Our first-ever Virtual Midyear Conference took place on May 14-17, and was an enormous success with attendees, presenters, and sponsors. More than 400 attendees made history as members from around the world tuned in, made new connections, and actively engaged with AONN+ leadership and peers. A moving talk about navigation now, delivered by Program Director Sharon Gentry, was the emotional heart of the event.
Each day of the conference was packed with informative general sessions and breakouts, and interactive opportunities with peers from across the oncology space. There was also time for some virtual socializing, as far-flung attendees explored the new medium together at a safe distance, and enjoyed the best of both worlds.
On Saturday, the first full meeting day, the sessions started early and focused on some hot topics in navigation today. As they did on the previous day, attendees jumped into the discussion through social media, bringing a whole new dimension to the conference events. With their questions to the moderators and their sharing of information and sources, members fully engaged in the educational process.
Here is the second part of our recap of some of the meeting highlights.
Patient Navigation and COVID-19
“And so are the days of our lives,” began Ms Gentry, hearkening back to the oft-repeated opening lines to a long-running soap opera—a television program that helped give shape to 20th-century popular life and culture for more than 50 years. This phrase, she said, has been resonant for her over the past 3 months, as we collectively grapple with a force larger than all of us and reckon with the ways in which we have changed as a society in the wake of the pandemic, “like sands through the hourglass.”
In this special session dedicated to the COVID-19 crisis and how it is affecting oncology care now—both on the personal and professional levels—Ms Gentry offered a moving assessment of the crisis and the measures employed during this time. An emotional high point of the conference, Ms Gentry also shared navigators’ frontline stories in a not-to-be-missed presentation.
In a historical overview, Ms Gentry outlined the events that have unfolded since March of this year, and the dramatic way in which we adapted to stay-in-place orders, telehealth, and more. The infamous smoggy skies over Los Angeles cleared, and, she noted, the normally traffic-clogged arteries of large cities became car-free zones to zip from one end to the next. All of this has been happening so swiftly and so thoroughly that it is hard to take it all in.
Ms Gentry commended navigators for their incredible dedication to their profession and thanked them for their sacrifices, large and small; she gave a special shout out to “international navigators who have been doing the best they can” under extraordinary circumstances.
“Navigators have been creative,” she said. Some have adorned their surgical gowns with photos of themselves so that their patients, who are among those at highest risk for coronavirus illness, would be able to recognize them through their protective gear.
“Masks that are so critical have now become a fashion statement and will become an accessory over time,” she said, referring to the initial crisis over personal protective equipment shortages and the resultant self-help movement that created masks for the masses. “Many have made free masks to find usefulness in these times,” she said, and this will undoubtedly continue to be an area where individuals can express their desire to help in their creativity and individuality.
Navigators have responded in other ways, too. Many have become educators not only for their patients, but for the communities to which they belong. Recognized as healthcare experts, they have taken the role as informed and concerned advocates for patients, family, friends, and neighbors. Accurate health information has never been more essential, and navigators have helped to spread crucial knowledge about the coronavirus and dispel myths, rumors, scams, and propaganda that have stirred racism, stigma, and violence.
“Navigation did not go away at the same time, however,” as the work of caring for patients with cancer continued for most, although not all navigators. Some have been furloughed, and others have been reassigned to other posts.
Just as navigation does not go away, neither does cancer. Many patients have had their treatments and screenings delayed, and the repercussions remain to be seen. And navigators will be there, whether in person or via telehealth, to do the work of caring for their patients.
Where There’s Smoke, There’s Fire: Vaping Poses Danger to Young Americans
After a collective sigh of relief when cigarette smoking reached a nationwide low, other forms of tobacco and nicotine use, such as vaping, rose to the attention of many, especially young people. Vaping has sometimes been called a new epidemic, and in the past year we witnessed a tragic loss of life connected to the practice. Healthcare educators and activists have been involved in trying to save lives among a rising tide of propaganda.
Although numbers are lower than in the past, with 34 million smokers in the United States, tobacco in all its forms remains the leading cause of preventable US deaths with approximately 500,000 annually, accounting for approximately 30% of all cancer deaths and 80% of lung cancer deaths.
With these statistics, it is crucial for navigators to cultivate awareness about the dangers of smoking, and about the risks involved with vaping and the use of electronic cigarettes. Marissa Brown, Senior Vice President of State & Local Advocacy for the American Cancer Society (ACS) Cancer Action Network (CAN), and Nancy Sayegh Rooney, RN, ONN-CG, NCTTP, Lung Nurse Navigator at Richmond University Medical Center, Staten Island, NY, presented troubling information about these products.
Some new tobacco products are contributing to a rise in the number of young people who are smoking. Among tobacco-using youths in 2019, e-cigarettes were favored, with 27.5% of users choosing them. There has recently been a 48% increase in smoking among middle-school students, indicating the popularity and apparently easy accessibility, Ms Sayegh Rooney said. These products include flavored tobacco (think fruity and other sweet flavors) that young people favor, and which have been very important in initiating youths into smoking. Nearly all tobacco use originates in adolescence, said Ms Sayegh Rooney. Topping it off, a Juul-brand pod contains 55 to 60 grams of nicotine—approximately 3 times the amount found in a pack of cigarettes. “Any tobacco use among youth is unsafe, including e-cigarettes,” she said.
Vaping, which has become especially popular among youth and despite some believing e-cigarette vapor is harmless, it may contain volatile organic compounds, ultrafine particles, heavy metals, and carcinogenic chemicals. According to Ms Sayegh Rooney, vaping pods contain glycerol, a byproduct in soap manufacturing that is used as an emollient and laxative, and for making explosives and antifreeze. They also contain propylene glycol, a carcinogenic byproduct of fossil fuel used to make polyurethane plastic. Another ingredient, benzoic acid, is used in insect repellants.
First named in August 2019, e-cigarette– or vaping product–associated lung injury (EVALI) has affected 2602 individuals nationwide, with 57 deaths among them, according to the Centers for Disease Control and Prevention (CDC). With symptoms resembling pneumonia or the flu, EVALI can be difficult to diagnose, Ms Sayegh Rooney said. Treatments for EVALI include corticosteroids, antibiotics, and antivirals. Although long-term data are lacking, it is known that EVALI can recur.
Although Tobacco 21 is the law of the land, making it illegal to sell tobacco products to people under 21, implementation is uneven, since state laws and federal laws sometimes differ. Passed in December 2019, the legislation does not prohibit the sale of flavored e-cigarettes; however, FDA guidance has mandated the removal of some flavored, cartridge-based e-cigarettes from the market, and will order the removal of products targeting young people, although it remains unclear how these provisions will be enforced. Among middle- and high- school students who use tobacco, 68.8% report having used flavored e-cigarettes in the past month, Ms Brown reported. The FDA’s Youth Tobacco Prevention Plan also includes education for both youth and tobacco retailers, according to Ms Sayegh Rooney.
Ms Brown explained that we know what works in slowing rates of cigarette smoking, including increased tobacco taxes, 100% smoke-free laws, fully funded evidence-based prevention and cessation programs, and cessation coverage.
Regular, significant tobacco tax increases are among the most effective ways to reduce its use, Ms Brown said. ACS CAN advocates for increasing cigarette taxes by $1 or more per pack, with equivalent increases on other tobacco products, including e-cigarettes. Although nearly three-quarters of US states’ tobacco taxes meet or exceed the national average, fewer than half tax e-cigarettes.
Shown to reduce secondhand smoke and increase cessation, smoke-free laws should include e-cigarettes, Ms Brown asserted. Whereas many states have a smoke-free law for restaurants, bars, and other establishments, some do not include e-cigarettes in those prohibitions.
Tobacco Control Funding
The CDC has provided recommendations for state tobacco control programs, including funding amounts, Ms Brown said. Only 6 states fund their tobacco control programs at more than 50% of the CDC-recommended level. Overall, for every $12 the tobacco industry spends on marketing for cigarettes and smokeless tobacco, states are spending only $1 on tobacco control.
Medicaid coverage of tobacco cessation is somewhat dismal, with only 12 states covering individual, group, and telephone counseling, along with all 7 FDA-approved cessation treatments. More than half of US states cover at least 1 type of counseling and at least 1 FDA-approved treatment, however. Comprehensive cessation coverage should not include copayments, prior authorizations, treatment duration limits, dollar limits, stepped-care therapy, or counseling requirements for medications, Ms Brown asserted.
Evidence-based messaging for public health campaigns against e-cigarettes includes emphasizing that nicotine is unsafe in any form for youths, potentially harming adolescent brain development; affecting learning, memory, and attention; and priming the brain for addiction.
Oncology Biosimilars: A 2020 Update
Jim Koeller, MS, Professor at the University of Texas (UT) at Austin and UT Health, offered a primer on biosimilars and an update on FDA rules for their approval during the AONN+ Virtual Midyear Conference. Helping to reduce costs and increase access to novel drugs, biosimilars are playing a growing role in the oncology treatment landscape. And while they have been in the news recently, they have been used for more than 35 years.
Biologics encompass a wide array of agents derived from cell lines of living organisms that prevent, treat, or cure a disease. Although these drugs represent a breakthrough in cancer treatment, their high cost proves prohibitive for many patients. Defined by the FDA as “highly similar” to their biological reference product (RP), aside from small differences in clinically active ingredients, biosimilars have no clinically meaningful differences in safety, purity, or potency from the RP based on the “totality of evidence,” Mr Koeller explained, emphasizing that biosimilars are different from generic drugs.
Representing a developmental paradigm shift, the FDA’s totality-of-evidence approach builds on the existing knowledge base of the RP while reducing the need for extensive animal and clinical testing for biosimilars. Testing for immunogenicity, the tendency of a biologic to induce the formation of antidrug antibodies, is always required, however.
“Biosimilars are NOT generics,” said Mr Koeller, as he began his discussion. Although biosimilars are highly similar to their biologic RPs, they are not identical. No batch of any RP is identical to another; however, inherent variability is a normal feature of biotechnology. Manufacturers keep careful control over heterogeneity to ensure a drug’s quality attributes are within a prespecified range. The process of manufacturing a biologic can undergo changes after the drug is approved, and such process changes are evaluated through comparability studies to assess differences in safety or efficacy. This in-depth process is subject to health authority review, Mr Koeller explained.
Comparability studies for biosimilars employ a “fingerprint-like” analysis, using advanced analytical tools, such as peptide mapping. These analyses examine physicochemical properties, as well as bioactivity. If any uncertainty remains about the similarity of a biosimilar to its RP, comparative clinical trials assess safety and effectiveness. Extrapolation of indications, the approval of a biosimilar for an indication held by the RP but not directly studied in a comparative trial with the biosimilar, requires scientific justification for each additional indication, said Mr Koeller.
Released in May 2019, the FDA’s final rules on interchangeability require additional data to demonstrate no increased risk in safety or efficacy from alternating between a biosimilar and its RP. According to Mr Koeller, the rules appear to offer greater flexibility to allow for global competitors, although a “bridging” trial is required between US and non-US formulations. As opposed to efficacy, the primary outcome proving interchangeability is pharmacokinetics and pharmacodynamics. In addition, studies are required to include 2 switches from the RP to the biosimilar and back, as opposed to the previous standard of 1 switch. Many individual states have their own laws pertaining to biosimilars, he added.
Once a biosimilar gains approval, it has other hurdles to surmount. Getting a place on formularies means getting the acceptance of a facility’s Pharmacy & Therapeutics Committee, which can take time. Other obstacles include the RP manufacturer trying to thwart a biosimilar with disinformation, pricing competition, alternative products, or exclusive pricing, customer concerns, or lack of advocates within institutions, Mr Koeller said. He added that a biosimilar’s approval does not mean it is commercially available. Months, to years, of litigation are possible before a biosimilar comes to market.
The FDA’s long-awaited Biosimilars Action Plan of 2018 sought to improve the development and approval process, maximize scientific and regulatory clarity, and support market competition by mitigating the “gaming” of FDA requirements for market release. Despite this, the plan has raised more issues than it solved, according to Mr Koeller. Still, he advised patience, as more biosimilars are in the pipeline.
The Navigator’s Role in Performance Improvement
Navigators play an instrumental role in identifying gaps in care and facilitating performance improvement initiatives to drive practice change and quality, according to JoAnn Lovins, MS, RN, NEA-BC, Senior Director, Oncology Service Line, UCHealth, Fort Collins, CO, who discussed the topic Saturday afternoon.
Saying that navigators should think of a problem as an invitation to the table for brainstorming and creativity, Ms Lovins described 2 processes for strategizing performance improvement initiatives—“plan-do-check-act” (PDCA) and “Lean” methodology. The Lean methodology involves identifying the following:
- Reason for Action
The reason for action could be problems along the continuum of care that could have been prevented with early referral or by having a no defined process for referrals, for example:
The aim would be to meet the objectives of navigation to identify and remove barriers for patients, as well as to ensure timely access to high-quality care.
- Current and Target State
Similar to the reason for action, the current state is the quandary of inconsistent referrals, the lack of a referral process, The target state would be that providers who value oncology nurse navigators (ONNs) would share their views, or all new patients would be electronically referred to an ONN and financial case counselor.
- Gap, Metrics, and Completion Plan
First, it is important to become familiar with the value of ONNs, as well as measures of their impact on patients. Measure progress as plans are enacted, and implement countermeasures to modify what is not working as the process moves along, Ms Lovins advised.
Invoking the timely example of COVID-19 and the need to postpone or resequence treatment modalities for oncology patients, Ms Lovins outlined how PDCA could be employed to improve performance in this area.
The planning stage should involve gathering information about what can change and what must remain the same. In addition, the navigator should clarify goals and define the measures to achieve them; include upstream and downstream stakeholders; and communicate process changes.
The “do” portion of this methodology would include the implementation of changes, along with ensuring continued communication and actively soliciting feedback from all stakeholders in the equation.
Once changes are implemented, a tangible process must be put in place to review input on a regular basis. From there, ONNs and other stakeholders can define what is working to achieve targeted outcomes, as well as identify barriers and constraints. This will allow countermeasures and proposed changes to be identified and communicated.
In this stage, ONNs have completed the necessary groundwork to implement the final process change, Ms Lovins said.
In addition to these 2 methodologies, national oncology quality measures, along with the AONN+ standardized metrics, can be employed to improve performance and demonstrate value.