why Do We Need to Profile Patients?

Much of Burris’ session centered on the central role of molecular profi ling in helping to move the clinical trial process forward: It often drives participation in clinical trials and is necessary. Why exactly? Here are his top 3 reasons:

• For the patient/individual benefit

• For clinical research/drug development (trial accrual)

• For cancer research/benefi t of all (biology, drug resistance)

“How do you not do broad-based molecular profi ling?” Burris asked. He noted the great need to aggregate data to better understand, for example, just why patients who are resistant to a certain course of therapy have developed that resistance, or why some patients respond better than others. The biology of a cancer is quickly outpacing a cancer’s site of origin as the number-1 factor directing clinical choices in how to treat patients.

Driving much of this data gathering is the increasing quantity of diagnostic studies.

“For our community practices, being able to profi le our patients, aggregate those data, and understand whether you have that [trial] population is going to be critical to interacting with pharma and biotech on whether you’re a great site for participating in a clinical trial,” Burris stated.

“This is the new role of data,” he pointed out, “and that enables us to provide clinical decision support and to bring these trials to our patients.”

Burris said that Sarah Cannon’s desire to have clinical trials brought to patients, instead of making patients travel to other sites, is 2-pronged. It would:

1. Allow more patients and treating physicians access to exciting clinical trials by bringing earlier-phase research and novel trial designs to the traditional late-phase clinics

2. Contribute to accelerated drug development by opening large expansion cohorts in the clinics where the patients are being seen

What is Needed to Bring Clinical Trials to the Patients?

Waving a magic wand won’t help, and hospitals still need to be close by in case of adverse events like cytokine release syndrome, or for occasional overnight

observation.

Therefore, in order to bring the trials to the patients, the proper infrastructure must be in place, Burris noted. This will require signifi cant investments in the clinical trial pipeline, regulatory measures, safety, contracting and budget services, site development and management, central internal review boards, quality assurance, information technology (IT) capabilities and support, and marketing support.

The IT systems, in particular, must have a multitude of capabilities: for starters, to capture e-signatures needed to route and execute documents; to allow parties to post and access trial materials; to perform molecular profiling so patients can be matched to the most appropriate trials; and to act as an electronic medical record to capture patients’ visit information. Essentially, the IT system would be the clinical trial management system.

“We’ve got to be able to gather these data remotely,” Burris stressed. “Being able to take care of patients with telehealth, being able to include clinical trials for patients and sites with the use of virtual technology and digital technology—the remote monitoring for clinical trials has long been [available], and with the crisis, we’ve actually had to implement that full speed.”

He wrapped up by reiterating that COVID-19 has changed biopharma and clinical research in 5 fundamental ways. There will be:

1. Renewed interest in vaccines.

2. More adoption of artifi cial intelligence.

3. A rapid increase in automation.

4. More virtual and digital clinical trials

5. Increasing regulatory fl exibility.

“It’s just clear that this pandemic is paving the way for us to have the ability to include more patients, more practices, and more physicians and participants in cancer research,” Burris said.