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NCCN Academy Includes Utilization Management Strategies, Improving Patient Engagement through Technology, and Discussion with NCCN Guidelines Panelists

Katie Kiley Brown, Communications Manager, NCCN, Editor

On July 14, 2015, the National Comprehensive Cancer Network® (NCCN®) hosted its Academy for Excellence and Leadership in Oncology™: School of Pharmaceutical and Biotech Business at The Rittenhouse Hotel, in Philadelphia, Pennsylvania.

Clifford Goodman, PhD, The Lewin Group, moderated this interactive program that featured discussion among NCCN Member Institution leadership, as well as esteemed leaders from the payer, patient advocacy, pharmaceutical, and biotechnology sectors.

New Trends in Utilization Management Strategies for Systemic Therapies and Diagnostics

The day’s first module, New Trends in Utilization Management Strategies for Systemic Therapies and Diagnostics, included the following panelists: Dane Dickson, MD, Molecular Evidence Development Consortium (MED-C); Matthew Farber, MA, Walgreen Co.; John Fox, MD, MHA, Priority Health; Elaine Jeter, MD, Palmetto GBA; and Steve Miller, MD, Express Scripts.

Dr. Goodman opened the first roundtable with discussion of pharmacy benefit management (PBM) and its effect on cost, patient access, and value. In the wake of the recent price war for hepatitis-C drugs, Dr. Miller, Senior Vice President and Chief Medical Officer, Express Scripts, eluded that a tactic that is similar to what was used to lower the overall drug cost in hep-C can be used to control cost—and therefore, value—for cancer drugs.  In diseases where cure rates and outcomes for two drugs appear to be equivalent, the price of these drugs should, in turn, be comparable, he explained. The panel agreed, expressing that lower prices will improve patient compliance, especially with oral medications. Dr. Miller also shared information about pharmacy and medical data collection that assists in predicting patient adherence.

Mr. Farber, Senior Director, Oncology Disease State, Walgreen Co., expounded that specialty oncology drugs are not the only concern, citing that people with cancer take an average of seven medications. With a growing specialty pharmacy business, Mr. Farber noted that Walgreens has the opportunity to properly manage and educate their patients, in turn raising adherence rates. For instance, he said, for a patient on a drug that has a known side effect at day10, Walgreens can reach out to the patient, educate them about this side effect in real time, reminding them that the symptoms will subside in a specified timeframe. This patient outreach exercise, he explained, will help ensure adherence, as well as safeguard against unneeded ER visits or emotional distress.

The panel turned to data, noting the necessity for quality data to determine value in cancer care—not only clinical trial data, but also aggregated information from electronic health records (EHR) and long-term outcomes measurements.  Dr. Fox, Associate Vice President of Medical Affairs, Priority Health, said that even though a patient may be on the correct drug for his disease, the cost will continue to increase. To ensure that there is still value for the coverage provided, the correct data is necessary and, in cancer, he noted, outcomes indeed are easier to track than in other disease types, due to the average length of treatment.

Ideally, explained Dr. Dickson, Chief Executive Officer, MED-C, reliable, “real-world” data needs to be united with clinical trial data. The panel called on all constituents in the cancer care continuum to collaborate to collect, “de-silo,” and implement such data in a broader, useful way.

There is still work to be done in the regulation and management of molecular diagnostics, said Dr. Jeter, MolDx Medical Director, Palmetto GBA. For molecular diagnostics, retrospective and prospective studies are needed to meet the Medicare standard for reasonable and necessary criteria for evidence, she noted.  

Giving the example of retired patients who winter in warmer climates, Dr. Jeter explained how, for larger national labs, reimbursement still varies from state to state and the same patient may be reimbursed for testing in one location but not the other. There is a need to determine appropriate testing required at commencement of treatment, she added.

In closing, Dr. Goodman asked the panel to offer bottom-line advice for surviving in the environment of benefit and utilization management. The panel declared that industry must collaborate to identify shared resources and quality data in order to illustrate value and accountability for cost, as well as more actively communicate with stakeholders about innovation in the marketplace.

Improving Patient Engagement; Using Technology to Support the Navigation and Delivery of Quality Cancer Care

Panelists discussed the advantages and challenges of patient engagement during the day’s second session, Improving Patient Engagement; Using Technology to Support the Navigation and Delivery of Quality Cancer Care. The panelists for this roundtable included Loreen Brown, MSW, Lash Group, AmerisourceBergen; Gabriel Eichler, PhD, PatientsLikeMe; Mr. Farber; Jeffrey Pollard, MD, 23andMe; Mark Redlus, Polaris Health Directions; and Ronald S. Walters, MD, MBA, MHA, MS, The University of Texas MD Anderson Cancer Center.

The roundtable commenced as panelists described their organizations’ core tactics for patient engagement. Mr. Farber elaborated on his earlier comments, describing how the Walgreens patient support services are designed to ensure patient access to the support they need throughout the course of their treatment, including, but not limited to, information about financial assistance, caregivers resources, and side effect management. Further, he noted, the community pharmacists provide face-to-face interaction that is very important to some patients.

Ms. Brown, Senior Vice President of Product Management and Not-for-Profit Operations, Lash Group, AmerisourceBergen, added that it is imperative that support systems include outreach to understand patients’ particular needs in order to provide the right services to the right patient at the right time.

Dr. Goodman then identified seven emerging attributes to patient engagement that were illuminated in the panelists’ opening statements: cost, caregivers, immediacy, uniqueness, transition/survivorship, a “soft landing”/non-intrusiveness, and interaction. Of these key attributes, immediacy and interaction resonated instantly with the panelists.

On that note, Dr. Goodman asked the panelists to touch on telemedicine and its reimbursement. Dr. Walters, Associate Vice President of Medical Operations & Informatics, Professor, Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, explained that behavior health was the first specialty to get a foothold in telemedicine, due to its low dependence on technology. Telemedicine in oncology, he added, will be a bigger hurdle.

The panel noted that modern technology and communication methods indeed have created a demand among the patient population for immediate response and verification. Explaining that there are technological hindrances to successful implementation today, Mr. Redlus, Senior Vice President of Labs and Innovation, Polaris Health Directions, stated that nonetheless, the industry is moving in the direction of telemedicine. Taking the initial development of urgent care and walk-in clinics as a model, telemedicine with specialists can fill the need felt by patients who want immediacy, but whose local urgent care centers lack specialists, he said.

In line with society’s yearning for immediacy, Dr. Pollard discussed 23andMe, a company through which consumers can purchase germ-line DNA testing for less than 100 dollars. While the ability to privately initiate genetic testing empowers consumers to take initiative in their health care, panelists expressed their concerns. Ms. Brown and Dr. Walters noted disquiets about reimbursement based on private testing results, as well as the need for genetic counseling. Dr. Pollard explained that there are decision-assist and education tools in development that will address such concerns.

Dr. Eichler, General Manager, Client Services & Strategic Initiatives, PatientsLikeMe, discussed the role of online patient communities and how these virtual environments allow patients to congregate with others, creating an honest, valuable comradery, especially among patients with rare cancers. According to Dr. Eichler, these larger, empowered bases of patients offer a plethora of background, driving massive sums of longitudinal data that can illuminate insights into side effect management and distress that do not exist in other forums.

Interactivity, according to Mr. Redlus, needs not only to pertain to patient-to-patient relationships. Wearable technology, he said, is currently being testing as a psychosocial support tool for people with cancer through a study at MD Anderson Cooper that asks people with breast cancer to use the Apple Watch to answer questions through the day regarding their psychosocial well-being. According to Mr. Redlus, in order for wearable tools to be successful, three outcomes must be achieved: (1) The technology must take advantage of the instantaneous, bi-directional reaction; (2) the patient cohort must broaden; and (3) the tool must lead to better self-discovery with more engaged patients, passively and actively.

Mr. Redlus did expound that there is still work to be done and accessibility is, today, an issue; however, manufacturers continue to overcome these hurdles.

The ideal opportunity for success lies in the complimentary relationship between all of the existing tools—apps, wearables, communities, and in-person services, explained Mr. Farber.

In five to 10 years, what will technology and patient engagement look like?, asked Dr. Goodman.

The panel agreed that technology indeed will have expanded and there will be fewer patients and physicians who are wary about technology, leading to patients who are more like consumers, carrying their health information with them at all times.

Meet the Guidelines Experts

As is customary with NCCN Academy, the third and final roundtable of the day, Meet the Guidelines Experts, featured the following leaders from NCCN and the NCCN Member Institutions who focus on the treatment of Melanoma, Multiple Myeloma, Myeloid Growth Factors, and Non-Hodgkin’s Lymphomas: Kenneth C. Anderson, MD, Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Chair, NCCN Guidelines Panels for Multiple Myeloma and Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma; Robert W. Carlson, MD, Chief Executive Officer, NCCN, Former Founding Panel Chair, NCCN Guidelines for Breast Cancer; Jeffrey Crawford, MD, Duke Cancer Institute, NCCN Panel Chair, Myeloid Growth Factors; Leo I. Gordon, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Vice-Chair, NCCN Guidelines Panel for Non-Hodgkin’s Lymphomas; and Anthony J. Olszanski, RPh, MD, Fox Chase Cancer Center, Panel Member, NCCN Guidelines for Melanoma.

Dr. Goodman opened the panel by discussing evidence in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and how panel consensus comes into play with NCCN Guidelines® development. The panel agreed that ideally, prospective clinical trial data would exist for all treatment regimens; however, that simply is not the case, especially for rare cancers. The compounded, unique experience of the panel members, according to the speakers, makes it possible to include qualified treatment options in the NCCN Guidelines where the data is not present. Even when there is no phase three clinical trial data, said Dr. Carlson, a physician must still make a decision on how to treat a patient.

For instance, myeloid growth factors is a limited field, noted Dr. Crawford, but it crosses over solid tumors and hematologic malignancies. Therefore, he said, the panel must take one piece of data and apply it to various situations—without consensus, the application to the community is not so strong, he said. What makes the NCCN Guidelines so strong, he added, is how this expert consensus allows the algorithms to apply to patients in front of the physicians in real time.

Although all of the NCCN Guidelines panels follow the same process for publication, the evaluation of evidence and threshold for bringing a new therapy onto a guideline will vary by disease type, depending on the available evidence and what treatment options already exist from panel to panel, explained Dr. Carlson.

Dr. Anderson added that it is nearly impossible for a practicing physician—especially one treating multiple cancers—to stay abreast of all treatment advancements as the industry grows so rapidly. The NCCN Guidelines, he said, allow oncologists to have all this information with them in real time.

In response to the day’s earlier conversations, the speakers confirmed that “real-world” data indeed can be submitted for consideration by NCCN Guidelines panels. For instance, a toxicity analysis based on data aggregated from a patient registry may be considered for approved agents, depending on the population and endpoints, added Dr. Carlson.

Moving from efficacy to cost, Dr. Goodman asked Dr. Carlson to discuss the newly initiated NCCN Evidence Blocks. The Evidence Blocks, according to Dr. Carlson, are visual decision-support tools intended to help physicians and their patients make informed decisions about their treatment based on five elements: efficacy, safety (toxicity), quality of evidence, consistency of evidence, and affordability (cost).

According to Dr. Anderson, the NCCN Guidelines panel members and the oncology community, in general, are obliged to have information regarding affordability, as cost affects patient access. Dr. Carlson noted that panelists are asked to consider “total cost,” including acquisition, administration, growth factors, antiemetics, hospitalizations, etc.

One aspect to consider with cost, noted Drs. Gordon and Anderson, are alternatives to the “least affordable” therapies. If the alternative to the least affordable drug is a combination therapy, the physician and patient must consider the total cost of that combination, which may end up costing just as much as, or more than, the cost-prohibitive monotherapy.

According to Dr. Olszanski, accessibility to new treatments needs to be considered in combination with affordability. For melanoma, it has only been in the last few years that drugs have been introduced that significantly extend survivorship, and although these regimens are expensive, they are prescribed for survival benefit. However, he explained, not all parts of the United States have the same access to drugs and the physicians need to consider patient access in choosing appropriate therapy.

Also tied to affordability and efficacy is the inclusion of biosimilars into the NCCN Guidelines. The first biosimilar approved by the U.S. Food and Drug Administration (FDA) for use in oncology, figrastim-sndz, has been included in the NCCN Guidelines for Myeloid Growth Factors as a supportive care regimen. According to Dr. Crawford, with limited level 1 evidence, the panel relied on strong pre-clinical data coupled with inferences on the original biologic, as well as studies from Europe. However, going forward, inclusion of a biosimilar as a therapeutic in the NCCN Guidelines will be a challenge, he said.

Dr. Gordon added that biosimilars pose a unique problem when considering affordability as new, high-cost biologics are introduced to the market to replace a therapy while lower-priced biosimilars will be brought in to do the same.

In closing, Dr. Goodman asked the panel to fast-forward to year 2020—for the NCCN Guidelines to be successful, what needs to be done very well?

The panelists noted that the multidisciplinary representatives to the NCCN Guidelines panels will be key to continued success and, in the future, will need to be consistently reconsidered in order to ensure that the appropriate stakeholders are represented for each disease. Moreover, the NCCN Guidelines panels need to remain adaptive and proactive in their approach, as they will always value access and choice, carefully considering new technology and new treatments.

About NCCN Academy

During NCCN Academy, pharmaceutical and biotechnology professionals are given the opportunity to view operational issues from the provider and payer perspectives. Participants improve their working knowledge of key business, policy, coverage, reimbursement, informational, and operational issues in oncology and gather valuable insights material to developing effective strategies for navigating the various constituencies in cancer care. Through this interactive program, pharmaceutical and biotech professionals learn from key stakeholders what they view to be the most pressing issues in oncology today and how to apply this knowledge to create mutually-successful working relationships. Professionals from marketing, sales, medical affairs, clinical research, policy and government affairs, and other business areas are better able to serve their customers with improved knowledge of real-world oncology issues after completion of this program.

The next NCCN Academy will be held Wednesday, March 30, 2016, in conjunction with the NCCN 21st Annual Conference: Advancing the Standard of Cancer Care™, at The Diplomat, in Hollywood, Florida. To learn more about this program, visit NCCN.org/Academy.