Efforts to improve oral chemotherapy adherence target multilevel barriers
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Development and use of oral chemotherapy medications has increased substantially over the past decade, offering many patients with cancer a more convenient and less stressful treatment option.
However, barriers to adherence have hindered optimization of the drugs among these patients, who frequently face comorbidities, polypharmacy and financial struggles.
Source: Fox Chase Cancer Center
“Adherence to oral medications is challenging in oncology,” R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, FASCO, professor of hematology/medical oncology and pharmacology/chemical biology at Emory University School of Medicine, told Healio | HemOnc Today. “It affects the most vulnerable patients in lots of ways — these are often older individuals with multiple conditions and medications. As we continue to work toward turning cancer into a chronic disease, we’re going to be facing as many, if not more, adherence challenges in the future.”
Healio | HemOnc Today spoke with experts about challenges to oral chemotherapy adherence, efforts underway to improve tracking and monitoring of these drugs, and actions clinicians can take to address the problem.
‘A very big issue’
Oral chemotherapy nonadherence has been difficult to gauge, with some studies estimating adherence rates as low as 50%.
“It can be a very big issue,” Hanna K. Sanoff, MD, MPH, professor of medicine, division of oncology at UNC Lineberger Cancer Center, told Healio | HemOnc Today. “Anecdotally, I take care of people who run the gamut from taking their oral anticancer drugs on time every day to people who miss more than half of their doses.”
Although there are ways to track prescription and receipt of medications, it is more difficult to know whether patients are actually taking these medications, Harvey said.
“We certainly have refill rates, but refill rates and the frequency with which patients pick these medications up doesn’t give us information about the actual ingestion of the medication,” he said. “It means the patient has gotten the medication, but it doesn’t mean they are taking it. So, our ability to measure true adherence is not good.”
Evaluating barriers
Barriers to adherence are manifold and exist at the patient, provider, pharmacy and insurer levels, according to experts with whom Healio | HemOnc Today spoke.
Issues around insurance copays are a particularly common and troublesome issue, Sanoff said.
“Multiple studies have shown that people with high copays for their medicine are at higher risk for nonadherence,” Sanoff said. “This means that because of the cost of their medicines, they are not able to get cancer treatment. Patients can also be reluctant to discuss this with their cancer team.”
A 2018 study published in Journal of Clinical Oncology showed an association of higher out-of-pocket costs with increased rates of treatment initiation delays and abandonment of insurer-approved prescriptions for oral anticancer drugs. About one in eight patients in the study sample incurred out-of-pocket costs exceeding $2,000 for their first prescription, and nearly half abandoned these prescriptions at the pharmacy.
Efforts have been made to address this barrier at the state legislative level. According to the Leukemia and Lymphoma Society, 43 states and the District of Columbia have adopted oral anticancer therapy parity laws to ensure equal coverage and cost-sharing between oral and IV anticancer medications. However, the requirements of these laws vary between states, and studies indicate that they have not led to improved adherence to oral chemotherapy drugs.
In addition to the financial challenges associated with oral chemotherapy regimens, patients from underserved populations may encounter socioeconomic and sociocultural barriers, according to Jamie M. Jacobs, PhD, a clinical psychologist and program director of Center for Psychiatric Oncology and Behavioral Sciences, director of Caregiving Research, Cancer Outcomes Research Program and assistant professor at Harvard Medical School.
“Patients from historically underserved and underrepresented backgrounds face additional systemwide factors that prevent them from having certain conversations with their providers or interacting the same way with the institution or the care team,” Jacobs said. “They also face barriers such as medication cost, being underinsured and discrimination, which place them at additional risk for nonadherence.”
Psychosocial factors are another major barrier to oral chemotherapy adherence, according to Jacobs.
“It is well established that depression is a major risk factor for nonadherence,” she said. “Early assessment and treatment of mood symptoms, such as depression, anxiety and demoralization, can lead to better adherence and improved patient emotional and physical health outcomes.”
She cited ASCO guidelines published in April that recommend cognitive behavioral therapy as first line treatment for depression and anxiety in patients with cancer. These guidelines reflect the known impacts of these mental health disorders on adherence to treatment, Jacobs said.
Complicated or inconsistent treatment regimens are another major barrier to oral chemotherapy adherence, according to experts. Harvey noted that oral chemotherapy regimens often involve potentially confusing schedules compared with other, more regular medications.
“We ask patients to take drugs for 2 weeks, and then take a third week off, or we ask them to take drugs on a weekly basis for 3 weeks and then take a week off,” he said. “These are not like other medications that patients take every day consistently. We ask them to do even more.”
Some of the additional medications prescribed to patients with cancer are aimed at managing chemotherapy adverse effects, which frequently present barriers to adherence.
“Sometimes, a patient will experience a lot of side effects because of the medication,” Allison Ward, MSN, OCN, CCRN, RN-BC, an oncology nurse at Fox Chase Cancer Center and creator of an oral chemotherapy tracker, told HemOnc Today | Healio. “Then, instead of contacting us, they opt to stop taking it on their own.”
This unilateral decision-making is one of the potential downsides of patients receiving treatment in the comfort of their homes, according to Jacobs.
“They’re at home taking their medications and they’re not getting that routine check-in, so they are more likely to make decisions on their own without consulting their team,” she said. “So, they might skip doses because they’re having symptoms and side effects. People who are coming in for their treatments are getting that face-to-face touchpoint — that immediate responsiveness.”
The value of communication
Although in-person appointments can facilitate patient-clinician communication around oral chemotherapy adherence, research has identified ways these discussions can be improved.
Sanoff and colleagues conducted one such study, which evaluated transcripts of 24 patient-oncologist office visits acquired from a national database. The adult patients all had been prescribed capecitabine for colorectal cancer.
The researchers assessed the oncologists’ delivery of medication information, discussion of adherence to medication, and offering of self-management support for adverse events.
Results showed that although the oncologists provided extensive medication information to patients who had not yet initiated treatment, those actively undergoing treatment received less information. Clinicians discussed ongoing use or discontinuation of medication with all 18 patients who initiated therapy. However, discussion of how the patients took these medications occurred less frequently. Clinicians commonly offered self-management strategies but generally only in response to a specific symptom.
“The oncologists performed well when it came to reviewing the symptoms patients experienced from their chemotherapy and how to manage them,” Sanoff said. “However, there was definitely room for improvement when it came to asking how patients are taking their medications and if they have any problems with accessing their medicines. This is particularly important given the published data on how the cost of drugs leaves many patients facing the difficult decision about skipping treatments because of the out-of-pocket expense.”
Although oncologists can and should play a role in ensuring patient adherence to oral chemotherapy, this responsibility should not rest entirely on clinicians, Sanoff said.
“I do not think it should be only the oncologist’s job. Helping patients address financial toxicity through financial navigation is a key piece of this,” she said. “I also feel that the expertise of clinical pharmacists to help monitor adherence, tolerance and safety of oral anticancer therapy is absolutely crucial.”
Oral chemotherapy tracker
To improve oral chemotherapy adherence at Fox Chase Cancer Center, Ward and her colleague Maria Market, BSN, PCCN, developed an oral chemotherapy tracker.
The idea came when, as part of the 2020 Quality Oncology Practice Initiative (QOPI) certification program, Fox Chase discovered that only about one-third of its patients on oral chemotherapy had a known oral chemotherapy plan, only 7% had been evaluated for adherence and none had documentation of efforts to address nonadherence.
The tool Ward and Market designed, and Fox Chase’s Epic computer software team created, is a standard form within the patient’s electronic medical record. The “smart form” accompanies the patient from chart to chart, and allows providers to document treatment plans, education and monitoring of oral chemotherapy regimens. The tool has been incorporated into nurse, physician and pharmacist workflows.
“Our Fox Chase retail pharmacy also acts as a specialty pharmacy,” Ward said. “So, if a patient comes in, meets with the doctor and decides they are going to start on a new oral chemotherapy drug, the physician prescribes it and they send it automatically to the Fox Chase pharmacy.”
The pharmacy team verifies insurance for the patient and determines whether or not the pharmacy is authorized to fill the prescription based on insurance restrictions. If the drug can be dispensed and is in stock, the pharmacy contacts the patient and arranges for delivery. They then contact the patient after 7 days, and then every 30 days for refills.
In cases where the pharmacy is not able to fill the prescription, the team notifies Ward or another designated nurse that an oral medication needs to be filled by an external pharmacy.
“They get the physician to forward the prescription to that specialty pharmacy, and we send reminders to the primary nurse for that physician,” Ward said. “We remind them that they need to contact the patient in 7 to 14 days to make sure they have started the medication, and that they need to repeat this process every 6 to 8 weeks.”
About a year ago, Ward and Market, who has since left the department, initiated an 8-week pilot study of the smart form to see if it would improve monitoring of and adherence to oral chemotherapy drugs.
During the study period, 223 patients receiving oral chemotherapy visited with clinicians in the clinic. Afterward, 45% had completed the smart form and 41% had documentation of an oral chemotherapy plan. Moreover, 87% had a medication administration schedule vs. 81% before implementing the form.
In terms of monitoring, the proportion of patients contacted after the start of oral chemotherapy increased from 4% to 35%, and discussions pertaining to adherence went from zero to 78%.
Implementation of the new tool has been going well, according to Ward, but it has involved a bit of a learning curve for some of the providers. Another issue in collaborating with specialty pharmacies is that the monitoring process may be duplicative, Ward said.
“Based on the feedback I’ve been getting from my own patients, it seems the outside specialty pharmacies are also calling them and going through some of these same questions about dosing schedule, missed doses and side effects,” she said. “However, because we are not in the same system, we still have to do something on our end to confirm compliance.”
Ward added that she and her team have been able to improve the process through communication and education. Ward regularly checks in with patients to ensure they are receiving their medications in a timely manner.
“I had one patient for whom the medication was on backorder at her [specialty] pharmacy, and she had about 10 days’ worth remaining,” Ward said. “That gave me time to contact our pharmacy. We had it in stock and found out this could be overridden with insurance if needed. We had a backup plan so that she wouldn’t be out of the medication.”
A call to action
Failure to adhere to an oral chemotherapy regimen can have significant consequences for patients, especially when they do not communicate with their providers about nonadherence.
“If a patient is nonadherent to an agent, they don’t have side effects or adverse events, and the cancer progresses,” Harvey said. “If we don’t know that our patient is having trouble getting or taking their medication, we just chalk it up to disease biology and we go on to the next line of therapy without addressing the potential real issue, which is adherence to therapy.”
Clinicians can help improve adherence by considering the individual patient and their possible challenges, according to Harvey.
“The first thing is making sure you’ve checked the boxes of all possible barriers to adherence in a given patient,” he said. “You want to ask about their insurance, whether they can get the drug easily, and whether they have someone to contact with questions or concerns with the drug once they receive it.”
Providing patient education and psychosocial support is another essential component of improving adherence to oral chemotherapy, Jacobs said. As a psychiatrist, she works with patients to manage the psychosocial factors that may interfere with adherence while providing support for family members and caregivers.
“Caregivers play such a pivotal role in this, but they don’t get the same type of education, preparation and support,” she said. “I think providing better support for caregivers can directly impact patient outcome. They play an instrumental role in how the patient adheres to their treatment and we need to support them. In many ways, they are the invisible patient in the room.”
Asking open-ended questions and using nonjudgmental language is another way to facilitate clear, honest communication around medication adherence, Harvey said.
“I avoid using the word ‘compliance,’ for example, because that tends to place the blame on the patient when it might be out of the patient’s control,” he said. “I also ask them questions such as, ‘What problems are you having with obtaining or taking your medications?’ This is all about providing a space where the patient is comfortable allowing communication to occur.”
Efforts to improve adherence to oral chemotherapy should ideally begin before a drug even reaches the market, Harvey said.
“I believe a lot of adherence starts during the drug development process,” he said. “We need better formulations of oral anticancer drugs that are more targeted.”
Harvey said the FDA and pharmaceutical industry have begun to address the need to optimize doses of oral chemotherapy drugs to ensure better compliance.
“Often, we have drugs approved where the dose is just too high, and you don’t get any more anticancer benefit, but you do get more side effects,” he said. “So, I think it is the responsibility of people like me and of the pharmaceutical industry to make sure we’re getting the dose right as soon as possible for these patients.”
References:
- ASCO updates guideline for management of depression and anxiety in adult cancer survivors. Available at: dailynews.ascopubs.org/do/asco-updates-guideline-management-anxiety-and-depression-adult-cancer-survivors. Published April 20, 2023, Accessed May 5, 2023.
- Doshi JA, et al. J Clin Oncol. 2018;doi:10.1200/JCO.2017.74.5091.
- Fox Chase Cancer Center nurses harness electronic medical record tool to better monitor oral chemotherapy use (press release). Available at: https://www.foxchase.org/news/2022-04-18-fox-chase-cancer-center-nurses-harness-electronic-medical-record-tool-to-better-monitor-oral-chemotherapy-use. Published April 18, 2022. Accessed April 27, 2023.
- Jacobs JM, et al. J Natl Cancer Inst. 2019;doi:10.6004/jnccn.2018.7098.
- Leukemia and Lymphoma Society. Advancing oral parity because the way we treat cancer has changed. Available at: http://www.lls.org/advocate/advancing-oral-parity-because-way-we-treat-cancer-has-changed. Accessed March 23, 2023.
- Levit LA, et al. J Clin Oncol. 2022;doi:10.1200/JCO.21.02529.
- Nguyen BKH, et al. JCO Oncol Pract. 2020;doi:10.1200/JOP.19.00550.
- Whooley PD, et al. J Clin Oncol. 2021;doi:10.1200/JCO.2020.39.28_suppl.265.
For more information:
R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, can be reached at Winship Cancer Institute of Emory University, 1365-C Clifton Road NE, Atlanta, GA 30322; email: rdharve@emory.edu.
Jamie M. Jacobs, PhD, can be reached at Mass General Cancer Center: Psychiatric Oncology and Behavioral Sciences, 55 Fruit St., Boston, MA 02114; email: jjacobs@mgh.harvard.edu.
Hanna K. Sanoff, MD, MPH, can be reached at UNC Lineberger Cancer Center, 170 Manning Drive, CB #7305, Chapel Hill, NC 27599; email: hanna.sanoff@med.unc.edu.
Allison Ward, MSN, OCN, CCRN, RN-BC, can be reached at Fox Chase Cancer Center, 333 Cottman Ave., Philadelphia, PA 19111; email: allison.ward@fccc.edu.
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