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Evidence-Based Oncology February 2017
Keeping Pace With the Immunotherapy Revolution
Joseph Alvarnas, MD
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Patient Navigation in Immuno-Oncology
Shawn M. Regis, PhD
From Bench to Community Oncology Clinic: The Promise of Immunotherapy
Sumeet Chandra, MD
Managing Patient Expectations With Immuno-Oncology
Surabhi Dangi-Garimella, PhD
Advanced APMs and the Emerging Role of Immuno-Oncology Agents: Balancing Innovation and Value
Michael V. Seiden, MD, PhD; Marcus Neubauer, MD; and Diana Verrilli
Helping Cancer Patients and Caregivers Navigate Immunotherapy Treatment
Claire Saxton, MBA; Joanne Buzaglo, PhD; Sue Rochman, MA; and Alexandra Zaleta, PhD
Q&A With Dr Jae Park on the Promise of CAR-T Cells in Cancer Care
Surabhi Dangi-Garimella, PhD
Medical World News, February 2017
Surabhi Dangi-Garimella, PhD
AJMCtv® Interviews, February 2017
Produced by Nicole Beagin and Laura Joszt

Patient Navigation in Immuno-Oncology

Shawn M. Regis, PhD
Patient navigation is immensely helpful in relieving some of the burden placed on cancer patients, and there are some particularly unique aspects of navigation as it pertains to immuno-oncology.
BEING DIAGNOSED WITH CANCER is often the scariest news a patient will hear in his or her lifetime. In addition to the physical toll of the disease itself, there are numerous other factors associated with a cancer diagnosis that can be far too burdensome for a patient to handle alone. For this reason, care coordination for all oncology patients is critical in providing the best possible outcome. With disease treatment being the main focus, communication among primary care physicians, oncologists, and other specialists involved in patient care becomes very important. Patient comorbidities and treatment side effects often need to be addressed as well. This could require involvement of a range of subspecialty providers, including those in pulmonology, cardiology, dermatology, nutrition, and physical and occupational therapy (Figure 1).
Beyond these physical concerns, there is a large psychosocial burden associated with a cancer diagnosis. We know that psychosocial issues affect oncology patients regardless of stage and that the patient’s emotional response to the diagnosis has an impact on both morbidity and mortality.1 While many patients do eventually adjust effectively to their new circumstances without requiring intervention, more than one-third will experience significant distress requiring clinical support2; although many patients depend on family, friends, and religious leaders for support, others also need intervention in the form of a social worker or psychologist.
Beyond the clinical needs, there are also financial and logistical considerations when coordinating cancer care. Fighting cancer can be an expensive battle, and assistance from a financial counselor (either personal or assigned by the hospital) can prove beneficial. Patients also need to coordinate transportation to and from their (often multiple) appointments to receive care while deciphering the logistics to take time away from work if necessary. All of these factors combined make managing a cancer diagnosis a daunting task for any patient, and assistance from a navigator can help ease the burden (Figure 2). This is true for all oncology patients, but there are some unique challenges pertaining to the rapidly developing field of immuno-oncology (I-O).
Educating Patients and Providers
The field of I-O has grown rapidly over the past 5 years, enough to now be considered the “fourth pillar” of oncology treatment,3 along with surgery, radiation, and chemotherapy. One of the side effects of being a relatively new modality is that knowledge of the field is somewhat limited among patients and even some providers. A needs assessment conducted by the Association of Community Cancer Centers, in 2014, showed that only 7% of community clinicians reported being “extremely familiar” with emerging I-O therapies, while 39% responded that they were either “not at all familiar” or only “slightly familiar” with these therapies.3 Thus, the very first piece of the puzzle in care coordination is to ensure providers are familiar with these treatments so they can discuss them with patients when appropriate. The patient must also be well informed to be effectively engaged in a shared decision-making process. However, with increasing demands on physicians’ time, they may not be able to devote as much time as preferred on patient education. Therefore, a patient navigator who is knowledgeable of the field can be a great asset in answering patient questions and marshaling available resources as needed.
Not Your “Typical” Side Effects
Often times, when patients think about the side effects of cancer treatment they jump to horror stories they have heard about the hair loss, nausea, and vomiting, historically attributed to cytotoxic chemotherapy. While it is true that I-O drugs do not have these same side effects, significant toxicities can still occur. Because the goal of I-O drugs is to ramp up the immune response against cancer, it can also trigger unwanted autoimmune or inflammatory responses.4 Common side effects associated with I-O are diarrhea, rash, and fatigue; additionally, I-O agents have been known to cause toxicity in the liver, thyroid, lung, and colon. Making patients aware of these adverse events should be a part of patient education, and patients should also have access to resources to help manage these side effects—access to dermatologists or gastrointestinal specialists who are familiar with the field of I-O. Coordinating appointments with these specialists, in addition to the regular treatments, is an important patient navigator function. 
The Cost of Immunotherapy
An argument could be made that a patient navigator can have the most impact in the care coordination of I-O patients by helping them navigate financial assistance. By 2020, the cost of cancer care in the United States is expected to reach $157 billion.5 This high cost could, in part, be attributed to I-O therapies, as the average cost for a course of this treatment in the United States is $120,000 to $150,000 per patient and could go higher if combination therapies are indicated.6 Of note, some predict the market size for I-O agents alone will be over $30 billion by 2022, equal to the cost of all anticancer drugs in the United States for 2016.4 With specialty tiers of insurance typically requiring patients to pay somewhere in the range of 20% to 25% of medication costs,6 patient co-pays could range anywhere from $35,000 to $40,000. This can often lead patients to either refuse I-O therapy due to the high cost, or choose between treatment and other necessities in their lives. Adding in the fact that many patients can’t work while undergoing treatment, and therefore may lose insurance, the problem becomes even more complex. 
Data suggest that patients with cancer are roughly 2.5 times more likely to go bankrupt than those without cancer and that the severe financial distress caused by out-of-pocket expenses related to cancer treatment is associated with a 79% increased risk of death.7 With such high stakes, the costs for which the patient may be held responsible should be part of the shared decision-making process regarding cancer treatment, although often that is not the case. The conventional decision flow when it comes to cancer treatment selection is drug effectiveness, followed by drug toxicity, and finally cost.8 It is important for patients to be made aware of the expense they can expect to incur as a result of receiving I-O for cancer treatment, and what options are available for financial assistance. A patient navigator can play a huge role in this area.

Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
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