By Christine MacCracken, MSHEd, BSN, Senior Director, Business Insights
This is the second of a two-part series featuring highlights from the biannual NCCN Academy for Excellence & Leadership in Oncology™, held July 10-11, 2012 in Philadelphia. Attending the conference were representatives from the Pharmaceutical and Biotech industries, policy experts, and payors, as well as patient advocacy organizations.
Day One of the program closed with a standard Academy panel, "Meet the Experts: NCCN Guidelines Panel Members Address Hot Topics and Your Burning Questions," moderated by Scott Gottlieb, MD, of the American Enterprise Institute, and included Timothy Kuzel, MD, of Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Jerald P. Radich, MD, of Fred Hutchinson Cancer Research Center, and Andrew Zelenetz, MD, PhD, of Memorial Sloan-Kettering Cancer Center.
The discussion began with Dr. Gottlieb asking the panel about general processes related to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel meetings. The Academy Panel discussed the overarching processes that govern all of the NCCN Guidelines® Panels, such as the minimum of one meeting per year for major updates, with ad hoc meetings or teleconferences throughout the year to address new data within the NCCN Guidelines. For example as Dr. Zelenetz offered, following the American Society of Hematology (ASH) meeting each year, a call is held to discuss new data and their application to the NCCN Guidelines. Additionally, Dr. Zelenetz noted the structured process for submission of data (http://www.nccn.org/about/submissions.asp), and how these and other data are circulated among panel members for rigorous review prior to each meeting or call.
Dr. Radich described a similar process for the Chronic Myelogenous Leukemia (CML) Panel, articulating how and why certain data is considered relative to the disease. In cases where Phase III studies are not likely to occur, such as in the case of polymerase chain reaction (PCR), determination studies presented at ASH last year, the panel concluded this prognostic test should be included due to the high level of evidence demonstrated in the Phase II studies, said Dr. Radich. The frequency beyond the once-a-year meeting was discussed by Dr. Kuzel, noting that, depending on the tumor type and new discoveries or lack thereof, the schedule is determined; however, anytime a new agent is approved, the panel meets post-haste to discuss the new data.
Dr. Gottlieb then turned the experts' attention to diagnostics and how emerging technology would impact the Guidelines. Confusion related to biomarkers, Dr. Radich noted, is widespread due to the varied testing methods. Currently in the CML Guideline, the right versus wrong assay is not what is currently addressed, but rather the characteristics of the assay to be done, said Dr. Radich. Biomarkers for accurate diagnosis of lymphomas is crucial, said Dr. Zelenetz, lamenting the differences among biomarkers, and varied antibodies utilized by labs. The issues are complex and, as further noted by Dr. Zelenetz, only now is the community grappling with an understanding of how to apply biomarkers.
The panel also provided their insights into challenges of the current approval process for biomarkers. With the FDA increasingly demanding a package approval of a drug with its companion diagnostic, the approval process can be arduous. In cases where relatively few tests would be done, such as for rare leukemias, the cost and time must be considered and reasonable compromise must be made, said Dr. Radich. To that end, Dr. Gottlieb noted recent guidance from FDA to non-oncology companies, where a company is permitted to utilize a home brewed or non-approved test as long as the pharmaceutical company controls the test. This, said Dr. Gottlieb, allows the company to promulgate the test, but also essentially requires them to operate or at least partner with a Clinical Laboratory Improvement Amendments (CLIA) lab.
Dr Gottlieb closed the panel by asking the experts what concerns they have moving forward. Dr. Zelenetz reflected on the earlier discussion relative to shifts in resource allocation and how oncology may be impacted. Imaging and diagnostics to identify risk for disease, noted Dr. Radich, are not helpful to a patient if there are no drugs to treat a disease. Further, changes to the healthcare system are required so that patients have access to treatment. Dr. Kuzel referred to the shift in care occurring in his home state of Illinois, and the loss of control physicians are experiencing due to new governance of their practice and the narrowing of choices.
Day Two opened with an expert panel of payors and was moderated by Loreen Brown, MSW of Xcenda, LLC. Joining Ms. Brown, were John Fox, MD, MHA of Priority Health; Ira Klein, MD, MBA, of Aetna Insurance Company; Maria Lopes, MD, MS, of AMC Health; and Matthew P. Mitchell, PharmD, MBA, MHP of Select Health. Ms. Brown opened the discussion by asking each of the panel members, "What keeps you up at night?" The fate of community oncologists was on the minds of Drs. Fox and Klein, both commenting on the role of costs and government will play in terms of payment. Further, Dr. Klein noted that technology is important for enhancing community practices, but depending on the size of a payor organization, a group may not be able to obtain the attention of oncologists to accept new technology.
As with other panels, the shift in site of care and creative ways to preserve community practices was also front of mind for this panel. Dr. Fox was concerned with the preservation of access to, and viability of, the community practices. He further noted that his group has tried to be creative with reimbursement models by paying a fair care management fee on a monthly basis for oral or IV drugs administered within a practice. Due to the complexity of oncology care, Dr. Klein reflected that it is important for cancer to be treated in an appropriate setting. Further, explained Dr. Klein, for diagnoses requiring combined modalities, it may be more difficult for a community oncologist to coordinate care versus single modality, due to the number of experts involved and the complexity of the coordination, especially if complications occur. This coordination, or challenges of coordination, seem to stem from what Dr. Klein called a "lack of triage", noting that our current system is unable to triage patients to the most appropriate setting.
Additionally, quality of care and corresponding reimbursement were discussed among the experts, with Dr. Klein describing Aetna's current use of Quality Oncology Practice Initiative (QOPI) measures. While Aetna does not reimburse QOPI certified practices at a higher level currently, Dr. Klein expects this will occur at some point in the future. However, said Dr. Fox, quality certification does not always translate to quality care, and there is limited technology that allows a payor to measure impact of quality performance on outcomes.
For Dr. Lopes, the issue of disparate data and/or missing data creates a complex picture for assessing care and leveraging this data to drive change due to the varied systems and points of data entry. The panelists also discussed various approaches to reimbursement, such as pathways.
Dr. Fox described the Select Health process that allows providers to determine preferred treatments rather than having company determined pathways imposed upon them. He noted that this is feasible because trust has been built among the providers based on Select Health's stance that pathways are not used to pay based on adherence, but rather to determine predictability of costs.
As Dr. Klein noted, costs are one factor, but there may be additional benefits to tiering physicians according to quality, allowing the ability to use benefit design to reduce costs and improve patient experience in measurable ways. Cost effectiveness was also considered by the panel, and was acknowledged as a challenge for payors. Due to lack of established societal thresholds above which companies refuse to pay for drugs, as well as regulatory constraints, cost effectiveness is difficult to achieve, said Dr. Lopes. Instead, Dr. Lopes relies upon prior authorization to force physicians to consider decisions relative to what isin guidelines. Finally, biomarker testing and the issues surrounding reimbursement were discussed. Dr. Fox and Mr. Mitchell both acknowledged that when a biomarker is present in the NCCN Guidelines, it is reimbursed; however, more challenging for them is how to handle tests that are not approved or performed in many different laboratories.
The final expert panel of the program, "Innovations in Oncology," was co-presented by Xcenda, LLC and moderated by Loreen Brown, MSW of Xcenda, and included Ivy Ahmed, MPH, MCHES of Cancer Support Community; Kenneth Berlin, JD, Rosetta Genomics; Jack Mahoney, MD, MPH, Florida Health Care Coalition; and Kurt Neumann, MD, ION Solutions.
Focusing on innovations that positively impact patients and providers alike, Dr. Mahoney highlighted FHCC's project to educate their employers on benefit design and interactions with health plans, which builds upon the collaboration between National Business Group on Health (NBGH) and NCCN. Additionally, presenteeism tools are being utilized, which measure engagement at the workplace, said Dr. Mahoney. Ms. Ahmed articulated the anticipated benefits of data resulting from the Cancer Support Community's Distress Screening Tool, anticipating that, due to its compliance with electronic health records, it will be possible to anticipate outcomes relative to distress, with the ultimate goal of having this tool, and its data, in the clinical trial space to support reimbursement of distress screening in cancer care.
Dr. Neumann described the ION Solutions approach to innovation, which focuses on data entry and retrieval, with short term plans for web-based compliance tools for pre-authorization and decision support. Longer term plans include a health information exchange that allows interface among several systems or technology in a common database for ION practices, said Dr. Neumann.
Similar to the other Academy panels, this group of experts considered impacts of the Accountable Care Act (ACA). Dr. Neumann noted that it is weighted heavily toward institutions coalescing and episodes of care, making it difficult to remain independent. Dr. Mahoney built upon this sentiment, claiming that the disruption in the marketing place is due to the lack of coordination of cancer care. Noted Dr. Mahoney, this includes the fact that more than 60 percent of oncologists in Central Florida are now salaried and, due to consolidation, patients only have two network hospitals to choose from.
From a diagnostic perspective, Mr. Berlin stated that the impact to testing utilization and fees is largely unknown right now. User fees are not yet impacted due to the tests being regulated by CLIA and not FDA, acknowledging that this could change if the FDA becomes involved in the regulation of testing. While all of these concerns ultimately impact patients, Ms. Ahmed noted the more personal and positive impacts of the ACA on patients. Specifically, the opportunity for organizations to apply for grants from the Patient Centered Outcomes Research Institute (PCORI) to demonstrate better outcomes as a result of patient screening. Additionally, there is opportunity to implement patient screening measures through Accountable Care Organizations (ACO), said Ms Ahmed.
Ms. Brown concluded the discussion with asking the panel what manufacturers can provide to continue to support quality cancer care. Dr. Mahoney said that education for the employer as well as the employee for specialty drugs and adherence to treatment would be useful. Mr. Berlin asked for greater transparency from manufacturers and, building upon that request, Ms. Ahmed asked not only for transparency but also collaboration to provide unbiased education to patients. Finally, Dr. Neumann requested that education of physicians on overall economics, not just the cost of drugs would be helpful, but standardized process items that span across pharmaceutical industry would benefit clinicians and office personell.
About NCCN Academy for Excellence & Leadership in Oncology™ School of Pharmaceutical & Biotech Business
Through his interactive program, pharmaceutical and biotechnology professionals are given the rare opportunity to view the oncology space, its future, and its current operational issues from the provider and payor perspectives, among others. Present by dynamic experts in the field, NCCN Academy features modules that focus on real-world trends, including policy, coverage, reimbursement, and informational and operational issues in oncology.
Professionals from marketing, sales, medical affairs, clinical research, policy and government affairs, and other business areas within pharmaceutical and biotech industries gather valuable insights in developing effective strategies for navigating the various constituencies in cancer care, and are better able to serve their customers upon completion of this program. NCCN has also made NCCN Academy Video Modules available to license to companies for internal training purposes.