The Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015.
Current national and international guidelines recommend the prophylactic administration of recombinant human granulocyte-colony stimulating factors (G-CSFs), including filgrastim, lenograstim, pegfilgrastim, and lipegfilgrastim, for patients with cancer who are at greater (20% or higher) risk of potentially life-threatening febrile neutropenia (FN) while receiving myelosuppressive chemotherapy. G-CSFs are also recommended for patients with additional risk factors, such as comorbidities or advanced age, even if their risk of FN is under 20%.
The high cost of biological medications such as G-CSFs is a major concern for national healthcare systems operating under limited resources. Less expensive filgrastim biosimilars have been available in the European Union since 2008, and in Italy, biosimilar filgrastim products represented 30.2% of the consumption of and 15.3% of the expenditure for the entire G-CSF therapeutic class in 2015.
However, the Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015. The guidance aimed to improve the appropriate prescribing of G-CSFs. The guidance considered all G-CSFs (biosimilar and reference) as therapeutically equivalent for the prevention of chemotherapy-related FN. As part of the process, a specific program was established to monitor implementation of the guidance using the existing Electronic Therapeutic Plan Registry (ETPR).
Francesco Trotta, PhD, of the Lazio Regional Health Service, and colleagues, used the ETPR to study prescribing patterns for G-CSFs in a large, real-world population in the region. The ETPR was established for clinical research purposes, and includes information on the indication of use (prevention of chemotherapy-related FN) and clinical settings (treatment-naïve and experienced patients). Their study, published in BioDrugs, shows that it is possible to change attitudes towards the prescribing of less expensive biosimilar G-CSFs for FN prevention when the prescriber’s decision-making processes are supported by evidence that includes regulatory and clinical information as well as an analysis of clinical practice data.
The researchers evaluated temporal trends regarding G-CSF products and compared the frequency of therapeutic plans (TPs) for each G-CSF during the pre- and post-intervention periods. A total of 7082 TPs, corresponding to 6592 patients, were eligible for analysis.
The researchers found that the frequency of TPs prescribed after intervention indicated a significant increase in the use of a filgrastim biosimilar (14.4% difference; P<.001) and significant decreases in the use of lenograstim (-6.0% difference; P<.001) and pegfilgrastim (-7.8% difference; P<.001). The temporal trends analysis showed an increase in TPs using a filgrastim biosimilar, rising from 34.4% in July 2015 to 49.8% in June 2016 (P<.0001), and a decrease in TPs using lenograstim and pegfilgrastim during the same period. Analyses in both naïve and experienced settings resulted in similar findings.
The impact of the guidance is estimated to save €500,000 per year, or almost 5% of the total yearly expenditure on G-CSFs in the Lazio region of Italy.
This study indicates that a decision-making process supported by evidence that includes both regulatory and clinical information, together with analysis of clinical practice data, can alter attitudes regarding the use of G-CSFs. “In particular, we were able to shift prescriptions towards less expensive drugs in the FN setting,” the authors said. Furthermore, the analysis also shows that pharmaceutical policy decisions should be continuously monitored over time to evaluate their impact in clinical practice.