Tag Archives: ICLIO

Immuno-Oncology: Moving Forward Together

By Lee S. Schwartzberg, MD, FACP, Chair, ICLIO Advisory Committee


As the momentum surrounding immuno-oncology continues to build, the Institute for Clinical Immuno-Oncology (ICLIO) is meeting the need for practical, real-world resources and education for all members of the multidisciplinary cancer care team.  Find out how in this just-released ICLIO white paper, which illuminates current progress with these exciting therapies, real-world challenges, and emerging concerns around continued access as immunotherapy moves into the community setting.

You’ll want to read Immuno-Oncology: There’s More to Discover for:

  • A concise recap of 2016 immunotherapy clinical highlights
  • An update on ICLIO education, resources, and what to expect in 2017
  • A snapshot of policy issues and pressing concerns impacting the future of immuno-oncology in practice.

In this rapidly changing landscape, I encourage all you to partner with the ICLIO. Whatever your role in caring for patients with cancer, the latest ICLIO white paper will provide insight and perspective on the evolving field of immuno-oncology.  Through ICLIO, let’s continue to move forward together on the exciting immuno-oncology journey.

Explore the hub of immuno-oncology information and resources available for the entire multidisciplinary cancer care team at accc-iclio.org and follow ICLIO for updates. ICLIO is an institute of the Association of Community Cancer Centers (ACCC).

ICLIO Conference: Top-Level Takeaways

By Amanda Patton, ACCC Communications

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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

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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

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:

  1. Get approval for everything and enroll all patients in patient assistance programs.
  2. Add dedicated reimbursement staff. Patient financial advocate/support positions pay for themselves ten times over, she said.
  3. Get a seat at the table. Meet with your payers on a quarterly basis and include your pharmacy reimbursement staff in the meeting.
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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.

Required Reading: “Advancing Immuno-Oncology in the Community Setting”

Lee-Schwartzberg-220x209By Lee Schwartzberg, MD, FACP
Chair, Institute for Clinical Immuno-Oncology, Advisory Committee

Along with their copies copy of the January/February Oncology Issues, ACCC members will receive “Advancing Immuno-Oncology in the Community Setting,” the inaugural white paper from the Institute for Clinical Immuno-Oncology (ICLIO), an institute of the Association of Community Cancer Centers (ACCC).

As members of the oncology community well know, the last five years have brought us thrilling advances in immunotherapy. We’ve seen the introduction of checkpoint inhibitors and vaccines that are unleashing the power of an individual’s immune system to fight cancer. In the past few months, we’ve witnessed a surge of new FDA indications for immunotherapy agents in a number of disease sites, including melanoma, lung cancer, and renal cell carcinoma.

Immuno-oncology is now emerging as the fourth pillar of cancer treatment. It is a new field, bringing new promise and new challenges for patients, providers, and payers.

As Chair of the ICLIO Advisory Committee, I urge you to take a few minutes to explore the ICLIO white paper. Whatever your role in cancer care delivery, you’ll benefit from learning about the resources ICLIO offers today and those planned for tomorrow. Here are three reasons to learn about ICLIO:

  1. The immunotherapy momentum continues to build. There is a robust pipeline of new immunotherapies in development, as well as emerging combination therapies. Staying up-to-date on advances in this new field is imperative—for your cancer program and your patients.
  2. Empowered, informed patients and their families will be asking about (and for) these new immunotherapy options.
  3. The challenges of integrating new therapies occur on many fronts—clinical, administrative, programmatic—and across disciplines. ICLIO brings a multidisciplinary approach to addressing these challenges with practical resources that help build a bridge from bench to bedside so that eligible patients in the community can access these new therapies and receive care in an evidence-based way.

For more, explore ICLIO resources online at accc-iclio.org and learn about future ICLIO initiatives. Take advantage of our upcoming ICLIO webinars in January:

Immunotherapies for the Treatment of Metastatic Renal Cell Carcinoma (mRCC)
January 15, 2016
12 pm, ET

Navigating Patient Assistance Programs for Immunotherapy Treatment
January 21, 2106
12 pm, ET

Coordination of Care for Immunotherapy Patient
January 27, 2016
12:30 pm, ET

Learn more and register for the webinars here. Join our community centered on transformative care!

Institute for Clinical Immuno-Oncology (ICLIO) Conference Spotlights Challenges & Strategies

By Amanda Patton, ACCC Communications

media-ICLIO-iceberg-540x202“The promise of immunotherapy that was seen 100 years ago is now a reality,” said ICLIO Advisory Committee Chair Lee Schwartzberg, MD, FACP, in remarks kicking off the first Institute for Clinical Immuno-Oncology Conference on Oct. 2, in Philadelphia. “Where we are today, particularly with checkpoint inhibitors, is just the tip of the iceberg. . . . We are starting a new era with combination immunotherapy. . . . The challenge is how we will afford these new treatments.”

Conference sessions reflected the reality that adoption of immunotherapy in the community setting comes with challenges, and that strategies for successful implementation are already emerging. Read on for some key conference takeaways.

Immunotherapy is a completely different therapy.

From the clinical perspective, there is the need to understand differences in patients’ responses to immuno-oncology (I-O) therapy, to understand how to manage toxicities, and to educate all members of the multidisciplinary care team, the broader provider community, and patients and caregivers.

In a panel on Immuno-Oncology Applications, Sigrun Hallmeyer, MD, Oncology Specialists, SC, described her experience with implementing immunotherapy in the community setting. “This is really a completely different therapy,” she said. “What happens to patients in terms of side effects is unpredictable. . . . You can have twenty patients with no side effects and the twenty-first patient will have every side effect.”

Despite the challenge of understanding toxicities, Hallmeyer said, “What we are seeing in our community practice mirrors what is happening in clinical trials in terms of efficacy and side effects. . . . This is no longer a niche therapy for one or two tumor types.”

“We need to think in broad terms about educating other providers about immunotherapy toxicities,” said panelist Lee Schwartzberg, MD, The West Clinic, PC. Immunotherapy and toxicity profiles should be discussed in providers’ multidisciplinary conferences and during tumor boards, he said.

Panelist Gordana Vlahovic, MD, MHS, Duke University Medical Center, has been proactive in teaching residents at her program about toxicity profiles. The promise of these therapies is fueling demand, she said. “My practice has referrals from 45 states. Immunotherapy is something that people usually ask for.”

Dr. Hallmeyer agreed. “My patients are educated and well informed. They’ve known about these drugs. There was huge anticipation from the patient perspective and also from physicians.”

Advances in immunotherapy are accelerating more rapidly than the healthcare system’s ability to integrate them, particularly in terms of coverage and reimbursement, panelists agreed. It can take months for new drugs to be assigned J codes. In the meantime, payers may put a “hold” on drug claims, essentially putting the claim in limbo—neither denied or approved. Without a denial, patients cannot apply to patient assistance programs for help.

These are costly therapies, and “insurance and payment for these agents is a huge issue,” said Dr. Hallmeyer. Listen to a podcast of the Immuno-Oncology Applications session here.

Immunotherapy from the payer perspective.

Any discussion of new cancer therapies today must include cost and issues of financial toxicity—for the health system as a whole, for cancer programs and practices, and for patients. “It’s impossible not to be enthusiastic about the topic of today’s discussion,” said Michael Kolodziej, MD, Aetna, “but that doesn’t mean it’s easy.” From the payers’ perspective immunotherapy presents a problem that requires collaborative effort—the critical need to understand the patient population that responds to I-O. “We need to get the right treatment to the right patient at the right time, and we need you [providers] to help us figure it out,” he said.

Over the next two years, a number of immunotherapy drugs are likely to be approved for new indications, increasing the financial challenges, said panelist Michael Seiden, MD, PhD, McKesson Specialty Health. Listen to a podcast of the Payer Directions session here.

Immunotherapy comes with unique administrative challenges.

Three core administrative challenges in I-O implementation were spotlighted by Niesha Griffith, MS, RPh, FASHP, The Arthur G. James Cancer Hospital, The Ohio State University, in a panel discussion on tackling I-O integration challenges:

  • Managing the deluge of immunotherapy information for patients and staff
  • Ensuring appropriate triage of patients
  • Managing reimbursement and patient financial support

Reinforcing the need for provider and staff education on immunotherapy, Griffith cited the critical issue of patients needing emergent care. “Everyone in the practice needs to understand that immunotherapy patients need to be treated differently when they go to the emergency department.”

“Education about I-O toxicities is critical,” commented panelist Steven D’Amato, BSPharm, BCOP, New England Cancer Specialists. “It’s especially important in order to avoid emergency department admissions and unintended downstream costs.”

In tackling the reimbursement and financial issues related to I-O therapies, Griffith said, “I can’t say enough about the importance of financial advocate support.” A key to success at her program has been adding dedicated reimbursement specialists to the pharmacy department.

Using patient assistance programs for immunotherapy agents is essential, she said. And to do this effectively, reimbursement specialists and the clinical team must work together. Administrative staff needs information from and communication with the clinical team to help patients access these therapies. “Financial advocates need to know everything about these new agents,” Griffith said.

While physicians are excited by these new therapies, in private practice it’s essential to have processes and efficiencies in place, especially on the back-end, to ensure reimbursement for I-O therapies, said panelist Spencer Green, MS, MBA (HA), Bozeman Deaconess Cancer Center. “Smaller cancer programs need access to experts to help think through the challenges of implementing new immunotherapy agents,” he said. Listen to a podcast of this session here.

I-O care coordination requires consistent, strong communication before, during, between, and after treatments.

Attendees got a bird’s-eye view from the frontlines of I-O implementation from panelists Catherine Schott, RN, BSN, CCRC, Wheaton Franciscan Healthcare; Jennifer Diehl, RN, Moffitt Cancer Center; and Gary Cohen, MD, Greater Baltimore Medical Center. Ms. Schott offered three essentials for care coordination of I-O patients:

  • Begin care coordination early
  • Encourage early reporting of adverse events
  • Encourage compliance and long-term follow-up visits

Providers and staff—including office staff answering phone lines—need to be well educated about potential adverse events, said Ms. Schott. Educating patients and their families is equally important. She emphasized three key steps in care coordination of patients on I-O therapy:

  • Conducting ongoing patient and caregiver education
  • Providing wallet cards or symptoms logs for patients
  • Encouraging accurate reporting of adverse events.

Schott stressed the importance of good communication during, between, and after treatment. “It’s important to know there may be late occurring side effects,” she said. “As more patients are treated with immunotherapy agents, we need to be vigilant about late occurring side effects.”

“For immunotherapy patients, it’s important to know who to call 24/7,” said panelist Jennifer Diehl. “Other providers may not be familiar with I-O agents, side effects, and treatments.”

Provider-to-provider communication is essential, said Dr. Cohen. Treating patients with these new immunotherapy agents is very different from “our experience in treating cancer patients with traditional chemotherapy or other modalities,” he said.  Assessment of patients is very different. With immunotherapy progressive disease may not always be due to metastasis. Toxicities are different. “With immunotherapy we have to teach our radiation oncologists, our endocrinologists about how immunotherapy agents work.”

Immuno-oncology indications are rapidly evolving.

The conference’s closing session featured Timothy Kuzel, MD, FACP, Northwestern University, discussing evolving I-O indications in renal cell carcinoma and melanoma, and Renato G. Martins, MD, MPH, Seattle Cancer Care Alliance, presenting on evolving immunotherapy indications for lung cancer. “We believe very strongly that molecular profiling is a key component of improvement of care in non-small cell lung cancer,” said Dr. Martins. Listen to a podcast of Dr. Martins’ presentation here.

Learn more from the ICLIO Conference: Access session podcasts and view presentations here.

The Institute for Clinical Immuno-Oncology is a hub of I-O information and resources for the entire multidisciplinary cancer care team—both clinical and non-clinical program staff. Access webinars, articles, and join the ICLIO community: Transform care today!


The Association of Community Cancer Centers (ACCC) established the Institute for Clinical Immuno-Oncology (ICLIO) to empower multidisciplinary cancer care teams to advance application of immuno-oncology by providing comprehensive I-O resources.

Preparing Ourselves for a New Frontier

By Steven L. D’Amato, BSPharm, BCOP, President, ACCC

The current pillars of cancer treatment incorporate radiation, surgery, and chemotherapy, with the goal of targeting the tumor and inducing complete or partial responses. Immuno-oncology (I-O) is a rapidly developing area of science and treatment that focuses on harnessing the ability of the patient’s own immune system to fight cancer. While great strides have been made in the fight against cancer, improved survival remains a challenge for some advanced malignancies. Surveillance, Epidemiology, and End Results (SEER) program data from 2014 show the five-year survival for lung, colorectal, kidney and renal pelvis, and melanoma to be 3.9, 12.5, 12.3 and 16 percent respectively. Specifically, malignant melanoma, renal cancer, and prostate cancer are potentially immunogenic, which makes them good candidates for immunotherapeutic approaches. Currently, more than 900 I-O clinical trials are in various phases of development.

A Long Road

The history of immunotherapy dates all the way back to 1796 when Edward Jenner used cowpox to induce immunity to smallpox. In 1890, Coley demonstrated that bacterial products (Coley toxins) had benefits for inoperable cancers, which led to the application of Bacillus Calmette-Guerin (BCG) in the 1960s. More than two decades later interferon-alpha was approved as hairy cell leukemia cancer immunotherapy, followed closely by interleukin-2 which was approved for the treatment of renal cell carcinoma and melanoma. Then came the birth of the monoclonal antibodies bevacizumab and cetuximab in 2004, followed by panitumumab in 2006. The first cellular immunotherapy (sipuleucel-T) was approved for prostate cancer in 2010. Ipilimumab (anti-CTLA-4) was approved for advanced melanoma in 2011. This year saw the first programmed cell death protein 1 (PD-1) monoclonal antibody inhibitors (nivolumab and pembrolizumab) approved.

These two new PD-1 inhibitors are currently indicated for the treatment of advanced melanoma (nivolumab, pembrolizumab) and squamous non-small cell lung cancer (nivolumab). These agents also have activity in a variety of other disease states and are currently being evaluated in numerous clinical trials. In addition to the development of anti-PD-1 agents, agents are being developed that target the PD-1 receptor and its ligands (PD-L1/2). I-O therapies have the potential to be used as monotherapy or as a part of combination regimens. Combinations of complementary I-O therapies with chemotherapy, radiotherapy, and targeted therapy have the potential to enhance antitumor effects. One can imagine the complexities of incorporating these new agents into the treatment of various diseases as more agents are developed and approved for use.

The anti-PD-1/PD-L1 agents are relatively well tolerated. However, there are many drug-related adverse events with potential immune-related causes, such as pneumonitis, vitiligo (a skin condition where skin loses its pigmentation), colitis, hepatitis, hypophysitis (inflammation of the pituitary gland due to autoimmunity), and thyroiditis. Because most tumor-associated antigens are also expressed in normal cells, the potential exists for toxicity against healthy tissues. Adverse events can be serious and potentially lethal, demanding vigilance throughout and after treatment. When combined with other forms of cancer treatment, I-O therapies can lead to numerous toxicities that must be identified early and managed appropriately. Another caveat with I-O is the monitoring of response with these new agents. Therapies that affect the immune system may not induce a measurable effect on tumor growth immediately. After initiating I-O therapy, immune activation and T-cell proliferation can start within days to weeks, but measurable antitumor effects may not be realized until weeks to months after initial treatment; the potential effects on survival may not be seen until several months after initial administration.

A New Frontier

This new frontier of medicine requires specialized education so that we can understand the immune system, its relationship to different tumor types, how these new agents interact with the immune system, and how to identify and manage immune-related events. To meet this critical need, ACCC formed the Institute for Clinical Immuno-Oncology (ICLIO), which launched in June 2015. ICLIO translates the latest I-O scientific research and findings for the multidisciplinary cancer care team, making the information accessible and—most importantly—breaking it into digestible action items that can be easily implemented in the community setting. ICLIO has brought the new frontier of immuno-oncology to your door. The next step is up to you. Visit accc-iclio.org today for information about clinical optimization, coverage and reimbursement, management best practices, patient access and advocacy, and training and development.

On Oct. 2, the ICLIO National Conference in Philadelphia, Pa., will bring together multi-disciplinary oncology team members to discuss the “how to’s” for putting immunotherapy into practice. I hope you’ll join me for this exceptional event.

Steven L. D’Amato, BSPharm, BCOP, is President of the Association of Community Cancer Centers, 2015-2016. He is Executive Director of New England Cancer Specialists.