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360-Degree Perspective from the ACCC Institute for Clinical Immuno-Oncology Policy Summit

By Amanda Patton, ACCC Communications

On August 30, the U.S. Food and Drug Administration (FDA) approved the first CAR Chimeric Antigen Receptor (CAR) T-cell therapy, tisagenlecleucel (Kymriah). With this approval of the first cancer gene therapy in the U.S., immuno-oncology took a historic step forward.

Later that same day, in a press release titled, “Innovative Treatments Call for Innovative Payment Models and Arrangement,” the Centers for Medicare & Medicaid Services (CMS) congratulated the scientists and researchers involved in the development of the new treatment, while emphasizing the agency’s  on-going commitment to working with stakeholders on “innovative payment arrangements.”

In hindsight, opening remarks at the ACCC Institute for Clinical Immuno-Oncology (ICLIO) Policy Summit held less than two weeks earlier, seem prophetic:  “Immunotherapy is a hallmark of what’s going on in oncology. . . wonderful, but expensive new therapies, how are we going to make this work? ” said Lee Schwartzberg, MD, FACP, ICLIO Advisory Committee Chair.  Dr. Schwartzberg is Chief, Division of Hematology/Oncology, The University of Tennessee;  Medical Director, The West Clinic.

“Immuno-oncology presents remarkable opportunities and challenges at the same time,” said ACCC President Mark Soberman, MD, MBA, FACS, welcoming participants to the Summit. “We have to figure out how to leverage immuno-oncology for our patients in a very sustainable way in our cancer eco-system.” Dr. Soberman is Medical Director, Oncology Service Line; Chief Physician Executive, Monocacy Health Partners, Frederick Regional Health System.

The by-invitation only, August 18, 2017, ICLIO Policy Summit brought together oncology stakeholders including representatives from patient advocacy groups, pharmacy, research, government, industry, oncology clinician leadership, oncology nursing leadership, and a payer representative to share perspectives on current real-world challenges in immuno-oncology through the lens of:

  • Clinical and Policy Issues
  • Alternative Payment Models
  • Application and Impact of Quality Measures
  • Payer Management of I-O (Immuno-Oncology)
  • Future Challenges and Opportunities

Watch video for comments from ICLIO Policy Summit participants:

360-Degree Perspective

The ICLIO Policy Summit discussion by these diverse stakeholders revealed a 360-degree perspective on the current landscape for the translation of immunotherapy from bench to bedside. Top-level themes from the Summit are highlighted below:

Biomarkers. All stakeholders concur that there is a pressing need to identify biomarkers for immuno-oncology agents in order to address the issue of identifying those patients mostly likely to benefit from being treated with an I-O agent and to help mitigate cost.

Education. New agents are emerging with new mechanisms of action, and combinations and sequencing of immuno-therapy agents are on the horizon. Understanding of side effects, late effects, and long-term effects, and the nuances of immunotherapy delivery for patients in the community continues to evolve. On-going education is imperative, not just for the multidisciplinary oncology team but also for other providers who care for these patients (e.g., primary care, endocrinologists, pulmonologists, radiologists, emergency department staff) and for the patients who will receive these therapies and their caregivers.

Community Perspective. The arrival of new immuno-oncology agents has fundamentally changed the landscape of clinical practice over the past three years. In the community setting, programs need to “take a systematic approach to I-O implementation,” commented community-based provider. P&T Committees must have the capacity to address issues around appropriate use, inventory management, and cost of expensive new and emerging I-O agents to avoid financial toxicity for patients, providers, and institutions.

More Evidence Needed.  I-O is far from plateauing, participants agreed, but more evidence is needed around combination therapy and sequencing of these agents. “We don’t know which combinations are superior and which are superior to single agents,” commented a clinician participant. But that evidence “is coming very quickly,” he added.  “I think combinations are going to be important,” commented a research clinician, “rational combinations,” adding that the “PD-1 pathway is foundational.”

Access to I-O therapies. Prior authorizations continue to be a barrier to access, stakeholders agreed. Pharmacy and PBM participants, in general, indicated that they follow the lead of the NCCN Drugs & Biologics Compendium, but the high-cost of these agents leads to critical pharmacy issues of how to afford these expensive therapies and how the cancer program’s physicians will use them.

Discussion of pathways, pre-authorizations, and “totality of the evidence” for FDA approval (the summit discussion touched on expedited clinical review for I-O based on review of the ‘totality of evidence,’ as is currently the case for FDA review of biosimilar agents)—brought the conversation back to biomarkers. “We need to focus on biomarkers. . . selecting the right patients for the right agents,” emphasized a researcher participant. And he added, “We need multiple modalities because cancer is very clever.”

Clinical Trial Enrollment.  Referencing a recent New York Times article, participants cited the challenge of accruing patients to the many open immuno-oncology trials. At the same time, greater access to I-O clinical trials in the community setting may lessen access barriers to these agents for some patients, commented a researcher participant.

Risky Business: Alternative Payment Models. Discussion of alternative payment models (APMs) focused primarily on the CMS Oncology Care Model (OCM).  Summit attendees participating in the OCM agreed that during the first year of the model, efforts centered largely on “getting all the mechanisms in place”—readying practice infrastructure for OCM requirements. With that accomplished, priorities for OCM practices include reducing inpatient admissions and ER visits, and avoiding adverse events.  However, participants agreed that the need to address issues around high-cost anticancer agents is nearing.  In a risk-sharing payment model, it will be critical to find methods to sustain small and large practices, commented a physician leader.

Stakeholders agreed that a challenge with OCM design is that the episode being measured is too brief; it does not follow the patient’s entire cancer journey. Outcomes such as cure or disease-free survival, for example, are not included in the OCM.  “The model looks at cost, not value,” noted a participant.

Still, the OCM provides a path toward demonstrating attributes of patient-centered care that are components of the new value-based payment models, participants said.

Quality Measures & I-O. Coming to consensus on quality measures in oncology remains a challenge. Patient advocate stakeholders pointed to the study by Basch and colleagues presented at ASCO 2017 showing that just by tracking patient-reported outcomes (PROs), patients lived longer. From the patient advocate perspective quality measure concerns are multifold, including:

  • Tension between the driving trend in oncology toward standardized measure sets (pathways, etc.) and precision medicine, i.e., the need to support appropriate variation in order to individualize patient care.
  • Current patient satisfaction measurement tools that do not assess what really matters to patients (e.g., quality of life and outcomes).
  • Quality measures that assess process (much of which is already being done), rather than outcomes measures that would be tangible to patients (e.g., staying out of the hospital).

In response, patient advocacy groups are developing their own quality measures based on what patients’ say is important to them, including not just clinical measures but quality of life measures such as disruption to work, childcare, and transportation to treatment.

Payer Management of I-O. As the current healthcare reimbursement landscape continues to evolve, key concerns identified during the ICLIO Summit were:

  • The need for biomarkers for patient selection to ensure those most likely to benefit from the I-O therapy will receive it and those who won’t, don’t.
  • The need for the healthcare system to be more nimble and adaptable in “looking at good data.”
  • One of the biggest challenges for clinicians is variation in coverage under different health plans. As an example, a provider sees five different patients with the same cancer type, each with a different health plan, each with its own coverage options and requirements. The end result: guidelines to reduce variation are not working, commented a health system executive.
  • Prior authorizations creating barriers to access and uncertainty for patients, providers, and practices. “We’re taking on risk with . . .value-based payment, but we’re still saddled with prior authorization. Maybe it should be one or the other,” said a clinician leader.
  • Managed care organizations and others are looking at how to bundle oncology products into trend management pools.

Looking to the Future

The final discussion block looked to the future. In a lightening round, Summit participants were asked to share their perspectives one key challenge or opportunity for immuno-oncology in the near future—summed up in a sentence or two.  Their responses offer a final 360-degree look ahead at real-world issues facing immuno-oncology:

  • We need to develop a quality measure that is “patient returns to functional status.”
  • In the value discussion, there is realistic, and then there is reality. A lot of what becomes value is tied to your resources. [Many times] in medical situations, that’s not taken into consideration.
  • Future treatment decisions informed by biomarkers and life circumstances.
  • View all navigators as integral parts of the cancer care system.
  • Adapt [the] delivery system to be more nimble to adopt major advances.
  • We need to look at real-world evidence for comparative effectiveness. We have to go beyond the regulatory system to really understand the value in the community that each agent brings.
  • Will we have enough doctors, nurses, social workers, and navigators to treat patients with these complex therapies?
  • We need to develop and implement patient-reported outcomes, and we need to understand the real cost of care.
  • Between academic programs, the federal government, [industry], and the community, we need to get more serious around biomarker development and who is most likely to benefit from expensive therapies and those not likely to benefit.
  • Clinical trials. . . how can we bring clinical trials to community hospitals? We need a process to open clinical trials [so that the community can] benefit from access to these drugs early on.
  • Evidence generation. . . stakeholders need to generate evidence.
  • Preparing the nursing workforce [to move] from a disease-state specific [care model] to a more biomarker-driven model.
  • Form follows function; if the future of medicine is biomarker driven, then resources have to be organized along that line.
  • Greater investment in analytics so that we can get more nimble feedback; greater degree of analytic support.
  • Establish and maintain a national registry to capture and analyze data from real-world care.

In closing the ICLIO Policy Summit, Advisory Committee Chair Lee Schwartzberg, MD, FACP, thanked participants: “We come from different points of view, but we have common ground. . . . Communication is the way we’re going to go forward with new therapies in [our] complex [healthcare] system.

The ACCC Institute for Clinical Immuno-Oncology is the only comprehensive initiative to prepare multidisciplinary cancer care providers for the complex implementation of immuno-oncology in the community setting.  View ICLIO’s robust resources, webinars, education offerings, and more, on the ICLIO website accc-iclio.org.

ICLIO Conference: Top-Level Takeaways

By Amanda Patton, ACCC Communications

ICLIO Conf-Dr. Schwartzberg-for web

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

ICLIO Conf panel-for web

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.
ICLIO Conf Edward Li-for web

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.

SGR is Over: What Does it Mean for Providers?

By Maureen Leddy, Policy Coordinator, ACCC

U.S. Capitol On April 14, 2015, after years of uncertainty and 17 short-term “doc fix” patches to prevent severe annual cuts to physician payments, Congress approved H.R. 2, Medicare Access and CHIP Reauthorization Act (MACRA). This bipartisan, bicameral compromise finally puts an end to the sustainable growth rate (SGR) formula. MACRA provides physicians with the predictability in payments needed to continue to provide high-quality cancer care, while transitioning over a 10-year period to a new dual Medicare reimbursement system.

What’s in Store?

Under MACRA physicians must eventually participate in a Merit-Based Incentive Payment System (MIPS) or an Alternative Payment Model System. Through June 2015, MACRA calls for Medicare physician reimbursement at the rate set by last year’s “doc fix” patch. Then, for five years, through 2019, annual 0.5% increases to payment rates are established.

In 2020, a second five-year phase begins during which reimbursement rates remain flat. During this second phase, providers will need to transition to the Merit-Based or Alternative Payment Model Systems. Ultimately MACRA encourages providers to participate in Alternative Payment Model Systems through higher incentive payments; beginning in 2026, physicians will receive automatic payment updates of 0.75% if participating in an APM, and 0.25% if participating in MIPS, with an opportunity to receive additional bonus payments based on performance. Payments under the MIPS will be subject to positive or negative adjustments based on the following performance criteria:

  • quality of care
  • resource use
  • clinical practice improvement activities
  • use of electronic health records (EHR) technology.

During the second five-year phase through 2024, providers participating in an Alternative Payment Model will  be eligible for annual lump-sum bonuses equaling 5% of the prior year’s payments upon achieving specified targets in transitioning from fee-for-service payments.  Providers participating in MIPS will be eligible during this second five-year period for additional positive adjustments in rates for exceptional performance.

Payment Model Technical Advisory Committee

MACRA encourages the development of Alternative Payment Models applicable to specialties and small practices, as well as models that align private and state-based payers. The legislation calls for creation of a Payment Model Technical Advisory Committee that will recommend additional Alternative Payment Models to CMS. CMMI’s recently launched Oncology Care Model (OCM) already provides one venue for many cancer providers to participate in an Alternative Payment Model. Visit ACCC’s Oncology Care Model Resource Center for answers to providers’ questions on eligibility, reimbursement, and key considerations for participation in this new payment model, plus links to application forms and CMMI OCM materials.

Going forward, ACCC will be vigilantly monitoring the Payment Model Technical Advisory Committee recommendations for other Alternative Payment Models that may be relevant to oncology practices.

ACCC looks forward to working with our members to effectively implement the bill and transition towards a new future for physician reimbursement.

On Wednesday, April 22, ACCC is hosting a members-only conference call with presenter Dan Todd, former Senior Health Counsel, Senate Finance Committee, and a primary author of MACRA, that will provide an in-depth look at what MACRA means for oncology providers and the future of physician reimbursement. ACCC members can access call-in information here.

Stay tuned.