Immuno-Oncology Will Require Extensive Staff Training

Immuno-oncology (I/O) drugs have the potential to improve the level of care in many respects, but they bring with them a host of problems related to implementation that require a completely new set of strategies, according to a white paper released by the Institute for Clinical Immuno-Oncology (ICLIO). High among these problems is the need for extensive staff training, because I/O is still a frontier of discovery and providers’ understanding of the many new drugs that have been approved is by no means complete.

In addition, the paper said, patient perspectives need to be incorporated into providers’ understanding of how and when to use these new drugs. This is because patients’ own perception of value is sometimes very different from the way providers see things. “While there is as yet little consensus on how to best define and measure the specific value of I/O therapeutics, including combinations—ICLIO Stakeholder Summit participants broadly agreed that any adequate assessment of value needs to move beyond the cost of a particular drug and its biologic effectiveness and incorporate patient perspectives on value,” the paper said. For example, patients may be more concerned about quality of life and length of life.

The paper, “Immuno-Oncology: There’s More to Discover,” was based on discussion and conclusions from the ICLIO Stakeholder Summit held in late 2016 in Philadelphia. Other hindrances to adoption of I/O therapies include restrictive payer policies and the lack of a comprehensive method of weighing the clinical and cost value of these new therapies, the paper said.

Payers are very cautious about covering immunotherapies, an expensive class of medicine for which much data are still needed to understand health benefits, and this means that physicians often don’t have the flexibility they would like to prescribe medications, the paper said. Payer policy changes tend to lag behind FDA label changes and new medication approvals, payer guidelines sometimes define indications for drugs more narrowly than the FDA does, and payment requirements are often complicated and time-consuming. “It is increasingly evident that some payers request extensive prior authorization information from providers,” the authors wrote.

In addition, no fully useful drug valuation system has been established so far to help physicians and patients clearly understand the costs and benefits of these drugs. Several drug valuation tools have emerged in recent years, and these hold out promise for resolving the conflict between payer notions of value and physician and patient ideas about value. However, the paper described these as “first generation” tools, and, indeed, there are fresh efforts underway to inject clarity into the debate over how much clinical and cost value immunotherapies bring to the treatment of cancer. A group of oncology industry professionals who discussed these issues at the Society for Immunotherapy of Cancer meeting in November has developed a position paper on the need for greater refinement in judging the value of I/O drugs and intends to spearhead a drive to improve existing valuation tools or develop a new one.

One of the concerns identified by the ICLIO paper is that there is a need to look beyond the costs and benefits of individual I/O drugs and weigh the supplementary care that may be required as patients progress through the treatment process. Additional costs of care will arise as these drugs are increasingly combined with other medications. “This will make it more difficult to assign a dollar amount to the concept of value,” the authors wrote.

Whereas providers are concerned about the levels of payer willingness to cover I/O drugs, they are also concerned about payment models and whether they will accommodate innovative approaches to using I/O drugs, the paper said. Established payment models represent an obstacle to progress, because their quality measures tend to emphasize lowering costs more than promoting innovation. The newer alternative payment models that are emerging offer some hope of relief because they are more focused on managing the cost of care while maintaining or improving care quality, the paper said. Immuno-oncology drugs, if they turn out to be as cost effective and beneficial as some believe, potentially could fit well with these models and the way their financial incentives are designed.

The new alternative payment models promoted by CMS as a way to improve outcomes, reduce cost, and develop cooperative systems of care are only just emerging and providers could face financial penalty for failure to meet certain measures of performance.

Although payers are moving cautiously with respect to I/O drugs, patients are embracing these new agents, and this also is a reason for concern, the ICLIO paper said. With the advancing tide of information about I/O drugs, patients have become more assertive about requesting them. This means that physicians are spending more time discussing treatment options with physicians, the paper said. Oncology specialists worry that advertising has the potential to mislead patients and add to the difficulty of guiding them along the optimal treatment paths. “Patients may incorrectly interpret direct-to-consumer (DTC) advertising content to mean that a particular immunotherapy has benefit for all patients. This misinterpretation can lead to complex discussions with providers about patient eligibility for a particular therapy.”

The paper called for strategies to improve patient and provider education—for the selection of appropriate treatment and for understanding how to manage that treatment successfully. “In addition to educating patients about whether immuno-oncology is right for their particular circumstances, the real-time implementation of immunotherapy in community settings requires strategies to support the recognition and management of responses to treatment, pseudoprogression, and the unique characteristics of immune-related adverse events (irAEs).”

The educational component of implementing I/O therapies requires oncology practices to spend money and dedicate other resources toward the effort. This will be a challenge for some of the less-well funded and equipped practices in the United States, especially those in rural areas, the paper said. “Immuno-oncology drugs are not only expensive to purchase but their administration requires specialist personnel and highly educated staff (such as immuno-oncology dedicated pharmacists), thereby generating additional costs.”

To help solve some of these problems for practices so that they can offer immuno-oncology to their patients, the ICLIO in January 2017 launched a Visiting Experts program, through which members of the Association of Community Cancer Centers will dispatch a team of immuno-oncology experts to conduct one-day workshops at individual practices. The team includes a nurse, clinician, administrator, and a pharmacist, who will provide actionable strategies and “engage with participants on the nuances and complexities of immuno-oncology effective practices.” Providers are also taught how to optimize patient care and overcome payment challenges, in sessions that are tailored to the specific needs of the practice that is hosting the workshop.

The paper said that nurses can play a larger role in the expansion of I/O treatment at practices. One way is to enable them to develop localized expertise by establishing distinct immunotherapy treatment space within infusion centers, with dedicated I/O resources and nursing staff. “Implementation of immuno-oncology in real-time, as therapies are approved, will require ongoing nursing education on immunotherapies, especially in relation to the prevention, recognition, mitigation, and management of immuno-oncology related toxicities and immune-related adverse events,” the paper said. In addition, the spread of telehealth and clinical trial opportunities may also represent means of expanding access to immunotherapy, the paper said.

In the coming year, oncology practices will have to learn more about how to optimize clinical response using immunotherapy, develop team approaches to using this medication, find ways to understand the value of immunotherapy, and break through the access barrier so that more of their patients can benefit, the authors wrote.

Institute for Clinical Immuno-Oncology. Immuno-oncology: there’s more to discover. http://accc-iclio.org/. Published January 17, 2017. Accessed January 27, 2017.