Administration for Pegfilgrastim Biosimilars Should Minimize Clinic Visits, Consider Patients’ Preferences

Authors of a review article examined administration options and economic considerations for pegfilgrastim biosimilars in supportive oncology in the United States with the aim of maximizing the benefit to patients.

Because of the “growing acceptance of same-day pegfilgrastim administration and the ever-present financial burden of medications for patients,” the authors said, these are pertinent topics. Their review discussed administration options with a focus on minimizing clinic visits and proposed a patient-centric model of pegfilgrastim administration for febrile neutropenia prophylaxis.

The granulocyte colony-stimulating factor (G-CSF) biologics filgrastim and pegfilgrastim are used to reduce the risk of febrile neutropenia in patients undergoing myelosuppressive chemotherapy, by stimulating production, maturation, and survival of neutrophils. According to the authors, febrile neutropenia can delay treatment and necessitate dose reductions, limiting the efficacy of treatments and negatively affecting patient health or reducing survival rates. Of the 2, pegfilgrastim, which is a pegylated, long-acting form of filgrastim, is the most commonly used G-CSF in the United States.

Although the high cost of biologics can limit access to treatments, the authors noted that lower-cost pegfilgrastim biosimilars have been available for several years. There are currently 6 pegfilgrastim biosimilars approved in the US for prophylaxis of febrile neutropenia.

The reviewers wrote that cost savings could have a “significant impact on the financial stress experienced by patients with cancer,” citing research that found up to 48% of cancer survivors experience financial toxicity. They added that financial stress can cause survivors to skip future medical treatments.

Administration Options for Minimizing Clinic Visits

In general, pegfilgrastim is administered once per chemotherapy cycle and is usually injected 24 hours or more after chemotherapy. Although the FDA-approved indication for febrile neutropenia prophylaxis is next-day administration at the clinic, the authors said multiple options are available.

For example, The National Comprehensive Cancer Network also supports same-day administration, which they said has been helpful for minimizing clinic visits during the COVID-19 pandemic. The authors added that same-day administration is likely preferable for patients who live far from the clinic or prefer to minimize visits because of “emotional and physical exhaustion following chemotherapy.”

The reviewers discuss the positives and negatives associated with the 3 approaches to pegfilgrastim administration that minimize clinic visits:

• Same-day administration after chemotherapy
• Use of an on-body injector (OBI) that delivers pegfilgrastim approximately 27 hours after chemotherapy
• Self-administration by the patient or a caregiver at least 24 hours after chemotherapy. Their view is that “consideration of each option should be based on the individual patient-specific needs and comfort level.”

Although self-administration reduces clinic visits and may improve quality of life for patients, correct self-injection techniques are crucial. Barriers to self-injection include fear, anticipated pain, patient age, and comorbidities. The OBI device is applied the same day as chemotherapy and delivers a standard dose of pegfilgrastim 27 hours after application. Failure rates for the OBI range from 1.7% to 6.9%. Not all patients accept the device, and “patient education may be required to ensure the effectiveness of pegfilgrastim OBI and to handle device failure.”

The OBI provides an alternative to self-injection, but OBI devices that deliver biosimilar pegfilgrastim at a lower cost are currently unavailable. According to the authors, 1 pegfilgrastim biosimilar (pegfilgrastim-cbqv) OBI is in development.

The third option for minimizing clinic visits is the off-label use of same-day injection of pegfilgrastim following chemotherapy. This option still eliminates the second clinic visit, and it may be a preferable option for patients who are unable or unwilling to self-inject pegfilgrastim and are uncomfortable having the OBI device attached to their skin.

According to the reviewers, concerns about same-day administration originated from observations that shorter-acting filgrastim could exacerbate neutropenia in some cases.“However, same-day administration of pegfilgrastim is not uncommon in clinical practice, and an increasing number of studies across various tumor types have not detected differences in outcomes compared with next-day administration,” they wrote.

Same-day Pegfilgrastim Administration in the Context of COVID-19

The reviewers said that minimizing clinic visits is an important objective, since patients with cancer have a greater risk of infection compared to healthy individuals, and “frequent hospital visits may further increase the risk of contracting COVID-19 during the current pandemic, especially in immunocompromised older patients with poor functional status.” While the pandemic continues, they said, outpatient visits for patients with cancer should be minimized “without compromising adequate patient care.”

Although same-day administration has not been studied in the context of the COVID-19 pandemic, the authors wrote, “these methods were successfully used before the COVID-19 pandemic and may provide risk-minimization opportunities.” Plus, same-day administration may have an added benefit: “Reducing patient visits can also reduce the workload for health care workers, who are currently overburdened and overworked because of COVID-19.”

The reviewers recommended that the pegfilgrastim administration method “should be based on the patient’s specific needs, while also considering mitigating factors, such as the economic burden associated with biologic medications and the risk of COVID-19.”

Reference

Humphreys SZ, Geller RB, Walden P. Pegfilgrastim biosimilars in US supportive oncology: a narrative review of administration options and economic considerations to maximize patient benefit. Oncol Ther. 2022:1-11. doi: 10.1007/s40487-022-00207-2