Routine screening is an important tool for the prevention and early detection of breast and cervical cancer among women. Breast cancer screening guidelines using mammography vary among guiding bodies, including the American Cancer Society and the American Academy of Family Physicians. For women of age 50 to 74 years with average risk factors, the most liberal guidelines recommend biannual mammography.

 Through cervical cancer screening, abnormal cells in the cervix may be identified and treated before they progress to cancer.

The US Preventive Services Task Force recommends women at average risk who are between the ages of 21 to 29 receive cervical cytology alone every 3 years and that women of age 30 to 65 years receive primary high-risk human papillomavirus (hrHPV) testing every 5 years, both cervical cytology and hrHPV testing every 5 years, or cervical cytology alone every 3 years.

 Routine screening for cervical cancer and its precursors has been proven to improve overall cervical cancer outcomes.

Many factors influence adherence with routine cancer screening. Socioeconomic status, access to care, lack of transportation, and lack of insurance are commonly noted barriers. Perceived barriers to mammography were studied between 2006 and 2011 at the Alvin J. Siteman Cancer Center, a National Cancer Institute (NCI)–designated Comprehensive Cancer Center in Missouri.

 The study was conducted to investigate why women did not get mammograms.

In the study, responses from registrants included fear of cost, mammogram- related pain, and fear of bad news.

 Compounding these barriers, the COVID-19 pandemic in early 2020 resulted in a sharp reduction in cancer screenings across the United States.

During the first months of the pandemic, specifically during the stay-at-home order, several large studies measured a substantial reduction in cervical and breast cancer screenings.

 The decline in cervical cancer screening was one of the most significant declines in preventive screening rates in the United States.

 In the years just prior to 2020, there was a slight uptrend in the rates of cervical and breast cancer screenings; however, both declined substantially by spring 2020.

In both breast and cervical cancer screenings, Epic Health Research Network identified a 94% decline compared with averages before the COVID-19 pandemic, as demonstrated in 2.7 million patient records from 39 organizations spanning 23 states. Additionally, another study identified a 68.2% decline in cervical cancer screenings.

 Furthermore, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) observed an 87% and 84% decline in NBCCEDP-funded breast and cervical screenings, respectively, during April 2020 compared with the previous 5-year averages for April.

However, multiple studies demonstrated some improvement in breast and cervical cancer screening rates by June 2020. Epic Health Research Network data showed that weekly volumes in June remained 29% and 35% lower than pre–COVID-19 levels for breast and cervical cancer screenings, respectively.

 The NBCCEDP research showed that in June 2020, screening rates were 39% and 40% below the 5-year average for that month for breast and cervical cancer screenings, respectively.

The impact of this decrease in cervical cancer screenings during the beginning of the pandemic remains unknown. From March to June 2020, Epic Health Research Network estimated that 285,000 breast and 40,000 cervical exams were missed or delayed. Additionally, one modeling study using a 70% decline in cervical and breast cancer screening over a 3-month period projected 38,500 women with a delayed cancer diagnosis.

Although some variation in the United States would be expected, some insight can be gained from a European modeling study that evaluated the impact of 6-month screening delays.

 This model demonstrated that a 6-month screening delay across the population would result in approximately 4 additional cases of cervical cancer per 100,000 women. On the other hand, women who miss an entire 3- to 5-year screening cycle have a 7-fold higher rate of cervical cancer vs those with a 6-month delay. The impact of screening delays for cervical cancer is expected to be greatest among women of age 40 to 49 years, with vaccination against HPV mitigating the effect of the delay in younger women.

Some reports suggest that screening rates for breast and cervical cancer began to exceed pre-pandemic numbers in late 2020. In one study evaluating
patients in the Massachusetts General Brigham system, screening for breast and cervical cancer from September to December 2020 exceeded pre–COVID-19 levels by 14% and 2%, respectively.

 There was also an increase in positive diagnoses for both breast and cervical cancers during this time.

Despite these improvements in screening rates post pandemic, providers have expressed concerns that we will continue to see an increase in cancers diagnosed at later, less-treatable stages.

 Additionally, recent research has demonstrated that socioeconomic and racial disparities in screening persist.

Members of the Community Oncology Alliance and Avalere Health looked at the impact of the COVID-19 pandemic on cancer screening rates using a multipayer database that included Medicare, Medicaid, and commercial insurance.

 Although there was an increase in breast cancer screenings in the months following the stay-at-home order among all groups, the rate of increase was slower for those with a reduced income level and in certain racial and ethnic minority groups.

 The COVID-19 pandemic highlighted these disparities, giving cancer clinicians a push to focus on improved education and access to care for these groups.

Moving forward, screenings for patients who are overdue must be prioritized.

 Survey research to determine why patients are hesitant to pursue timely screening is ongoing.

 Not only are some patients anxious to go to a health care facility because of the risk of acquiring COVID-19, but others may have lost employment or child care, making it difficult for them to make time for physician appointments and/or pay for health care. Understanding these barriers will help us improve screening rates and potentially mitigate screening declines in the event of a future pandemic.

Improved access to care and increased patient education require coordinated efforts among providers. For a variety of reasons, many patients do not use primary care providers as their first access point to health care.

 Other health care professionals in the community, such as local pharmacists and public health departments, can reinforce the importance of screenings and educate patients.

Furthermore, to reduce issues relating to transportation burdens, coordinating mobile mammography and community outreach projects in underserved areas can bring screenings closer to home. Additionally, grants that provide low-cost or free transportation could also help to remove transportation barriers for patients. Advances in user-friendly, at-home screening tests may also improve cancer screening rates.

Multiple studies have also evaluated the potential impact of at-home HPV tests.

 Although these at-home tests appear to be accurate and effective, a statistical difference in the detection of precancer lesions has not been demonstrated.

The COVID-19 pandemic impacted cancer care and cancer screenings more than any event in recent history. Although studies show there is movement toward pre-pandemic cervical and breast cancer screening rates, the disparity among patients of different socioeconomic, racial, and ethnic communities continues. To reduce barriers, health care providers must be innovative and work together to serve these patients.

, regional clinical pharmacist at
the American Oncology Network, LLC.

, regional director of operations at the American Oncology Network, LLC.

1. Breast cancer screening guidelines for women. Centers for Disease Control and Prevention. Reviewed September 22, 2020. Accessed May 18, 2022. https://www.cdc. gov/cancer/breast/pdf/breast-cancer-screening-guidelines-508.pdf

2. Cervical cancer: screening. US Preventive Services Task Force. August 18, 2018. Accessed May 18, 2022. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening

3. Fayanju OM, Kraenzle S, Drake BF, Oka M, Goodman MS. Perceived barriers to mammography among underserved women in a breast health center outreach program.

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4. Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of cancer screening deficit in the United States with the COVID-19 pandemic. 

. 2021;7(6):878-884. doi:10.1001/jamaoncol.2021.0884

5. Velazquez AI, Hayward JH, Gregory B, Dixit N. Trends in breast cancer screening in a safety-net hospital during the COVID-19 pandemic. 

. 2021;4(8):e2119929. doi:10.1001/jamanetworkopen.2021.19929

6. Bakouny Z, Paciotti M, Schmidt AL, Lipsitz SR, Choueiri TK, Trinh QD.
Cancer screening tests and cancer diagnoses during the COVID-19 pandemic.


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7. Nathoo A, Weng I, Kim J, Ortuno A. Routine chronic disease screenings and oncology biomarker tests plummet during COVID-19. Komodo Health. April 28, 2020. Accessed May 18, 2022. https://knowledge.komodohealth.com/hubfs/white-papers/research-briefs/ Komodohealth-covid19-2020-04-28.pdf

8. Mast C, Munoz del Rio A. Delayed cancer screenings—a second look. Epic Research. July 17, 2020. Accessed May 18, 2022. https://ehrn.org/articles/ delayed-cancer-screenings-a-second-look

9. DeGroff A, Miller J, Sharma K, et al. COVID-19 impact on screening test volume through the National Breast and Cervical Cancer Early Detection
Program, January-June 2020, in the United States. 

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10.Murray, A, Kleinrock, M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 29, 2020. Accessed December 20, 2020. https://www.iqvia.com/insights/the-iqvia-institute/covid-19/ shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era

11.Castanon A, Rebolj M, Pesola F, Sasieni P. Recovery strategies following COVID-19 disruption to cervical cancer screening and their impact on excess diagnoses.

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12.Labaki C, Bakouny Z, Schmidt A, et al. Recovery of cancer screening tests and possible associated disparities after the first peak of the COVID-19 pandemic. 

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13. Printz C. Cancer screenings decline significantly during pandemic. 

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14.Arbyn M, Smith SB, Temin S, Sultana F, Castle P; Collaboration on Self-Sampling and HPV Testing. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. 

15. Winer RL, Lin J, Tiro JA, et al. Effect of mailed human papillomavirus test kits vs usual care reminders on cervical cancer screening uptake, precancer detection, and treatment: a randomized clinical trial. 

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Articles

Breast cancer screening guidelines using mammography vary among guiding bodies, including the American Cancer Society and the American Academy of Family Physicians.

The Impact of COVID-19 on Cervical, Breast Cancer Screenings

Past initiatives in standardizing concentrations of intravenous (IV) or liquid oral medications have focused mostly on gaining efficiency in the drug supply chain, improving distribution, and generating cost savings. Improvements in medication safety with standardized concentrations were often a secondary goal of the initiatives and did not address patients moving across different care settings. Even with some standardization, many health systems still have multiple concentrations of the same drug across their own systems.

Recent data and their promotion by the American Society of Health-System Pharmacists (ASHP), FDA, Institute for Safe Medication Practices (ISMP), and other groups show that IV admixture standardization programs can aid in reducing errors and improving transitions of care.

 Using concentrations that vary by location within a health system puts patients at risk of medication errors and is a concern that should be formally addressed by a national standard. Health systems must minimize the number of concentrations they keep to a maximum of 1 to 3 when possible.

Using commercially available products is a great starting point but does not address all products. Simplifying processes can reduce medication errors in compounding, IV pump programming, and physician order entry.

The ASHP, ISMP, Pediatric Pharmacy Association, and other stakeholders have long argued for a national practice standard for standardized concentrations of IV medications and oral liquid medications. The major driving factor behind these efforts is the prevention of medication errors. Errors occur with these products as patients navigate the health care system through various settings. In addition to improving patient safety, standardizing IV medication concentrations can benefit the drug supply chain with the use of premixed products, improve patient outcomes, reduce overall health care costs, and simplify ordering with fewer choices for prescribers.

Previous attempts to standardize IV concentrations have mostly been health system or product-specific efforts. Any standardization program initiative should aim to address key areas in the compounding, dispensing, and administration processes. These include concentrations and dosing units for continuous pediatric medications and IV continuous medications, concentrations for compounded oral liquid medications, concentrations of epidural and patient-controlled analgesia medications, IV intermittent medications, and doses for oral liquid medications. Sites should evaluate what is commercially available, adopt these products when possible, and use commercially available products as a standard across the system when feasible. Standardizing liquid doses is also key (eg, 250.0 mg vs 225.6 mg). Common drugs that are standardized in concentration include amiodarone, diltiazem, dobutamine, and dopamine.

The ASHP recently received federal funding from the FDA’s Safe Use Initiative to develop and promote a national standardized concentration initiative for IV
and oral liquid medications. The Standardize 4 Safety program is a collaboration among nurses, pharmacists, physicians, and other stakeholders. Although previous efforts undertook similar initiatives at the local and state levels, this is the first funded national interdisciplinary effort to promote and standardize medication concentrations. So far, results include the development of standardized concentration lists, with additional lists expected as the program progresses.

 This program began looking at evidence-based standardized concentrations for 32 IV medications. The first efforts examined patients with an elevated risk of harm because of dosage errors. The goal is to reduce medication errors that occur during transitions of care.

It is long past time for the pharmacy profession to take the lead in establishing a national standard in IV and oral liquid medication concentrations with a patient safety focus. All pharmacists have a role in promoting such efforts by participating, providing feedback,
and educating others. Engaging stakeholders in their organizations with data from the ASHP Standardize 4 Safety initiative will help educate them and remove barriers. Having a national standard helps pharmacies better communicate and coordinate across health care settings to ensure consistency and patient understanding. Interdisciplinary teamwork is essential in this process, and there must be a national effort for adoption to overcome obstacles until the Standardize 4 Safety initiative is complete. To learn more about the effort or to participate, sign up for updates and resources online at https://www.ashp.org/pharmacy-practice/standardize -4-safety-initiative#s4sresources.

 is an associate professor of pharmacy practice, administration, and research, director of experiential learning, and manager of clinical support services at Marshall University School of Pharmacy in Huntington, West Virginia.

1. Traynor K. Medication standardization effort aims to improve patient safety. American Society of Health-System Pharmacists. July 13, 2016. Accessed April 6, 2022. https://www.ashp.org/news/2016/07/13/medication_standardization_effort_aims_to_ improve_patient_safety

2. Standardize 4 Safety. American Society of Health-System Pharmacists.
October 19, 2016. Accessed March 15, 2022. https://www.ashp.org/-/media/assets/ pharmacy-practice/s4s/docs/s4s-iv-adult-continuous-infusion-guiding-principles.ashx

3. Larsen GY, Parker HB, Cash J, O’Connell M, Grant MC. Standard drug concentrations and smart-pump technology reduce continuous-medication-infusion errors in pediatric patients. 

. 2005;116(1):e21-e25. doi:10.1542/peds.2004-2452

4. ISMP achievements. Institute for Safe Medication Practices. Accessed
March 16, 2022. https://www.ismp.org/about/accomplishments

Simplifying processes reduces errors in compounding, IV pump programming, and physician order entry.

Developing Standardized Concentrations, Overcoming Barriers

Specialty pharmacy medications now represent over 50% of pharmacy spending in the United States, with oncology medications accounting for 18.3% of the total expenditure.

 Oral oncology medications are often associated with high out-of- pocket (OOP) costs, and as novel oral anticancer agents are increasingly utilized for treatment, this can lead to financial stress and have a negative impact on the well-being of patients and caregivers.

Financial toxicity is a relatively new concept that considers the potential health outcomes and other consequences of financial hardship attributed to prescription regimens, such as the impact of skipping doses of medication to delay OOP costs. According to the National Cancer Institute, patients with a cancer diagnosis are more likely than those without cancer to experience financial toxicity, given the combination of OOP drug costs, other medical expenses, and lost work productivity. Even when measures have been taken
to address prescription costs, such as the narrowing of the Medicare Part D coverage gap phase, or “donut hole,” the OOP costs of most orally administered anticancer drugs continue to increase at a rate greater than the rate of inflation.

Patient assistance programs (PAPs) can significantly reduce patient OOP costs for oral oncology therapies. Support through PAPs can be generous, potentially covering the entirety of coinsurance for patients receiving high-cost cancer therapies.

 However, PAPs, which are most often funded by external grants, foundations, and sometimes drug companies, can be confusing and difficult to access.

In June, Shields Health Solutions and Aptitude Health will copresent a program on financial toxicity, specifically in the context of oral oncolytics and how PAPs coordinated by health system specialty pharmacies (HSSPs) can mitigate this type of toxicity. The panelists and participants in this discussion
will include pharmacists, nurses, advanced practice professionals, and financial coordinators who manage oncology patients through integrated HSSPs.

The discussion will explore a variety of questions related to the impact of the cost of oral oncology medications on clinical and economic outcomes
in patients with cancer managed by HSSP clinical programs, including the following:

What aspects of the integrated HSSP care model allow for optimal use and coordination of financial assistance programs for oral oncology patients?

What is the patient journey with respect to a PAP at an integrated HSSP?

How are patients on oral oncolytics identified as candidates for PAPs?

What HSSP staff members are responsible for management of PAPs, and what are their roles and responsibilities?

What categories of drugs and what types of cancers most frequently receive PAP funding?

What manufacturer PAPs are considered most effective in improving health outcomes for oral oncology patients?

What role do charitable foundation programs play in improving health outcomes for patients with cancer?

What are the observed impacts of PAPs on clinical outcomes in oral chemotherapy patients (eg, time to therapy initiation, emergency department/ hospitalization rate related to cancer diagnosis, quality of life)?

Financial toxicity is a stark reminder of disparities in health equity, and there is a great deal to be learned about how best to address the financial challenges of cancer treatment. The results from several studies on the impact of financial assistance programs have been reported in the literature, but these reports tend to be observational, without a full assessment of the impact of the programs on clinical outcomes in this population. For example, a retrospective study of prescription anticancer medication costs and PAP coverage from one academic cancer center’s specialty pharmacy demonstrated that a minority of prescriptions received financial assistance from PAPs, and the proportion of financial assistance was small relative to the price billed to insurance.

A retrospective, cross-sectional analysis of outpatient pharmacy, medical, and cancer registry records at The University of Texas MD Anderson Cancer Center in Houston, the largest tertiary cancer center in the United States, demonstrated that fewer than 5% of the patients with cancer who received prescription medications from the outpatient pharmacy were enrolled in a PAP, and the program provided financial support primarily for supportive care medications.

Elsewhere, in a pilot feasibility study, 34 patients with cancer with nonmetastatic solid tumors received a financial education course followed by monthly contact with a financial counselor and case manager for 6 months. Although self-reported financial burden did not change over time, anxiety about treatment costs decreased in 33% of patients enrolled in the financial education program.

In an integrated HSSP model, a patient’s point of contact with a PAP is likely to be a pharmacy liaison or a financial coordinator or navigator. Often embedded in specialty clinics, the liaisons help speed time to start of therapy, assess needs and provide support with every refill, coordinate drug delivery, address any new insurance and/or co-pay challenges, and monitor for adherence. The benefit of an integrated model in addressing financial toxicity—and other social determinants of health, for that matter— is that the risks will be identified as early as possible, often at the time of first fill. Furthermore, all the relevant resources of the health system, including outreach to a PAP, if available, will be targeted toward solving the problem or mitigating it before the clinical outcome is compromised.

, is a manager of clinical outcomes at Shields Health Solutions in Stoughton, Massachusetts.

Tichy EM, Schumock GT, Hoffman JM, et al. National trends in prescription drug expenditures and projections for 2020. 

. 2020;77(15):1213-30. doi:10.1093/ajhp/zxaa116

Coughlin SS, Dead LT, and Cortes JE. Financial Assistance Programs for Cancer Patients. 

 2022;14(7):1605. doi:10.3390/cancers14071605

Dusetzina SB, Huskamp HA, Keating NL. Specialty Drug Pricing and Out-of-Pocket Spending on Orally Administered Anticancer Drugs in Medicare Part D, 2010 to 2019. 

. 2019;321(20):2025-2027. doi:10.1001/jama.2019.4492

Olszewski AJ, Zullo AR, Nering CR, Huynh JP. Use of Charity Financial Assistance for Novel Oral Anticancer Agents. 

. 2018;14(4);221-228. doi:10.1200/JOP.2017.027896

Zullig LL, Wolf S, Vlastelica L, et al. The Role of Patient Financial Assistance Programs in Reducing Costs for Cancer Patients. 

. 2017;23(4):407-411. doi:10.18553/jmcp.2017.23.4.407

Felder TM, Lal LS, Bennett CL, et al. Cancer patients' use of pharmaceutical patient assistance programs in the outpatient pharmacy at a large tertiary cancer center. 

. 2011;8(6):279-286. doi:10.1016/S1548-5315(12)70023-2

Shankaran V, Leahy T, Steelquist J, et al. Pilot feasibility study of an oncology financial navigation program. 

. 2018;14(2):122-129. doi:10.1200/JOP.2017.024927

PAPs can significantly reduce OOP costs for patients.

Assessing the Impact of Patient Assistance Programs on Financial Toxicity in Oral Oncology

Follicular and marginal zone lymphomas (MZLs) are incurable malignancies requiring multiple lines of treatment over time. The treatment landscape for relapsed/refractory MZL and follicular lymphoma (FL) is shifting from intravenous chemotherapy and monoclonal antibodies to oral oncolytic therapy or CD19-directed chimeric antigen receptor (CAR) T-cell therapy. A trio of experts updated pharmacists on “Emerging Treatments for Indolent Lymphomas: The Role of the Oncology Pharmacist in Treatment and Toxicity Management” at the 2022 Hematology/ Oncology Pharmacy Association Annual Meeting.

Jordan Miller, PharmD, BCPS, BCOP, CPP, reviewed first-line therapy of FL and MZL, which consists of chemotherapy combined with an anti-CD20 monoclonal antibody. He explained that management of relapsed or refractory MZL and FL has largely shifted to oral oncolytic therapies which have diverse mechanisms of action. He presented data supporting FDA approval and inclusion in the National Comprehensive Cancer Network guidelines for oral oncolytic and CAR T-cell therapies. The immunomodulator lenalidomide in combination with rituximab is an option in both first-line and relapsed/refractory FL and MZL. The PI3K inhibitors idelalisib, copanlisib, duvelisib, and umbralisib are preferred options in third-line and subsequent therapy in FL and MZL. The Bruton tyrosine kinase (BTK) inhibitors ibrutinib and zanubrutinib are preferred treatment options in second-line therapy of MZL. Tazemetostat, an EZH2 inhibitor, is appropriate for third-line therapy of FL. Axicabtagene ciloleucel is a CD19-directed CAR T-cell therapy recently approved for third-line and subsequent therapy of FL. Dr Miller touched on bispecific antibodies under investigation in FL including mosunetuzumab, epcoritamab, and glofitamab and PI3K inhibitors under investigation in MZL, such as parsaclisib and zandelisib.

Dr Miller highlighted that the unique mechanisms of action for all of the novel therapies in FL and MZL correspond to unique adverse effect profiles. He noted class effects associated with BTK inhibitors include bleeding, atrial fibrillation, and pneumonia. Diarrhea, hyperglycemia, neutropenia, hepatotoxicity, and infection are observed in patients receiving PI3K inhibitors. Tazemetostat is associated with myelosuppression. Significant grade 3 or 4 adverse effects, including myelosuppression, infection, cytokine release syndrome, and neurotoxicity, are observed in patients receiving CAR T-cell therapies. Dr Miller explained that the transition from intravenous to oral therapy in lymphoma poses new challenges including facilitating medication adherence, mitigating drug−drug interactions, and monitoring and managing adverse effects. He reminded pharmacists that with the exception of lenalidomide, oral oncolytic therapies used to manage FL and MZL are subject to drug−drug interactions mediated by the CYP450 pathway.

Karen Fancher, PharmD, BCOP; Kelly Valla, PharmD, BCOP; and Dr Miller then applied the data to personalize treatment for patients with FL and MZL in a case-based panel discussion. They provided strategies to mitigate adverse effects and optimize care for patients receiving treatment with oral oncolytics, CD19-directed CAR T-cell therapy, and bispecific antibodies.

The treatment landscape for relapsed/refractory MZL and follicular lymphoma (FL) is shifting from intravenous chemotherapy and monoclonal antibodies to oral oncolytic therapy or CD19-directed chimeric antigen receptor (CAR) T-cell therapy.

Multiple Options Mean More Time for Patients With Indolent Lymphoma

Patients who recieve a diagnosis of chronic lymphocytic leukemia (CLL) should not be overlooked in any pharmacy setting. Many of these patients are in dire need of support, encouragement, and care coordination. They will endure a grueling process of coping with diagnosis, treatment, and, in cases of recovery, the fear of recurrence. All these stages will impact the patient emotionally and physically.

As the most accessible member of the health care team, the pharmacist can provide the information and support patients with cancer need to get through what might be the most challenging period of their lives. Pharmacists’ willingness to help at this crucial time demonstrates a caring and concern that patients will likely never forget.

Originally, EM came into the pharmacy complaining of extreme fatigue. At the time, the pharmacist on duty told EM to follow-up with his primary care provider for an evaluation because the fatigue was out of the ordinary and not due to any lifestyle change.

During their conversation, the pharmacist also noticed EM seemed to have lost a lot of weight, yet his abdomen looked enlarged compared with the rest of his body. Upon evaluation with his primary care provider, EM had laboratory work done, with the results showing EM had an enlarged spleen; this led to him receiving a diagnosis of active CLL.

During the evaluation, EM admitted to having awful night sweats and fevers. He was tested repeatedly for COVID-19, thinking he may have been infected. When his tests came back negative, he resorted to trying to ignore his symptoms before ultimately receiving the CLL diagnosis.

EM is a 68-year-old man who has CLL and frequents your health care system. CLL has been a burden in addition to his multiple comorbidities. EM continuously struggles to understand CLL treatment options and is concerned about what this cancer means for his overall quality of life.

None of EM’s family members have had cancer or blood disorders, so receiving a CLL diagnosis threw an unexpected curve ball into his life. A retired salesman, EM has a limited support system because he is divorced and his adult children live out of state. To manage this disease, EM relies on his pharmacy team and other members of the hematology clinic.

Today, EM returns for follow-up after completing chemotherapy, and he is asking you to refill some of his monthly medications. As the 2 of you talk, he complains of worsening back pain to the point where he cannot stand up straight or walk well. He also mentions he feels short of breath and is still very fatigued.

When looking at the laboratory values on the paperwork EM has handed you, you see he has normal liver and renal function but his platelets and white blood cell counts are off. You explain to him that the immune system of individuals with CLL may not work efficiently because it may be making abnormal antibodies against its own red blood cells and/or platelets. These antibodies may then destroy the red blood cells, causing anemia or low numbers of platelets.

Antibodies that attack the body’s own red blood cells are called autoantibodies, and individuals with CLL can develop these autoantibodies at any time. However, the development of these autoantibodies is not necessarily related to the severity of the CLL. You stress to EM not to panic over the numbers and offer to help him arrange a follow-up with his hematologist to get further clarity over their meaning.

EM explains to you that he often wonders why he is not feeling better, is stressed over needing more tests and treatments, and doesn’t understand the different type of leukemias. He also explains that he often feels anxious about his future and has a hard time going to sleep and getting up in the morning.

After listening to EM, you encourage him to share these thoughts and feelings with his immediate care team so they can better support his needs holistically. Based on what he has explained, it seems possible EM is clinically depressed.

In this situation, as the pharmacist, you are not a primary decision maker on the care team. However, you can see many nonpharmacological ways that you can help EM, and you can make recommendations to his health care providers based on your observations.

It is also important to remember you are EM’s most accessible resource. For this reason, you set aside some time to talk to EM and explain the different types of CLL treatments available. After finding out that he’s not up-to-date on his immunizations, you encourage him to get those updated and you review with him the benefits of stopping smoking. EM tells you he appreciates your patience and how you talk things through with him in ways he can understand.

You also review EM’s “as needed” medications and realize he is overusing his prescribed anxiety, sleep, and pain medications. Upon noticing this, you offer to follow-up with EM’s care team, address the issues, and get him on a plan that can help have more lasting effects.

EM also explains he is not drinking water, which means he has been frequently dehydrated. In addition, he is not eating a balanced diet or getting any exercise.

After hearing this, you observe that, despite his weight loss due to the CLL, his most recent lipid panel is out of range, so you take his blood pressure and notice it is significantly elevated. EM does have documented dyslipidemia and hypertension, and he admits he no longer takes the medications for the chronic conditions. You express concern for his cardiac health and suggest he follow-up with his care team and get back on his prescribed medications after evaluation.

Regarding exercise, you talk about a support group that EM’s son recommended he seek out in his community because the group has a walking club. This type of regular activity may be beneficial, so you tell EM that once his pain is more managed, it may be easier for him to move around and perform his daily activities. This ease in movement could also help with his fatigue and mood.

Lastly, you note how important EM’s bone health and deep vein thrombosis prevention are and encourage him to join the walking club. These small efforts may seem minimal, but you mention that they all help aid his fight against the disease and support improvements in his quality of life.

, is a clinical pharmacy specialist in Chicago, Illinois, and Milwaukee, Wisconsin.

A patient with CLL relies on his pharmacy team for support.

Brown Bag Consult®: Chronic Lymphocytic Leukemia

Oncology had a pivotal moment with the first FDA approval of a supportive care biosimilar in 2015, bringing to the forefront an alternative therapy to a costly innovator drug. This was followed by the approval of primary therapy biosimilars in 2019. Since then, a multitude of biosimilar oncology treatments have emerged, challenging providers to keep up with the growing body of science that comes with each new development.

Consequently, providers have turned to oncology-trained pharmacists more and more to gain a critical understanding of the emerging new agents on the market. As this increased reliance on pharmacists has come to the fore, the pharmacist has become even more vital as the trusted advisor to medical oncologists and the care team. Because of this shift, pharmacists have supported increased utilization of biosimilars due to their enabling providers to become comfortable using these new agents.

As the cost of cancer drugs continues to escalate, many practices are utilizing biosimilar therapeutic interchange (TI) processes as a way to reduce cost of care, enabling success in value-based delivery models. Given the deep expertise of oncology pharmacists, they are well positioned to play a leading role in developing and managing these rapidly growing TI programs.

Traditional distribution activities are still the core function of the work of pharmacists who are specifically trained in oncology, as they oversee the safe acquisition and preparation of specialized oncology drugs prior to patient administration. Additionally, these pharmacists assist the care team in complex drug selection, adverse event monitoring, and treatment of adverse effects. In many organizations, pharmacists are also assuming an even larger role by developing and managing TI programs, making them a vital member of the practice.

TI processes are best driven by pharmacists, as they are highly skilled at navigating the complicated decision-making process of selecting drugs in the same category with similar therapeutic indications. Further, handling biosimilars that have similar nomenclature has introduced the risk of medication-related safety events because of misreading, and pharmacists participating in this workflow can help mitigate these types of errors. Having these clinically trained specialists review and ensure the safe use of biosimilar agents has become a necessary investment every care team should make to improve patient care.

A critical first step in building a TI program is to establish a pharmacy and therapeutics (P&T) committee. Functioning as a governing body of the provider, the P&T committee provides a framework that gives more autonomy to pharmacists to make changes and ensures that physicians agree with the TI processes. Pharmacists tend to support most P&T committees and play a critical role in gathering the clinical and cost data about the drugs to inform decision makers when picking a preferred agent.

TI programs enable practices to efficiently move toward more utilization of biosimilars, providing many benefits to stakeholders, including the following:

• Patients have access to cheaper treatment options without sacrificing clinical efficacy. Specifically, this is facilitated through the growing number of biosimilars increasing competition, decreasing the price to patients who are facing rising deductibles and coinsurance costs.

• Biosimilar utilization that is enabled by TI programs provides a foundation for practices to succeed in value-based care, because biosimilars can provide significant cost savings over innovator products.

• Through TI programs, payer relationships can be enhanced, as biosimilars enable practices to utilize drugs that are still effective but lower priced. This provides tremendous value to payers by helping to control cost of care.

Obstacles exist that can block or slow TI. In smaller clinics, pharmacies often concentrate on the distribution channel more than other initiatives. However, the emergence of new drugs, such as biosimilars, makes it essential for practices to invest in bringing pharmacists onto care teams. These knowledgeable specialists keep up with changes and new therapies, facilitating adherence to agreed-upon P&T initiatives for preferred drugs.

Additionally, because providers want to remain independent, implementing a TI program can be met with resistance because it adds a layer of supervision. To effectively address this resistance, building trust between providers and the pharmacy is critical. Further, pharmacies can implement processes and procedures that can help them overcome any pushback.

The US Oncology Network Offers Remote Clinical Reviewer Services

Evidence continues to demonstrate the value oncology pharmacists bring to a practice. In a recent review of chemotherapy regimen orders within a community oncology practice, investigators found substantial benefits could be gained by using a clinical pharmacist trained in oncology.

The investigators observed that of the documented reviews over a 10-week period, 49.2% lead to modifications by the pharmacist, resulting in improvements of $106,000 and a $462,000 reduction in total cost of care for medications.

 Based on these results, the investigators concluded that an oncology pharmacist was a cost-effective and valuable member of the care team, improving safety and regimen optimization and demonstrating a significant financial impact for practice, payers, and patients.

Unfortunately, despite the clear benefits of having pharmacists on the care team, many small community practices either do not have pharmacists or they have a small pharmacy staff with limited time to review regimens, which can make TI less likely to occur. Because of this current deficit in pharmacists at smaller centers, The US Oncology Network developed a clinical pharmacist review program called ClinReview, which provides remote pharmacist services to practices.

Oncology-trained pharmacists electronically review all chemotherapy regimens, identifying opportunities to modify therapies based on clinical components, waste reduction, and responsible stewardship of financial resources. Practice policies determine which modifications may be made by their pharmacy staff, and other recommendations are discussed with the patient’s oncologist. The program provides a strong return on investment by optimizing medication regimens, improving medication utilization and safety, and reducing medication expenses.

Many biosimilars that have been around for several years are now highly utilized, with some payers making their own policy decisions for these agents. However, these decisions can often create challenges for practices by requiring step edits. When this occurs, layers of paperwork and scrutiny inhibit care while providers dispute arbitrary drug selection.

Pharmacists can help with these challenges by educating physicians on the payer’s changing landscape of drug selection and showing payers why step edits should not be followed for a particular drug. This ultimately allows the provider to make the best decision in cost- effective drug selection. By demonstrating the continued success of this process, payers may remove the practice from step edit processes.

Oncology is getting more complex by the day, not only because of biosimilars and TI programs but also because of the continued evolution of new drugs and oral therapies. These agents are very specific and are targeted to the disease and to specific disease states within a cancer diagnosis.

Because of this growing complexity, a highly knowledgeable specialist should be monitoring all aspects of these treatments—a role ideally suited to oncology pharmacists. These clinically trained professionals should be part of the care team and have clearly defined responsibilities, empowering them to play a vital role in ensuring patients receive safe, high-quality care.

, is vice president of pharmacy and clinical programs for the US Oncology Network.

1. Kula J, Hough S, Howell J. Impact of a central review oncology clinical pharmacist in a community oncology practice. 

. 2020;39(suppl 28):68. doi:10.1200/JCO.2020.39.28_suppl.68

Biosimilar therapeutic interchange processes can mitigate high costs of cancer drugs.

Oncology Pharmacists Are Essential in Therapeutic Interchange

In the past 2 years, great strides have been made toward improving patient access to oncology therapies. The COVID-19 pandemic helped raise awareness about preexisting challenges many patients face when it comes to health care access. However, these challenges have long existed for patients with cancer, who may need to travel extensive distances to access care. Additionally, the specialty pharmacies that provide patients with the medications they need may not always be close by, sometimes requiring extensive travel just to retrieve medication.

These challenges can cause delays in treatment start times, which is a critical period in the treatment journey. Further, barriers to care and treatment can place added strain on the mental health of patients with cancer, as hope in the potential for a positive treatment outcome remains crucial for them to successfully face the difficulties that may lie ahead. When patients learn they may have a multitude of barriers to overcome to access treatments that could save their lives—whether the barriers be financial, travel, or otherwise—it can become far more difficult to maintain the hope they need to persevere and successfully fight the disease.

In this way, maintaining patients’ hope in the potential for positive treatment outcomes is critical. For many, that hope can be made possible with the presence of an oncology drug expert on their team: the pharmacist. Pharmacists can act as a 1-stop shop for everything a patient needs to know and understand about the treatment journey, from co-pay and financial assistance programs to refill coordination and treatment adherence checkups.

In our cover story, on page 10, Josh Howell, PharmD, BCOP, discusses the role of the pharmacist in facilitating biosimilar therapeutic interchange processes, which can help to reduce the cost of care and enable success in value-based delivery models.

On page 19, coauthors Brooke Peters, PharmD, BCOP, and Christine Pfaff, RPh, discuss the critical role pharmacists play in patient education on the importance of using routine screenings for the prevention and early detection of breast and cervical cancer among women, which can help lower the cost of cancer care or eliminate the need entirely.

The efforts of pharmacists remain critical to the success of treatment outcomes, yet their impact can be much greater when they are also included on patient care teams to maximize their role in addressing the access barriers many patients may face during cancer treatment throughout the country.

The efforts of pharmacists remain critical to the success of treatment outcomes.

The Role of Pharmacists in Improving Patient Access to Oncology Drugs

Today, the positive impact of oncology product approvals has evolved to the point where, in many cases, there are multiple treatment options to choose from when targeting a specific disease state. However, this opportunity for drug selection has opened the door for payers to leverage one drug over another in terms of coverage offerings, creating new challenges for care teams and patients during the treatment process.

Furthermore, the oncology products patients receive may vary from what was ordered by the oncology professional due to not only the broader treatment options available but also the higher costs of treatments and subsequent payer coverage decisions. However, the oncology pharmacy team often has their own reimbursement specialist with the experience, background, and relationships necessary to ensure what was originally ordered remains in the patient’s treatment plan.

Because of this changing dynamic in product selection and access, the role of oncology pharmacists as key patient therapy advocates has strengthened, as oncology pharmacists work on the patient’s care team to ensure patients have access to lifesaving therapies that meet their clinical needs.

Receiving a cancer diagnosis is a lifealtering experience for the patient and their family, with therapy selection as just one of many factors to consider on the road ahead. Under the best of circumstances, the health care system can be daunting to traverse for patients, but following a cancer diagnosis, it can become significantly more challenging.

However, there are newer and more efficacious therapies available that have evolved and emerged over the past several years. Yet, patients faced with the bewildering task of navigating the health care system alone in order to receive these emerging treatments may come up short in terms of reaching the best possible outcome available for the treatment of their disease.

A patient with a new diagnosis will benefit greatly from the support of a care team that includes the medication expertise of oncology pharmacists to help them navigate the complexity of the treatment landscape that lies ahead. With support from an oncology pharmacist, the oncology team can help alleviate a host of anxieties for patients who are starting and then adhering to a complex oncology treatment plan.

When a patient receives a diagnosis, the clinical oncology pharmacist can immediately support the care team by helping to develop a treatment plan. Once the drug component is selected, the pharmacy opens their toolkit of solutions for patient access challenges, including setting up prior authorizations and co-pay assistance. Depending on the dosage form, the oncology pharmacy team can also ensure the selected products can be paid for by the patient.

Additionally, the route of administration or dosage form may be infused, subcutaneous, or oral, and in most cases a mixture of all 3. The logistics of ordering the products and ensuring they are all made available to the patient or provider in a timely manner can be coordinated by a clinical oncology pharmacist.

The reimbursement specialist on the oncology pharmacy team also can help minimize the patient’s out-of-pocket costs by ensuring what was ordered remains in the patient’s treatment plan. The reimbursement specialist’s toolkit often includes information technology resources and databases to help handle the required documents in a paperless and expedited manner.

Over the past 3 to 5 years, real-time access to coverage has emerged, and terms, such as electronic benefit verification and electronic prior authorizations, have been refined so the oncology team or specialty pharmacy can identify what is covered; offer alternative therapies, if appropriate; and assess the fiscal impact of each selection, including co-pays. The results of such assessment can help guide decisions around seeking alternative forms of payment, which are often tied to electronic resources such as manufacturer-sponsored patient assistance programs (PAPs).

In the United States, the majority of patients with cancer are often buffered from the extraordinary costs of oncology drugs through employer health insurance, Medicaid, or Medicare. However, payer plans have emerged that create gaps in coverage tied to formulary restrictions that often put a heavy burden on patients, even those with good health insurance coverage. Patients with cancer who don’t have health insurance or adequate prescription drug coverage are often confronted with the challenge of deciding how and whether they can pay for their medications out of pocket, which may total tens of thousands of dollars.

Manufacturers of these higher-cost therapies generally make available reimbursement options for patients in the form of PAPs. These sponsored programs are promoted as a safety net for individuals who may have no health insurance or inadequate financial resources to offset the out-of-pocket costs of these therapies. The objective of these PAPs is to provide financial assistance to help patients access drugs for little to no cost.

There are also options for financial assistance for patients in the form of co-pay assistance, which helps patients with cancer who have insurance pay the co-pays related to their care and treatment. However, such payment assistance can be inadequate for the underinsured, leaving oncology patients’ out-of-pocket costs to have a detrimental impact on their financial well-being, which can potentially eliminate or reduce their access to lifesaving treatments.

To help facilitate patient access to the best therapies available, the oncology team must understand several variables, including the patient’s deductible, out-of-pocket maximum, and percentage paid by the insurance, as well as the amount paid by the insurance over what period of time. Ultimately, the oncology team produces a treatment plan that will include what the patient’s monetary responsibility is before they receive that first therapy, combined with alternative forms of payment.

Over the past several years, there has been a shift from infusion drugs to oral oncology therapies, which has been a positive trend for the industry. This shift has helped empower patients to maintain a bit more normalcy in their lives during the difficult process of cancer treatment by allowing them to be freed from long and painful infusions.

However, this positive shift has come with tradeoffs in relation to reimbursement. In most cases, an oral oncolytic will be covered by the drug benefit of a patient’s insurance, which is most often administered by a pharmacy benefit manager.

Typically, oral therapies have higher cost sharing vs infused products, which are billed by the clinic. This is referred to as buy-and-bill, which means the infused products tend to have better coverage because they are being billed through a patient’s medical benefit. With oral therapies, these higher costs frequently result in significant financial challenges for patients, which is referred to as financial toxicity.

With the challenge that is financial toxicity comes the important role of the oncology pharmacy team in working with payers to obtain prior authorizations and using their knowledge and experience to navigate the reimbursement gauntlet on behalf of the patient. This work can help ensure they are able to break through the bureaucratic requirements necessary for the approvals of the right therapies for the patient’s treatment.

Oral oncology products that have an associated limited distribution policy often have their own specific challenges. This can especially be true if it is mandated that the patient have the product dispensed by a different specialty pharmacy than the one on their care team. When this occurs, not only does the patient receive mixed pharmacy services, but they often experience treatment delays before they can start therapy. Because of these challenges, oncology pharmacies and oncologist dispensers are working to develop strategies that can help to combat limited distribution drug (LDD) practices by forming networks and advocating with the manufacturer on behalf of patients.

With the growth of oral oncology options, the number of new dispensing specialty pharmacies in hospitals and community oncology clinics has also exponentially increased. This increase is significant because the dispensing specialty pharmacy plays a significant role in facilitating patient access to therapies. The dispensing specialty pharmacy staff are trained to communicate directly with the oncology team, leading the benefits investigation process. Additionally, it is up to the oncology specialty pharmacy to react quickly and communicate with the oncology team on what they learn relative to what is covered and at what cost so any changes to therapy that may be required can happen in a timely manner.

In today’s practice environment, pharmacy systems typically do not interface with the clinic’s overall electronic medical record (EMR) system. Additionally, there is work under way at some institutions to transition oral oncology orders into the overall EMR system. This integration will lead to a faster response time, thereby facilitating better and more cost-effective patient care.

The oncology team and the dispensing specialty pharmacy can work together to help enhance patient adherence to treatment plans and administer supportive care to conquer the potential clinical implications of payer overmanagement of drug benefit and LDDs. Facing this challenge together, they can meet it head-on to navigate the waters of product access for patients, putting their needs above all other concerns.

Oncology pharmacists can help ensure patient access to lifesaving therapies.

June 2022