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White paper outlines progress, challenges of immunotherapy in community setting
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The Association of Community Cancer Centers’ Institute for Clinical Immuno-Oncology issued a white paper titled “Immuno-Oncology: There’s more to discover.”
The 16-page document examines the progress, challenges and priorities of immunotherapy in the community cancer care setting.
The document outlined several concerns, such as: payer and coverage policies that limit access to immunotherapies; the need for alternative payment models geared toward value-based reimbursement; the need for these models to include input and buy-in from the oncology community; and how the management of immune-related adverse events creates additional expense and requires more resources across the continuum of care.
The paper also highlighted the need for ongoing education about these agents so physicians are equipped to discuss the benefits and risks of immunotherapies with their patients.
HemOnc Today spoke with Jennie R. Crews, MD, FACP, president of the Association of Community Cancer Centers (ACCC), medical director for Seattle Cancer Care Alliance Network, medical director for research integration at Seattle Cancer Care Alliance and associate professor of medicine at University of Washington, about key findings outlined in the report and how the association plans to address continuing challenges.
Question: Can you describe the purpose of the white paper?
Answer: There were several purposes. One was to review the clinical developments in immunotherapy during the past year to ‘set the stage’ for the current environment. The second was to review the work of Institute for Clinical Immuno-Oncology (ICLIO) and how it is evolving based upon the needs of cancer programs. The third purpose was to acknowledge the challenges that oncologists and cancer care programs often are faced with regarding the rapid development of immunotherapy, and to find a way for ICLIO to address these challenges.
Q: What do you consider the key findings?
A: Immunotherapy use is expanding rapidly, and the indications for immunotherapy are increasing. There has been an expansion for how we are using immunotherapy with more combination treatments, and there are products coming into the market very rapidly. Additionally, there is a need to validate resources. We have had almost 42,000 visitors to the ICLIO website since it launched. This shows validation that community oncology programs are looking for resources to help with implementation and management of immunotherapy. With new combinations and new indications for these agents, oncology programs will continue to have needs. These fall into the five core domains that ICLIO addresses — clinical optimization, coverage and reimbursement, management of best practices, patient access/advocacy, and training and development.
Q: How will ACCC address these needs?
A: The way in which we will address these challenges falls into several categories, including education, the development of subcommittees within ICLIO that tackle specific areas, and by instituting our visiting experts program. This program allows a selected site to have personalized learning from a multidisciplinary team of experts who are well versed in immunotherapy. This program will launch this year.
Q: What types of challenges remain?
A: Challenges include issues with payers and coverage implementation, and with alternative payment models. For example, in the realm of payer coverage challenges, we have heard from our members and stakeholders that payers are not always consistently providing coverage according to a drug’s specific indication. There is variation across the country. There are challenges with the burden of obtaining prior authorization for immunotherapy, challenges within practices regarding resources to obtain prior authorization, and concern around coverage for clinical trial participation for patients. In the realm of implementation — as immunotherapy becomes more widespread and patients are hearing about the therapy — we receive a lot of requests from patients about immunotherapy. Those requests may or may not be appropriate for that patient’s condition.
Q: How can that be addressed?
A: There is an educational requirement for providers and patients to have discussions about these agents and where they are appropriate. There is an increasing need to discuss risk vs. benefit with patients, because these drugs do have a unique set of side effects. When combining these agents with other types of therapy, a new host of toxicities may arise or the severity of toxicity may increase. We need to be able to educate providers, but also help providers educate patients regarding the risks and benefits of immunotherapy. There are always concerns with practices in the community regarding the limitation of resources. There are financial and clinical needs that require resources, such as inventory management and providing patients assistance and financial counseling. Clinical needs consist of administration and side effects management. There are needs for more comprehensive support services in the oncology care model. Practices that use immunotherapy also have extended support service needs to provide for their patients.
Q: Is there anything else that you would like to mention?
A: ICLIO has many different educational opportunities to help practices. I encourage readers to visit the website at www.accc-iclio.org to take advantage of the resources offered there. – by Jennifer Southall
For more information:
Jennie R. Crews, MD, FACP, can be reached at jrcrews@hotmail.com.
Disclosure: Crews reports no relevant financial disclosures.
Perspective
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J. Philip Kuebler, MD, PhD
The rapid expansion over the last few years of research involving cancer immunotherapy, followed by the accelerated approval of multiple new immuno-oncology drugs, inevitably has led to the rapid evolution of immunotherapy as an accepted and increasingly utilized therapeutic approach. However, this has led to a number of significant challenges faced by both patients and providers, as noted in the rather comprehensive white paper released by the Institute for Clinical Immuno-Oncology, an advisory group of immunotherapy experts established by the Association of Community Cancer Centers in 2014.
The increasing indications and future potential for the use of checkpoint inhibitors and other immune therapies has descended upon community oncologists who seem somewhat ill-prepared to handle the introduction of this new and complex treatment. The ICLIO has made use of innovative technologies in the establishment of educational programs for providers and support personnel, but it is unclear to what extent this material has been utilized in the community.
Many challenges remain. Multidisciplinary immunotherapy teams are encouraged, but few have been established. Biomarkers offer the advantages of precision immunotherapy, but there are few confirmed indications for their use and more research is needed. There is little information available on the efficacy of various immune therapies relative to their toxicities, and optimal management of the latter has not been established. As pointed out, preauthorization for immunotherapy has been onerous at best, making coverage and reimbursement issues even more challenging and complex for the community oncology practice.
Given the high cost of these new cancer therapies, the consensus of all stakeholders regarding the value generated by individual immunotherapies will be of paramount importance. However, as noted, this will be difficult in the absence of a clear definition of overall therapeutic benefit to patients with cancer. The white paper by the ICLIO is an excellent review of the issues and challenges faced by all oncologists as we enter this new era in cancer care delivery.
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