Kelly Davio

To date, there has been little information available about the uptake of filgrastim-sndz in the United States compared to the use of other granulocyte colony-stimulating factor (G-CSF) agents. In a 

 funded by Envision Market Access Solutions (part of Envision Pharma Group) and presented at the 22nd Annual International Meeting of The International Society for Pharmacoeconomics and Outcomes Research, researchers sought to identify physicians’ documented G-CSF use, with a particular focus on the use of filgrastim-sndz since its entry into the marketplace.

The first biosimilar approved in the United States, 

 has been approved for 5 of 6 licensed indications for its reference product (including prophylaxis for and treatment of febrile neutropenia in patients undergoing myelosuppressive chemotherapy) and has been available in the US market since September 2015. 

The researchers identified mentions of G-CSF agents in physicians’ records of patient consultation as documented in RealHealthData (a transcription database) for the period of January 1, 2016, to March 31, 2017. The records comprise notes from both office visits and healthcare facility consultations, and included physicians’ intentions to treat with a G-CSF at the time of the consultation, a patient’s G-CSF treatment history, or both. 

In addition to tabulating occurrences of the names of 4 G-CSF agents, namely pegfilgrastim (Neulasta), filgrastim (Neupogen), tbo-filgrastim (Granix, Neutroval), and filgrastim-sndz (Zarxio, Zarzio), the researchers also evaluated their prophylactic or curative use against 

Per the analysis, physicians made 17,770 mentions of G-CSF agents in 2016: 

In the first quarter of 2017, mentions of filgrastim increased to 39.6% of the total number of G-CSF mentions, while mentions of tbo-filgrastim increased to 12.8%. Pegfilgrastim, however, retained the highest share of the total with 47% of mentions. 

The data show that, over the full study period, general practitioners were the most frequent providers to mention pegfilgrastim, filgrastim, and tbo-filgrastim (though hospitalists mentioned tbo-filgratim the most often). Data also demonstrate an influence of location: physicians in Pennsylvania mentioned pegfilgrastim the most often, physicians in Texas noted tbo-filgrastim the most often, and providers in Kansas mentioned filgrastim-sndz the most often. 

Explaining that their study provides only a proxy of G-CSF use for specific time periods rather than documented treatment patterns for such agents, the authors state that providers’ notes may have been repeated in cases of patient hospitalization over a period of days. Furthermore, the data do not represent all US states, so the study’s findings are not representative of national trends. 

Yet the researchers conclude that, among 21,222 records considered in this study, only 140 mentions (0.7% of total mentions) of filgrastim-sndz were noted in the first 18 months of the product’s entry into the US market, and there was no significant increase in the product’s mentions in the first quarter of 2017 when compared with the 2016 period. The researchers also suggest that differences among mentions of filgrastim-sndz and other G-CSF agents across provider types and geographies may indicate differences in formulary listings and clinical treatment patterns across regions. 

 of biosimilars among clinicians and payers, the authors conclude, may be required in order for filgrastim-sndz to see increased uptake. 

Articles

In a study presented at the 22nd Annual International Meeting of The International Society for Pharmacoeconomics and Outcomes Research, researchers sought to identify physicians’ documented granulocyte colony-stimulating factor (G-CSF) use, with a particular focus on filgrastim-sndz since its entry into the marketplace, and identified a slow US uptake for the biosimilar. 

Analysis of Physicians' Notes Shows Slow Uptake for Filgrastim-sndz

 on May 22, 2017, at the 22nd Annual International Meeting of The International Society for Pharmacoeconomics and Outcomes Research, researchers from Brazil found that switching from reference products to biosimilars can create substantial cost savings for payers in private healthcare systems. 

The researchers developed a 5-year cost minimization analysis model to measure the impact of switching infliximab (

 in patients undergoing treatment for rheumatoid arthritis (RA) in the Brazilian private healthcare system. The analysis considered direct medicine costs (which are regulated by the Brazilian Ministry of Health) for the treatment of a cohort of 2 million patients, and drew upon data from the 10 largest private healthcare plans in Brazil. 

The model employed a switch rate of 30% in year 1, which increased by 5% annually, to arrive at 50% in year 5. Using this schedule, and employing a population growth-rate adjustment of 0.09% after year 1, the researchers found that switching RA patients to the infliximab biosimilar generated a cost savings of 15.6 million to 26.2 million Brazilian reais (an amount equivalent to 4.81 million to 8.08 million US dollars). That savings represents up to a 20.8% reduction of overall acquisition costs. When considering a reduced 5-year switch rate of only 40%, savings on acquisition costs were still strong at up to 13.78%. 

The researchers concluded that switching from reference products like infliximab to biosimilar products can provide payers with substantial cost-savings opportunities. Such savings, the researchers suggest, are not only positive news for payers seeking to reduce their expenditures, but also for patients; lower prices have the potential to spur greater patient access to biological agents, and may improve overall treatment availability. 

Research From Brazil Highlights the Role of Biosimilars in Reducing Private Healthcare Costs

The International Society for Pharmacoeconomics and Outcomes Research’s 22nd Annual International Meeting

 in Boston, researchers presented new findings concerning switching between Amgen’s biological agent etanercept (Enbrel) and its first biosimilar product in the German marketplace.

“Preliminary Real World Data on Switching Dynamics Between Etanercept and its Recently Marketed Biosimilar Counterpart,”

 a study sponsored by Pfizer and conducted by researchers from University Medicine Berlin, Pfizer, and QuintilesIMS, was designed to provide initial data concerning market penetration of the first etanercept biosimilar (EtnBS). The study sought to evaluate the switching dynamics between etanercept and EtnBS in real-world clinical settings. Following its launch in Germany in February 2016, EtnBS has been used by rheumatologists as an alternative to etanercept, a tumor necrosis factor inhibitor used in the treatment of certain 

The study considered 5349 patients, identified retroactively through the German Longitudinal Prescriptions database (which represents approximately 60% of the statutory health insurance market), who were initiating EtnBS therapy. Immediately prior to treatment with EtnBS, 48% of the study’s patients had not been treated with a biological agent, 36% had been treated with etanercept, and 16% had been treated with another biological agent. Of the patients who had been treated with etanercept previously, the majority had approximately 3 years of treatment prior to switching to the biosimilar. Among the patients previously treated with etanercept, 53% administered the product using injection pens, and 47% used pre-filled syringes. 

The researchers found that the use of EtnBS has been steadily increasing since the product’s 2016 launch in the German marketplace, and that EtnBS reached a market share of 10% in March 2017 (compared with a 31% market share for the originator product).

However, the researchers found that, among patients who changed their treatment from etanercept to EtnBS, 10% switched back to the original product within a 3-month period. Of those patients who returned to etanercept treatment, a large proportion (72%) returned to using the same administration method that they had employed previously. The study’s authors suggest that the type of device used may have influenced the patients’ decisions to switch back to etanercept. 

When considering all biological agents available (including adalimumab, rituximab, and infliximabBA, among others), the researchers found that 8% to 16% of patients initiating treatment with EtnBS changed to another biological agent within a 3- to 4-month period. The percentage of patients who switched from EtnBS was higher among those patients who had been treated with biological agents prior to initiating EtnBS.  

The study’s authors caution that longer-term studies will be necessary to confirm these preliminary findings, and to better understand why some patients choose to return to treatment with reference products after treatment with biosimilar products. Understanding these reasons may hold the key to increasing uptake of biosimilars and controlling the 

 of treating diseases using biological agents. 

Kelly Davio

Analysis of Physicians' Notes Shows Slow Uptake for Filgrastim-sndz

Research From Brazil Highlights the Role of Biosimilars in Reducing Private Healthcare Costs

Research Shows Patients Switching From Biosimilars to Reference Products