Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure

Abstract

Febrile neutropenia (FN) is a serious complication of chemotherapy, which can cause significant morbidity and mortality, result in dose delays and reductions and, ultimately, reduce cancer survival. Over the past decade, the availability of biosimilar filgrastim (short-acting granulocyte colony-stimulating factor [G-CSF]) has transformed patient access, with clear evidence of clinical benefit at preventing FN at reduced costs. In 2019, seven biosimilar pegfilgrastims (long-acting G-CSFs) were licensed, creating optimal market conditions and choice for prescribers. FN affects up to 117 per 1000 cancer patients, with mortality rates in the range of 2-21%. By reducing FN incidence and improving chemotherapy relative dose intensity (RDI), G-CSF has been associated with a 3.2% absolute survival benefit. Guidelines recommend primary prophylaxis and that filgrastim be administered for 10-14 days, while pegfilgrastim is administered once per cycle. When taken according to the guidelines, pegfilgrastim and filgrastim are equally effective. However, in routine clinical practice, filgrastim is often under-dosed (< 7 days) and has been shown to be inferior to pegfilgrastim at reducing FN incidence, hospitalisations and maintaining RDI. Once-per-cycle administration with pegfilgrastim might also aid patient adherence. The introduction of biosimilar pegfilgrastim should instigate a rethink of neutropenia management. Biosimilar pegfilgrastim offers countries using biosimilar filgrastim opportunities to improve adherence and thus cancer survival, whilst offering economic benefits for countries using reference pegfilgrastim. These benefits can be realised in full if biosimilar pegfilgrastim becomes part of routine clinical practice supported by drug and therapeutic committees implementing guidelines with multidisciplinary support in the hospital.

A retrospective review of the real-world experience of the Pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®)

“…33 For over two decades, G-CSFs have been the mainstay of the treatment and prevention of chemotherapyinduced neutropenia complications, however, the high cost of G-CSF agents may limit access for some patients. 15 With the current evidence that both pegfilgrastim agents were equally efficacious and with a similar safety profile, cost minimization analysis was justified to determine the cost-savings benefit of Lapelga V R . The incremental cost savings of using Lapelga V R as an alternative to branded pegfilgrastim was $1080.34 per-patient drug costs each cycle.…”

“…12,14 Experimental and real-world studies suggest that pegfilgrastim may provide more effective prophylaxis against FN when compared to filgrastim. [14][15][16][17][18] Pegfilgrastim is intended to improve treatment adherence due to the need for fewer administrations and has demonstrated better maintenance of relative dose intensity and reduced hospital visits in comparative effectiveness studies. 14,17,19 While G-CSF biologics are important for the prophylaxis of FN, they have been identified as significant drivers of global healthcare costs.…”

Unlocking the Value of Anti-TNF Biosimilars: Reducing Disease Burden and Improving Outcomes in Chronic Immune-Mediated Inflammatory Diseases: A Narrative Review

“…In Sweden, the introduction of biosimilar filgrastim reduced costs and resulted in a fivefold increase in GCSF uptake [48]. Finally, a recent review noted that the reduced costs and increased access that biosimilar pegfilgrastim affords could allow countries to switch from the shorter-acting filgrastim, improving adherence and enabling patients to receive their full chemotherapy treatment, without dose delays or reduced dose intensities, improving patient outcomes [49].…”

Supportive care in patients with cancer during the COVID-19 pandemic

“…Fatalities can arise due to infection/sepsis, as well as chemotherapy delays, dose reductions or discontinuations that impact cancer treatment outcomes. 42 Patients with FN have a high risk of infection-related mortality and of requiring secondary care. Therefore, FN is an essential consideration under normal circumstances, but particularly during a pandemic where clinicians strive to keep patients infection-free and out of the hospital.…”