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Reviews published in Critical Reviews in Oncology/Hematology, based on the past 15 years of experience with the first filgrastim biosimilar (Zarxio), examined preclinical, clinical, and real-world evidence and cost-effectiveness data, and compared the biosimilar to the reference agent (Neupogen). demonstrated comparable safety and efficacy measures between the two. ).
Filgrastim products are recombinant human granulocyte colony-stimulating factors that stimulate the proliferation and maturation of neutrophils and promote their release into the bloodstream. These products are approved in several indications to reduce the risk of patients developing febrile neutropenia, a life-threatening condition associated with chemotherapy.
There are three filgrastim biosimilars approved by the FDA (Zarxio, Nivestym, and Releuko) and seven approved by the European Medicines Agency (Accofil, filgrastim hexal, Grastofil, Nivestym, Ratiograstim, Tevagrastim, and Zarzio) . Additionally, there is Granix, which was approved in the US before the biosimilar approval pathway was established, and is by definition a biosimilar to Neupogen, but not according to the FDA’s official standards.
Syringes and vials | Photo Syringes and vials Image credit: weyo – Stock.adobe.com
Zarxio, also known as EP2006, was approved by the European Medicines Agency in 2009 and the FDA in 2015. Zarxio is also the first official biosimilar to receive FDA approval.
Real world evidence of EP2006
Multiple real-world studies and meta-analyses provide increasing evidence supporting the efficacy and tolerability of EP2006 in cancer patients receiving chemotherapy. Results from the international observational study MONITOR-GCSF show efficacy and safety outcomes comparable to the reference drug in patients receiving prophylaxis with EP2006, even with under- or over-prophylaxis. I did. This analysis suggested the potential benefit of overprophylaxis to reduce chemotherapy-induced complications. Additionally, a comparison of the PIONEER trial and a real-world study (MONITOR-GCSF) revealed similar frequencies of febrile neutropenia, although the frequency of febrile neutropenia was lower in the PIONEER trial, likely due to differences in study design. A high rate of adverse events was observed.
Subanalyses within MONITOR-GCSF highlighted consistent efficacy and safety of EP2006 across patient populations and timing of prophylaxis. Furthermore, real-world studies in France and Italy confirmed the effectiveness of his EP2006 in preventing febrile neutropenia and maintaining chemotherapy dose intensity.
A retrospective analysis comparing EP2006 with reference filgrastim and other biosimilars revealed similar efficacy but some differences in adverse event profiles. Furthermore, real-world evidence in hematopoietic stem cell mobilization demonstrated the efficacy and safety of EP2006, comparable to or superior to reference filgrastim in various patient populations in different countries. These findings support the expected efficacy and safety of EP2006 in the context of both cancer treatment and stem cell mobilization.
Cost-effectiveness analysis
Researchers assessed the impact of EP2006 on markets in New Zealand, Italy, the United States, Saudi Arabia, Austria, France, and Germany.
A New Zealand study found that since the launch of EP2006 in 2012, price competition had saved the country NZ$5 million (approximately US$3 million) by 2014. At that time, filgrastim usage increased by 25%.
In Italy, the use of another filgrastim biosimilar, EP2006 and XM02, resulted in healthcare cost savings of 86% and 56%, respectively, compared to the reference filgrastim. Furthermore, another real-world study found that the use of EP2006 resulted in cost savings of €225.25 compared to the reference product and €262.00 compared to lenograstim over a 5-day period.
The US analysis found that prophylaxis with EP2006 was consistently associated with significant cost savings compared with the reference product and prophylaxis with pegfilgrastim. In a separate U.S. analysis of 3542 patients, EP2006 demonstrated significant cost savings compared to reference filgrastim for the treatment of febrile neutropenia in the U.S., resulting in lower average healthcare costs. ranged from $8,040 to $30,003.
A retrospective analysis of U.S. claims data shows that EP2006 has seen rapid uptake since its launch in 2015, with 47% of filgrastim doses administered among commercially insured individuals and 42% of filgrastim doses administered among Medicare Advantage beneficiaries by March 2018. %. Medicare Part B usage skyrocketed from January to August 2016. , surpassed reference filgrastim by November 2017 and contributed to a 30% decrease in overall filgrastim spending since 2015. Furthermore, EP2006 accounted for 49.1%, 46.0%, and 38.7% of filgrastim claims in Medicare Part B, Part D, and Medicaid, respectively. , 2018.
A cost simulation of 10,000 patients with lung cancer and non-Hodgkin’s lymphoma (NHL) found EP2006 to be the most cost-effective option for preventing febrile neutropenia. Furthermore, in a separate cost-effectiveness analysis, secondary prevention was compared to secondary prevention in patients with breast cancer, non-small cell lung cancer (NSCLC), and NHL receiving curative chemotherapy at intermediate febrile neutropenic risk. Primary prevention with EP2006 proved advantageous.
Another study conducted in Saudi Arabia compared EP2006 with reference filgrastim and pegfilgrastim in 4,000 cancer patients undergoing s6ix treatment cycles and found significant cost savings from biosimilar conversion. revealed the possibility. This could increase access to supportive care and treatment for cancer without increasing budgets. In addition, in a final cost-effectiveness analysis, primary prophylaxis with EP2006 or the biosimilar pegfilgrastim in intermediate-risk breast cancer, NSCLC, and NHL patients with febrile neutropenia and evaluated secondary prevention.
Based on data from Austria, France, and Germany, EP2006 consistently demonstrated cost-effectiveness in each cancer type and country when used as primary prevention compared to secondary prevention . EP2006 also achieved a lower incremental cost-effectiveness ratio than pegfilgrastim. Since its approval, EP2006 has been widely adopted and proven to be cost-effective, resulting in cost savings in a variety of markets.
reference
Gascón P, Harbeck N, Rapoport BL, et al. Filgrastim biosimilars (EP2006): review of the evidence 15 years after approval. Crit Rev Oncol Hematol. Published February 22, 2024. doi:10.1016/j.critrevonc.2024.104306
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