Tag Archives: immunotherapy for cancer

From ASCO to ICLIO to Your Program—Immunotherapy Moves into the Community

By Amanda Patton, ACCC Communications

Once again immuno-oncology (I-O) was center stage at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting (June 2-6, 2017) where more than 250 presentations featured checkpoint inhibitors. Currently, six immune checkpoint inhibitors have received FDA approval for more than nine cancers, with more than 1,000 studies in progress.

On June 2 at ASCO, two pre-eminent immunotherapy investigators provided perspective on the rapidly evolving immuno-oncology landscape with a look back and a look to the future.  During their presentation, “On the Shoulders of Giants: Historical Approaches to Immunotherapy in Solid Tumors,” James P. Allison, PhD, of The University of Texas MD Anderson Cancer Center, and Suzanne L. Topalian, MD, of the Bloomberg-Kimmel Institute for Cancer Immunotherapy, touched on some of the critical challenges the oncology community faces with these new and emerging therapies, including:

  • How to deal with the flood of information from clinical studies
  • The need to better understand the biologic processes underpinning of side effects of these new therapies
  • The imperative to identify biomarkers.

Read highlights from their presentation in this ASCO Daily News article.

ICLIO’s Evolving Role—Supporting Integration of I-O into Practice
Just as insights from ASCO 2017 will continue to ripple throughout the broader cancer community for weeks and months to come; the wave of new approvals and indications in immuno-oncology will continue to spread from academic settings into community programs and practices, where it is estimated that 85% of the nation’s cancer care is delivered.

Since its inception more than two years ago, the ongoing mission of ACCC’s Institute for Clinical Immuno-Oncology (ICLIO) is to create education, resources, and tools that provide practical, real-world support for multidisciplinary team members engaged in bringing immunotherapy to patients in their communities. Hear about ICLIO’s growth and latest initiatives in this ASCO Post interview with ICLIO Advisory Committee Chair Lee Schwartzberg, MD, FACP, Chief, Division of Hematology Oncology; Professor of Medicine, The University of Tennessee; The West Clinic, PC.

ICLIO In the Community
In 2017, ICLIO launched two exciting new programs—ICLIO Visiting Experts and Case Studies in Immuno-Oncology—that bring clinicians with immunotherapy expertise out to providers in the community.

“It’s an area that ICLIO is spearheading,” said ICLIO Visiting Expert Jarushka Naidoo, MBBCh, Assistant Professor of Oncology at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University and Bloomberg-Kimmel Institute for Cancer Immunotherapy.  With the ICLIO Visiting Experts program, “Investigators such as myself who are particularly interested in immunotherapy can actually go to community providers and give our hands-on experience of how we give these agents, what are the common side effects that we see, and what are some of the ways we’ve gotten around some of those particular considerations. We’re able to interact with the workshop participants one-on-one and talk about specific cases they’ve managed, some challenges they’ve had, and how we might have dealt with that from an academic perspective.”

Learn more in this Hem/Onc Today interview with Dr. Naidoo:

For the just-launched Case Studies in Immuno-Oncology, an ICLIO faculty member will travel to an ACCC-member program for a 60-minute case-based tumor board discussion on immunotherapy treatment decision-making and the management of associated immune-related adverse events. Learn more and apply.

Stay Tuned
Take advantage of the upcoming June 27 ICLIO webinar featuring post ASCO 2017 immuno-oncology highlights presented by ICLIO Advisory Committee Chair, Lee Schwartzberg, MD, FACP. Register today.

View all ICLIO has to offer by visiting accc-iclio.org.

Cooling Down ICER? Five Questions to Consider

By ACCC Communications

Three jigsaw puzzles pieces (sm)Although the value-based reimbursement train has definitely left the station and is picking up speed, those in the oncology community continue to grapple with the thorny issues around understanding and defining value in cancer care. Treatment innovations and costs are driving the value discussion in oncology. New and emerging immuno-oncology therapies, while bringing unprecedented clinical value to many patients, often carry price tags of $100,000 a year or more, and are front and center in these discussions. Patient access in an era of high-priced pharmaceuticals continues to be a major challenge, particularly as many of these innovative therapeutics entail high co-pays and/or co-insurance payments. The result is that some patients face major hurdles to accessing these innovative options.

For those in the oncology community, staying up-to-date on current and proposed value frameworks is essential—not only to advance innovation in cancer care and to ensure patient access to new therapeutic options, but also to protect cancer program economic viability in an era where payment and reimbursement may become increasingly tied to value.

In a recent Institute for Clinical Immuno-Oncology (ICLIO) webinar, a panel of leading experts provided real-world perspectives on value framework development in oncology in the U.S., with a particular focus on the Institute for Clinical and Economic Review (ICER), which has gained prominence in the past 18 months.  For those in the oncology community who may not be familiar with ICER, panelist Jennifer Hinckel, MSc, McGivney Global Advisors, provided background and offered the following five questions to consider in assessing the organization’s recent report related to non-small cell lung cancer (NSCLC):

  • Does ICER have the appropriate expertise to interpret complex clinical data given that there are not disease-specific clinical experts on staff or advisory panels?
  • Does ICER have processes in place to adequately prevent or limit bias or policy/political aims from slipping into its reports?
  • Is ICER’s approach of evaluating products close to the time of approval (or pre-approval) appropriate, given its methodology of including only randomized controlled trial (RCT) data?
  • Does ICER have sufficient staffing to review and update reports in disparate disease areas and to ensure accuracy?
  • Would ICER’s various approaches meet the standards of peer view in a widely published journal?

In a recent op-ed published in the Oncology Business Review, leading lung cancer experts (including ICLIO Advisory Committee Chair, Lee Schwartzberg, MD, FACP) suggest some level-setting principles for value frameworks including the following:

  • Have disease experts as evaluators and authors
  • Have patient-centered endpoints, conclusions, and definitions of value
  • Use rigorous methodologies reflecting evidence-based medicine
  • Apply continuous review and revision
  • Hold peer review and authorship to scientific standards.

Listen to the full ICLIO webinar discussion here.

As noted in a newly-released white paper from the Institute for Clinical Immuno-Oncology, all of the existing first-generation value frameworks have strengths and weaknesses. Each wrestles with defining value, and each exposes inherent tensions between payer concepts of value and the perspectives of patients and providers. As the field of immuno-oncology continues to expand, all stakeholders will need to stay informed and be prepared contribute to ongoing development of value frameworks that consider not only cost and clinical benefit, but patients’ perspectives on value in cancer care.  In the months ahead as the oncology community contributes to the discussion on value determination methodologies in the context of payer negotiations and political pressure to lower costs and enact drug pricing reform, as well as working to ensure access to new and emerging immunotherapy and combination therapies, ICLIO will continue to offer support and resources for the multidisciplinary team serving patients in communities close to home.


ICLIO is an Institute of the Association of Community Cancer Centers (ACCC). In September 2016,  ACCC submitted comments in response to ICER’s national call for proposed improvements to its Value Assessment Frameworks. 

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.

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!

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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.