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

By 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

“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!

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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.