Mindy Waizer

With 12 biosimilars already approved by the FDA and more than 70 currently in development, the oncology community is preparing for the practical and theoretical considerations involved with incorporating these treatments into practice.

During a preconference presentation at the Association of Community Cancer Centers 35th National Oncology Conference in Phoenix, a panel of experts discussed the challenges they foresee with the wave of new biosimilar launches expected in 2019. The panel included Marc Earl, PharmD, BCOP; Kashyap B. Patel, MD; and Nimer Alkhatib, PharmD, MS, PhD (candidate).

Moderator Ali McBride, PharmD, MS, BCOP, Clinical Coordinator, hematology/oncology, The University of Arizona Cancer Center, questioned what the panel&rsquo;s biggest hindrances were for including biosimilars in to their healthcare systems, or if any issues have been raised in addressing biosimilars related to cost models.

Patel, Medical Oncologist, Carolina Blood and Cancer Care Associates, and Earl, Assistant Director of Pharmacy-Oncology, Cleveland Clinic, agreed that one of the biggest hindrances was the lack of availability of therapeutic biosimilars in the oncology setting. While supportive care was not an issue, availability was. &ldquo;I'm interested to see, now that we have multiple therapeutic biosimilars in the market, what that does to our health system,&rdquo; Earl said.

McBride added that 2019 may be a very active one. &ldquo;We expect almost an overload of market-based biosimilar shares,&rdquo; he said. &ldquo;We are going to have a lot of release dates.&rdquo;

When asked what problems might arise from an institutional operationalization perspective in trying to incorporate these biosimilars into practice, Earl explained there are 3 major issues to be taken in to consideration.

&ldquo;I have all my protocols built with a reference product. How do we swap that out in the IT system?&rdquo; he said. &ldquo;I also foresee some questions for extrapolating to all indications. What will make a provider feel comfortable with a biosimilar if the institution has decided it will use biosimilars. And, I think the third interesting question is: What role does the patient play, and should we be giving them the choice?&hellip;You're not going to notice the difference, but it is a different product. Maybe it's administered differently.&rdquo;

In terms of financial assistance, Patel recognized the possibility of manufacturers&rsquo; unwillingness to participate in programs may become a barrier, as well as gaps in patient education and in getting staff on board.

&ldquo;As a practitioner&hellip;patients and insurance companies have trusted me (to act as a trustee) with part of their collective fund and I have to see if I can find ways that are less expensive without compromising the outcome.&rdquo;

Similarly, practitioners will have to address the overall pharmacoeconomic picture, too. Alkhatib, Pharmaceutical Economics, Health and Policy Outcome, Center for Health Outcomes and PharmacoEconomic Research (HOPE), College of Pharmacy, University of Arizona, explained that the way healthcare economists calculate value is based on four main considerations:

Alkhatib added that, while these factors are correct, the way they are calculated now is based on a single-payer system used in Europe. The United States uses a multi-payer system model, in which different payers have different budgets, there is a more diverse population, and there are individuals who pay out of pocket. Therefore, Alkhatib suggested for practitioners to customize pharmacoeconomic evaluations by payer for greater accuracy.&nbsp;

In addition, practitioners can incorporate the financial concerns of patients into the calculation economic utilitysomething the European model doesn't do. Alkhatib suggested practitioners measure the patient perspective on financial value, and in turn, patient satisfaction with cost savings will increase utility value, which includes quality of life factors.

"If we evaluate the cost utility to include the financial value of biosimilars, from the US perspective, we would have more real-world analysis and outcomes," Alkhatib summarized in a post-conference interview with

In closing, Alkhatib shared his hope that the introduction of biosimilars in the market will change the dynamic, in that big pharmaceutical companies will have no choice but to lower their prices to compete with biosimilars.

There are more than 70 biosimilars in development, Alkhatib said, and more biosimilars mean that patients will see the benefit of reduced prices. "I am so excited about the future," he said. &nbsp;

Biosimilar product information. US Food and Drug Administration website.

https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm580432.htm

. Updated July 20, 2018. Accessed October 18, 2018.

Articles

During a preconference presentation at the Association of Community Cancer Centers 35th National Oncology Conference in Phoenix, a panel of experts discussed the challenges they foresee with the wave of new biosimilar launches expected in 2019.

Expert Panel Discusses the Financial and Economic Impact of Biosimilars

As regulatory complexity continues to grow and medical developments require staff to constantly learn about new treatments and changes in protocols, the oncology field is as high-stress as ever. Moreover, healthcare teams often feel overwhelmed with limits on staffing and increased workloads, as well as the emotional toll of daily contact with patients coping with illness. In a presentation during the Association of Community Cancer Centers 35th National Oncology Conference (NOC),&nbsp;Vicki Hess, RN, MS, discussed how&nbsp;oncology teams become more resilient in the face of these challenges.

Hess's presentation focused on ACCC's key theme this year: creating a resilient, results-driven oncology team. The goal, Hess said, is to consider what brings one joy at work and then incorporate that into daily practice. Each individual should assess what makes them feel satisfied, energized, and productive at work. In that way, they can become "chief paradise officer" of their own jobs no matter what is happening around them, and in turn, they become more engaged.

The elements that make someone satisfied, energized, and productive differ from person to person. For an oncology nurse working in an infusion center, it could be the relationships they build with people over time. For a manager, it could be watching their staff grow and develop. For a nurse practitioner, it could be finding a treatment plan that makes a real difference in someone's quality of life.

In many organizations, the culture contains the belief that it is the leader of the organization's job to create optimal workplace culture. In Hess&rsquo; paradigm, it is a tripod: the organization, the leader, and the individual all need to take responsibility for employee engagement, effectiveness, and results.

According to Hess&rsquo; "professional paradise" paradigm, &ldquo;your beliefs drive your mindset, which drives your actions, and ultimately your outcomes,&rdquo; she said.

To change beliefs, employees must change the way they respond to stimuli, and internalize a process that increases joy. One cannot always control the stimuli, but they can train themselves to choose how to react to them, Hess explained.

A poll of the audience at the presentation revealed that difficult people at work were the leading stressor encountered by attendees. Though one cannot control others&rsquo; actions, one can use mindfulness practices to control their own reactions to them, Hess said, adding that when a person is better able to control their reactions, they feel more powerful and more empowered.

According to Hess, three ways to shrink the effect of negative external stimuli at work are to:

When someone has an attitude at work, it is because they want to be right, or they feel entitled. But if one can shake off negative responses, they free themselves from the feelings that cause a cloud of negativity that follows.

Often at work, employees rehash something that has happened in the past, and keep talking about it and complaining about it.

If one connects to what makes them feel satisfied, energized, and productive, they will feel empowered to effect change. These coping skills can enable them to take ownership of their problems and solve them.

&ldquo;It's not what happens to you, it's how you deal with what happens to you (that matters),&rdquo; Hess said in an interview with

. &ldquo;I might not be able to change whether the copier is broken, but I can change how I am responding.&rdquo;

In addition to controlling one&rsquo;s reactions, Hess added, one must actively pursue things that make them feel satisfied, energized, and productive. In other words, &ldquo;choose joy.&rdquo;

One way to pursue joy is by spreading appreciation. &ldquo;You feel good when you are the appreciator, and you feel good when you are the appreciate(d),&rdquo; she said.

Another way is to develop an attitude of gratitude, actively creating triggers in one&rsquo;s mind. Choose something that is that is already happening, that can trigger an emotion of gratitude. Hess&rsquo; triggers are food, and when she is washing her hair. At those times of the day, she takes a moment to be grateful in the moment.

&ldquo;It&rsquo;s simple things. Maybe when you&rsquo;re pulling into the parking lot at work,&rdquo; she said. &ldquo;Maybe it&rsquo;s when you get your team together in a huddle&hellip;Working in oncology, we know, there are a lot of things to be grateful for. You want to put it into the fabric of the day. You want to embody it so people can own their own gratitude.&rdquo;

&ldquo;There have been a tremendous amount of studies in the field of positive oncology that show that gratitude really does change the physiology of your body,&rdquo; she added. &ldquo;It definitely benefits you from a health perspective. It doesn&rsquo;t cost anything. Doesn&rsquo;t require advanced skills. It doesn&rsquo;t even require a lot of time. It just requires attention. What are the triggers?&rdquo;

A third strategy for increasing joy, Hess noted, is to &ldquo;keep discussing what matters most.&rdquo; Put things in perspective and consider what is really important.

Hess recommended a 5-step process to effecting these changesthe SHIFT&nbsp;process, an acronym for:

&ldquo;If you get really good at the first step, you might not even need the other four,&rdquo; she said.

In a presentation during the Association of Community Cancer Centers 35th National Oncology Conference (NOC) in Phoenix, Arizona, featured speaker Vicki Hess, RN, MS, discussed how oncology teams can become more resilient in the face of challenges.

The Key to Becoming a More Resilient Member of the Oncology Team

Groundbreaking developments in cancer therapies can change lives, extending survival and sending patients who previously thought their chances were slim into remission. But these therapies come at a cost, and many patients reel at the prospect of heavy financial burdens. To help patients and programs meet the challenges of affording cancer treatments, community cancer centers are expanding the role of financial advocates in their organizations.

According to the Association of Community Cancer Centers (ACCC), financial advocates may be financial counselors, navigators, and advocates; social workers; nurses; patient advocates and navigators; pharmacy technicians; practice managers; billers and coders; patient benefit representatives; and others.

What they all share is the goal of minimizing the economic impact of cancer therapy on patients and the institutions that treat them.

During a preconference presentation at the Association of Community Cancer Centers 35th National Oncology Conference in Phoenix, Arizona, 2 experts shared how the role of the financial advocate is evolving within a value-based system where patient access and patient-centered care are key. Nikki L. Barkett, RN, BSN, OCN, Oral Antineoplastics Nurse Navigator, University of Arizona Cancer Center, and Eric Dallara, RPh, Head Pharmacist, New England Cancer Specialists offered insights from the clinician and oncology pharmacy perspectives.

Barkett and Dallara presented a case study in which a 53-year-old woman with rectal cancer who was prescribed adjuvant capecitabine (Xeloda). They described how a pharmacy patient advocate and oral antineoplastics nurse navigator (AONN) worked together to manage the patient&rsquo;s care, ensuring that they kept a close eye on adverse events.

The pharmacy patient advocate obtained insurance authorization and managed drug dispensing. The OANN met with the patient to assess existing barriers of care and provide drug-specific education. Because the AONN called the patient weekly to assess adherence and adverse events (AEs), dose reduction and eventually discontinuation of capecitabine resulted.

&ldquo;The patient might tell us [advocates] things they might not tell a doctor,&rdquo; Dallara said.

The patient was a violinist and she couldn&rsquo;t feel her fingers when taking the medication, said Barkett. Treatment was delayed and ultimately stopped based on AEs. An oral antineoplastics pharmacist reviewed test results and worked with the provider team for any required dose adjustments. Close communication between the multidisciplinary team provided patient-centered care, considering the effect that treatment would have on the patient&rsquo;s livelihood and adjusting the medication appropriately.

To provide the best care, clinicians need to ensure that patients are complying with doctors&rsquo; orders, and taking their medication as directed. When patients try to cut costs by cutting their dosages, it has a negative effect on their treatment. Compliance issues with expensive oral oncolytics are common. In a value-based care model, oral compliance is required for QOPI certification and a part of the Oncology Care Model. Dallara and Barkett recommend:

integrating compliance measures into the electronic medical record system

requiring staff to conduct &ldquo;compliance calls&rdquo; and

using smartphone apps that integrate with EMR and pharmacy software

Making process improvements in nurse workflow can also improve compliance. The University of Arizona Cancer Center implemented an oral antineoplastics program to improve patient outcomes and comply with the Oncology Care Model. The system incorporates documentation of all calls by the AONN in their systems, with a rigorous algorithm supporting follow-up calls at intervals depending on compliance and AEs.

Financial advocates can take part in improving the current system by noticing issues as they advocate for their patients, telling their stories, and contributing to the conversation around reducing financial burdens on a larger scale. Two examples where financial advocates have noticed opportunities for improvement are in the areas of compassionate care and drug waste.

Dallara shared a story about a 69-year-old retired schoolteacher with multiple myeloma on her husband&rsquo;s Medicare companion plan who had had 7 prior therapies and who was denied a new oral oncolytic that is currently in phase 3 clinical trials with good outcomes and slated to be approved in 2019. The woman&rsquo;s financial advocate appealed to the drug company for free drugs, but her retirement income was deemed too high.

&ldquo;There should be the same accessibility to compassionate care for oral medications [as with their IV counterparts], especially if there are data supporting this regardless of the patient&rsquo;s income,&rdquo; Dallara said.

Though 43 states have enacted &ldquo;Oral Anti-Cancer Therapy Access&rdquo; laws, according to Dallara, the states differ and the laws apply only to commercial insurance. The challenge is to apply it to Medicare as well.

Barkett described frequent situations in which there is an appalling waste of expensive oral oncolytic medications.

&ldquo;When a patient qualifies for a free drug, the drug companies sometimes send them up to a year&rsquo;s supply at a time,&rdquo; said Barkett. &ldquo;If they have to stop taking after 3 months, what happens to the rest of the drugs?&rdquo;

Dallara tells of an 83-year-old snowbird who was placed on cabozantinib (Cabometyx). His dose was held due to toxicities, but the drug company kept sending him the medication so that he would have a supply when the treatment started up again. When he came to Dallara&rsquo;s office in the summer to continue his treatment and was changed to immune-oncology therapy, the patient brought in a bag with $175,000 of unopened cabozantinib. &ldquo;He had no idea how expensive it was,&rdquo; Dallara said.

Finding a way to reduce drug waste and reuse unopened medication should be a priority among healthcare professionals. Dallara and Barkett acknowledged that verifying the quality of returned medications is a barrier to reusing them. As one member of the audience at the presentation pointed out: &ldquo;What if a person left the drug in their car for 3 days in 130&deg; heat?&rdquo;

Dallara and Barkett recommend not sending refills on prescriptions of oral oncolytics to mail order pharmacies. They emphasize that there is not a more efficient way to get a patient their oral oncolytic medications than at the point of care, and they recommend advocating for oncology practices to dispense medications to patients.

The ACCC offersa training program to help healthcare professionals hone skills needed to advocate for patients. For more information, visit

Financial Advocacy Network. ACCC website.

www.accc-cancer.org/home/learn/financial-advocacy

Barkett NL, Dallara E. Financial advocacy in a value-based world. Presented at:&nbsp;Association of Community Cancer Center 35th National Oncology Conference; October 17-19; Phoenix, AZ.&nbsp;

files.eventsential.org/bc5400c1-3613-4d6d-8f86-1c1e8cefd794/event-12103/182728878-OPEN_Financial-Advocacy-Value-Based-World-Barkett_Dallara.pdf

Mindy Waizer | Authors

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Expert Panel Discusses the Financial and Economic Impact of Biosimilars

The Key to Becoming a More Resilient Member of the Oncology Team

Financial Advocacy Grows Under the Value-Based System