Most cancers are diagnosed in the later stages, but if this disease could be diagnosed earlier and with greater accuracy, patient outcomes could be much better, said Joshua Ofman, MD, MSHS, chief of corporate strategy and external affairs, Grail, Inc. “I know that nothing can keep you up at night like the concerns people have about cancer,” Ofman said, as he began his keynote address during Patient-Centered Oncology Care, the annual multistakeholder gathering presented by 

Although there are eff ective screening methods for some cancers, most are not screened for at all, and the process is inefficient: screening for one type of cancer at a time. Furthermore, screening rates are “suboptimal,” Ofman said. As a result, most cancers are diagnosed in later stages, when outcomes are poorer. Finding cancer in later stages means the cost of care will be dramatically higher, too.

On the fl ip side, however, there are concerns that when cancers are diagnosed early, there can be overdiagnosis or cancers diagnosed that might not cause harm. Ofman pointed to controversies over recommendations for mammography and prostate-specifi c antigen testing.

According to the data Ofman presented, approximately 2000 Americans die each day due to cancer. By 2020, cancer care is projected to cost more than $150 billion dollars.

“So, we have got to transition our current healthcare system away from a ‘break it and fix it’ healthcare system and toward a healthcare system that focuses on prevention and early detection,” he said. “And if we don’t do that, these numbers are not going to change.”

New technologies are the key to focusing on early detection. Sequencing the human genome and reading the code of DNA is allowing the healthcare system to find mutations and changes, but we are not yet at a place where we can distinguish cancer from noncancer just based on mutations, Ofman explained.

The next step in technology has been the convergence of machine learning and artifi cial intelligence. This technology is allowing Grail to look into blood to identify fragments of DNA that degrading cancer cells release. However, healthy cells also degrade and release fragments. Any test of these cell fragments would have to be able to discriminate a cancer cell from a noncancer cell with high specifi city in order to create few false positives. And that test would have to be able to tell clinicians what tissue it was from to localize the cancer.

In a study, Grail examined the methylation patterns in DNA. Methylation patterns change the activity of a DNA segment and tell cells what cells to become and what tissue to go to. Grail also looked at RNA, mutations, and DNA code in order to determine the best way to detect cancer.

The Circulating Cell-Free Genome Atlas Study included more than 15,000 participants with and without cancer and compared how efficient the technologies were at detecting cancer, how many false-positive test results there were, and how well they could identify where the cancer was localized.

The study revealed that DNA methylation was the best method, and adding on any of the other methods, such as mutations, did not improve the test. Then, Grail trained a machine learning algorithm to detect the cancer and determine its location.

The test can diagnose or find more than 24 different types of cancer, but Ofman presented on a subset of the 12 deadliest cancers that account for about 70% of cancer mortality. The test detected cancer across these 12 cancers with 76% sensitivity and the false-positive rate was below 1%. In comparison, the false-positive rate for mammography is 10%. The test was also able to accurately localize the cancer in more than 90% of cases.

The low false-positive rate is important, as the test identifies early-stage cancers. Ofman presented data that showed patients whose cancers were diagnosed by the Grail test had a worse mortality rate, which appears to mean that the Grail test is diagnosing harmful and lethal cancers.

“And that’s really important for an early-detection test, because as you know, one of the biggest concerns with cancer detection right now is that we’re fi nding too many false positives,” Ofman said. “And we’re fi nding early cancers that probably don’t need to be treated as aggressively as they’re being treated. So, we can be fairly confi dent based on these early data that the cancers the Grail test is finding required treatment, which is exactly what you want to know.”

What does this test mean for overall public health? If everyone in the United States from age 50 to 79 were eligible for screening and they were all given the Grail test, or a test like it, almost half a million cancers would be identifi ed, and many of these cancers would not have been identifi ed without this test because there is no capability to detect the cancer that early.

If the same population went through current screenings, such as mammography for breast cancer, Cologuard (Exact Sciences Corporation, Madison, WI) for colon cancer, or low-dose computed tomography for lung cancer, the tests would diagnose 150,000 cancers but produce about 9 million false positives. Adding the Grail test to the current screening assessments would find 3 times as many cancers but only add 1 million false positives.

Grail also looked at how its test could intercept cancers at an earlier stage and what impact this finding would have. Looking at the participant data of those likely to die in the next 5 years from cancer, Grail found it could intercept at an earlier stage for 68% of cancers. This interception would fl ip the current distribution of diagnosis, which is mostly happening at stage III or stage IV. This test has the potential to reduce the cancer mortality rate by 37%.

“This is all a projection, and it’s early modeling, and there’s much more to come, but this paints the magnitude of the opportunity that we’re staring into, to focus on early detection,” Ofman said.

Articles

Evidence-Based Oncology

Joshua Ofman, MD, MSHS, gave his keynote address during Patient-Centered Oncology Care, the annual multistakeholder gathering presented
by The American Journal of Managed Care® in Philadelphia, Pennsylvania.

Keynote Address: Using Technology to Intervene Earlier in Cancer and Improve Survival Rates

The Fast Pace of CAR T-Cell Innovation Caused an Array of Treatment Challenges

Evidence shows that chimeric antigen receptor (CAR) T-cell therapies are eff ective, but their price tags are high, raising concerns about how many patients will receive treatment. During a discussion at  

The American Journal of Managed Care®’s Patient- Centered Oncology Care

® meeting in Philadelphia, panelists outlined the efficacy of the 2 FDA-approved therapies, Medicare reimbursement for CAR T-cell therapies, and the pace of innovation in healthcare.

Tisagenlecleucel (Kymriah) has been used successfully to treat children and young adults, up to age 25, with relapsed or refractory acute lymphoblastic leukemia, explained Shannon L. Maude, MD, PhD, assistant professor of pediatrics in the Division of Oncology at the Children’s Hospital of Philadelphia, and medical director of the Center for Cellular Immunotherapies at the University of Pennsylvania Perelman School of Medicine. In the trials that led to FDA approval, patients treated with tisagenlecleucel had a remission rate of 81% after relapsing more than once after the best standard of care.

 In some of the longer-term data now being seen, patients who went into remission have a relapse-free survival rate of 66%.

The other FDA-approved therapy, axicabtagene ciloleucel (Yescarta), is indicated in adults with diff use large B-cell lymphoma, which typically aff ects people in their 60s and 70s, said John W. Sweetenham, MD, FRCP, FACP, FASCO, professor of medicine and associate director of clinical aff airs at the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern. For 15 to 20 years, treatment for disease has be relatively the same: chemotherapy is front line followed by a bone marrow transplant. But if those 2 treatments are unsuccessful, the patients had essentially no other options.

Now, there have been extraordinary responses with CAR T-cell therapy, he said. There are patients who, in the past, he would have anticipated have a bad outcome after relapsing, who have  now survived more than a year after treatment.

“This treatment is like nothing we’ve ever seen before in terms of its ability to turn very sick people around,” Sweetenham said. However, because these therapies are so diff erent from conventional treatments, there are still plenty of unknowns. For example, there have not been any randomized trials to compare the CAR T-cell therapy treatment with more standard treatments.

As a result of how successful CAR T-cell therapies have been and how unique they are, they cost upwards of $373,000 per treatment

—the good news, said Erika Miller, JD, senior vice president and counsel at CRD Associates, is that patients only need the treatment once. The problem is that regulators and legislators are concerned about safeguarding the Medicare trust fund, and these therapies are a big hit, financially.

There is concern that if Medicare pays the full cost, that it “is sending a signal” to drug makers that the price tag is not a problem, and they might even be able to ask for more for the next treatment. “[Regulators and legislators] are concerned about how many patients are going to get this,” Miller said. “They’re afraid of a tsunami. And then, this is all happening at the same time that everyone in Washington [DC] is talking about the price of drugs.”

She echoed Sweetenham and Maude’s comments that everyone is still waiting to see how eff ective the treatments will be in the long term. In addition, a greater concern is that there are other CAR T-cell therapies in the pipeline, which will only add to the costs.

“Medicare doesn’t change on a dime,” she said. “It takes them a long time to change their policy. They have mechanisms for payment that have been in place for a long time that they are reluctant to change.”

The pace of innovation has been, perhaps, too fast. It has outpaced changes in payment, but also, “in some ways, we’re ahead of the evidence,” Sweetenham said.

“We don’t want to end up in a situation where patients are potentially missing out on effective treatment because it’s taking us too long to get the evidence that we really need,” he added. Putting together clinical trials is complicated and expensive, and researchers need a solid partnership with all the stakeholders in terms of getting needed clinical trials moving, Sweetenham said.

Maude added that when trials are set up, they need to be optimized so researchers can identify which patients will benefit the most from CAR T-cell therapies and, thus, improve the current outcomes. There is additional cost in setting up those types of trials, but they will be more cost effective in the long run, she said.

Moving forward, improving patient access to these treatments is critical, Miller said. The cost of CAR T-cell therapies is so high that academic medical centers are losing out on more than $100,000 for each patient treated.

 As a result, there are some centers that are deciding not to off er CAR T-cell therapy.

Maude and Sweetenham also highlighted the access challenges. Because so few centers offer CAR T-cell therapy, patients often have geographic barriers and must drive long distances in order to get treatment. Patients with commercial insurance tend to have less trouble getting the treatment approved than patients who

Although the current administration has been reluctant to pay the full price tag for these therapies, it has shown it is very focused on promoting innovation, Miller said. “There’s recognition that there’s innovation here that can’t be choked off,” she added. The administration is listening, and there has been some progress

with the increased new technology add-on payment,

 but with an election next year, there could be a new administration in the White House with a diff erent perspective.

When asked to peer into the future, Miller predicted there would be a payment model for CAR T-cell or cellular therapies being tested. Next year, there might be a CAR T-cell therapy for multiple myeloma, which has a large patient base, so there will be more pressure on CMS to create a payment model.

Maude and Sweetenham are hoping to see more longer-term follow-up data and better predictions about which patients will benefit the most. Sweetenham is also anticipating that these treatments will move more into the outpatient setting and hopes to see patients getting better access to the treatments.

“Pessimistically, I haven’t seen the field really move that far in 5 years,” Sweetenham said.“

1. Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439-448. doi:10.1056/NEJMoa1709866. 

2. Grupp SA, Maude SL, Rives S, et al. Tisagenlecleucel for the treatment of pediatric and young adult patients with relapsed/refractory acute lymphoblastic

leukemia: updated analysis of the ELIANA clinical trial. Biol Blood Marrow Transplant. 2019;25(3):S126-S127. doi: doi.org/10.1016/j. bbmt.2018.12.410.

3. Andrews M. Staggering prices slow insurers’ coverage of CAR T cancer therapy. Kaiser Health News. http://www.khn.org/news/staggering-prices-

slow-insurers-coverage-of-car-t-cancer-therapy/. Published July 17, 2018. Accessed January 2, 2020.

4. Manz CR, Porter DL, Bekelman JE, et al. Innovation and access at the mercy of payment policy: the future of chimeric antigen receptor therapies [published online ahead of print November 1, 2019]. J Clin Oncol. doi: 10.1200/JCO.19.01691.

5. Rosenberg J. CMS proposes increased reimbursement for CAR T-cell therapy; price hikes for rural hospitals. The American Journal of Managed Care.® http://www.ajmc.com/newsroom/ms-proposes-increased-reimbursement-for-car-tcell-therapyprice-hikes-for-rural-hospitals. Published April 24, 2019. Accessed

Innovation in Care Also Means a Better Patient Experience

When one hears the term innovation in oncology care, the first thought can be keeping up with unprecedented advances in therapy. But changes to the delivery system—the use of navigators, the rise of data-driven quality measurement, the advance of decision-support tools&mdash;are equally important in bringing therapies to patients. How do health systems keep up and turn the corner? It’s not easy, according to a panel, Innovation in Oncology Care and Treatment, at Patient-Centered Oncology Care® in Philadelphia, Pennsylvania, held November 8, 2019.

“Innovations are coming at a pace that I’ve never seen before. And I’ve been doing this for 23-plus years,” said event Cochair Joseph Alvarnas, MD, who moderated the panel featuring:

 director of Strategic Practice Initiatives for the Community Oncology Alliance;

, vice president, Network Solutions for the Blue Cross Blue Shield Association;

 vice president, Innovation and Solution Development, Premier Inc, of Charlotte, North Carolina; and

, chief operating officer at Fox Chase Cancer Center, Philadelphia.

“It’s an exciting time because there’s so much happening so very fast,” Gamble said. The infrastructure of oncology practice—especially reimbursement systems&mdash;has not caught up to advances in therapies and technology. On one hand, Gamble said, CMS tells oncologists that the old fee-for-service billing model is “archaic,”

and many doctors agree. But when it comes to finding new ways to measure the value of new technology, agreement has proven elusive, he said.

“We can’t even agree on which is better: overall survival or progression-free survival,” Gamble said.

Hospitals operating on slim margins must fi gure out how to advance the delivery system while staying at the forefront of care, said Bachman. “We want to invest in all these new technologists,” but a new diagnostic tool must be balanced against deferred maintenance and “all the bread-and-butter stuff ,” such as replacing software systems.

“You’re constantly rolling the dice and trying to measure the risk for the organization,” she said. “And very few businesses run on the kinds of margins that we run on. I mean, even a good hospital today, they’re lucky if they’re making 6% to 8% margin. I don’t think any of the companies that we have to interface with would tolerate that.” 

Asked for the payer’s perspective, Atkins said, the Blues are focused on improving coordinating of care and improving patient experience. “Everything that we do as a payer is focused on [the] member and that member experience,” she said, and fixing “what we continue to see as a fragmented system is our ultimate calling.”

“I do think that we have made a lot of progress,” Atkins said.

Advances in treatment such as chimeric antigen receptor (CAR) T-cell therapy initially caught payers off guard, but the Blues responded by designating facilities as CAR T-cell specialists. “I felt like the manufacturers had gotten a little bit ahead of us, but we were able to launch our Blue Distinction Centers on January 1,

2019, for CAR T therapy,1 and we envision that as a chassis to build off of for additional therapies,” she said.

Oskouei, whose fi m provides actionable data to improve delivery and pharmacy operations for health systems, said just keeping up with the tidal wave of information is a challenge. “There’s a statistic that there’s new evidence development every 26 seconds,” she said. Converting all that information to “optimize patient care is a big challenge.”

Giving providers good point-of-care clinical decision-support tools lets them off er patients the best outcomes, she said. With all these challenges, Alvarnas asked, “How do you make sure that innovation stays patient centric?” And, how can health systems make the pace of change sustainable from a physician point of view?

Atkins said keeping innovation patient centric starts with asking, “What are your goals in treatment? Do you want to go to your daughter’s wedding? Is this about getting to a graduation?” This shifts the defi nition of patient-reported outcomes to one “that I think we can certainly drive in a meaningful way.” So, Alvarnas asked, what are the barriers to more of this happening now?

“You know, I’m going to be really transparent with you,” Atkins said. Incorporating patient-recorded outcomes is not easy, because the data are less traditional and not as rigorous as registry data. As a payer, “I’ve had to challenge my own thinking on it.” Bachman said listening to the patient is “a huge part” of what happens at Fox Chase—via patient surveys and service gap analyses. Through this process, the staff learned that what matters most to patients is reliability.

“Imagine being in the hospital and having a schedule and actually knowing when something is going to happen to you,” she said. Fox Chase built systems with navigators and better scheduling to make commitments to its patients and deliver on them “and measure our ability to do that.”

Gamble said in other areas, technology makes it possible for consumers to expect greater value for what they pay, but oncology and healthcare generally haven’t followed this approach. Alvarnas pointed out that the system is increasingly unsustainable—more and more responsibility is being pushed onto the physician as

science rapidly evolves. Oskouei said that’s where technology can play a role in clinical decision support—by updating staging criteria, new treatment guidelines, and rapidly changing product indications. “Having that information at the fi ngertips is critical,” she said. But, Alvarnas said, patient education must be part of the equation, too. “At a deep level, you’re talking about investment, when someone is at home using wearables or other technology to monitor them.”

“We need to have specifi c education strategies for all the stakeholders, patient fi rst and foremost, but also for the payers themselves, [and for] the employers are having to pay for the insurance,” Gamble said.” Federal rules can create barriers to innovation that make change unaff ordable.

“It’s going to take a lot of teamwork and bringing up bright minds to say, ‘Lead the charge.’ Let’s not be afraid of it. Let’s tackle it,” he said.

But how? Bachman said information technology investments will be essential. Physicians must be surrounded by teams. Navigators work. Alvarnas said much of this change must be captured in coding, so that payers will reimburse. Atkins highlighted a Blue Cross Blue Shield of Minnesota program that is trying to do this. 

During a discussion at  The American Journal of Managed Care®’s Patient- Centered Oncology Care® meeting in Philadelphia, panelists outlined the efficacy of the 2 FDA-approved therapies, Medicare reimbursement for CAR T-cell therapies, and the pace of innovation in healthcare.

Innovation and Novel Therapies

Technology Remains a Small Part of Innovating Cancer Care Delivery

Contrary to popular belief, innovation in healthcare does not necessarily refer to technology, although technology can assist. Innovation is about improving experiences, explained Rebecca Kaul, MBA, vice president and chief innovation offi cer at The University of Texas MD Anderson Cancer Center.

The greatest new technology is not actually about the technical specs, she said. When Apple released the first iPod, the interest it generated, and its ultimate success, was not necessarily about the technical details, but instead that the iPod was something small and convenient that delivered an experience people wanted.

“For me, success is not completion of a project plan,” Kaul said. “Success is delivery of value, delivery of experience.” If new inventions cannot be converted into something people can use to change their lives, “have you really driven change? Have you really innovated?” she asked.

When comparing the healthcare sector to the consumer environment, the industry falls short, she said.

“I would say that our experience in healthcare is, at most, functional, not necessarily desirable,” Kaul said, and as a result, the industry is seeing big companies, like Apple and Amazon, trying to enter the industry to disrupt it. However, these companies are not necessarily bringing novel technology, they are trying to innovate how healthcare is delivered to bring an experience people need and want.

Delivering better care and a better experience means going beyond metrics and truly understanding the person you are delivering care to. There is a lot of buzz about data in healthcare and how to aggregate it, create interoperability, and utilize artifi cial intelligence to make meaning of the data. “We have to be careful with data,” Kaul said, “because correlation doesn’t necessarily mean causality.”

For instance, she provided the example that the divorce rate in Alabama correlates with per capita consumption of high fructose corn syrup. However, that doesn’t mean divorce rates in Alabama are caused by consumption of high fructose corn syrup. So, data are important, but it’s also important to know what to do with the data and how to dig deeper and understand what the data are saying.

“You look for those themes and patterns in data,” Kaul said. “You make creative leaps and inferences you can test. But then, the most important part is using qualitative design research to verify [or] debunk. And that’s really the point here: You can’t just take what you’re seeing in the data at face value.”

As someone who has worked in the field of innovation for a decade, Kaul has learned that 99% of eff orts should be spent finding solutions to human problems and only 1% on solutions to technology problems. She ran a technology development center, where the employees built the technology they thought would be most valuable, but it’s crucial to fi rst understand the problem being solved and the experience that should be delivered.

Kaul provided the example of an employee at MD Anderson who showed her a 30-day predictive algorithm that had been developed, but the person who created it had never thought about how the doctor would use it in practice. What should the doctor do after receiving the prediction? What intervention should there be?

“So, the question becomes: How useful is a prediction if we don’t know how we’re going to action it—if we’re not actually going to translate that prediction into something that actually impacts our patients impacts our experience?” she asked.

In another example, Kaul explained the challenge of ill-defined problems. At MD Anderson, she was told early on that there needed to be more chairs in the infusion center. This didn’t seem like a problem in her area, but she decided to take a look and found that during the course of a day, there was never a time when a chair was not available, but there was still a waiting room full of people. She then dug deeper to understand why people weren’t getting past the waiting room faster and found a myriad of issues including orders weren’t signed, labs weren’t ready, drugs weren’t mixed, and even nurses weren’t available.

The underlying problem was how to make an appointment meaningful and optimize patient flow. This was an instance when technology was useful, because the cancer center was able to utilize machine learning to understand the best time to make an appointment because everything that had to happen to meet that commitment could actually be done in time.

However, there were times when technology was not the answer. MD Anderson has been expanding its footprint with new buildings in the community, so people have a convenient place to receive care closer to home. The people in operations and technology wanted to make these new buildings more effi cient so that patients could check in at a kiosk, get a wristband, and do everything else they need to do, such as pay the bill, at the computer. Next, they took the time to understand the experience this setup would deliver. Patients would be greeted with a computer screen and as a medical record number. So, then the employees in operations and technology went to talk to the patients.

“What patients wanted was a human experience,” Kaul said. “They’re scared. They just got diagnosed with cancer.”

Usually, patients are coming in for multiple procedures, such as examinations, imaging, labs, and potentially chemotherapy. “They’re usually coming in for appointment after appointment, having to address something that is really scary, and what they want is someone to greet them, someone to give them the feeling that it’s going to be okay, and that they are being taken care of now,” she explained.

Yes, patients want effi ciency, but they want a human experience, too. This fi nding resulted in designing a better experience even before the patient arrives at the center by reviewing schedules, providing directions to get around the facility, and filling out paperwork before they arrive.

MD Anderson also created a new role for someone to greet patients as they arrived. Instead of sitting behind the desk, this staff member would be out on the floor, wearing an identifi able shirt, available to help answer questions and make patients feel comfortable when they arrived.

And in the end, they did incorporate technology in the form of biometrics to gather patient information and maintain patient records. However, “technology ends up being that last mile,” Kaul said.

Technology alone isn’t the solution, she said. Everything that goes around technology makes up the solution to a problem. “We can’t just follow shiny objects,” Kaul added. “We can’t implement technology for technology’s sake; we have to understand the problem space.”

Personalized Medicine Brings Diagnostics to the Value Equation

Can oncology care follow pathways—ensuring patients eceive evidence-based care&mdash;and at the same time meet individual needs? That was the question for the panel, “Personalized Medicine and Value-Based Care,” at Patient-Centered Oncology Care®. Moderator and co-chairman Joseph Alvarnas, MD, led the discussion with:

 physician lead for Oncology, Laboratory, and Personalized Medicine at Humana;

 president of the Personalized Medicine Coalition, which represents more than 200 innovators, scientists, providers, and payers; and

, vice president and national medical director of Clinical Eff ectiveness, LabCorp.

Loy said that as a pathologist, one view of the term “personalized medicine” is targeting therapies to the right patient based on abnormalities. But it is more than that, he continued. “At least at my payer, it’s what can we learn about our members—or your patients if you’re a doctor&mdash;and how can we create a better experience?”  not help if patients go home to an empty refrigerator or have no transportation for follow-up care. Thus, the broader meaning of personalized medicine is to identify the “highest-quality, least toxic, most eff ective, and convenient care for our members.”

Abrahams agreed, adding that personalize d medicine means “marrying diagnostics and learning everything we can about the patient in order to prescribe the right therapies,” while accounting for patient values and experiences. This makes the term different from precision medicine, which he said is preferred by scientists.

Almas said his view of the term is informed by his experience working on the joint CMS and FDA parallel review

 for Foundation Medicine’s CDx product, which was later reopened for a National Coverage Determination.

 From there, Almas served as a medical director for the Molecular Diagnostics Services (MolDX) Program

at Palmetto GBA, the Medicare administrative contractor that developed early expertise in approving diagnostics. Based on these experiences, he still sees some barriers. In clinical trials, Almas said, “we still run into resistance with some commercial barriers—not so much with Medicare.”

Reimbursement has often been the rub, Alvarnas said. Value-based care is supposed to be about arriving at care that is high quality and sustainable, not a race to low-cost care. How can that be achieved, he asked.

At times, Loy said, “value-based care overemphasizes the dollars when, in fact, this should be about the patient’s values, which in my mind leads into shared decision making and real-world evidence.”

Abrahams agreed, saying, “Value-based care, in my estimation, is not the least expensive, it’s the most eff ective.”

Both Alvarnas and Almas commented that it is not always that simple, and Almas noted that is why the development of real-world evidence is important. Testing companies are often asked if they have a randomized clinical trial to prove the clinical utility of their products, but designing such trials is difficult. Partnering with payers to develop evidence is more sensible, he said.

Designing the right data models is also challenging, Alvarnas pointed out. The numbers must be large enough to ensure that researchers “get it right,” but turnaround is important, too. Still, the fi eld has moved a long way from registry studies that did not provide answers for 5 to 10 years. “The rate of innovation is outpacing our old models of gathering data,” Alvarnas said.

Key considerations, according to the panelists, include:

• the quality of the test or diagnostic being used;

• addressing knowledge gaps that lead to physicians not ordering the right tests;

• dealing with situations when the test is ordered, but the results are ignored, so the patient gets no benefit; and

• ensuring that reimbursement discussions address not only tests for genomic alterations but also screening, such as increasing the population tested.

Alvarnas said all these problems call for changes in physician behavior. “This is a real challenge, and it doesn’t happen infrequently,” he said. “How do you keep this from happening?”

Loy noted that current reimbursement models also do not reward physicians for the most important test of all: does the patient want a $300,000 treatment, or a drug that costs $10,000 a month? “I don’t think we can afford to run the test without first asking the question, ‘Do you want to be treated?’”

Payment models must be flexible, he said, because not all practices are at the same point in transitioning from fee-for-service to value-based care.

Alvarnas asked whether commercial payers or Medicare are more likely to drive change, and Loy credited the Center for Medicare and Medicaid Innovation for “cracking the ice” with the Oncology Care Model. There are “refi nements” that commercial payers can offer, especially making sure the voice of the employer is heard.

“Employers are in a unique position to experiment creatively around the next steps,” said Alvarnas, whose portfolio includes employer strategy at City of Hope, where he is a hematologist/oncologist.

Rewarding physicians for taking time to understand what patients want is essential, Almas said. “You’re going to want to talk to patients to truly have shared decision making about whether they want to pursue targeted treatment,” he said. If patients don’t want to do the test, “we don’t want to do a test,” because it is wasteful when the results are not used. “That doesn’t help anybody,” Almas said.

1. Ramamurthy L, Maxwell K, Sawchyn B, Anhorn R. Perspective: FDA/CMS parallel review advances coverage for cancer comprehensive genomic profiling. Am J Manag Care 2018; 24(SP6):SP193-SP196.

2. Inserro A, Caffrey M. CMS agrees to cover NGS for Medicare patients with breast, ovarian, other cancers. The American Journal of Managed Care® website. ajmc.com/newsroom/cmsagrees-to-cover-ngs-for-medicare-patients-with-breast-ovarian-other-cancers. Published January 27, 2020. Accessed February 4, 2020.

Rebecca Kaul, MBA, vice president and chief innovation officer at The University of Texas MD Anderson Cancer Center, said the best technology improves the patient experience.
 

Personalized Medicine: The Role of Technology and Diagnostics in Driving Change

Most patients who want the most advanced cancer care, such as the chance to take part in a clinical trial, can fi nd it close to home in a community oncology practice. But experts say this type of care, which fl ourished throughout the 1990s, is under siege. If nothing changes, the cost of care will rise for everyone, according to Jeffrey Patton, MD, chief executive offi cer of Tennessee Oncology.

Payers have a crucial role in the future of community oncology, he said, because it’s in their interest to help this lower-cost option thrive. “I say this at least 5 times a week. I’m a business guy now. And in most businesses, the low-cost, high-quality provider gets rewarded. And I think the payers are starting to recognize it,”

Payers, he said, should reward community oncology practices by sending patients where care costs less. Academic medical centers should handle the small percentage of cases that can be handled only there. “But let’s work together and recognize what you already know,” Patton said. “Push patients our way.”

Patton’s presentation, “Innovation Is Disruptive,” offered attendees at Patient-Centered Oncology Care® a history of community oncology’s contributions to better care and improved survival, which picked up steam with the 1991 approval of ondansetron (Zofran) to treat nausea caused by chemotherapy. Suddenly, patients could drive to infusion appointments and go straight home. “This really revolutionized how we give chemotherapy,” Patton said. “It’s probably the most patient-centric thing that’s happened in my career.”

Innovation at the community level didn’t stop there, Patton said. With each evolution of the delivery system, community practices kept pace:

• When the early 2000s brought a rise in the use of oral medication, community practices opened their own on-site pharmacies.

• To save money, in 2011 Raintree created the first national oral oncology group purchasing organization with community oncology practices.

• In 2012, Barbara McAneny, MD, a future president the American Medical Association, developed the Community Oncology Medical Home (COME HOME) pilot, which

tested principles that CMS later used to create the Oncology Care Model (OCM).

• Community practices account for 85% of OCM participants.

Today, Patton is living through another wave of disruption, one brought on by the transition to value-based payment models that promote same-day appointments, aim to keep patients out of the emergency department, and seek greater patient and caregiver involvement through advanced care planning. As a founder of OneOncology, he has formed a partnership that aims to help community practices stay independent by leveraging technology and shared insights, creating the scale that practices need to gain attention from payers and pharmaceutical companies for value-based programs.

The trend toward care given closer to home led to 85% of chemotherapy being given in community practices by the late 1990s, he said. Since then, the pendulum has swung the other way, brought on by economic forces favoring larger enterprises.

Government policies often gave hospitals an advantage, such as Medicaid’s 340B program that allowed hospitals to buy chemotherapy drugs at discount and policies that work against community practices when they treat dual-eligible patients. Many practices could no longer compete and were bought out by hospital systems, and the result is higher costs, Patton said.

He presented data showing that physician offi ces now account for 54% of chemotherapy administration; meanwhile, since 2004, the percent of chemotherapy administered in 340B hospitals increased from 3% to 23.1%.

“Patient choice is not talked about enough in being patientcentric,” he said. If patients were choosing the community setting, then limiting access to this delivery system fails to give them what they want, he said.

Community oncology clinics in Tennessee have delivered on changes such as off ering more access to clinical trials and improving practice management. Entities such as The US Oncology Network showed that business techniques could be delivered at scale while keeping high-quality care close to patients, Patton said. Academic centers have a diff erent role in innovation, Patton said. He pointed in particular to the development of the National Comprehensive Cancer Network guidelines. “They really were at the forefront of standardizing care,” he said. As the idea for clinical pathways took shape, the University of Pittsburgh Medical Center partnered with community oncology groups to develop pathways, which became Via Oncology.

In the area of advocacy, community oncology has taken the lead, he said, with the Community Oncology Alliance (COA) was formed in a community oncology office in Memphis, Tennessee. “Today, COA is the voice of advocacy and policy for oncology,” he added. Payers and pharmacy leaders can support the lower-cost option

of community oncology by entering into value-based contracts and doing more to ease the administrative burdens on practices. He pointed to data that show the number of healthcare administrators is rising far faster than the number of physicians.

“All of the increase in administration—it’s just to get paid,” Patton said. These are dollars that are not being spent to hire a dietitian or a social worker, he said, which would add value for patients. OneOncology and other network affiliations in the community oncology realm are the most recent innovation to keep practices from being forced into hospital systems. Each one is different, Patton said. “Economies of scale works for everything&mdash;insurance, anything you purchase. It also frees you up to have capital to invest in other ancillary services,” he said.

The network also allowed the group of practices to collectively announce plans to use biosimilars, which Patton said was important to dispel the myth that physicians profi t by prescribing high-cost drugs. “It’s just not true. It’s been published,” he said. “We have chosen publicly to choose the less expensive drug. And I think this is a narrative that we should be jumping on together.”

As payers get wise to the savings in community practice, they stand to save between $16,000 and $37,000 per patient per year, based on data from UnitedHealth Group, he said. That translates to $4 billion year.

Finally, community practices are an essential resource for patients to support research, whether a clinical trial or the expanded use of real-world evidence. “The good news is, there’s more opportunity coming,” he said.

Payers have a crucial role in the future of community oncology, said Jeffery Patton, MD, of OneOncology, because it’s in their interest to help this lower-cost option thrive. 

Community Oncology Can Still Innovate for Less, Patton Says

How well patients say they are faring, both during and after cancer treatment, is more important than ever to payers. But measuring that feedback isn’t easy, and ensuring that measurement is fair to both patients and providers is harder still.

Kashyap Patel, MD, cochair of Patient-Centered Oncology Care

, led the discussion, “Patient-Reported Outcomes and Quality Metrics” just days after the Center for Medicare and Medicaid Innovation (CMMI) presented its outline for the successor to the Oncology Care Model (OCM), called Oncology Care First (OCF). A distinguishing feature of OCF is its call for the use of electronic patientreported outcomes (ePROs),

 something that Kashyap Patel says makes sense in theory but could be hard to implement with patients who are poor or live in rural areas.

“Half of my patients still don’t have a smartphone—they use a flip phone,” he said. Giving patients a preloaded iPad to answer questions about symptoms may not solve the problem, because internet service may be spotty where patients live, or patients may not be able to afford service.

“So, how do we circumvent those issues?” he asked. The following panel members joined Kashyap Patel for “We’re very interested in getting beyond the patient-reported outcomes, and [we’re] rapidly looking at where the market is going, into patient-originated data,” Gosse said. Workflow issues are critical, because apps can create enrollment issues, and it’s diffi cult to add another process to the clinic setting—there can’t be a new enrollment for every new drug. “There’s lots of opportunity,” he said, “We’re working to get things past the real active, manual effort it takes to be successful today.”

Kashyap Patel said usefulness of these data still comes down to what’s being measured, and he asked Pitzen if measures will account for the socioeconomic differences such as those he sees in his practice, which is located in South Carolina. Pitzen said the NCIS tool measures 3 symptoms—nausea, pain, and constipation&mdash;which are symptoms “that regardless of where you are on your cancer journey, those symptoms need to be addressed in pretty rapid fashion so that chemotherapy can continue.”

The NCIS tool is free and practices can add additional symptoms to track, but she would not recommend tracking every symptom for every patient. An academic medical center using the tool is experimenting with using diff erent collection methods, including paper. One concept is installing patient portals in the clinic, so that patients can log in their symptoms when they arrive at an appointment. Edge said this method would save time for providers. Methods that provide information before the appointment starts save time, but this can also include better nursing assessments.

Kashyap Patel said making changes to add ePROs will require up-front investment, but that this could lead to long-term savings. When his practice adjusted its scheduling and operations to free up 2 slots for same-day appointments—to meet requirements of the OCM&mdash;it seemed like a money-loser. But the reduction in emergency department visits and hospital stays has made the change a winner. He said the question is, what kind of electronic collection device will make ePROs worth the investment in 5 years?

Wearable devices are 1 solution, Amila Patel said. They don’t require surveys—and the information comes straight to the provider. Many parameters must be worked out, she noted. “I think we’re going to have to make them part of our daily life,” Edge said of PROs. To some extent, PROs are already here, but clinics have not always

Investments can be worth it, Gosse said. Oncology networks already working with McKesson to incorporate new tools have seen the efficiencies that result, as well as patient satisfaction. “The eff ort of getting the new mindset in place, the new staffi ng in place—you’re changing the phone trees and how the people are answering the phones; you’re empowering nurses or care teams in new ways. And that’s a significant transformation&mdash;that’s more than technology. . . .It’s really rewiring the practice in some ways.”

Ultimately, Pitzen said, “You can’t improve something if you’re not measuring it.” She agreed with Edge that the best approach to metrics is not punitive but rather a method that measures symptoms so patients can continue chemotherapy and have a better experience. “It’s what is actually best for patients,” she said.

The following panel members joined Kashyap Patel for the discussion:

 the vice president for Healthcare Outcomes Policy and professor of oncology at the Roswell Park Cancer Institute;

 a clinical measure developer at Minnesota Community Measurement;

 the director of Clinical Product & Content, Clinical Oncology at Flatiron Health; and 

vice president of Product Management at McKesson.

Edge said the point of data collection and quality measures should not be to yield results that compare physicians for comparison’s sake. “Unfortunately, I still see too many people saying we need to find quality measures that diff erentiate one doctor from another doctor to say that, “They’re a good doctor. They’re a bad doctor.’ ”

Measurement, Edge said, should be used to highlight problems and swiftly turn around data to implement change quickly. A system that spots the fact that a doctor hasn’t started a patient on chemotherapy, for example, helps both the doctor and the patient. He and Amila Patel agreed that ePROs are valuable to this process. Amila Patel said for data collection to yield meaningful results, the process must be integrated into the workflow. “You really need to build tools that work for patients and providers and reduce the burden.”

Edge said when he was developing early quality measures for the Commission on Cancer, he learned the importance of asking patients what they find valuable.

Gosse said when it comes to incorporating ePROs into McKesson’s system, which supports 2000 oncology providers, these measures are “1 slice of how we’re bringing the broader patient voice to the care discussions and into care operations.”  He agreed with the need to integrate the process into the physician’s workflow. 

So, how are measures developed that represent meaningful results for people with cancer? Pitzen outlined a process that led to a measure in the National Cancer Information System (NCIS) for the severity of nausea on particular days of a chemotherapy cycle. It began with convening a stakeholder group, and it followed what Pitzen called “guiding principles,” which include:

• ensuring that measures are appropriate for PROs—

measures in cancer will be diff erent than those in other conditions, such as diabetes;

• using strong “psychometric properties,” so that measures are valid; and 

• ensuring that outcomes can be quantified.

Ideally, measures are in the public domain, Pitzen said. “We don’t want to tamper with the validity and reliability of the tool,” she said. Many national measures now in use started this way.

Kashyap Patel asked the panelists to discuss how to strike the right balance between gathering enough information without overwhelming patients with questions—and how to find methods that make sense and will not overwhelm clinical staff . He brought the group back to his fl ip phone example.

“We want to make sure that we’re building technology to account for all of those situations,” said Amila Patel. “We can’t just build tools for people that are literate and have access. . . . We need to build tools for patients from diff erent socioeconomic backgrounds that take literacy into account, different language barriers.”

Mobile phones and apps are not for everyone, she said. Having more than 1 method, whether it’s using tablets in the clinic, or giving caregivers diff erent options to log into a computer—and training them on how to do this&mdash;are all ways to boost adoption. 

“First, I think we need to keep the tools simple,” Edge said. Tools that help patients and doctors, as much as assessing them, will be used and will make a diff erence, he said. Reducing barriers, including financial ones, is essential.

“There is evidence that we would save money by providing people with the smartphone, by providing them with the iPad,” he said, citing studies in chronic disease management. Kashyap Patel said that as CMMI develops the OCF, these costs could be factored into an alternative payment model. He then asked Gosse what kinds of challenges these ideas would present to McKesson if ePROs had to be incorporated quickly.

Gosse said ePRO implementation creates 2 distinct customers: the patients and the providers. Even if patients have a smartphone, will they want to fi ll out a survey every time they get a text message? Patients may ask, “Is it worth my time? What am I going to get from it?”

From the provider standpoint, it’s only worthwhile to set up the patient to send in ePROs if its feeding into a dashboard that someone sees and can act upon quickly. “We’ve got to get those 2 teams really empowered, as seeing value on both sides, before we can really start to bring value to our payers or to our pharma partners,” he said.

“We’re very interested in getting beyond the patient-reported outcomes, and [we’re] rapidly looking at where the market is going, into  patient-originated data,” Gosse said.

Workflow issues are critical, because apps can create enrollment issues, and it’s difficult to add another process to the clinic setting—there can’t be a new enrollment for every new drug. “There’s lots of opportunity,” he said, “We’re working to get things past the real active, manual eff ort it takes to be successful today.”

Kashyap Patel said usefulness of these data still comes down to what’s being measured, and he asked Pitzen if measures will account for the socioeconomic diff erences such as those he sees in his practice, which is located in South Carolina.

Pitzen said the NCIS tool measures 3 symptoms—nausea, pain, and constipation&mdash;which are symptoms “that regardless of where you are on your cancer journey, those symptoms need to be addressed in pretty rapid fashion so that chemotherapy can continue.”

The NCIS tool is free and practices can add additional symptoms to track, but she would not recommend tracking every symptom for every patient. An academic medical center using the tool is experimenting with using diff erent collection methods, including paper. One concept is installing patient  portals in the clinic, so that patients can log in their symptoms when they arrive at an appointment. 

Edge said this method would save time for providers. Methods that provide information before the appointment starts save time, but this can also include better nursing assessments.

Wearable devices are 1 solution, Amila Patel said. They don’t require surveys—and the information comes straight to the provider. Many parameters must be worked out, she noted.

“I think we’re going to have to make them part of our daily life,” Edge said of PROs. To some extent, PROs are already here, but clinics have not always put them to use.

Investments can be worth it, Gosse said. Oncology networks already working with McKesson to incorporate new tools have seen the effi ciencies that result, as well as patient satisfaction. “The eff ort of getting the new mindset in place, the new staffing in place—you’re changing the phone trees and how the people are answering the phones; you’re empowering nurses or care teams in new ways. And that’s a significant transformation&mdash;that’s more than technology. . . . It’s£really rewiring the practice in some ways.”

Patient-Centered Oncology Care 2019

Keynote Address: Using Technology to Intervene Earlier in Cancer and Improve Survival Rates

Innovation and Novel Therapies

Personalized Medicine: The Role of Technology and Diagnostics in Driving Change

Community Oncology Can Still Innovate for Less, Patton Says

The Patient's Voice Matters, but What's the Best Way to Measure It?

Learning From the Oncology Care Model to Move APMs Forward

Through Networks, Collaboration Keeps Oncology Care in the Community