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The Promise & Practice Challenges in Immunotherapy

Eastman, Peggy

doi: 10.1097/01.COT.0000515179.02259.1e
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A new white paper from the Association of Community Cancer Centers (ACCC) highlights the promise immunotherapy holds for cancer patients, but also stresses the policy, cost, administrative, and reimbursement challenges this groundbreaking field holds for practicing oncologists.

The white paper, Immuno-Oncology: There's More to Discover, was produced by the ACCC's Institute for Clinical Immuno-Oncology (ICLIO). The paper notes there is going to be a “coming tsunami of immuno-oncology therapies;” that today “the potential of immunotherapy is being realized as a chief pillar of oncology treatment;” and that providing immunotherapies to patients raises a host of real-world infrastructure issues for oncologists.

The new white paper was written by a panel of experts including ICLIO Advisory Committee Chair Lee S. Schwartzberg, MD, FACP, Chief of the Division of Hematology and Oncology and Professor of Medicine at the University of Tennessee, Memphis; ACCC President Jennie R. Crews, MD, MMM, FACP, Medical Director of the SCCA Network and Research Integration at the Seattle Cancer Care Alliance and a member of the ICLIO Advisory Committee; and ACCC Executive Director Christian Downs, JD, MHA.

Schwartzberg was an invited speaker at a workshop on immunotherapy sponsored by the National Cancer Policy Forum (NCPF) of the National Academies of Sciences, Engineering, and Medicine in February 2016. At that workshop, he stressed the great need for immunotherapy training among clinicians. He also said patients need much more education on immunotherapy, but NCPF workshop speakers noted clinicians are not reimbursed for that educational time.

The ACCC established ICLIO in 2014 to help translate immunotherapy advances into practical applications for practicing community oncologists. ICLIO, which holds educational programs and online courses, has just launched the pioneering ICLIO Visiting Experts Program. By applying to this new hands-on program, selected ACCC cancer program members will receive an on-site 1-day training workshop from a veteran team of multidisciplinary providers experienced in the integration of immunotherapy into clinical practice. The goal is to help community oncologists learn about strategies to achieve optimal patient care, operational management, and ways of overcoming reimbursement hurdles, among other practice challenges.

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Issues to Consider

The cancer community and cancer patients have welcomed advances in immunotherapy, now a bright field that was considered a scientific stepchild when it began 100 years ago. As previously reported in Oncology Times, ASCO chose immunotherapy 2.0—next generation immunotherapy—as its major advance of the year for 2017 (March 10, 2017 issue). Immunotherapy was ASCO's major advance of the year for 2016.

The new ACCC white paper highlights six immunotherapy approaches that can alter the host response to cancerous tumors:

1. vaccines;

2. immune modulatory antibodies;

3. adoptive T-cell therapies;

4. cytokines;

5. oncolytic viruses; and

6. reversal of immunosuppression.

The paper notes checkpoint inhibitors are anticipated to move increasingly into first-line cancer treatment, and combinations of immunotherapies with other agents are under study and poised to become effective treatments across tumor types in the clinic.

Immununotherapies do not work for all patients, and they are expensive. The cost of immunotherapy drugs is flagged as a key challenge for oncologists in the ACCC white paper: “Cost has become a notable concern as these agents can induce a highly valuable durable response in only a fraction of patients.”

Among the immunotherapy policy issues identified in the ACCC white paper of critical importance to practicing community oncologists are the following:

* Payer and coverage policies for immunotherapies continue to pose barriers. Payers do not consistently provide coverage according to a drug's specific indication, leading to under-coverage, which may be due partially to payer policies that lag behind FDA label changes and approval of new medications. Coverage is also limited because some payer-driven clinical pathways define the indication for drugs more narrowly than FDA indications. Some payers persist in onerous reimbursement requirements that request extensive prior authorization information from providers, thus placing a burden on both oncologists and their patients. Payers also appear reluctant to cover immunotherapies in the clinical trial setting, so strategies are needed to support expanded access to clinical trials for patients.

* Patients themselves are increasingly driving discussions about expanded access to immunotherapies, and many patients are becoming more assertive about demanding these drugs. However, some patients may have been misled by problematic information, and they also may not understand the risks of immunotherapies, such as immune-related adverse events (irAEs).

* Recognition and management of irAEs are going to become increasingly important in the clinic, which will generate additional expense and resource requirements across the cancer care continuum. This increased vigilance may require 24/7 access to providers who have immunotherapy expertise, since patients may experience side effects when community oncologists are not on duty.

At the NCPF workshop, Schwarzberg said small- to medium-sized community cancer practices, which provide up to 80 percent of U.S. cancer care, may face special challenges in addressing the side effects of immunotherapies, especially if these side effects are reported during the weekend when practice clinicians are not available. This off-hours reporting may lead to a hospital admission and care by someone unfamiliar with immunotherapies.

Treatment combinations may only increase this need for vigilance. According to the white paper, “the approval of combination immunotherapies is likely to grow the significance of immunologic toxicities in community cancer programs.” Thus, community oncologists must plan and budget for support to manage irAEs in their patients. One strategy cited in the white paper is to develop a distinct space devoted to immuno-oncology within infusion centers, with dedicated immuno-oncology resources and nursing staff—a strategy that offers the advantage of building localized clinical expertise among nurses.

* Alternative payment models focused on value-based care must include input and buy-in from the oncology community as the U.S. healthcare system transitions away from the fee-for-service payment model. For community oncologists, the current “buy and bill” model for cancer drug acquisition poses specific reimbursement challenges for immunotherapy, given the costs of these drugs. The white paper notes that “many physicians pay out-of-pocket to stock and store expensive immunotherapies, without being reimbursed until after administration of the immuno-oncology agent.” Alternative payment models such as the Oncology Care Model offer the chance to provide high-quality care through a realigned financial incentive system and may help to ease oncologists' risk upfront.

* The complexity and number of different value-based frameworks for measuring the quality of cancer care, including immunotherapies, pose challenges in establishing value for distinct therapeutic options. There is often an inherent conflict between payer concepts of value and physician and patient ideas about value.

For example, whereas payers highlight the cost of immunotherapy drugs, physicians highlight their effectiveness. The white paper notes that “the complexity inherent in the process of determining value will likely exacerbate existing tensions in the payer-provider relationship.” The development of immunotherapy value measurement models will likely continue as more information emerges on which patients will benefit from these therapies and which will not.

Looking to the future, the ACCC white paper notes immuno-oncology “requires a well-educated multidisciplinary team that can effectively communicate to its constituent parts. As immunotherapy for cancer continues to evolve, clinical, administrative, and infrastructural operations education will become increasingly important. In the coming year, immuno-oncology professionals will have to sustain their efforts toward optimizing response rates, creating a team-based approach to immuno-oncology care, crafting value determination methodologies, and increasing overall access to available and emerging agents and combinations.”

Peggy Eastman is a contributing writer.

Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.
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