January 2014 Edition Vol.8, Issue 1

2014 Forecast Series-Insights from Neal Meropol, MD

2014 Forecast Series-Insights from Neal Meropol, MD

The Case Comprehensive Cancer Center is a partnership organization between Case Western Reserve University, University Hospitals Case Medical Center, and the Cleveland Clinic that is designated by the NCI. We spoke with Neal Meropol, MD, the Division Chief, Hematology and Oncology, University Hospitals Case Medical Center; Associate Director for Clinical Research of the Case Comprehensive Cancer Center; and Associate Director, Clinical Programs, UH Seidman Cancer Center, to get his insights into the outlook for 2014.

OBR: First, Can you describe your treatment facility for us? Is University Hospitals an academic center that oversees a regional network of oncology practices?

NM: Yes, the University Hospitals Health System provides care throughout northeast Ohio through hospitals and outpatient clinics. This is kind of a hub and spoken arrangement, with the University Hospitals main campus contiguous with Case Western Reserve University.  University Hospitals owns numerous hospitals in community settings and also employs or is directly affiliated with oncology practitioners in community sites. The Seidman Cancer Center is the branding for the University Hospitals cancer program, and there are about a dozen Siedman Cancer Center outposts in northeast Ohio. We seek to provide high quality oncology care near people’s homes, and also give patients access to clinical trials in their community. As a major academic hospital and referral center, the main campus of Case Medical Center provides the latest in technology and high-tech multi-disciplinary care.

As part of our effort to ensure a consistent model of care, we oversee quality at these sites in a variety of ways. First of all, we provide medical and administrative support and oversight at all sites, and establish practice expectations. For example, all of our sites are required to take part in multidisciplinary tumor boards and use our chemotherapy order templates to insure consistency across the sites. Our multidisciplinary disease teams develop consensus practice standards for treatment and surveillance that are disseminated throughout our system. We hold regular educational and other engagement activities to ensure communication and cross-fertilization between main campus and regional site physicians. Some of our physicians who are primarily stationed in the community will also see patients on the main campus one day per week, and vice-versa. We’ve recently established the expectation that all of our sites will take part in the QOPI Program, which is the quality improvement program of ASCO.  Importantly, all of the oncologists across our sites have clinical faculty appointments in our division of hematology and oncology, which permits an additional layer of collaboration and practice oversight.

OBR: Is this a model unique to your geography and should others take note of your arrangement?

NM: I think it is an attractive model, in so far as we can provide certain systems, practice management, electronic health records, clinical trials oversight, and access to clinical trials.  We can handle all of the billing and collections, coordinate purchase of drugs, and we provide communication with leaders in the field that can facilitate tertiary care when necessary. 

OBR: Moving to your interest in clinical trials, we know that NCI funding is flat or decreasing when adjusted for inflation. Do you view community oncology as an untapped resource as a way to increase the number of patients eligible to participate in cancer clinical trials?

NM: No question about it. More cancer patients are cared for in the community setting than at major cancer centers. If we’re going to put our money where our mouth is and provide high quality care to patients near their homes, we need to be able to offer those patients the opportunity to participate in innovative clinical trials for which they might be eligible. A component of the highest quality of cancer care is the opportunity for a patient to participate in a clinical trial. Clinical trials represent innovation and an opportunity to obtain a potential treatment that a patient otherwise would not have access to. Moreover, cancer trials can provide hope in settings where a good standard-of-care therapy isn’t yet available. I firmly believe that the more we can make clinical trials available to patients, the higher the quality the care that they are going to receive. And that’s not to say that a clinical trial is the right thing for every cancer patient, but it should be an option, if at all possible.

OBR: In looking forward to 2014, is there anything we can hope for to help improve the cancer trial situation? Are there any systems to track and measure whether participation in cancer trials is increasing? 

NM: This has been a major interest for me: Developing methods to improve accrual to clinical trials and understand why accrual rates are so low. Each of the practices that join our cancer center is required to employ clinical trial staff. In turn, we train and oversee that staff and track all clinical trial activity centrally. To encourage clinical trial participation, we meet with the community investigators on a regular basis, and provide feedback. At each of our community sites, we have identified clinical trial champions, who provide both oversight and advocacy for clinical trials within their practices.

At ASCO this year, I reported the results of a study in which we developed a web-based educational program for patients about clinical trials. Patients took a survey and then, based on their responses, viewed a set of videos to fill in their knowledge gaps about clinical trials and address certain attitudes towards participation on a trial. We demonstrated that this individually-tailored video delivery improved knowledge and attitudes, and also improved preparation for considering clinical trial participation. Currently, we’re working on a dissemination plan to make the program widely available. We’re also developing something called Trial Prospector. Trial Prospector is an automated tool that we’ve developed that reaches into the medical record and the clinical trials database and matches patients to available clinical trials. So at the point of care, a physician can be prompted with available clinical trials for that patient. It’s in its earliest phases right now, but we reported on an early prototype of the program at ASCO as well.

OBR: Moving over to big data, how do you see CancerLinQ or other big data initiatives progressing? Are they starting to mature in 2014?

NM: I think the thing that’s going to be most prominent in 2014 is how the oncology community is going to deal with tumor genomics, including the widespread availability of tumor gene sequencing tests. For a reasonable cost, we can now sequence hundreds or thousands of genes within a tumor; and these genomic tests are commercially available. Many physicians are using the tests to help guide therapy, and in many cases without validation of the link between the test result, an appropriate therapy, and an outcome. As the cost of these tests comes down, demand is rising. Most of the tests are being ordered outside the context of a clinical trial and outside the context of prospective data collection. Our challenge is how do we learn from the experiences of individual physicians who are ordering the tests and their patients’ outcomes. We need to find a way to capture these data, such that we can learn what will help patients and what won’t.

OBR: If you were able to aggregate all the genomic information and gene sequencing information resulting from these tests, and then look at resulting outcomes, would it enhance the clinical trial process and allow for us to become less dependent on large Phase 3 studies?

NM: Certainly the prospective randomized Phase 3 clinical trial is the gold standard of clinical evidence, but I think we are learning that information from registries can also provide a valuable tool to gain new insights. At a minimum, we need to be creating registries at the national level that house the genomic information of patients and link that to the treatment they received and their outcomes. 

I would say that in some ways, 2014 might look a lot like the Wild West, in terms of an increase in genomic testing of tumors without an evidence base to guide the interpretation. Physicians are recognizing the potential opportunity in genetic testing and there’s tremendous excitement surrounding it. Genomic medicine really represents a huge opportunity for us in the coming years. I think it will be increasingly common for us to select treatments based on a genomic profile rather than the appearance of a tumor under the microscope. We’re really on the cusp of this happening with much greater frequency.

OBR: Will this personalization add to the increasing cost of cancer treatment?

NM: We’ve lost alignment between the pricing of cancer therapeutics and diagnostics and their true value. The cost of treatment has accelerated so rapidly, and my concern is that more and more patients will lose their access to the highest quality care. Additionally, the rising cost of treatment is increasingly resulting in implicit rationing of care, which has potential to widen disparities. Empirical data support this risk. So I think payment reform is needed to better align reimbursement for treatments and services with the value they provide.

In a recent editorial in the JNCI, I pointed out that the out-of-pocket expenses associated with cancer treatment are higher than that of other chronic medical conditions. Empirical data support the hypothesis that out-of-pocket expenses often affect the type of treatment a patient receives. In short, the rising costs of cancer care are forcing patients to make cancer treatment-related decisions based on their personal finances. This is a path that a just and moral society should aggressively seek to avert.

OBR: Do you have some insight into how we can avert that problem?

NM: First we need to demand higher value with new innovations and technologies. Given the distaste for cost-effectiveness analyses in the U.S., we need to come up with an alternate consensus on how to quantify and compare value. Second, incentives must be better aligned with high-quality care. This will clearly require payment reform. A variety of proposed solutions that may help include value-based insurance designs, bundled payments, and pay for performance; likely, a combination of these will be needed.

Finally, we must support and incentivize the development of new evidence. This includes clinical research, tackling barriers to clinical trial participation, and addressing reimbursement for data collection for registries when a prospective clinical trial is not feasible. Broad data collection and compilation efforts can only be met if industry standards are developed and adopted for electronic medical records, which permit seamless sharing of information. 

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