By Amanda Patton, ACCC Communications
ICLIO Advisory Committee Chair Lee S. Schwartzberg, MD, FACP
The Institute for Clinical Immuno-Oncology (ICLIO) National Conference on September 30 in Philadelphia provided a window into the real-world immuno-oncology (I-O) issues facing providers, patients, and payers.
Across conference sessions some overarching themes emerged. One prevailing message: there is an on-going need for practical, real-world education on immunotherapy, immune-related side effects, and response patterns—not just for the multidisciplinary cancer care team and allied specialties, but also for Emergency Department (ED) staff, hospitalists, and all others who connect with patients, including front desk staff.
To reduce barriers to accessing I-O, a message reiterated throughout the day was: make immunotherapy clinical trials more widely available in the community. Citing the Cancer Moonshot Blue Ribbon Panel Recommendation #2, which calls for a clinical trials network for immunotherapy, ICLIO Advisory Committee Chair Lee S. Schwartzberg, MD, FACP, said, “It would be a shame to limit this to [just] a few institutions. The entire community needs to be engaged,” including populations that are currently not well-represented in clinical trials, such as the elderly and underserved patient populations.
Implementing I-O: Real-World Challenges
Providing Community and Academic Perspectives on I-O Implementation, Panelists (L to R) Jose Lutzky, MD, FACP; Tara Gangadhar, MD; Lee S. Schwartzberg, MD, FACP
In a panel discussion on Community and Academic Perspectives on Implementing immunotherapy, Dr. Schwartzberg noted that I-O has moved out into the community “very quickly.” His own clinic’s experience tells the story. In 2014, his clinic treated two patients with immunotherapy. To date in 2016, that number has climbed to 306 patients treated with immunotherapy.
What issues are top of mind in clinic every day? Response rate and patterns, pseudo-progression, and immune-related adverse events, said Dr. Schwartzberg.
Panelist Tara Gandahar, MD, Abramson Cancer Center, University of Pennsylvania, emphasized that “patients on immunotherapy need 24/7 access to providers who can assess issues and make a plan,” and that night coverage is of critical importance. Patients who experience toxicity require increased monitoring both by phone and with in-person visits, she said. At the same time, it’s important to reassure patients that discontinuing therapy for toxicity does not mean they won’t see a therapeutic response.
Delivery of immunotherapy requires the involvement of multiple specialties, in particular gastroenterology and endocrinology, added panelist Jose Lutzky, MD, FACP, Mount Sinai Medical Center Comprehensive Cancer Center. Education on immunotherapy is needed for primary care providers, ED staff, ICU staff, surgeons, as well as house staff, he said. Bringing immunotherapy to patients requires a collaborative team effort—with physicians, nurses, social workers, pharmacists, financial advocates, and others.
Building an I-O Dream Team
During a panel focused on the ideal team for successful implementation of I-O in the community, Gary Cohen, MD, Greater Baltimore Medical Center, urged that in preparing the general community for handling these agents, providers not become “complacent” in giving I-O drugs. “They must be ready for the rare side effects,” he said.
Dr. Cohen outlined the I-O dream team as including oncologists (medical, radiation, surgical), family and caregivers, nurses (especially important in terms of side effects education and monitoring), pharmacy, financial counselors/advisors, business managers, plus other medical specialists as needed such as endocrinology, GI, pulmonology, neurology, and radiology.
For smaller hospitals contemplating integrating I-O in the community setting, panelist Carole Miller, MD, St. Agnes Hospital, suggested the following six essential I-O program building blocks:
- Multidisciplinary care
- Shared decision-making
- Expertise, especially regarding side effects of immunotherapy treatment
- Patient education and support
- Clinical trials
- Administration buy-in and understanding of the importance of I-O.
Her cancer program has created an Immuno-Oncology Center, a separate space just outside the infusion center with I-O resources and a dedicated nursing staff.
Sigrun Hallmeyer, MD
As immunotherapy for cancer has grown, so has the size of the I-O dream team, said Sigrun Hallmeyer, MD, Cancer Specialists, SC. Still, the “backbone” of her I-O program remains her nursing staff. A theme throughout the conference was the critical role nurses play in educating patients on I-O side effects, monitoring and following up with patients on symptoms and side effects. Dr. Hallmeyer’s practice uses an educational sheet that nurses go through with patients when they start on immunotherapy. The practice pharmacist will not release the I-O drug unless the patient sheet on side effects is signed off on by the nurse and entered into the electronic medical record (EMR). Early detection of toxicity is the team’s goal.
Looking at the Value-Based Environment Ahead
As the healthcare system transitions to value-based reimbursement models, providers, patients, and manufacturers all confront the question of how these new payment models will impact I-O and innovation. During a panel discussion on alternative payment models (APMs) and immunotherapy, numerous concerns were raised, including the following:
- Pathways and/or bundles: If these are mandated, how will they affect clinical advances and innovation?
- Will the value-based environment constrain innovation?
- How will CMMI’s Oncology Care Model (OCM) impact oncology and I-O? How might use of immunotherapy agents impact performance under the OCM? If CMS deems the model successful, it’s likely to spread rapidly to private payers, noted panelist Michael Seiden, MD, PhD.
- How will APMs incentivize innovation? To get buy-in, APMs must reward innovation, otherwise incentives will be driven in the wrong direction, cautioned panelist Jennifer Hinkel, MSc, McGivney Global Advisors.
Pharmacy Operations & Issues
Reimbursement challenges were a central issue during a pharmacy-focused panel discussion. Whether in the academic or community setting, “immunotherapy agents are creating a lot of work in terms of getting reimbursed. It’s resource and time intensive,” said panelist Niesha Griffith, MS, RPh, FASHP, University of West Virginia Health Center. She shared three practical steps to improve I-O reimbursement:
- Get approval for everything and enroll all patients in patient assistance programs.
- Add dedicated reimbursement staff. Patient financial advocate/support positions pay for themselves ten times over, she said.
- Get a seat at the table. Meet with your payers on a quarterly basis and include your pharmacy reimbursement staff in the meeting.
Ed Li, PharmD, MPH, BCOP
Clinical issues are merging with administrative issues which is impacting the care delivery infrastructure, commented Edward Li, PharmD, MPH, BCOP, University of New England. Looking to the future, “as we start to replace standard of care chemotherapy and move to trying to cure our patients, as we incorporate genetics and molecular testing, how will these fit into pathways?”
Panelist Nicky Dozier, PharmD, Virginia Oncology Associates, cited the growth in the number of pathways as a burden for providers. “Oncology pathways need to do more than just restrict decision making,” she said. Greater transparency is needed in terms of who has participated in the creation of the pathway, for example, were oncologists involved?
Take a deeper dive into the ICLIO National Conference by viewing the speaker slide presentations. Visit the ICLIO website for practical resources to help the multidisciplinary team with real-world issues in implementing immunotherapy for cancer.