Managing Adverse Events in Cancer Care: Addressing Blood Cell Counts and Drug Management

Pharmacy Times Oncology Edition, August 2021, Volume 3, Issue 4

A proactive approach can ensure that the patient is getting the right therapy at the right time and the right treatment plan with the least amount of waste.

Specialty medications accounted for 52% of drug spend in 2020,1 with an increase in drugs approved to treat cancer. In fact, the FDA approved 53 new drugs last year,2 including 20 with indications related to oncology.3

A number of key strategies are available to ensure that oncology patients receive appropriate care and management. With a focus on improved individual outcomes and an enhanced patient experience, a proactive approach to patient engagement can maximize therapeutic opportunities, provide education and information, and help employers and other stakeholders create accountability and predictability around oncology drugs.

The goal is to ensure that the patient is getting the right therapy at the right time and the right treatment plan with the least amount of waste. Preemptive activities should examine patient adherence to their treatment regimen to make sure the individual is considered an appropriate candidate for a particular drug. These initiatives will further reduce waste, minimize adverse effects, and lower health care costs.

Although adverse events resulting from cancer therapy are common, they can be minimized. In a retrospective cohort study, 400 adult patients who had breast, colorectal, or lung cancer and were treated at a comprehensive cancer center were selected by stratified random sampling. The study's authors concluded that 34% of these patients had at least 1 adverse event and 16% of the patients had 1 or more preventable or mitigable adverse events.4

One of the consequences of cancer treatment is a severe low blood cell count, which can lead to serious complications that may delay or prevent the continuation of the cancer therapy regimen.5 While other considerations exist in treatment, this is one of the key elements of a comprehensive treatment plan.

Low red blood count causes anemia, which often develops gradually with no initial symptoms before the onset of fatigue, shortness of breath, dizziness, rapid heartbeat, and feeling cold. Low white cell count causes neutropenia, which negatively impacts the body's ability to fight infection. Symptoms may include a temperature of 100.4oF or higher, chills or sweating, diarrhea, painful urination, and persistent cough, among others.5

For treatment care teams, it is important to take the most optimal approach to managing adverse events related to low blood cell counts. For instance, when a patient experiences an adverse event, harnessing technology to close the loop between the patient and provider can avoid unneeded spend, speed up the care process, and enhance the patient outcome. Also, staying closely connected to the patient through a specialty pharmacy benefit manager (SPBM) can more quickly address any challenges facing the patient or caregiver.

As care coordinators, SPBMs play a role in monitoring and managing cancer patients for adverse events to ensure that the patient is getting the right therapy at the right time, the right treatment plan with the least amount of waste, and site optimization for the right care in the right setting.

Managing Blood Cell Counts During Cancer Treatments

Chemotherapy may lead to low blood counts, causing the possibility of a variety of symptoms, which depend on the type of low blood cell count.6 SPBMs can provide expertise on supportive therapies for chemotherapy regimens that can impact blood counts.

Because chemotherapy can kill some bone marrow, the body makes fewer white blood cells, raising the chances of the patient contracting febrile neutropenia (FN). Colony-stimulating factors (CSFs), including biosimilars, help prevent infection during chemotherapy and increase the number of white cells in the patients' blood, lowering the risk for FN.7

CSFs include the injectables filgrastim (Neupogen; Amgen), pegfilgrastim (Neulasta; Amgen), and sargramostim (Leukine; Partner Therapeutics).7 In terms of adverse events, CSFs can cause pyrexia, rash, nausea, vomiting, headache, epistaxis, diarrhea, arthralgia, leukocytosis, spleen rupture, acute respiratory syndrome, and capillary leak syndrome.8

The American Society of Clinical Oncology recommends the prophylactic use of CSFs to reduce the risk of FN when the risk of FN is approximately 20% or higher and no other equally effective and safe regimen that does not require CSFs is available. Primary prophylaxis is recommended for the prevention of FN in patients who are at high risk on the basis of age, medical history, disease characteristics, and myelotoxicity of the chemotherapy regimen.9

Dose-dense regimens that require CSFs should be used only within an appropriately designed clinical trial or if supported by convincing efficacy data. Current recommendations for the management of patients exposed to lethal doses of total-body radiotherapy, but not doses high enough to lead to certain death as a result of injury to other organs, include the prompt administration of CSFs.9

Guidelines for CSFs9-13:

  • Filgrastim—This synthetic injection is used to treat neutropenia caused by medicines for treating cancer and helps bone marrow make new white blood cells. One study showed that 5 days of filgrastim use was noninferior to 7 or 10 days of filgrastim use. Given the recognized toxicity and cost of this agent, as well as the impact of health economics and patient morbidity, the shorter duration would be an option for patient care.
  • Pegfilgrastim—This bone-marrow stimulant is indicated to decrease the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of FN. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation and for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
  • Sargramostim—This granulocyte-macrophage colony stimulating factor (rGM-CSF) is considered medically appropriate for treatment of chemotherapy-induced FN in individuals who have not received prophylactic therapy with a graulocyte CSF and for individuals at risk of developing sepsis, absolute neutrophil count of < 100/mcL, duration of neutropenia expected to be greater than 10 days, pneumonia, or other clinically documented infections, or invasive fungal infection, or for patients hospitalized at the time of fever.

Guidelines for patients with anemia14:

  • Erythropoiesis-stimulating agents (ESAs)—ESAs, including biosimilars, may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to 10 g/dL. With the exception of selected patients with myelodysplastic syndromes, ESAs should not be offered to most patients with nonchemotherapy-associated anemia. During ESA treatment, hemoglobin may be increased to the lowest concentration needed to avoid transfusions. Iron replacement may be used to improve hemoglobin response and reduce red blood cell transfusions for patients receiving ESA with or without iron deficiency.

Specialty medications for patients undergoing chemotherapy often require specialized clinical support for patient administration, including complex dosing and injected or infused delivery. SPBMs can help ensure adherence while monitoring patients for safety issues and possible adverse effects. SPBM clinical experts have a deep knowledge of possible drug adverse effects and understand ways to mitigate them. These specialists reach out to physicians when patients need additional monitoring or require therapy changes to reduce adverse effects, improve efficacy, and lower patient out-of-pocket costs.

Benefits of a SPBM Partner

SPBMs facilitate ongoing positive patient outcomes through persistence, adherence, compliance, and supportive, collaborative patient management. Professional teams regularly measure and track treatment effectiveness and, across the continuum of providers, validate savings and opportunities for improved outcomes.

SPBMs also offer pharmacists the benefits of technology, analytics, and clinical services designed for oncology cost containment. As a result, they serve as the fulcrum of a central approach to facilitate the care management approach.

For oncologists, SPBMs serve as a hybrid of traditional and innovative approaches that target specific cancer populations. They provide programs that empower both the patient and their caregiver after a diagnosis and referral. SPBMs also play a critical role in providing a personalized approach in treatment options, evidence-based clinical policy bulletins and pathways, utilization management, and other clinical assessments.

SPBMs provide flexible, tailored drug management solutions driven by client needs to increase patient safety, improve health outcomes, identify appropriate sites of care for treatment, reduce waste and cost with effective medication management, and offer negotiated dispensing rates as well as increased transparency.

They deliver significant value for patients by offering specialty pharmacy and infusion networks that specialize in data, analytics, and cost modeling, as well as real-time front-end prescription triage to help patients receive the right care at the right time. These programs also utilize technology to manage and streamline the specialty pharmacy prescription process among the physician, patient, specialty pharmacy, and health insurance plan.

SPBM programs also capture, integrate, and provide prescription data and health care outcome analytics in a real-time platform, providing accurate insights into patient care, provider prescription value, prescription trends, specialty pharmacy performance, dose optimization, treatment paths, and other clinical intervention reports.

Ensure Site of Care Optimization

SPBMs play a key role in optimizing site of care, a key strategy that encourages patients to move from higher-cost settings, such as inpatient hospitals and institutions, to lower-cost settings, such as physicians' in-office infusion suites, stand-alone infusion centers, home care, and self-administration.15

SPBM programs can also assist caregivers. These individuals helping a family member or friend through cancer treatment may perform a number of activities, including taking the cancer patient to the doctor, making meals, coordinating care services, and providing emotional and spiritual support.

Patient-Centric Treatment Monitoring

The best SPBMs take a patient-centric approach to the care continuum that is broadly focused on all aspects of the patient journey, including prevention, diagnosis, treatment, care monitoring for adverse events, and outcomes. Understanding the patient journey is essential to identifying unmet needs and implementing the best medical and nonmedical interventions.

New technologies are allowing providers to diagnose and treat cancers better. To optimize treatment, each stage of the patient journey, including monitoring for low blood cell count, is critical for improving the patient/caregiver experience and outcomes.

SPBMs can ensure that the necessary documentation is in place for patients, caregivers, providers, and pharmacies and that care is being handled appropriately. They consider the whole care of the patient, beyond lab results, to ensure that every need of the patient and caregiver is being met and well managed.

Dea Belazi is president and CEO of AsscellaHealth, a global specialty pharmacy and health care services organization serving payers, providers, life sciences, and patients. Belazi has more than 20 years' experience in the health care industry, including developing and managing pharmacy benefit management companies.

REFERENCES

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9. Smith TJ, Bohlke K, Lyman GH. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2015;33(28):3199-212. doi:10.1200/JCO.2015.62.3488

10. Clemons M, Fergusson D, Simos D, et al. A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer. Ann Oncol. 2020;31(7):951-957. doi:10.1016/j.annonc.2020.04.005

11. Filgrastim (injection route). Mayo Clinic. Updated February 1, 2021. Accessed June 22, 2021. https://www.mayoclinic.org/drugs-supplements/filgrastim-injection-route/description/drg-20071547

12. Pharmacy medical necessity guidelines: pegfilgrastim products. Tufts Health Plan. Updated February 15, 2021. Accessed June 22, 2021. https://tuftshealthplan.com/documents/providers/guidelines/pharmacy-medical-necessity-guidelines/pegfilgrastim-products

13. BlueCross BlueShield of Tennessee medical policy manual. BlueCross BlueShield of Tennessee. Updated June 9, 2020. Accessed June 22, 2021. https://www.bcbst.com/mpmanual/!SSL!/WebHelp/Sargramostim.htm

14. Bohlius J, Bohlke K, Castelli R. Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. J Clin Oncol. 2019;37(15):1336-1351. doi:10.1200/JCO.18.02142

15. Johnson B. Site of Care Optimization. National Infusion Center Association. Published May 2, 2019. Accessed June 22, 2021. https://infusioncenter.org/infusion-center-news/site-of-care-optimization/