May 2020 Edition Vol.11, Issue 5

COA 2020: Clinical Trials, Applied Informatics, and Oncology Payment Reform

By Chase Doyle

The coronavirus pandemic has spotlighted a number of longstanding trends in the community oncology setting, including clinical research, big data, and payment reform. At the Community Oncology Alliance (COA) 2020 Annual Conference, virtual presenters across the country discussed modernizing the clinical trial process, navigating the complexity of cancer care with applied informatics, and improving value-based reimbursement. 

Clinical Trials in the Community Oncology Setting

According to Howard Burris, III, MD, FACP, FASCO, Chief Medical Officer & President of Clinical Operations at Sarah Cannon Research Institute, the pandemic has paved the way for modernizing the clinical trial process to include more patients, physicians, and practices in cancer research. Although the remote monitoring needed to move clinical trials to the community setting has long been available, the COVID-19 crisis has forced practices to implement this technology at full speed.

“With the remote data monitoring and data capture enabled by telehealth, the time is right to take these trials to our patients,” said Dr. Burris.  

As community practices prepare for clinical trials, Dr. Burris noted the rise in tumor-agnostic studies and the increased relevance of biomarkers, as tumor sites of origin becomes less important for treatment than the underlying biology. The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to larotrectinib for solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, and Dr. Burris noted that broad molecular profiling is essential for identifying these fusions. Nearly 80% of patients respond to the targeted therapy.

Clinical researchers are also matching KRAS mutations to the appropriate therapy with increasing success. There are currently five KRAS inhibitors with three different modes of action available in the clinic, and more are on the way.

For community practices, being able to profile patients, aggregate data, and identify the right population is critical to interacting with pharmaceutical and biotech companies and securing participation in future clinical trials. In addition, there is a growing interest in plasma-based testing.

“There is so much to be learned from the molecular profile and the multitude of trials that are potentially habitable,” said Dr. Burris, who noted that bioinformatics needs to be incorporated into practices, and practices need to be able to handle the data to make the best selection for their patients.

Another trend in clinical research is the disappearance of standard phase 2 trials, as drugs are frequently approved off large expansion cohorts in phase 1 trials. Expansion cohorts are also enrolling rare tumor types or even minimally or untreated disease, as targeted therapies appear more promising than what’s available in the standard of care setting.  

“We need to allow more patients and treating physicians to have access to these trials to accelerate the development process,” said Dr. Burris. “Moving these trials into the clinics where patients are being seen will provide us with much needed answers faster, which is critical for cancer drug development.”

Dr. Burris also advocated for eligibility criteria that match the real world, i.e., the patients that are seen in the clinic on a daily basis. One study based on criteria proposed by ASCO and Friends of Cancer Research showed that the enrollment of patients with lung cancer in one clinical trial would nearly double (from 52.3% to 98.5%) with expanded inclusion criteria. 

Another study looking at men with breast cancer, who are typically excluded from breast cancer trials, utilized real-world data across multiple sites and led the FDA to expand the approved indications of the CDK4/6 inhibitor palbociclib to include men. 

“[The IBRANCE study] is a superb example of how real-world data can be utilized to achieve impressive results,” said Dr. Burris.  

Despite the obvious advantages of community practice participation in clinical research, Dr. Burris said it won’t be easy. Handling the growing complexity of clinical trials, including antibody-based cancer therapy, cellular therapy, and immune effector cell therapy, will require investment in a dedicated infrastructure support system or joining a research network that will provide that infrastructure. 

“This is going to be key to modernizing the clinical trial process and enabling practices to participate with the rest of the country,” he concluded.

Applied Informatics in Cancer Care: The Power of Large Numbers

According to Debra Patt, MD, MPH, MBA, Executive Vice President, Policy and Strategic Initiatives, Texas Oncology, informatics tools like big data can help navigate the heightened complexity of cancer care by empowering providers to understand molecular characteristics at a larger scale, and use that information to accrue to clinical trials, and understand diseases and their respective treatments in a larger population.

“Cancers that were more general have become much more specific either because of molecular specification, clinical presentation or diagnostic features,” said Dr. Patt. 

She explained that informatics is all about problem solving, and data sharing networks are an important way to aggregate data in order to derive clinical meaning. Researchers are using these networks to figure out how to accrue patients with rare molecular mutations to clinical trials, how to accrue patients on clinical trials for cancer of low prevalence, and how to get approval for drugs for cancers of low prevalence. They’re also analyzing the long-term toxicity and efficacy of cancer treatments.

Although big data is often about clinical meaning, problems can be operational too. For example, when practice management systems are integrated with electronic health records (EHRs) that are interacting with research platforms, providers can make better decisions about almost all aspects of care delivery.

“The power of large numbers can be utilized to understand the market context of how the pandemic is impacting clinic visits across the country,” said Dr. Patt. “This can be an important way to plan things like staffing and appropriate resource allocation to support our clinics.”

View an OBR interview with Dr. Patt: 

Clinical Decision Support

Given such complex systems, implementation of optimal therapeutic interventions can sometimes vary across sites. Clinical decision support, which integrates different sources taken from the EHR, consumption patterns, census tract data or other parameters, is one way to reduce the variability of compliance with evidence-based decision making.

“Clinical decision support is about facilitating decisions that we would like to see move forward by using a ‘nudge’ or choice architecture to make sure that preferential choices are easier to make and thus more likely to be chosen,” said Dr. Patt. 

A study conducted with the US Oncology Network of approximately 30,000 patients across nine statewide practices looked at implementation of a decision support system called Clear Value Plus, which put value-based clinical pathways into the EHR. Every time a chemotherapy prescription is written, the prescriber receives a nudge of preferential choices from the EHR. 

“Although they don’t have to abide by that nudge, if they put in an exception, they must have a reasonable reason,” said Dr. Patt, who reported an improvement in target compliance from 58% to 72%.

Another example of clinical decision support is electronic patient-reported outcomes (ePROs) linked to nursing triage. One ePRO tool study’s results for symptom monitoring during routine cancer treatment vs standard of care showed an improvement in both quality of life and overall survival [Basch et al. JAMA, 2017]. 

“Decision support mechanisms are about getting the right information to the clinical team at the right time, but it takes good policy to facilitate successful informatics solutions,” she concluded. Patt also noted that if the policy changes that the administration put forward in March were not partnered by the States, practices would not be able to offer these solutions to their patients.

Oncology Payment Reform: Updates on the OCM 1.0

As community practices scrambled in March to implement telehealth services amidst lockdown restrictions, value-based payment arrangements between health plans and providers have been disrupted. Whether shared savings, shared risk, or full risk arrangements, quality reporting deadlines are likely to be missed, said Bo Gamble, Director of Strategic Practice Initiatives, Community Oncology Alliance.

As always, the focus remains on quality cancer care, but practices are facing financial pressures. According to Flatiron Health, telehealth visits skyrocketed overnight, but also seen is a 33% drop in daily non-infusion visits, a 60% increase in appointment cancellations, and a 50% decrease in new patient visits will be challenging to recoup. 

As the Centers for Medicare and Medicaid Innovation (CMMI) has yet to update the number of practices participating in the Oncology Care Model (OCM), Flatiron Health estimated a 20% departure, which would leave approximately 140 programs in the group. A recent survey by COA also found that approximately one third of respondents were moving into downside risk despite not achieving enough savings to receive a performance-based payment. 

Given the pandemic’s extraordinary impact on practices, COA has asked CMMI to delay two-sided risk through the year and to extend the OCM as well.

View an OBR interview with Bo Gamble:

 

Oncology Care First (OCF) Model

As COA continues to learn and educate its members about the OCM, community providers are also anticipating the launch of the OCF model, which aims to improve health outcomes and increase the quality of care for Medicare beneficiaries. However, no information about the OCF has been provided following CMMI’s initial request for feedback. 

Lalan Wilfong, MD, Executive Vice President, Value Based Care & Quality Programs, Texas Oncology and COA Payment reform Co-Chair, presented COA’s request to CMMI. “One of the things we really want to request is that we not transition to any other models at this point,” he said.  

Because of the cost of COVID-19 and the number of people who are becoming unemployed and applying for Medicaid and other government programs, Dr. Wilfong noted that it’s more important than ever to think about how to define value-based care as it pertains to oncology patients. 

According to him, a one-year extension of the OCM would help community practices incapable of adopting any new initiatives during the crisis. Once the transition is made to a new model, however, he underscored the importance of transparency around enhanced payment structures so that community oncologists can predict and model the financial impact on their practices.

Dr. Wilfong also requested more emphasis on shared savings and less on gain sharing, so that practices are “rewarded for doing the right thing”. In addition, many practices continue to have doubts about OCM adjustments, so improvements in predicting the risk of patients must be made. Finally, Dr. Wilfong noted that many practices, such as those that treat multiple myeloma, provide complex care that isn’t appropriately adjusted. 

“Practices that integrate biosimilars or do therapeutic interchange to use more cost-effective drugs or manage patients who have more complex socioeconomic issues need to be rewarded for doing so,” he said.

OCM 2.0

As Dr. Wilfong reported, COA has also been working with its member practices and payer partners to develop a 2.0 version of the OCM. Some of the components they have focused on include attribution, care delivery, and quality measures. 

The new model should also work to improve care delivery, keeping patients out of hospitals and emergency rooms and adjusting risk to make sure they’re managed appropriately.

Drugs are also a major component of any model. Patients should be allowed to receive new drugs that truly improve their health outcomes, while practices need to be held accountable when drugs are overused or prescribed inappropriately.

For the OCM 2.0, COA is considering a three-tiered model based on the complexity and goals of the organizations involved.

 

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