Highlights From the 2022 Oncology Clinical Pathways Congress

As the official annual conference of the Journal of Clinical Pathways, the Oncology Clinical Pathways Congress (OCPC) spotlights the use and continued expansion of clinical pathways and their effect on patients, clinicians, payers, and health systems. Presentations from OCPC’s faculty, all leaders in their respective fields, included discussions on value-based care, the evolution of ePROs, the potential uses for artificial intelligence and machine learning in clinical pathways, and the need to include diverse populations in clinical trials. Below are some highlights from the three-day conference. Please visit the Journal of Clinical Pathways website to access comprehensive coverage from OCPC, including video interviews.

“In order to have a vision for tomorrow, we have to know what’s happening today,” Winston Wong, PharmD, President of W-Squared Group and Editor-in-Chief of the Journal of Clinical Pathways (JCP), began in presenting the results of the 2022 JCP survey.

Clinical pathways are continuing to become an integral part of oncology care, although the reasons for the continued interest are changing, said Dr Wong.

According to the survey results, payment model participation increased in multiple aspects compared to 2021. Fee-for-service appears to have gained ground in the last year (70% vs 32%) possibly due to the ending of the Oncology Care Model program, suggested Dr Wong. Performance-based and risk-bearing reimbursement arrangements also have significantly decreased.

Results of institutions that currently have pathways in place have increased in the last year from 37% to 53%.

Similar to 2021 results, social determinants and patient preferences continue to be strong considerations as oncology care is refocusing back to the patient. Pathway content is being driven by NCCN guidelines or other recognized compendia, according to 70% of respondents. Most practices reported having one to two pathway programs in place, with 31% responding they have three to four programs.

Some 80% of respondents indicated that reducing overall care costs was either a very important or most important pathway driver.

“Clinical pathways are viewed to have a beneficial impact on quality of care and controlling costs, and are used as an educational tool on new treatment options,” Dr Wong concluded. “The responses indicate a continued interest in clinical pathways, most likely associated with increased demand for improved quality of care and financial accountability.”

“Opportunities for Decision Support Through Structured Data”

Mary M. Ichiuji, MD, oncologist at Kaiser Permanente; and National Physician Lead, Beacon Oncology

Mary M. Ichiuji, MD, explained how the Kaiser Permanente (KP) Beacon Oncology Module – EPIC electronic health record (EHR) offers nearly 1,200 protocols developed through the collection of data from the KP network.

“With the rapidly changing therapeutic landscape, it’s difficult for physicians to keep up,” Ichiuji said.

In 2018, the KP National Oncology Drug Treatment Pathways was agreed upon, with the intent to develop internal oncology treatment pathways.

Developed with 11 subspecialty teams, the pathway is loaded onto the National Clinical Library and is integrated with Beacon EHR. This has resulted in pathways for a multitude of organ systems.

EHR integration is viewable from KP Health Connect or the KP Intranet for physicians, or orderable from the Patient Chart in the EHR, with multiple options and menus intended to provide specific pathways for specific individuals.

When deployed in 2020, initial use among network physicians was 16%. Now that number is up to 93%. In January 2021, about 20% of treatment plans utilized pathways, compared with 78% as of June 2022.

“The rapid adoption for the use of pathways is because we feel physicians trust the information; it was made by their peers,” Dr Ichiuji said.

“Pharmacy Benefits in Value-Based Pathways”

Sibel Blau, MD, Medical Director at Northwest Medical Specialties, PLLC; James Gelfand, President of the ERISA Industry Committee

From 2013 to 2018, spending on drug costs doubled from $29.4 billion to $56.7 billion in the US. One reason for this is the increased number of pharmacy benefit managers (PBMs), third-party administrators of prescription drug programs covered by a plan sponsor, said Sibel Blau, MD,  in her presentation with James Gelfand.

“We created the PBMs, we built them, and then we didn’t really create any rules for them, so they created their own rules,” Gelfand said. “Those rules are not going to drive value for the patient.”

The growth of PBMs’ influence has had a direct result on skyrocketing drug costs, Dr Blau said. And PBMs exert a considerable influence on injectable biosimilars and intravenous chemotherapies.

“These high drug prices created this monstrous development in the last several years,” she said. “Revenues are so high, so incredibly lucrative, that PBMs continue to grow. Market share in 2018—you look at CVS Caremark, Express Scripts, OptumRX—they have huge market shares. They started exerting more influence into the injectables and intravenous chemotherapies as well. So there is more and more coming into our practices, as we providers are getting less and less powerful, and this is also shifting to the patients’ pockets.”

Independent oncologists must deal with the paradox of drug margins vs value-based care.

“Drug pricing margin is always a fight,” she said. “People talk about this, we are incentivized by the margins. No, we have to have the margins to operate our clinics to be able to provide care so we don’t close our doors.”

Dr Blau is one of the founders of the Quality Cancer Care Alliance Network (QCCA), an organization of “fiercely independent” community oncology practices dedicated to leveraging their combined knowledge to improve clinical outcomes and the cancer care delivery system. Founded in 2015, the QCCA has grown and expanded, with the strategic goals of integrating and aggregating clinical data, research, value-based care, educational programs, and operational excellence. The QCCA now boasts one of the most complete community-based cancer data sets in the world, caring for more than 1.2 million patients.

Health Economic Outcomes Research is also a key component in the QCCA’s recently established research network, known as Exigent.

“HEOR is so important,” Dr Blau said. “You can take the real-world data and information that comes from that, and that information changes the behavior. Value-based care includes research. Research is the most important because we have to be finding the most economical ways.”

“Human Factors Engineering for EHR Design in Oncology Care—A Patient Journey Perspective”

Kellee Franklin, PhD, Chief Innovation Officer at Mindful Innovation Labs

“You always think you know a little bit of something until you get thrown into the deep end of the pool,” Kellee Franklin, PhD, said by way of introduction. “I got thrown into the deep end of the pool with my own health journey when I was diagnosed with triple-negative breast cancer.”

Franklin introduced herself as a strategic innovation consultant whose eyes were opened to the challenges with the system after her diagnosis in 2013.

“I was more focused on all the system challenges than I was on what I was going through as a patient,” Dr Franklin said. “I vowed if I survived that I would dedicate time and attention to calling your attention to what I believe my field of human-centered design can do to turn the dial with some of the things you’ve been talking about.”

Franklin called attention to Microsoft CEO Sayta Nadella, who changed the way that the company approaches collaboration and innovation.

“He’s shifted the mindset of a company culture that lauded itself on an expert mindset to one that was a growth mindset, and he emphasized empathy and diversity,” Dr Franklin said. “Empathy, putting yourself in the shoes of another person, and diversity, bringing different perspectives together, to be able to solve complex problems.”

Dr Franklin said that in her work for entities such as World Vision International, Boeing, the White House and the Pentagon, she has discovered that there are three keys to innovation: engage, educate, empower.

Engagement creates understanding, she said. “Every single one of us in this room beautifully has a way they view the world that is different from everyone else,” Dr Franklin told the assembly. “Historically, most organizational systems, when working to solve complex problems, assemble teams of like-minded people. And what do you think happens? We end up with the same problems. Engaging people from different perspectives allows us to look at challenges in our organizational systems … and helps us see possibilities.”

As the second key to innovation, education inspires transformation.

The final key to innovation is empowerment, which Dr Franklin believes accelerates innovation. And clinical pathways are proving to be a tool that is closing in on these three keys.

“How do we create tools and resources that allow patients to feel empowered by the choices they make?” Dr Franklin asked. “I think clinical pathways is a great resource that is on the brink of creating this tool that gives them the engagement piece and the education piece and is getting them close to that empowerment piece, where they’re at the center of the decision-making.”

“Measuring and Driving Quality of Care and Research Initiatives in Oncology”

Lee A. Fleisher, MD, CMS Chief Medical Officer, Director, Center for Clinical Standards and Quality

The Centers for Medicare & Medicaid Services Innovation (CMS) serves the public as a partner and steward, dedicated to advancing health equity, expanding coverage, and improving health outcomes, explained Lee A. Fleisher, MD.

Earlier this month,  CMS published its vision for the future in regard to coverage decisions and quality improvement. This initiative is especially important, given that approximately 1.6 million people are diagnosed annually with cancer, he said.

“These six pillars underlie everything we do,” he said. “Advancing health equity is number one, and you see that in the enhanced oncology model that underlies our health system; building on the Affordable Care Act and getting to that quality as well as affordable health care; engaging our partners; driving innovation—we want to partner and work very closely with the FDA, and really want to ensure that we’re driving that innovation but also ensuring that we’re getting that data back to see whether that innovation had the intended goals; always worried about the sustainability of the program; and the people.”

CMS has a strategic plan to achieve its vision over the next 10 years. The goal is a health care system that achieves equitable outcomes through high-quality, affordable, person-centered care.

“One of the goals is this focus by 2030 that every single patient is in an accountable relationship with a provider,” Dr Fleisher said.

Another goal is a CMS National Quality Strategy that includes, but is not limited to, embedding quality across the care journey, advancing health equity, fostering engagement with stakeholders, promoting safety, and embracing the digital age.

“Embracing the digital age I think is one of the key points,” Dr Fleisher said. “As we talk about the quality metrics, our hope is, how can we use our data, from a lot of the electronic medical records, pull that down so we can actually get those signals faster, reduce burden on the provider, and actually see the outcomes, and can we use those quality measures to look at the outcomes of some of those innovations.”

Shifting to the Oncology Care Model (OCM) and its future, Dr Fleisher spoke of the 6-year, voluntary payment and delivery model focusing on innovative payment strategies that promote high-quality, high-value cancer care in Medicare fee-for-service (FFS) beneficiaries who are undergoing chemotherapy treatment. OCM included 126 practices, five payer groups, and more than 10,000 cancer practitioners participating. This accounted for about 25% of the chemotherapy-related care for Medicare FFS beneficiaries in the US.

Looking ahead, Dr Fleisher described CMS’ newest model, the Enhancing Oncology Model (EOM), designed to preserve or enhance the quality of care furnished to beneficiaries undergoing treatment for certain cancer types, and with the expectation to reduce Medicare costs.

EOM is a 5-year, voluntary payment and delivery model that builds on lessons learned from OCM with required downside risk focusing on innovative payment strategies that promote high-quality, equitable, high-value cancer care in Medicare FFS beneficiaries who are undergoing chemotherapy treatment. The planned EOM performance period will run from 2023 through 2028.

“We moved heavily into the new model that really focuses on enhancing the oncology model by what we’ve learned,” Dr Fleisher said.

“Genomics: Sequencing-as-a-Service in the Clinic”

Mahek Shah, MD, MBA, MS, Physician Executive, Investor, Advisor and Managing Partner, Harvard University and WTM Advisors

As of May 2019, more than 30,000 genetic tests in the National Institutes of Health Genetic Testing Registry list next-generation sequencing (NGS) as their primary test method, reported Mahek Shah, MD, MBA, MS. Additionally, the clinical gene sequencing market is rapidly growing, with $10 billion spent in 2021, and a predicted $31 billion to be spent in 2027.

“I want to talk less about the science purely and more about where the field is going,” Dr Shah said. “It’s very much classic disruption theory: things that were done previously in a large institution—call it health system, call it hospital—are moving toward a different location of care, and this is where genomics and sequencing are going.”

The goal for the future, according to Dr Shah, is to enable gene sequencing-as-a-service in clinical settings without the capital expenditures or operating expenses. This includes automated sample preparation, labs at the needed locations, and on-demand sequencing that would result in faster turnaround. This also means that patients would pay per test.

“Diagnosis is impacted by gene sequencing because we have targeted therapies, we have awareness of subtypes of diagnoses, which requires a different pathway to treat,” Dr Shah explained. “Genetic screening is becoming more and more popular, both in the health care industrial complex but also in the home, and treatment is impacted by this revelation.”

A major benefit of this model is that gene sequencing samples would stay in the clinic.

Dr Shah explained technology advances such as microfluidics, next-generation sequencing, advanced bioinformatics powered by artificial intelligence/machine learning, and cloud scalability and accessibility to high-power computing all aid in the move to sequencing-as-a-service.

Strategic advances such as longitudinal studies, security and privacy concerns of genomic data, and precision medicine also help with this initiative.

“The thought that I want to leave you with is, what could oncology care look like when you move sequencing closer to the patient,” Dr Shah said.

“Artificial Intelligence in Cancer Care: Role in Precision Medicine”

Tushar Pandey, CEO, SimBioSys, Inc

Intolerance to uncertainty drives innovation. As recently as 10 years ago, a map was necessary to find your way around a new town. Now, an app on a cellphone can not only plan out your quickest route, but will also tell you exactly how long it will take you to reach your destination.

What does that evolution look like in cancer care? This was the question posed by Tushar Pandey.

Cancer care is broader than a dictionary definition of precision medicine, Pandey said. Cancer is an intimate journey that involves precision risk stratification, screening, diagnosis, tumor profiling and testing, treatment selection, dosing, monitoring and surveillance, and survivorship.

“We have to bring all of these individual components together if we’re going to truly realize the impact that a Google Maps has had on our lives,” he said.

So, what does precision medicine mean for the future, and how do we get to that reality? First, since the patient journey includes individualized and personalized factors, such as risk stratification, precision dosing, and monitoring plans, that means every patient’s journey and needs are different.

Second, we can’t get to that reality with human beings alone, Pandey said. The American Society of Clinical Oncology is projecting a shortage of oncologists by 2025, even though the demand for cancer treatment is expected to grow by 40% over the next 6 years.

Artificial intelligence (AI) has its place in medicine, but its impact in oncology has been unclear. The FDA released data on 521 devices they have recently approved over the last few years involving AI. A vast majority of these approvals have come in radiology.

A recent survey of radiologists shows that AI can have significant benefits in certain areas including breast, oncologic, thoracic, and neuro imaging, and AI saved time that could then be spent with patients. But AI can’t do it alone, either.

“Half of the respondents said that their patients don’t want to be treated by a machine, or diagnosed by a machine,” Pandey said. “There’s no future where a patient comes in and a machine diagnoses them and treats them. There’s a hybrid approach between the two.”

Currently, AI is being applied in areas such as patient engagement (eg, chatbots), drug development, data and analysis, and diagnostics.

“But this doesn’t get to the heart of the problem, which is what pathways has been trying to solve,” Pandey said. “How do we do better for patients when it comes to treatment planning?”

Looking to the future, perhaps the best use of AI in cancer care is through guided intelligence, which involves integration of multimodal data and individual components to present causality, the need to be transparent and explainable, and the opportunity for clarity on decisions and to derive insights justified by science.

“Guided intelligence is taking components of AI and bringing it together with traditional mathematical modeling approaches to be able to support physician decisions,” Pandey said. “It’s time to embrace the AI revolution beyond medical image interpretation.”

“Optimal Utilization of Telehealth to Enhance Patient Care and Clinical Trial Participation”

Matthew A. Lunning, DO, FACP, Associate Professor, Fred & Pamela Buffett Cancer Center, Associate Vice-Chair of Research Department of Medicine, Assistant Vice Chancellor of Clinical Research, University of Nebraska Medical Center, Omaha, Nebraska

Telehealth has supplemented clinical care, and it helped overcome the barrier to clinical research during the COVID-19 pandemic.

Even before COVID-19, telehealth was impactful across areas such as depression, pain management, chronic respiratory failure, congestive heart failure, and end-of-life care, said Matthew A. Lunning, DO, FACP, in the final presentation of the congress.

Dr Lunning found a study on palliative care and all the resources that are necessary for quality end-of-life care. Much of the time, patients with leukemia or lymphoma remain in the hospital. It is not ideal, nor is it desirable, for the hospital, the patient, and the patient’s family. So why do they remain in the hospital setting?

“Because we do not have confidence that they can receive the level of care outside the hospital that they need,” Dr Lunning said. “So how do you build confidence with the family that they can do this at home?”

To start, face-to-face interaction helped improve confidence. Telehealth allowed patients to see their physicians and allowed physicians to see any physical symptoms even when they were not in the same room.

Telehealth truly came to the forefront as the COVID-19 pandemic spread. The guidelines in April 2020 that restricted face-to-face contact jump-started the new era of telehealth. Using the paradigm set up several years earlier in dealing with Ebola, Dr Lunning’s practice set up similar guidelines.

Studies have shown that patients want to use electronic consent—overall preference for using a computer (65%) was far greater than paper (25%)—but the rate-limiting step is time. The proper time is required for patients to understand a trial.

In March 2020, with the COVID-19 pandemic beginning, Dr Lunning wrote a consent for a human biologic material protocol. He contacted patients via telehealth and sent them consent forms via email. It provided the potential participants with the time needed to understand the information.

“It was gold,” he said. “We accrued hundreds of patients, so that the next time they came in for a blood draw for clinical purposes, we grabbed their baseline blood. That was incredibly important because on the coast—where the pandemic spread earlier and more quickly—they had a lot of samples, but they didn’t have baseline data off the immune system of the patients who got COVID.”

While barriers still exist, particularly with FDA-regulated or DHHS-funded research, telehealth is proving to be an effective method in health care and could be used in clinical trials.

“I think we really need to press that telehealth or electronic methods are necessary and would increase clinical trial participation and diversity within clinical trials,” Dr Lunning concluded.