Pegfilgrastim Biosimilars in US Supportive Oncology: A Narrative Review of Administration Options and Economic Considerations to Maximize Patient Benefit.

Granulocyte colony-stimulating factor (G-CSF) biologics, such as pegfilgrastim, are a standard of care in supportive cancer treatment that are administered once per chemotherapy cycle to reduce the incidence of febrile neutropenia. The high cost of these biologics in the United States can be a limiting factor to accessing care; however, lower-cost pegfilgrastim biosimilars have been available for several years for patients requiring prophylaxis of febrile neutropenia. Different options for pegfilgrastim administration are also now available to accommodate specific patient preferences. As patients may want to minimize the risk of both neutropenia and SARS-CoV-2 infection, same-day administration is a pertinent option during the present COVID-19 pandemic. Therefore, individualized, patient-centered approaches and risk-management strategies should be considered when selecting the treatment and administration method for prophylaxis of febrile neutropenia. Three methods of administration would minimize hospital or clinic visits while also providing the prophylactic effect of G-CSF: same-day administration after chemotherapy, use of the US Food and Drug Administration-approved on-body injector delivering pegfilgrastim approximately 27 h after chemotherapy, or self-administration by the patient or caregiver > 24 h after chemotherapy. Choice of the specific administration option 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. Pegfilgrastim biosimilars can minimize the additional financial burden on patients and the health care system during this pandemic and beyond.

Real-world evidence of a successful biosimilar adoption program.

Biosimilars have introduced new opportunities to reduce the disproportionately high US healthcare spending on biologic medications. This article describes strategic utilization management program initiatives designed to promote biosimilar utilization, reduce biologic drug costs and increase sustainability in a US nonprofit health system. Key components of these biosimilar utilization management program initiatives included expedited procedures to evaluate and establish the formulary status of biosimilars, enhanced contracting negotiations, specially designed electronic medical record tools to guide physician prescribing, payer coverage analysis, evaluations of biologic-utilization trends and financial performance analysis. Within 2 years (2019-2020), this program has resulted in savings of USD$26.9 million for Providence St Joseph Health and biosimilar adoption rates that greatly exceed the US national average.

Biologics are medications that are effective treatments for many patients but have a high price that affects patients and healthcare systems. Biosimilars are medications that are nearly identical copies to an approved biologic medication and have been shown to have similar effectiveness and safety. As biosimilars have a lower price than the bio-originators, the use of biosimilars can help reduce healthcare costs. This article describes how Providence St Joseph Health, a large US nonprofit health system, encouraged the use of lower-cost biosimilars instead of the higher-cost bio-originators. Using several different tools, Providence St Joseph Health ensured that biosimilars are used wherever possible and has saved USD$26.9 million in 2 years.

Comparative efficacy of combination drug therapy in refractory epilepsy.

OBJECTIVE: We retrospectively examined treatment records of developmentally disabled adults with highly refractory epilepsy to determine whether any combinations of 8 of the most commonly used antiepileptic drugs (AEDs) possessed superior efficacy. METHODS: We obtained the treatment records from 148 developmentally disabled adults with refractory epilepsy cared for in 2 state-run institutions. These records charted monthly convulsive seizure occurrence and AED regimen over 30 years. We studied the effects of 8 commonly used AEDs alone and in combination on seizure frequency in within-patient comparisons. RESULTS: Out of the 32 most frequently used AED combinations, we found that only the combination of lamotrigine and valproate had superior efficacy, measured against both an aggregate measure of other AED regimens to which patients were exposed, and in head-to-head comparisons with other AED combinations. We also found that while use of 2 concurrent AEDs provided improved efficacy over monotherapy, use of 3 AEDs at a time provided no further benefit over two. CONCLUSIONS: These results suggest that at least one AED regimen provides significantly better efficacy in refractory convulsive epilepsy, and that AEDs should be used no more than 2 at a time. Limitations of the study include its retrospective design, lack of randomization, and small sample sizes for some drug combinations. Future prospective trials are needed in this challenging clinical population.